Sivextro
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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

 



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1. NAME OF THE MEDICINAL PRODUCT

Sivextro 200 mg film-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 200 mg tedizolid phosphate.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablet (tablet).

Oval (13.8 mm long by 7.4 mm wide) yellow film-coated tablet debossed with “TZD” on the obverse 
side and “200” on the reverse side.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in 
adults and adolescents 12 years of age and older (see sections 4.4 and 5.1).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Posology

Tedizolid phosphate film-coated tablets or powder for concentrate for solution for infusion may be 
used as initial therapy. Patients who commence treatment on the parenteral formulation may be 
switched to the oral presentation when clinically indicated.

Recommended dose and duration 
The recommended dosage for adults and adolescents 12 years of age and older is 200 mg once daily 
for 6 days. 

The safety and efficacy of tedizolid phosphate when administered for periods longer than 6 days have 
not been established (see section 4.4).

Missed dose
If a dose is missed, it should be taken as soon as possible anytime up to 8 hours prior to the next 
scheduled dose. If less than 8 hours remains before the next dose, then the patient should wait until the 
next scheduled dose. Patients should not take a double dose to compensate for a missed dose.

Elderly (≥65 years)
No dosage adjustment is required (see section 5.2). The clinical experience in patients ≥75 years is 
limited.

Hepatic impairment
No dosage adjustment is required (see section 5.2).

 



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Renal impairment
No dosage adjustment is required (see section 5.2).

Paediatric population
The safety and efficacy of tedizolid phosphate in children below 12 years of age have not yet been 
established. Currently available data are described in section 5.2, but no recommendation on a 
posology for children below 12 years of age can be made.

Method of administration

For oral use. The film-coated tablets can be taken with or without food. The time to tedizolid peak 
concentration with oral administration under fasting conditions is 6 hours faster than when 
administered with a high-fat, high-calorie meal (see section 5.2). If a rapid antibiotic effect is needed, 
the intravenous administration should be considered.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Patients with neutropenia

The safety and efficacy of tedizolid phosphate in patients with neutropenia (neutrophil counts 
<1,000 cells/mm3) have not been investigated. In an animal model of infection, the antibacterial 
activity of tedizolid was reduced in the absence of granulocytes. The clinical relevance of this finding 
is unknown. Alternative therapies should be considered when treating patients with neutropenia and 
ABSSSI (see section 5.1).

Mitochondrial dysfunction

Tedizolid inhibits mitochondrial protein synthesis. Adverse reactions such as lactic acidosis, anaemia 
and neuropathy (optic and peripheral) may occur as a result of this inhibition. These events have been 
observed with another member of the oxazolidinone class when administered over a duration 
exceeding that recommended for tedizolid phosphate.

Myelosuppression

Decreased platelets, decreased haemoglobin and decreased neutrophils have been observed in a few 
subjects during treatment with tedizolid phosphate. In cases where tedizolid phosphate was 
discontinued, the affected haematological parameters have returned back to pre-treatment levels. 
Myelosuppression (including anaemia, leucopenia, pancytopenia and thrombocytopenia) has been 
reported in patients treated with another member of the oxazolidinone class and the risk of these 
effects appeared to be related to the duration of treatment. 

Peripheral neuropathy and optic nerve disorders

Peripheral neuropathy, as well as optic neuropathy sometimes progressing to loss of vision, have been 
reported in patients treated with another member of the oxazolidinone class with treatment durations 
exceeding that recommended for tedizolid phosphate. Neuropathy (optic and peripheral) has not been
reported in patients treated with tedizolid phosphate at the recommended treatment duration of 6 days. 
All patients should be advised to report symptoms of visual impairment, such as changes in visual 
acuity, changes in colour vision, blurred vision, or visual field defect. In such cases, prompt evaluation 
is recommended with referral to an ophthalmologist as necessary.

 



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Lactic acidosis

Lactic acidosis has been reported with the use of another member of the oxazolidinone class. Lactic 
acidosis has not been reported in patients treated with tedizolid phosphate at the recommended 
treatment duration of 6 days.

Hypersensitivity reactions

Tedizolid phosphate should be administered with caution in patients known to be hypersensitive to 
other oxazolidinones since cross-hypersensitivity may occur.

Clostridioides difficile associated diarrhoea

Clostridioides difficile associated diarrhoea (CDAD) has been reported for tedizolid phosphate (see 
section 4.8). CDAD may range in severity from mild diarrhoea to fatal colitis. Treatment with 
antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile.

CDAD must be considered in all patients who present with severe diarrhoea following antibiotic use. 
Careful medical history is necessary since CDAD has been reported to occur over two months after the 
administration of antibacterial agents.

If CDAD is suspected or confirmed, tedizolid phosphate and, if possible, other antibacterial agents not 
directed against C. difficile should be discontinued and adequate therapeutic measures should be 
initiated immediately. Appropriate supportive measures, antibiotic treatment of C. difficile, and 
surgical evaluation should be considered. Medicinal products inhibiting peristalsis are contraindicated 
in this situation.

Monoamine oxidase inhibition

Tedizolid is a reversible, non-selective inhibitor of monoamine oxidase (MAO) in vitro (see
section 4.5).

Serotonin syndrome

Spontaneous reports of serotonin syndrome associated with the co-administration of another member 
of the oxazolidinone class together with serotonergic agents have been reported (see section 4.5).

There is no Phase 3 clinical experience in patients with co-administration of tedizolid phosphate with 
serotonergic agents such as selective serotonin re-uptake inhibitors [SSRI], serotonin norepinephrine 
reuptake inhibitors (SNRI), tricyclic antidepressants, MAO inhibitors, triptans, and other medicines
with potential adrenergic or serotonergic activity.

Non-susceptible microorganisms

Prescribing tedizolid phosphate in the absence of a proven or strongly suspected bacterial infection 
increases the risk of the development of drug-resistant bacteria.

Tedizolid is generally not active against Gram-negative bacteria. 

Limitations of the clinical data

The safety and efficacy of tedizolid phosphate when administered for periods longer than 6 days have 
not been established.

In ABSSSI, the types of infections treated were confined to cellulitis/erysipelas or major cutaneous 
abscesses, and wound infections only. Other types of skin infections have not been studied. 

 



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There is limited experience with tedizolid phosphate in the treatment of patients with concomitant 
acute bacterial skin and skin structure infections and secondary bacteremia and no experience in the 
treatment of ABSSSI with severe sepsis or septic shock.

Controlled clinical studies did not include patients with neutropenia (neutrophil counts 
<1,000 cells/mm3) or severely immunocompromised patients.

4.5 Interaction with other medicinal products and other forms of interaction

Pharmacokinetic interactions

In a clinical study comparing the single dose (10 mg) pharmacokinetics of rosuvastatin (Breast Cancer 
Resistant Protein [BCRP] substrate) alone or in combination with tedizolid phosphate (once-daily 200 
mg oral dose), rosuvastatin AUC and Cmax increased by approximately 70% and 55%, respectively, 
when coadministered with tedizolid phosphate. Therefore, orally administered tedizolid phosphate can 
result in inhibition of BCRP at the intestinal level. If possible, an interruption of the co-administered 
BCRP substrate medicinal product (such as imatinib, lapatinib, methotrexate, pitavastatin, 
rosuvastatin, sulfasalazine, and topotecan) should be considered during the 6 days of treatment with 
oral tedizolid phosphate.

In a clinical study comparing the single dose (2 mg) pharmacokinetics of midazolam (CYP3A4 
substrate) alone or in combination with tedizolid phosphate (once-daily 200 mg oral dose for 10 days), 
midazolam AUC and Cmax when co-administered with tedizolid phosphate were 81% and 83% of 
midazolam AUC and Cmax when administered alone, respectively. This effect is not clinically 
meaningful, and no dose adjustment for co-administered CYP3A4 substrates is necessary during 
tedizolid phosphate treatment.

Pharmacodynamic interactions

Monoamine oxidase inhibition
Tedizolid is a reversible inhibitor of monoamine oxidase (MAO) in vitro; however, no interaction is 
anticipated when comparing the IC50 for MAO-A inhibition and the anticipated plasma exposures in 
man. Drug interaction studies to determine effects of 200 mg oral tedizolid phosphate at steady state 
on pseudoephedrine and tyramine pressor effects were conducted in healthy volunteers. No 
meaningful changes in blood pressure or heart rate with pseudoephedrine were observed in the healthy 
volunteers, and no clinically relevant increase in tyramine sensitivity was observed. 

Potential serotonergic interactions
The potential for serotonergic interactions has not been studied in either patients or healthy volunteers
(see section 5.2).

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no data from the use of tedizolid phosphate in pregnant women. Studies in mice and rats 
showed developmental effects (see section 5.3). As a precautionary measure, it is preferable to avoid 
the use of tedizolid phosphate during pregnancy.

Breast-feeding

It is unknown whether tedizolid phosphate or its metabolites are excreted in human milk. Tedizolid is 
excreted in the breast milk of rats (see section 5.3). A risk to the breast-feeding infant cannot be 
excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain 
from tedizolid phosphate therapy taking into account the benefit of breast-feeding for the child and the 
benefit of therapy for the woman.

 



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Fertility

The effects of tedizolid phosphate on fertility in humans have not been studied. Animal studies with 
tedizolid phosphate do not indicate harmful effects with respect to fertility (see section 5.3).

4.7 Effects on ability to drive and use machines

Sivextro may have a minor influence on the ability to drive and use machines as it may cause 
dizziness, fatigue or, uncommonly, somnolence (see section 4.8).

4.8 Undesirable effects

Summary of the safety profile

Adults
The most frequently reported adverse reactions occurring in patients receiving tedizolid phosphate in 
the pooled controlled Phase 3 clinical studies (tedizolid phosphate 200 mg once daily for 6 days) were 
nausea (6.9%), headache (3.5%), diarrhoea (3.2%) and vomiting (2.3%), and were generally mild to 
moderate in severity.

The safety profile was similar when comparing patients receiving intravenous tedizolid phosphate 
alone to patients who received oral administration alone, except for a higher reported rate of 
gastrointestinal disorders associated with oral administration. 

Paediatric population
The safety of tedizolid phosphate was evaluated in one Phase 3 clinical trial, which included 
91 paediatric patients (12 to <18 years of age) with ABSSSI treated with IV and/or oral Sivextro
200 mg for 6 days and 29 patients treated with comparator agents for 10 days. 

Tabulated list of adverse reactions

The following adverse reactions have been identified in two comparative pivotal Phase 3 studies in 
adults treated with Sivextro (Table 1). Increased ALT, increased AST and liver function tests 
abnormal were the only adverse drug reactions reported in one comparative Phase 3 study in patients 
12 to <18 years of age. Adverse reactions are classified by preferred term and System Organ Class, 
and by frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); 
uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000). 

Table 1 Frequency of adverse reactions by System Organ Class in Phase 3 comparative 
clinical studies

System Organ Class Common Uncommon
Infections and infestations Vulvovaginal mycotic infection

Fungal infection

Vulvovaginal candidiasis

Abscess

Clostridioides difficile colitis

Dermatophytosis

Oral candidiasis

Respiratory tract infection

Blood and lymphatic system 
disorders

Lymphadenopathy

Immune system disorders Drug hypersensitivity

Metabolism and nutrition disorders Dehydration

 



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System Organ Class Common Uncommon
Diabetes mellitus inadequate 
control
Hyperkalaemia

Psychiatric disorders Insomnia

Sleep disorder

Anxiety

Nightmare

Nervous system disorders Headache Somnolence

Dizziness Dysgeusia

Tremor

Paraesthesia

Hypoaesthesia

Eye disorders Vision blurred

Vitreous floaters

Cardiac disorders Bradycardia

Vascular disorders Flushing

Hot flush

Respiratory, thoracic and 
mediastinal disorders

Cough

Nasal dryness

Pulmonary congestion

Gastrointestinal disorders Nausea Abdominal pain

Diarrhoea Constipation

Vomiting Abdominal discomfort

Dry mouth

Dyspepsia

Abdominal pain upper

Flatulence

Gastrooesophageal reflux 
disease
Haematochezia

Retching

Skin And subcutaneous tissue 
disorders

Pruritus 
Generalised

Hyperhidrosis
Pruritus
Rash
Urticaria
Alopecia
Rash erythematous
Rash generalised
Acne
Pruritus allergic
Rash maculo-papular
Rash papular
Rash pruritic

Musculoskeletal and connective 
tissue disorders

Arthralgia
Muscle spasms
Back pain
Limb discomfort
Neck pain

Renal and urinary disorders Urine odor abnormal

 



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System Organ Class Common Uncommon
Reproductive system and breast 
disorders

Vulvovaginal pruritus

General disorders and 
administration site conditions

Fatigue Chills
Irritability
Pyrexia
Peripheral oedema

Investigations Grip strength decreased
Transaminases increased
White blood cell count decreased

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V.

4.9 Overdose

In the event of overdose, Sivextro should be discontinued and general supportive treatment given. 
Haemodialysis does not result in meaningful removal of tedizolid from systemic circulation. The 
highest single dose administered in clinical studies was 1,200 mg. All adverse reactions at this dose 
level were mild or moderate in severity.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use, other antibacterials, ATC code: J01XX11

Mechanism of action

Tedizolid phosphate is an oxazolidinone phosphate prodrug. The antibacterial activity of tedizolid is 
mediated by binding to the 50S subunit of the bacterial ribosome resulting in inhibition of protein 
synthesis.

Tedizolid is primarily active against Gram-positive bacteria.

Tedizolid is bacteriostatic against enterococci, staphylococci, and streptococci in vitro.

Resistance

The most commonly observed mutations in staphylococci and enterococci that result in oxazolidinone 
resistance are in one or more copies of the 23S rRNA genes (G2576U and T2500A). Organisms 
resistant to oxazolidinones via mutations in chromosomal genes encoding 23S rRNA or ribosomal 
proteins (L3 and L4) are generally cross-resistant to tedizolid.

A second resistance mechanism is encoded by a plasmid-borne and transposon associated 
chloramphenicol-florfenicol resistance (cfr) gene, conferring resistance in staphylococci and 
enterococci to oxazolidinones, phenicols, lincosamides, pleuromutilins, streptogramin A and 
16-membered macrolides. Due to a hydroxymethyl group in the C5 position, tedizolid retains activity 
against strains of Staphylococcus aureus that express the cfr gene in the absence of chromosomal 
mutations.

 

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The mechanism of action is different from that of non-oxazolidinone class antibacterial medicinal 
products; therefore, cross-resistance between tedizolid and other classes of antibacterial medicinal 
products is unlikely.

Antibacterial activity in combination with other antibacterial and antifungal agents

In vitro drug combination studies with tedizolid and amphotericin B, aztreonam, ceftazidime, 
ceftriaxone, ciprofloxacin, clindamycin, colistin, daptomycin, gentamicin, imipenem, ketoconazole, 
minocycline, piperacillin, rifampicin, terbinafine, trimethoprim/sulfamethoxazole, and vancomycin 
indicate that neither synergy nor antagonism have been demonstrated.

Susceptibility testing breakpoints

Minimum inhibitory concentration (MIC) breakpoints determined by the European Committee on 
Antimicrobial Susceptibility Testing (EUCAST) are:

Organisms

Minimum Inhibitory Concentrations
(mg/L)

Susceptible (≤S) Resistant (R>)

Staphylococcus spp. 0.5 0.5

Beta haemolytic streptococci of Groups A,B,C,G 0.5 0.5

Viridans group streptococci (Streptococcus anginosus
group only)

0.25 0.25

Pharmacokinetic/pharmacodynamic relationship

The AUC/MIC ratio was the pharmacodynamic parameter shown to best correlate with efficacy in 
mouse thigh and lung S. aureus infection models.

In a mouse thigh infection model of S. aureus, the antibacterial activity of tedizolid was reduced in the 
absence of granulocytes. The AUC/MIC ratio to achieve bacteriostasis in neutropenic mice was at 
least 16 times that in immunocompetent animals (see section 4.4).

Clinical efficacy against specific pathogens

Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication 
that were susceptible to tedizolid in vitro.

Acute bacterial skin and skin structure infections

• Staphylococcus aureus
• Streptococcus pyogenes
• Streptococcus agalactiae
• Streptococcus anginosus group (including S. anginosus, S. intermedius and S. constellatus)

Antibacterial activity against other relevant pathogens

Clinical efficacy has not been established against the following pathogens although in vitro studies 
suggest that they would be susceptible to tedizolid in the absence of acquired mechanisms of 
resistance:

• Staphylococcus lugdunensis

 



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Paediatric population

The European Medicines Agency has deferred the obligation to submit the results of studies with 
Sivextro in one or more subsets of the paediatric population in the treatment of acute bacterial skin and 
skin structure infections (see section 4.2 for information on paediatric use).

5.2 Pharmacokinetic properties

Oral and intravenous tedizolid phosphate is a prodrug that is rapidly converted by phosphatases to 
tedizolid, the microbiologically active moiety. Only the pharmacokinetic profile of tedizolid is 
discussed in this section. Pharmacokinetic studies were conducted in healthy volunteers and 
population pharmacokinetic analyses were conducted in patients from Phase 3 studies. 

Absorption

At steady state, tedizolid mean (SD) Cmax values of 2.2 (0.6) and 3.0 (0.7) mcg/mL and AUC values of 
25.6 (8.5) and 29.2 (6.2) mcg·h/mL were similar with oral and IV administration of tedizolid 
phosphate, respectively. The absolute bioavailability of tedizolid is above 90%. Peak plasma tedizolid 
concentrations are achieved within approximately 3 hours after dosing after oral administration of 
tedizolid phosphate under fasted conditions.

Peak concentrations (Cmax) of tedizolid are reduced by approximately 26% and delayed by 6 hours 
when tedizolid phosphate is administered after a high-fat meal relative to fasted, while total exposure 
(AUC0-∞) is unchanged between fasted and fed conditions. 

Distribution

The average binding of tedizolid to human plasma proteins is approximately 70-90%.
The mean steady state volume of distribution of tedizolid in healthy adults (n=8) following a single 
intravenous dose of tedizolid phosphate 200 mg ranged from 67 to 80 L.

Biotransformation

Tedizolid phosphate is converted by endogenous plasma and tissue phosphatases to the 
microbiologically active moiety, tedizolid. Other than tedizolid, which accounts for approximately 
95% of the total radiocarbon AUC in plasma, there are no other significant circulating metabolites. 
When incubated with pooled human liver microsomes, tedizolid was stable suggesting that tedizolid is 
not a substrate for hepatic CYP450 enzymes. Multiple sulfotransferase (SULT) enzymes (SULT1A1, 
SULT1A2, and SULT2A1) are involved in the biotransformation of tedizolid, to form an inactive and 
non-circulating sulphate conjugate found in the excreta.

Elimination

Tedizolid is eliminated in excreta, primarily as a non-circulating sulfate conjugate. Following single 
oral administration of 14C-labeled tedizolid phosphate under fasted conditions, the majority of 
elimination occurred via the liver with 81.5% of the radioactive dose recovered in faeces and 18% in 
urine, with most of the elimination (>85%) occurring within 96 hours. Less than 3% of tedizolid 
phosphate administered dose is excreted as active tedizolid. The elimination half-life of tedizolid is 
approximately 12 hours and the intravenous clearance is 6-7 L/h.

Linearity/non-linearity

Tedizolid demonstrated linear pharmacokinetics with regard to dose and time. The Cmax and AUC of 
tedizolid increased approximately dose proportionally within the single oral dose range of 200 mg to 
1,200 mg and across the intravenous dose range of 100 mg to 400 mg. Steady-state concentrations are 
achieved within 3 days and indicate modest active substance accumulation of approximately 30% 

 



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following multiple once-daily oral or intravenous administration as predicted by a half-life of 
approximately 12 hours.

Special populations

Renal impairment
Following administration of a single 200 mg IV dose of tedizolid phosphate to 8 subjects with severe 
renal impairment defined as eGFR <30 mL/min, the Cmax was basically unchanged and AUC0-∞ was 
changed by less than 10% compared to 8 matched healthy subject controls. Haemodialysis does not 
result in meaningful removal of tedizolid from systemic circulation, as assessed in subjects with end-
stage renal disease (eGFR <15 mL/min). The eGFR was calculated using the MDRD4 equation.

Hepatic impairment
Following administration of a single 200 mg oral dose of tedizolid phosphate, the pharmacokinetics of 
tedizolid are not altered in patients with moderate (n=8) or severe (n=8) hepatic impairment 
(Child-Pugh Class B and C). 

Elderly population (≥65 years)
The pharmacokinetics of tedizolid in elderly healthy volunteers (age 65 years and older, with at least 
5 subjects at least 75 years old; n=14) was comparable to younger control subjects (25 to 45 years old; 
n=14) following administration of a single oral dose of tedizolid phosphate 200 mg. 

Paediatric population
The pharmacokinetics of tedizolid were evaluated in adolescents (12 to 17 years; n=20) following 
administration of a single oral or IV dose of tedizolid phosphate 200 mg and in adolescents (12 to 
<18 years; n=91) receiving tedizolid phosphate 200 mg IV or oral every 24 hours for 6 days. The 
estimated mean Cmax and AUC0-24h at steady state for tedizolid in adolescents were 3.37 µg/mL and 
30.8 µg·h/mL which were similar to adults.

Gender
The impact of gender on the pharmacokinetics of tedizolid phosphate was evaluated in healthy males 
and females in clinical studies and in a population pharmacokinetics analysis. The pharmacokinetics of 
tedizolid were similar in males and females.

Drug interaction studies

Effects of other medicines on Sivextro

In vitro studies have shown that drug interactions between tedizolid and inhibitors or inducers of 
cytochrome P450 (CYP) isoenzymes are unanticipated.

Multiple sulfotransferase (SULT) isoforms (SULT1A1, SULT1A2, and SULT2A1) were identified in 
vitro that are capable of conjugating tedizolid which suggests that no single isozyme is critical to the 
clearance of tedizolid.

Effects of Sivextro on other medicines

Drug metabolizing enzymes 
In vitro studies in human liver microsomes indicate that tedizolid phosphate and tedizolid do not 
significantly inhibit metabolism mediated by any of the following CYP isoenzymes (CYP1A2, 
CYP2C19, CYP2A6, CYP2C8, CYP2C9, CYP2D6, and CYP3A4). Tedizolid did not alter activity of 
selected CYP isoenzymes, but induction of CYP3A4 mRNA was observed in vitro in hepatocytes. 

A clinical study comparing the single dose (2 mg) pharmacokinetics of midazolam (CYP3A4 
substrate) alone or in combination with tedizolid phosphate (once-daily 200 mg oral dose for 10 days), 
demonstrated no clinically meaningful difference in midazolam Cmax or AUC. No dose adjustment is 
necessary for co-administered CYP3A4 substrates during treatment with Sivextro. 

 



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Membrane transporters
The potential for tedizolid or tedizolid phosphate to inhibit transport of probe substrates of important 
drug uptake (OAT1, OAT3, OATP1B1, OATP1B3, OCT1, and OCT2) and efflux transporters (P-gp 
and BCRP) was tested in vitro. No clinically relevant interactions are expected to occur with these 
transporters, with the exception of BCRP.

In a clinical study comparing the single dose (10 mg) pharmacokinetics of rosuvastatin (BCRP 
substrate) alone or in combination with the oral administration of tedizolid phosphate 200 mg,
rosuvastatin AUC and Cmax increased by approximately 70% and 55%, respectively, when 
coadministered with Sivextro. Therefore, orally administered Sivextro can result in inhibition of 
BCRP at the intestinal level.

Monoamine oxidase inhibition
Tedizolid is a reversible inhibitor of MAO in vitro; however, no interaction is anticipated when 
comparing the IC50 and the anticipated plasma exposures in man. No evidence of MAO-A inhibition 
was observed in Phase 1 studies specifically designed to investigate the potential for this interaction.

Adrenergic agents 
Two placebo-controlled crossover studies were conducted to assess the potential of 200 mg oral 
tedizolid phosphate at steady state to enhance pressor responses to pseudoephedrine and tyramine in 
healthy individuals. No meaningful changes in blood pressure or heart rate were seen with 
pseudoephedrine. The median tyramine dose required to cause an increase in systolic blood pressure 
of ≥30 mmHg from pre-dose baseline was 325 mg with tedizolid phosphate compared to 425 mg with 
placebo. Administration of Sivextro with tyramine-rich foods (i.e., containing tyramine levels of 
approximately 100 mg) would not be expected to elicit a pressor response.

Serotonergic agents 
Serotonergic effects at doses of tedizolid phosphate up to 30-fold above the human equivalent dose did 
not differ from vehicle control in a mouse model that predicts brain serotonergic activity. There are 
limited data in patients on the interaction between serotonergic agents and tedizolid phosphate. In 
Phase 3 studies, subjects taking serotonergic agents including antidepressants such as selective 
serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, and serotonin 5-hydroxytryptamine 
(5-HT1) receptor agonists (triptans), meperidine, or buspirone were excluded.

5.3 Preclinical safety data

Long-term carcinogenicity studies have not been conducted with tedizolid phosphate.

Repeated oral and intravenous dosing of tedizolid phosphate in rats in 1-month and 3-month 
toxicology studies produced dose- and time-dependent bone marrow hypocellularity (myeloid, 
erythroid, and megakaryocyte), with associated reduction in circulating RBCs, WBCs, and platelets. 
These effects showed evidence of reversibility and occurred at plasma tedizolid exposure levels 
(AUC) ≥6-fold greater than the plasma exposure associated with the human therapeutic dose. In a 
1-month immunotoxicology study in rats, repeated oral dosing of tedizolid phosphate was shown to 
significantly reduce splenic B cells and T cells and reduce plasma IgG titers. These effects occurred at 
plasma tedizolid exposure levels (AUC) ≥3-fold greater than the expected human plasma exposure 
associated with the therapeutic dose.

A special neuropathology study was conducted in pigmented Long Evans rats administered tedizolid 
phosphate daily for up to 9 months. This study used sensitive morphologic evaluation of 
perfusion-fixed peripheral and central nervous system tissue. No evidence of neurotoxicity, including 
neurobehavioral changes or optic or peripheral neuropathy, was associated with tedizolid after 1, 3, 6 
or 9 months of oral administration up to doses with plasma exposure levels (AUC) up to 8-fold greater 
than the expected human plasma exposure at the oral therapeutic dose.

 



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Tedizolid phosphate was negative for genotoxicity in all in vitro assays (bacterial reverse mutation 
[Ames], Chinese hamster lung [CHL] cell chromosomal aberration) and in all in vivo tests (mouse 
bone marrow micronucleus, rat liver unscheduled DNA synthesis). Tedizolid, generated from tedizolid 
phosphate after metabolic activation (in vitro and in vivo), was also tested for genotoxicity. Tedizolid 
was positive in an in vitro CHL cell chromosomal aberration assay, but negative for genotoxicity in 
other in vitro assays (Ames, mouse lymphoma mutagenicity) and in vivo in a mouse bone marrow 
micronucleus assay.

Tedizolid phosphate had no adverse effects on the fertility or reproductive performance of male rats, 
including spermatogenesis, at oral doses up to the maximum tested dose of 50 mg/kg/day, or adult 
female rats at oral doses up to the maximum tested dose of 15 mg/kg/day. These dose levels equate to 
exposure margins of ≥ 5.3-fold for males and ≥ 4.2-fold for females relative to tedizolid plasma 
AUC0-24 levels at the human oral therapeutic dose. 

Embryo-foetal development studies in mice and rats showed no evidence of a teratogenic effect at 
exposure levels 4-fold and 6-fold, respectively, those expected in humans. In embryo-foetal studies, 
tedizolid phosphate was shown to produce foetal developmental toxicities in mice and rats. Foetal 
developmental effects occurring in mice in the absence of maternal toxicity included reduced foetal 
weights and an increased incidence of costal cartilage fusion (an exacerbation of the normal genetic 
predisposition to sternal variations in the CD-1 strain of mice) at the high dose of 25 mg/kg/day 
(4-fold the estimated human exposure level based on AUCs). In rats, decreased foetal weights and 
increased skeletal variations including reduced ossification of the sternabrae, vertebrae, and skull were 
observed at the high dose of 15 mg/kg/day (6-fold the estimated human exposure based on AUCs) and 
were associated with maternal toxicity (reduced maternal body weights). The no observed adverse 
effect levels (NOAELs) for foetal toxicity in mice (5 mg/kg/day) as well as maternal and foetal 
toxicity in rats (2.5 mg/kg/day) were associated with tedizolid plasma area under the curve (AUC) 
values approximately equivalent to the tedizolid AUC value associated with the oral human 
therapeutic dose.

Tedizolid is excreted into the milk of lactating rats and the concentrations observed were similar to 
those in maternal plasma.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core

Microcrystalline cellulose
Mannitol
Povidone
Crospovidone
Magnesium stearate

Film coat

Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol
Talc
Yellow iron oxide (E172)

6.2 Incompatibilities

Not applicable.

 



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6.3 Shelf life

3 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container 

6 × 1 tablets in aluminum/Polyethylene Terephthalate (PET)/Paper foil and polyvinyl chloride 
(PVC)/polyvinylidene chloride (PVdC) clear film perforated child-resistant unit-dose blisters.

6.6 Special precautions for disposal 

No special requirements.

7. MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/991/001

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 23 March 2015
Date of latest renewal: 09 January 2020

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.

 



15

1. NAME OF THE MEDICINAL PRODUCT

Sivextro 200 mg powder for concentrate for solution for infusion

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each vial contains disodium tedizolid phosphate corresponding to 200 mg tedizolid phosphate.

After reconstitution each mL contains 50 mg tedizolid phosphate.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Powder for concentrate for solution for infusion (powder for concentrate).

White to off-white powder.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in 
adults and adolescents 12 years of age and older (see sections 4.4 and 5.1).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Posology

Tedizolid phosphate film-coated tablets or powder for concentrate for solution for infusion may be 
used as initial therapy. Patients who commence treatment on the parenteral formulation may be 
switched to the oral presentation when clinically indicated.

Recommended dose and duration 
The recommended dosage for adults and adolescents 12 years of age and older is 200 mg once daily 
for 6 days.

The safety and efficacy of tedizolid phosphate when administered for periods longer than 6 days have 
not been established (see section 4.4).

Missed dose
If a dose is missed it should be given to the patient as soon as possible anytime up to 8 hours prior to 
the next scheduled dose. If less than 8 hours remains before the next dose, then the physician should 
wait until the next scheduled dose. A double dose should not be given to compensate for a missed 
dose.

Elderly (≥65 years)
No dosage adjustment is required (see section 5.2). The clinical experience in patients ≥75 years is 
limited.

Hepatic impairment
No dosage adjustment is required (see section 5.2).

 



16

Renal impairment
No dosage adjustment is required (see section 5.2).

Paediatric population
The safety and efficacy of tedizolid phosphate in children below 12 years of age have not yet been 
established. Currently available data are described in section 5.2, but no recommendation on a 
posology for children below 12 years of age can be made.

Method of administration 

Sivextro must be administered by intravenous infusion over a 60-minute period. 

For instructions on reconstitution and dilution of the medicinal product before administration, see 
section 6.6

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Patients with neutropenia

The safety and efficacy of tedizolid phosphate in patients with neutropenia (neutrophil counts 
<1,000 cells/mm3) have not been investigated. In an animal model of infection, the antibacterial 
activity of tedizolid was reduced in the absence of granulocytes. The clinical relevance of this finding 
is unknown. Alternative therapies should be considered when treating patients with neutropenia and 
ABSSSI (see section 5.1).

Mitochondrial dysfunction

Tedizolid inhibits mitochondrial protein synthesis. Adverse reactions such as lactic acidosis, anaemia 
and neuropathy (optic and peripheral) may occur as a result of this inhibition. These events have been 
observed with another member of the oxazolidinone class when administered over a duration 
exceeding that recommended for tedizolid phosphate.

Myelosuppression

Decreased platelets, decreased haemoglobin and decreased neutrophils have been observed in a few 
subjects during treatment with tedizolid phosphate. In cases where tedizolid phosphate was 
discontinued, the affected haematological parameters have returned back to pre-treatment levels. 
Myelosuppression (including anaemia, leucopenia, pancytopenia and thrombocytopenia) has been 
reported in patients treated with another member of the oxazolidinone class and the risk of these 
effects appeared to be related to the duration of treatment.

Peripheral neuropathy and optic nerve disorders

Peripheral neuropathy, as well as optic neuropathy sometimes progressing to loss of vision, have been 
reported in patients treated with another member of the oxazolidinone class with treatment durations 
exceeding that recommended for tedizolid phosphate. Neuropathy (optic and peripheral) has not been 
reported in patients treated with tedizolid phosphate at the recommended treatment duration of 6 days. 
All patients should be advised to report symptoms of visual impairment, such as changes in visual 
acuity, changes in colour vision, blurred vision, or visual field defect. In such cases, prompt evaluation 
is recommended with referral to an ophthalmologist as necessary.

 



17

Lactic acidosis

Lactic acidosis has been reported with the use of another member of the oxazolidinone class. Lactic 
acidosis has not been reported in patients treated with tedizolid phosphate at the recommended 
treatment duration of 6 days.

Hypersensitivity reactions

Tedizolid phosphate should be administered with caution in patients known to be hypersensitive to 
other oxazolidinones since cross-hypersensitivity may occur.

Clostridioides difficile associated diarrhoea

Clostridioides difficile associated diarrhoea (CDAD) has been reported for tedizolid phosphate (see 
section 4.8). CDAD may range in severity from mild diarrhoea to fatal colitis. Treatment with 
antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile.

CDAD must be considered in all patients who present with severe diarrhoea following antibiotic use. 
Careful medical history is necessary since CDAD has been reported to occur over two months after the 
administration of antibacterial agents.

If CDAD is suspected or confirmed, tedizolid phosphate and, if possible, other antibacterial agents not 
directed against C. difficile should be discontinued and adequate therapeutic measures should be 
initiated immediately. Appropriate supportive measures, antibiotic treatment of C. difficile, and 
surgical evaluation should be considered. Medicinal products inhibiting peristalsis are contraindicated 
in this situation.

Monoamine oxidase inhibition

Tedizolid is a reversible, non-selective inhibitor of monoamine oxidase (MAO) in vitro (see 
section 4.5).

Serotonin syndrome

Spontaneous reports of serotonin syndrome associated with the co-administration of another member 
of the oxazolidinone class together with serotonergic agents have been reported (see section 4.5).

There is no Phase 3 clinical experience in patients with co-administration of tedizolid phosphate with 
serotonergic agents such as selective serotonin re-uptake inhibitors [SSRI], serotonin norepinephrine 
reuptake inhibitors (SNRI), tricyclic antidepressants, MAO inhibitors, triptans, and other medicines
with potential adrenergic or serotonergic activity.

Non-susceptible microorganisms

Prescribing tedizolid phosphate in the absence of a proven or strongly suspected bacterial infection 
increases the risk of the development of drug-resistant bacteria.

Tedizolid is generally not active against Gram-negative bacteria. 

Limitations of the clinical data

The safety and efficacy of tedizolid phosphate when administered for periods longer than 6 days have 
not been established.

In ABSSSI, the types of infections treated were confined to cellulitis/erysipelas or major cutaneous 
abscesses, and wound infections only. Other types of skin infections have not been studied. 

 



18

There is limited experience with tedizolid phosphate in the treatment of patients with concomitant 
acute bacterial skin and skin structure infections and secondary bacteremia and no experience in the 
treatment of ABSSSI with severe sepsis or septic shock.

Controlled clinical studies did not include patients with neutropenia (neutrophil counts 
<1,000 cells/mm3) or severely immunocompromised patients.

4.5 Interaction with other medicinal products and other forms of interaction

Pharmacokinetic interactions

In a clinical study comparing the single dose (10 mg) pharmacokinetics of rosuvastatin (Breast Cancer 
Resistant Protein [BCRP] substrate) alone or in combination with tedizolid phosphate (once-daily 
200 mg oral dose), rosuvastatin AUC and Cmax increased by approximately 70% and 55%, 
respectively, when coadministered with tedizolid phosphate. Therefore, orally administered tedizolid 
phosphate can result in inhibition of BCRP at the intestinal level. If possible, an interruption of the co-
administered BCRP substrate medicinal product (such as imatinib, lapatinib, methotrexate, 
pitavastatin, rosuvastatin, sulfasalazine, and topotecan) should be considered during the 6 days of 
treatment with oral tedizolid phosphate.

Pharmacodynamic interactions

Monoamine oxidase inhibitors
Tedizolid is a reversible inhibitor of monoamine oxidase (MAO) in vitro; however, no interaction is 
anticipated when comparing the IC50 for MAO-A inhibition and the anticipated plasma exposures in 
man. Drug interaction studies to determine effects of 200 mg oral tedizolid phosphate at steady state 
on pseudoephedrine and tyramine pressor effects were conducted in healthy volunteers. No 
meaningful changes in blood pressure or heart rate with pseudoephedrine were observed in the healthy 
volunteers, and no clinically relevant increase in tyramine sensitivity was observed. 

Potential serotonergic interactions
The potential for serotonergic interactions has not been studied in either patients or healthy volunteers 
(see section 5.2).

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no data from the use of tedizolid phosphate in pregnant women. Studies in mice and rats 
showed developmental effects (see section 5.3). As a precautionary measure, it is preferable to avoid 
the use of tedizolid phosphate during pregnancy.

Breast-feeding

It is unknown whether tedizolid phosphate or its metabolites are excreted in human milk. Tedizolid is 
excreted in the breast milk of rats (see section 5.3). A risk to the breast-feeding infant cannot be 
excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain 
from tedizolid phosphate therapy taking into account the benefit of breast-feeding for the child and the 
benefit of therapy for the woman.

Fertility

The effects of tedizolid phosphate on fertility in humans have not been studied. Animal studies with 
tedizolid phosphate do not indicate harmful effects with respect to fertility (see section 5.3).

 



19

4.7 Effects on ability to drive and use machines

Sivextro may have a minor influence on the ability to drive and use machines as it may cause 
dizziness, fatigue or, uncommonly, somnolence (see section 4.8).

4.8 Undesirable effects

Summary of the safety profile

Adults
The most frequently reported adverse reactions occurring in patients receiving tedizolid phosphate in 
the pooled controlled Phase 3 clinical studies (tedizolid phosphate 200 mg once daily for 6 days) were 
nausea (6.9%), headache (3.5%), diarrhoea (3.2%) and vomiting (2.3%), and were generally mild to 
moderate in severity.

The safety profile was similar when comparing patients receiving intravenous tedizolid phosphate 
alone to patients who received oral administration alone, except for a higher reported rate of 
gastrointestinal disorders associated with oral administration.  

Safety was additionally evaluated in a randomized, double-blind, multicenter study conducted in 
China, the Philippines, Taiwan, and the US, which included a total 292 adult patients treated with 
tedizolid phosphate 200 mg administered IV and/or oral once daily for 6 days, and 297 patients treated 
with linezolid 600 mg administered IV and/or oral every 12 hours for 10 days for ABSSSI. The safety 
profile in this study was similar to the Phase 3 clinical trials; however, infusion site reactions 
(phlebitis) were reported more frequently (2.7%) in tedizolid phosphate treated subjects than in the 
linezolid control group (0%), particularly among Asian patients. These findings suggest a higher 
frequency of infusion related reactions (phlebitis) than was observed in previous clinical studies with 
tedizolid phosphate.

Paediatric population
The safety of tedizolid phosphate was evaluated in one Phase 3 clinical trial, which included 
91 paediatric patients (12 to <18 years of age) with ABSSSI treated with IV and/or oral Sivextro 
200 mg for 6 days and 29 patients treated with comparator agents for 10 days. 

Tabulated list of adverse reactions

The following adverse reactions have been identified in two comparative pivotal Phase 3 studies and 
one post-authorisation study in adults treated with Sivextro (Table 1). Increased ALT, increased AST 
and liver function tests abnormal were the only adverse drug reactions reported in one comparative 
Phase 3 study in patients 12 to <18 years of age. Adverse reactions are classified by preferred term and 
System Organ Class, and by frequency. Frequencies are defined as: very common (≥1/10); common 
(≥ 1/100 to < 1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare 
(<1/10,000). 

Table 1 Frequency of adverse reactions by System Organ Class in Phase 3 comparative 
clinical studies

System Organ Class Common Uncommon
Infections and infestations Vulvovaginal mycotic infection

Fungal infection

Vulvovaginal candidiasis

Abscess

Clostridioides difficile colitis

Dermatophytosis

Oral candidiasis

Respiratory tract infection

 



20

System Organ Class Common Uncommon
Blood and lymphatic system 
disorders

Lymphadenopathy

Immune system disorders Drug hypersensitivity

Metabolism and nutrition disorders Dehydration

Diabetes mellitus inadequate 
control
Hyperkalaemia

Psychiatric disorders Insomnia

Sleep disorder

Anxiety

Nightmare

Nervous system disorders Headache Somnolence

Dizziness Dysgeusia

Tremor

Paraesthesia

Hypoaesthesia

Eye disorders Vision blurred

Vitreous floaters

Cardiac disorders Bradycardia

Vascular disorders Flushing

Hot flush

Respiratory, thoracic and 
mediastinal disorders

Cough

Nasal dryness

Pulmonary congestion

Gastrointestinal disorders Nausea Abdominal pain

Diarrhoea Constipation

Vomiting Abdominal discomfort

Dry mouth

Dyspepsia

Abdominal pain upper

Flatulence

Gastrooesophageal reflux 
disease
Haematochezia

Retching

Skin and subcutaneous tissue 
disorders

Pruritus 
Generalised

Hyperhidrosis
Pruritus
Rash
Urticaria
Alopecia
Rash erythematous
Rash generalised
Acne
Pruritus allergic
Rash maculo-papular
Rash papular
Rash pruritic

Musculoskeletal and connective 
tissue disorders

Arthralgia
Muscle spasms
Back pain

 



21

System Organ Class Common Uncommon
Limb discomfort
Neck pain

Renal and urinary disorders Urine odor abnormal
Reproductive system and breast 
disorders

Vulvovaginal pruritus

General disorders and 
administration site conditions

Fatigue Chills
Infusion site 
reactions 
(phlebitis)

Infusion site pain
Irritability
Pyrexia
Infusion related reaction
Peripheral oedema

Investigations Grip strength decreased
Transaminases increased
White blood cell count decreased

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V.

4.9 Overdose

In the event of overdose, Sivextro should be discontinued and general supportive treatment given. 
Haemodialysis does not result in meaningful removal of tedizolid from systemic circulation. The 
highest single dose administered in clinical studies was 1,200 mg. All adverse reactions at this dose 
level were mild or moderate in severity.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use, other antibacterials, ATC code: J01XX11

Mechanism of action

Tedizolid phosphate is an oxazolidinone phosphate prodrug. The antibacterial activity of tedizolid is 
mediated by binding to the 50S subunit of the bacterial ribosome resulting in inhibition of protein 
synthesis.

Tedizolid is primarily active against Gram-positive bacteria. 

Tedizolid is bacteriostatic against enterococci, staphylococci, and streptococci in vitro.

Resistance

The most commonly observed mutations in staphylococci and enterococci that result in oxazolidinone 
resistance are in one or more copies of the 23S rRNA genes (G2576U and T2500A). Organisms 
resistant to oxazolidinones via mutations in chromosomal genes encoding 23S rRNA or ribosomal 
proteins (L3 and L4) are generally cross-resistant to tedizolid.

A second resistance mechanism is encoded by a plasmid-borne and transposon associated 
chloramphenicol-florfenicol resistance (cfr) gene, conferring resistance in staphylococci and 
enterococci to oxazolidinones, phenicols, lincosamides, pleuromutilins, streptogramin A and 16-

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


22

membered macrolides. Due to a hydroxymethyl group in the C5 position, tedizolid retains activity 
against strains of Staphylococcus aureus that express the cfr gene in the absence of chromosomal 
mutations.

The mechanism of action is different from that of non-oxazolidinone class antibacterial medicinal 
products; therefore, cross-resistance between tedizolid and other classes of antibacterial medicinal 
products is unlikely.

Antibacterial activity in combination with other antibacterial and antifungal agents

In vitro drug combination studies with tedizolid and amphotericin B, aztreonam, ceftazidime, 
ceftriaxone, ciprofloxacin, clindamycin, colistin, daptomycin, gentamicin, imipenem, ketoconazole, 
minocycline, piperacillin, rifampicin, terbinafine, trimethoprim/sulfamethoxazole, and vancomycin
indicate that neither synergy nor antagonism have been demonstrated.

Susceptibility testing breakpoints

Minimum inhibitory concentration (MIC) breakpoints determined by the European Committee on 
Antimicrobial Susceptibility Testing (EUCAST) are:

Organisms

Minimum Inhibitory Concentrations
(mg/L)

Susceptible (≤S) Resistant (R>)

Staphylococcus spp. 0.5 0.5

Beta haemolytic Streptococci of Groups A,B,C,G 0.5 0.5

Viridans group streptococci (Streptococcus anginosus
group only)

0.25 0.25

Pharmacokinetic/pharmacodynamic relationship

The AUC/MIC ratio was the pharmacodynamic parameter shown to best correlate with efficacy in 
mouse thigh and lung S. aureus infection models.

In a mouse thigh infection model of S. aureus, the antibacterial activity of tedizolid was reduced in the 
absence of granulocytes. The AUC/MIC ratio to achieve bacteriostasis in neutropenic mice was at 
least 16 times that in immunocompetent animals (see section 4.4).

Clinical efficacy against specific pathogens

Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication 
that were susceptible to tedizolid in vitro.

Acute bacterial skin and skin structure infections

• Staphylococcus aureus
• Streptococcus pyogenes
• Streptococcus agalactiae
• Streptococcus anginosus group (including S. anginosus, S. intermedius and S. constellatus)

 



23

Antibacterial activity against other relevant pathogens

Clinical efficacy has not been established against the following pathogens although in vitro studies 
suggest that they would be susceptible to tedizolid in the absence of acquired mechanisms of 
resistance:

• Staphylococcus lugdunensis

Paediatric population

The European Medicines Agency has deferred the obligation to submit the results of studies with 
Sivextro in one or more subsets of the paediatric population in the treatment of acute bacterial skin and 
skin structure infections (see section 4.2 for information on paediatric use).

5.2 Pharmacokinetic properties

Oral and intravenous tedizolid phosphate is a prodrug that is rapidly converted by phosphatases to 
tedizolid, the microbiologically active moiety. Only the pharmacokinetic profile of tedizolid is 
discussed in this section. Pharmacokinetic studies were conducted in healthy volunteers and 
population pharmacokinetic analyses were conducted in patients from Phase 3 studies. 

Absorption

At steady state, tedizolid mean (SD) Cmax values of 2.2 (0.6) and 3.0 (0.7) mcg/mL and AUC values of 
25.6 (8.5) and 29.2 (6.2) mcg·h/mL were similar with oral and IV administration of tedizolid 
phosphate, respectively. The absolute bioavailability of tedizolid is above 90%. Peak plasma tedizolid 
concentrations are achieved within approximately 3 hours after dosing after oral administration of 
tedizolid phosphate under fasted conditions. 

Peak concentrations (Cmax) of tedizolid are reduced by approximately 26% and delayed by 6 hours 
when tedizolid phosphate is administered after a high-fat meal relative to fasted, while total exposure 
(AUC0-∞) is unchanged between fasted and fed conditions.

Distribution

The average binding of tedizolid to human plasma proteins is approximately 70-90%.
The mean steady state volume of distribution of tedizolid in healthy adults (n=8) following a single 
intravenous dose of tedizolid phosphate 200 mg ranged from 67 to 80 L.

Biotransformation

Tedizolid phosphate is converted by endogenous plasma and tissue phosphatases to the 
microbiologically active moiety, tedizolid. Other than tedizolid, which accounts for approximately 
95% of the total radiocarbon AUC in plasma, there are no other significant circulating metabolites. 
When incubated with pooled human liver microsomes, tedizolid was stable suggesting that tedizolid is 
not a substrate for hepatic CYP450 enzymes. Multiple sulfotransferase (SULT) enzymes (SULT1A1, 
SULT1A2, and SULT2A1) are involved in the biotransformation of tedizolid, to form an inactive and 
non-circulating sulphate conjugate found in the excreta.

Elimination

Tedizolid is eliminated in excreta, primarily as a non-circulating sulfate conjugate. Following single 
oral administration of 14C-labeled tedizolid phosphate under fasted conditions, the majority of 
elimination occurred via the liver with 81.5% of the radioactive dose recovered in faeces and 18% in 
urine, with most of the elimination (>85%) occurring within 96 hours. Less than 3% of tedizolid 
phosphate administered dose is excreted as active tedizolid. The elimination half-life of tedizolid is 
approximately 12 hours and the intravenous clearance is 6-7 L/h.

 



24

Linearity/non-linearity

Tedizolid demonstrated linear pharmacokinetics with regard to dose and time. The Cmax and AUC of 
tedizolid increased approximately dose proportionally within the single oral dose range of 200 mg to 
1,200 mg and across the intravenous dose range of 100 mg to 400 mg. Steady-state concentrations are 
achieved within 3 days and indicate modest active substance accumulation of approximately 30% 
following multiple once-daily oral or intravenous administration as predicted by a half-life of 
approximately 12 hours.

Special populations

Renal impairment
Following administration of a single 200 mg IV dose of tedizolid phosphate to 8 subjects with severe 
renal impairment defined as eGFR <30 mL/min, the Cmax was basically unchanged and AUC0-∞ was 
changed by less than 10% compared to 8 matched healthy subject controls. Haemodialysis does not 
result in meaningful removal of tedizolid from systemic circulation, as assessed in subjects with 
end-stage renal disease (eGFR <15 mL/min). The eGFR was calculated using the MDRD4 equation. 

Hepatic impairment
Following administration of a single 200 mg oral dose of tedizolid phosphate, the pharmacokinetics of 
tedizolid are not altered in patients with moderate (n=8) or severe (n=8) hepatic impairment 
(Child-Pugh Class B and C). 

Elderly population (≥ 65 years)
The pharmacokinetics of tedizolid in elderly healthy volunteers (age 65 years and older, with at least 
5 subjects at least 75 years old; n=14) was comparable to younger control subjects (25 to 45 years old; 
n=14) following administration of a single oral dose of tedizolid phosphate 200 mg. 

Paediatric population
The pharmacokinetics of tedizolid were evaluated in adolescents (12 to 17 years; n=20) following 
administration of a single oral or IV dose of tedizolid phosphate 200 mg and in adolescents (12 to 
<18 years; n=91) receiving tedizolid phosphate 200 mg IV or oral every 24 hours for 6 days. The 
estimated mean Cmax and AUC0-24h at steady state for tedizolid in adolescents were 3.37 µg/mL and 
30.8 µg·h/mL which were similar to adults.

Gender
The impact of gender on the pharmacokinetics of tedizolid phosphate was evaluated in healthy males 
and females in clinical studies and in a population pharmacokinetics analysis. The pharmacokinetics of 
tedizolid were similar in males and females. 

Drug interaction studies

Effects of other medicines on Sivextro 

In vitro studies have shown that drug interactions between tedizolid and inhibitors or inducers of 
cytochrome P450 (CYP) isoenzymes are unanticipated.

Multiple sulfotransferase (SULT) isoforms (SULT1A1, SULT1A2, and SULT2A1) were identified in 
vitro that are capable of conjugating tedizolid which suggests that no single isozyme is critical to the 
clearance of tedizolid.

Effects of Sivextro on other medicines

Drug metabolizing enzymes 
In vitro studies in human liver microsomes indicate that tedizolid phosphate and tedizolid do not 
significantly inhibit metabolism mediated by any of the following CYP isoenzymes (CYP1A2, 

 



25

CYP2C19, CYP2A6, CYP2C8, CYP2C9, CYP2D6, and CYP3A4). Tedizolid did not alter activity of 
selected CYP isoenzymes, but induction of CYP3A4 mRNA was observed in vitro in hepatocytes. 

A clinical study comparing the single dose (2 mg) pharmacokinetics of midazolam (CYP3A4 
substrate) alone or in combination with tedizolid phosphate (once-daily 200 mg oral dose for 10 days), 
demonstrated no clinically meaningful difference in midazolam Cmax or AUC. No dose adjustment is 
necessary for co-administered CYP3A4 substrates during treatment with Sivextro.

Membrane transporters
The potential for tedizolid or tedizolid phosphate to inhibit transport of probe substrates of important 
drug uptake (OAT1, OAT3, OATP1B1, OATP1B3, OCT1, and OCT2) and efflux transporters (P-gp 
and BCRP) was tested in vitro. No clinically relevant interactions are expected to occur with these 
transporters, with the administration of the parenteral formulation.

In a clinical study comparing the single dose (10 mg) pharmacokinetics of rosuvastatin (BCRP 
substrate) alone or in combination with the oral administration of tedizolid phosphate 200 mg, 
rosuvastatin AUC and Cmax increased by approximately 70% and 55%, respectively, when 
coadministered with Sivextro. Therefore, orally administered Sivextro can result in inhibition of 
BCRP at the intestinal level.

Monoamine oxidase inhibition
Tedizolid is a reversible inhibitor of MAO in vitro; however, no interaction is anticipated when 
comparing the IC50 and the anticipated plasma exposures in man. No evidence of MAO-A inhibition 
was observed in Phase 1 studies specifically designed to investigate the potential for this interaction. 

Adrenergic agents 
Two placebo-controlled crossover studies were conducted to assess the potential of 200 mg oral 
tedizolid phosphate at steady state to enhance pressor responses to pseudoephedrine and tyramine in 
healthy individuals. No meaningful changes in blood pressure or heart rate were seen with 
pseudoephedrine. The median tyramine dose required to cause an increase in systolic blood pressure 
of ≥30 mmHg from pre-dose baseline was 325 mg with tedizolid phosphate compared to 425 mg with 
placebo. Administration of Sivextro with tyramine-rich foods (i.e., containing tyramine levels of 
approximately 100 mg) would not be expected to elicit a pressor response.

Serotonergic agents 
Serotonergic effects at doses of tedizolid phosphate up to 30-fold above the human equivalent dose did 
not differ from vehicle control in a mouse model that predicts brain serotonergic activity. There are 
limited data in patients on the interaction between serotonergic agents and tedizolid phosphate. In 
Phase 3 studies, subjects taking serotonergic agents including antidepressants such as selective 
serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, and serotonin 5-hydroxytryptamine 
(5-HT1) receptor agonists (triptans), meperidine, or buspirone were excluded.

5.3 Preclinical safety data

Long-term carcinogenicity studies have not been conducted with tedizolid phosphate.

Repeated oral and intravenous dosing of tedizolid phosphate in rats in 1-month and 3-month 
toxicology studies produced dose- and time-dependent bone marrow hypocellularity (myeloid, 
erythroid, and megakaryocyte), with associated reduction in circulating RBCs, WBCs, and platelets. 
These effects showed evidence of reversibility and occurred at plasma tedizolid exposure levels 
(AUC) ≥6-fold greater than the plasma exposure associated with the human therapeutic dose. In a 
1-month immunotoxicology study in rats, repeated oral dosing of tedizolid phosphate was shown to 
significantly reduce splenic B cells and T cells and reduce plasma IgG titers. These effects occurred at 
plasma tedizolid exposure levels (AUC) ≥3-fold greater than the expected human plasma exposure 
associated with the therapeutic dose.

 



26

A special neuropathology study was conducted in pigmented Long Evans rats administered tedizolid 
phosphate daily for up to 9 months. This study used sensitive morphologic evaluation of 
perfusion-fixed peripheral and central nervous system tissue. No evidence of neurotoxicity, including 
neurobehavioral changes or optic or peripheral neuropathy, was associated with tedizolid after 1, 3, 6 
or 9 months of oral administration up to doses with plasma exposure levels (AUC) up to 8-fold greater 
than the expected human plasma exposure at the oral therapeutic dose.

Tedizolid phosphate was negative for genotoxicity in all in vitro assays (bacterial reverse mutation 
[Ames], Chinese hamster lung [CHL] cell chromosomal aberration) and in all in vivo tests (mouse 
bone marrow micronucleus, rat liver unscheduled DNA synthesis). Tedizolid, generated from tedizolid 
phosphate after metabolic activation (in vitro and in vivo), was also tested for genotoxicity. Tedizolid 
was positive in an in vitro CHL cell chromosomal aberration assay, but negative for genotoxicity in 
other in vitro assays (Ames, mouse lymphoma mutagenicity) and in vivo in a mouse bone marrow 
micronucleus assay.

Tedizolid phosphate had no adverse effects on the fertility or reproductive performance of male rats, 
including spermatogenesis, at oral doses up to the maximum tested dose of 50 mg/kg/day, or adult 
female rats at oral doses up to the maximum tested dose of 15 mg/kg/day. These dose levels equate to 
exposure margins of ≥ 5.3-fold for males and ≥ 4.2-fold for females relative to tedizolid plasma 
AUC0-24 levels at the human oral therapeutic dose.

Embryo-foetal development studies in mice and rats showed no evidence of a teratogenic effect at 
exposure levels 4-fold and 6-fold, respectively, those expected in humans. In embryo-foetal studies, 
tedizolid phosphate was shown to produce foetal developmental toxicities in mice and rats. Foetal 
developmental effects occurring in mice in the absence of maternal toxicity included reduced foetal 
weights and an increased incidence of costal cartilage fusion (an exacerbation of the normal genetic 
predisposition to sternal variations in the CD-1 strain of mice) at the high dose of 25 mg/kg/day 
(4-fold the estimated human exposure level based on AUCs). In rats, decreased foetal weights and 
increased skeletal variations including reduced ossification of the sternabrae, vertebrae, and skull were 
observed at the high dose of 15 mg/kg/day (6-fold the estimated human exposure based on AUCs) and 
were associated with maternal toxicity (reduced maternal body weights). The no observed adverse 
effect levels (NOAELs) for foetal toxicity in mice (5 mg/kg/day) as well as maternal and foetal 
toxicity in rats (2.5 mg/kg/day) were associated with tedizolid plasma area under the curve (AUC) 
values approximately equivalent to the tedizolid AUC value associated with the oral human 
therapeutic dose.

Tedizolid is excreted into the milk of lactating rats and the concentrations observed similar to those in 
maternal plasma.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Mannitol
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in 
section 6.6. Sivextro is incompatible with any solutions containing divalent cations (e.g., Ca2+, Mg2+), 
including Lactated Ringer’s Injection and Hartmann's Solution.

6.3 Shelf life

3 years.

 



27

The combined storage time (from reconstitution to dilution to administration) must not exceed 
24 hours when stored at either room temperature or in a refrigerator (2°C - 8°C).

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions. For storage conditions after 
reconstitution and dilution of the medicinal product, see section 6.3.

6.5 Nature and contents of container 

Type I (10 ml) clear borosilicate tubing glass vial with a siliconised grey chlorobutyl rubber stopper. 
Available in packs of 1 vial and 6 vials.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Sivextro vials are intended for single use only.

It must be administered as an intravenous infusion only. It must not be administered as an intravenous
bolus.

Aseptic technique must be followed in preparing the infusion solution. The contents of the vial should 
be reconstituted with 4 mL of water for injections, and be swirled gently until the powder has 
dissolved entirely. Shaking or rapid movement should be avoided as it may cause foaming.

For administration, the reconstituted solution must be further diluted in 250 mL of sodium chloride
0.9% solution for injection. The bag should not be shaken. The resulting solution is a clear colourless 
or light-yellow solution and should be administered over approximately 1 hour. 

Only limited data are available on the compatibility of Sivextro with other intravenous substances, 
therefore additives or other medicinal products should not be added to Sivextro single use vials or 
infused simultaneously. If the same intravenous line is used for sequential infusion of several different 
medicinal products, the line should be flushed before and after infusion with 0.9% sodium chloride.

The reconstituted solution should be inspected visually for particulate matter prior to administration. 
Reconstituted solutions containing visible particles should be discarded.

Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.

7. MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/991/002
EU/1/15/991/003

 



28

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 23 March 2015
Date of latest renewal: 09 January 2020

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.

 



29

ANNEX II

A. MANUFACTURERS RESPONSIBLE FOR BATCH 
RELEASE

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT

 



30

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

Laboratoires Merck Sharp & Dohme-Chibret
Route de Marsat, Riom
63963, Clermont-Ferrand Cedex 9
France

The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch.

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION

 Periodic safety update reports (PSURs)

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT

 Risk management plan (RMP)

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation 
and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

 At the request of the European Medicines Agency;
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 



31

ANNEX III

LABELLING AND PACKAGE LEAFLET

 



32

A. LABELLING

 



33

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Sivextro 200 mg film-coated tablets
tedizolid phosphate

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 200 mg tedizolid phosphate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet
6 x 1 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

 



34

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/15/991/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Sivextro 

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC
SN
NN

 



35

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Sivextro 200 mg tablets
tedizolid phosphate

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Peel, then push

 



36

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON (VIAL)

1. NAME OF THE MEDICINAL PRODUCT

Sivextro 200 mg powder for concentrate for solution for infusion
tedizolid phosphate

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains disodium tedizolid phosphate corresponding to 200 mg tedizolid phosphate.
After reconstitution each ml contains 50 mg tedizolid phosphate.

3. LIST OF EXCIPIENTS

mannitol, sodium hydroxide, hydrochloric acid 

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate for solution for infusion
1 vial
6 vials

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intravenous use after reconstitution and dilution
For single use only

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

 



37

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/15/991/002 1 vial
EU/1/15/991/003 6 vials

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC
SN
NN

 



38

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Sivextro 200 mg powder for concentrate 
tedizolid phosphate
IV

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

200 mg

6. OTHER

 



39

B. PACKAGE LEAFLET

 



40

Package leaflet: Information for the patient

Sivextro 200 mg film-coated tablets
tedizolid phosphate

Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Sivextro is and what it is used for
2. What you need to know before you take Sivextro
3. How to take Sivextro
4. Possible side effects
5. How to store Sivextro
6. Contents of the pack and other information

1. What Sivextro is and what it is used for

Sivextro is an antibiotic that contains the active substance tedizolid phosphate. It belongs to a group of 
medicines called “oxazolidinones”.

It is used to treat adults and adolescents 12 years of age and older with infections of the skin and 
tissues below the skin.

It works by stopping the growth of certain bacteria which can cause serious infections.

2. What you need to know before you take Sivextro

Do not take Sivextro
 if you are allergic to tedizolid phosphate or any of the other ingredients of this medicine (listed 

in section 6). 

Warnings and precautions
Your doctor will have decided if Sivextro is suitable to treat your infection.

Talk to your doctor or nurse before taking Sivextro if any of the following apply to you:
- are suffering from diarrhoea, or have suffered from diarrhoea whilst (or up to 2 months after) 

taking antibiotics in the past.
- are allergic to other medicines belonging to the group “oxazolidinones” (e.g., linezolid, 

cycloserine).
- are taking certain medicines to treat depression, known as tricyclics, SSRIs (selective serotonin 

reuptake inhibitors) or MAOIs (monoamine oxidase inhibitors). See Other medicines and 
Sivextro for examples.

- are taking certain medicines to treat migraine known as “triptans”. See Other medicines and 
Sivextro for examples.

Ask your doctor or pharmacist if you are not sure whether you are taking any of these medicines.

 



41

Diarrhoea
Contact your doctor straight away if you suffer from diarrhoea during or after your treatment. Do not 
take any medicine to treat your diarrhoea without first checking with your doctor.

Resistance to antibiotics
Bacteria can become resistant to treatment with antibiotics over time. This is when antibiotics cannot 
stop the growth of bacteria and treat your infection. Your doctor will decide if you should be given 
Sivextro to treat your infection.

Possible side effects
Certain side effects have been observed with another member of the oxazolidinone class when 
administered over a duration exceeding that recommended for Sivextro. Tell your doctor straight away 
if you suffer from any of the following while taking Sivextro:
 a low white blood cell count 
 anaemia (low red blood cells) 
 bleeding or bruising easily
 loss of sensitivity in your hands or feet (such as numbness, prickling/tingling, or sharp pains)
 any problems with your eyesight such as blurred vision, changes in colour vision, difficulty in 

seeing detail or if your field of vision becomes restricted.

Children
This medicine should not be used in children under 12 years of age as it has not been studied enough 
in this population.

Other medicines and Sivextro
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. It is especially important that you tell your doctor if you are also taking:
 amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, 

imipramine, isocarboxazid, lofepramine, moclobemide, paroxetine, phenelzine, selegiline and 
sertraline (used to treat depression)

 sumatriptan, zolmitriptan (used to treat migraine)
 imatinib, lapatinib (used to treat cancer)
 methotrexate (used to treat cancer, rheumatoid arthritis or psoriasis)
 sulfasalazine (used to treat inflammatory bowel diseases)
 topotecan (used to treat cancer)
 statins such as pitavastatin, rosuvastatin (used to lower blood cholesterol)

Sivextro can interfere with the effects of these medicines. Your doctor will explain more.

Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine.

It is not known if Sivextro passes into breast milk in humans. Ask your doctor for advice before 
breast-feeding your baby.

Driving and using machines
Do not drive or use machines if you feel dizzy or tired after taking this medicine.

3. How to take Sivextro

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.

 



42

The recommended dose is one 200 mg tablet once a day for 6 days. The tablets are swallowed whole 
and can be taken with or without food or drink.  
Talk to a doctor if you do not feel better, or if you feel worse after 6 days.

If you take more Sivextro than you should
Contact your doctor, pharmacist or nearest hospital casualty department as soon as possible if you 
have taken more tablets than you should, and take your medicine with you.

If you forget to take Sivextro
If you forget to take your medicine, take the dose as soon as possible anytime up to 8 hours prior to the 
next scheduled dose. If less than 8 hours remains before the next dose, then wait until the next 
scheduled dose. Do not take a double dose to make up for a forgotten dose. If in any doubt, contact 
your pharmacist for advice.

You should take all 6 tablets to complete your course of treatment, even if you have missed a dose.

If you stop taking Sivextro
If you stop taking Sivextro without the advice of your doctor, your symptoms may get worse. Talk to 
your doctor or pharmacist before you stop taking your medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor straight away if you suffer from diarrhoea during or after your treatment.

Other side effects may include:
Common side effects (may affect up to 1 in 10 people)
 Nausea
 Vomiting
 Headache
 Itching all over the body
 Tiredness
 Dizziness

Uncommon side effects (may affect up to 1 in 100 people)
 Fungal infections of skin, mouth and vagina (oral / vaginal thrush)
 Itching (including itching due to allergic reaction), hair loss, acne, red and/or itchy rash or hives, 

excessive sweating 
 Decrease or loss of skin sensitivity, tingling/prickling skin sensation
 Hot flush or blushing/redness in the face, neck or upper chest 
 Abscess (swollen, pus-filled lump) 
 Vaginal infection, inflammation or itching 
 Anxiety, irritability, shaking or trembling 
 Respiratory tract (sinuses, throat and chest) infection
 Dryness in the nose, congestion in the chest, cough 
 Sleepiness, abnormal sleep pattern, difficulty sleeping, nightmares (unpleasant/disturbing 

dreams)
 Dry mouth, constipation, indigestion, pain/discomfort in the belly (abdomen), retching, dry 

heaving, bright red blood in the stool
 Acid reflux disease (heartburn, pain or difficulty swallowing), flatulence/passing wind 
 Joint pain, muscle spasms, back pain, neck pain, pain/discomfort in limbs, decrease of grip 

strength

 



43

 Blurred vision, ‘floaters’ (small shapes seen floating in the field of vision)
 Swollen or enlarged lymph nodes
 Allergic reaction 
 Dehydration 
 Poor control of diabetes 
 Abnormal sense of taste 
 Slow heartbeat
 Fever 
 Swelling in ankles and/or feet 
 Abnormal smelling urine, abnormal blood tests 

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine.

5. How to store Sivextro

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton or blister label after 
“EXP”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Sivextro contains
 The active substance is tedizolid phosphate. Each film-coated tablet contains 200 mg of 

tedizolid phosphate.
 The other ingredients are microcrystalline cellulose, mannitol, povidone, crospovidone and 

magnesium stearate within the tablet core. The film coat of the tablet contains polyvinyl 
alcohol, titanium dioxide (E171), macrogol, talc and yellow iron oxide (E172).

What Sivextro looks like and contents of the pack
Sivextro is an oval, yellow film-coated tablet imprinted with ‘TZD’ on one side and ‘200’ on the other 
side.

It is available in 6 × 1 tablets in perforated unit-dose blisters.

Marketing Authorisation Holder 
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

Manufacturer
Laboratoires Merck Sharp & Dohme-Chibret
Route de Marsat, Riom
63963, Clermont-Ferrand Cedex 9

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


44

France

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

Belgique/België/Belgien
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
dpoc_belux@merck.com

Lietuva
UAB Merck Sharp & Dohme
Tel.: +370 5 278 02 47
msd_lietuva@merck.com

България 
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737
info-msdbg@merck.com

Luxembourg/Luxemburg
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
dpoc_belux@merck.com

Česká republika
Merck Sharp & Dohme s.r.o.
Tel.: +420 233 010 111
dpoc_czechslovak@merck.com

Magyarország
MSD Pharma Hungary Kft.
Tel.: +361 888 53 00
hungary_msd@merck.com

Danmark
MSD Danmark ApS
Tlf: +45 4482 4000
dkmail@merck.com

Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558)
malta_info@merck.com

Deutschland
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
e-mail@msd.de

Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000 (+31 23 5153153)
medicalinfo.nl@merck.com

Eesti
Merck Sharp & Dohme OÜ
Tel.: +372 6144 200
msdeesti@merck.com

Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00
msdnorge@ msd.no

Ελλάδα
MSD Α.Φ.Β.Ε.Ε.
Τηλ: +30 210 98 97 300
dpoc_greece@merck.com

Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
msd-medizin@merck.com

España
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00
msd_info@merck.com

Polska
MSD Polska Sp.z o.o.
Tel.: +48 22 549 51 00
msdpolska@merck.com

France
MSD France
Tél: + 33 (0) 1 80 46 40 40

Portugal
Merck Sharp & Dohme, Lda
Tel: +351 21 4465700
inform_pt@merck.com

 



45

Hrvatska
Merck Sharp & Dohme d.o.o. 
Tel: + 385 1 6611 333
croatia_info@merck.com

România
Merck Sharp & Dohme Romania S.R.L.
Tel: +40 21 529 29 00
msdromania@merck.com

Ireland
Merck Sharp & Dohme Ireland (Human Health) 
Limited
Tel: +353 (0)1 299 8700
medinfo_ireland@merck.com

Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: + 386 1 5204 201
msd_slovenia@merck.com

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel.: +421 2 58282010
dpoc_czechslovak@merck.com

Ιtalia
MSD Italia S.r.l.
Tel: +39 06 361911
medicalinformation.it@merck.com

Suomi/Finland
MSD Finland Oy
Puh/Tel: +358 (0) 9 804650
info@msd.fi

Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673 (+357 22866700)
cyprus_info@merck.com 

Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488
medicinskinfo@merck.com

Latvija
SIA Merck Sharp & Dohme Latvija
Tel: +371 67364224
msd_lv@merck.com.

United Kingdom
Merck Sharp & Dohme Limited
Tel: +44 (0) 1992 467272
medicalinformationuk@merck.com

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.

 



46

Package leaflet: Information for the patient

Sivextro 200 mg powder for concentrate for solution for infusion
tedizolid phosphate

Read all of this leaflet carefully before you start receiving this medicine because it contains 
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects 

not listed in this leaflet. See section 4.

What is in this leaflet

1. What Sivextro is and what it is used for
2. What you need to know before you are given Sivextro
3. How you will be given Sivextro
4. Possible side effects
5. How to store Sivextro 
6. Contents of the pack and other information

1. What Sivextro is and what it is used for

Sivextro is an antibiotic that contains the active substance tedizolid phosphate. It belongs to a group of 
medicines called “oxazolidinones.”

It is used to treat adults and adolescents 12 years of age and older with infections of the skin and 
tissues below the skin.

It works by stopping the growth of certain bacteria which can cause serious infections.

2. What you need to know before you are given Sivextro

Do not use Sivextro:
 if you are allergic to tedizolid phosphate or any of the other ingredients of this medicine (listed 

in section 6).

Warnings and precautions
Your doctor will have decided if Sivextro is suitable to treat your infection.

Talk to your doctor or nurse before being given Sivextro if any of the following apply to you:
- are suffering from diarrhoea, or have suffered from diarrhoea whilst (or up to 2 months after) 

being treated with antibiotics in the past.
- are allergic to other medicines belonging to the group “oxazolidinones” (e.g., linezolid, 

cycloserine).
- are taking certain medicines to treat depression, known as tricyclics, SSRIs (selective serotonin 

reuptake inhibitors) or MAOIs (monoamine oxidase inhibitors). See Other medicines and 
Sivextro for examples.

- are taking certain medicines to treat migraine known as “triptans”. See Other medicines and 
Sivextro for examples.

Ask your doctor or pharmacist if you are not sure whether you are taking any of these medicines.

 



47

Diarrhoea
Contact your doctor straight away if you suffer from diarrhoea during or after your treatment. Do not 
take any medicine to treat your diarrhoea without first checking with your doctor.

Resistance to antibiotics
Bacteria can become resistant to treatment with antibiotics over time. This is when antibiotics cannot 
stop the growth of bacteria and treat your infection. Your doctor will decide if you should be given 
Sivextro to treat your infection.

Possible side effects
Certain side effects have been observed with another member of the oxazolidinone class when 
administered over a duration exceeding that recommended for Sivextro. Tell your doctor straight away 
if you suffer from any of the following while taking Sivextro:
 a low white blood cell count 
 anaemia (low red blood cells) 
 bleeding or bruising easily
 loss of sensitivity in your hands or feet (such as numbness, prickling/tingling, or sharp pains)
 any problems with your eyesight such as blurred vision, changes in colour vision, difficulty in 

seeing detail or if your field of vision becomes restricted.

Children
This medicine should not be used in children under 12 years of age as it has not been studied enough 
in this population.

Other medicines and Sivextro
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. It is 
especially important that you tell your doctor if you are also taking:
 amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, 

imipramine, isocarboxazid, lofepramine, moclobemide, paroxetine, phenelzine, selegiline and 
sertraline (used to treat depression)

 sumatriptan, zolmitriptan (used to treat migraine)

Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or nurse for advice before using this medicine.

It is not known if Sivextro passes into breast milk in humans. Ask your doctor for advice before 
breast-feeding your baby.

Driving and using machines
Do not drive or use machines if you feel dizzy or tired after taking this medicine.

Sivextro contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially “sodium-
free.”

3. How you will be given Sivextro

Sivextro will be given to you by a nurse or doctor.

It will be given to you through a drip directly into a vein (intravenously) over approximately 1 hour.

You will be given one 200 mg infusion of Sivextro once a day for 6 days.
Talk to a doctor if you do not feel better, or if you feel worse after 6 days.

 



48

If you are given more Sivextro than you should 
Tell your doctor or nurse immediately if you are concerned that you may have been given too much 
Sivextro.

If you miss a dose of Sivextro
Tell your doctor or nurse immediately if you are concerned that you may have missed a dose.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor straight away if you suffer from diarrhoea during or after your treatment.

Other side effects may include:
Common side effects (may affect up to 1 in 10 people)
 Nausea
 Vomiting
 Headache
 Itching all over the body
 Tiredness
 Dizziness
 Infusion site pain or swelling.

Uncommon side effects (may affect up to 1 in 100 people)
 Fungal infections of skin , mouth and vagina (oral / vaginal thrush)
 Itching (including itching due to allergic reaction), hair loss, acne, red and/or itchy rash or hives, 

excessive sweating 
 Decrease or loss of skin sensitivity, tingling/prickling skin sensation
 Hot flush or blushing/redness in the face, neck or upper chest 
 Abscess (swollen, pus-filled lump) 
 Vaginal infection, inflammation or itching 
 Anxiety, irritability, shaking or trembling 
 Respiratory tract (sinuses, throat and chest) infection
 Dryness in the nose, congestion in the chest, cough 
 Sleepiness, abnormal sleep pattern, difficulty sleeping, nightmares (unpleasant/disturbing 

dreams)
 Dry mouth, constipation, indigestion, pain/discomfort in the belly (abdomen), retching, dry 

heaving, bright red blood in the stool
 Acid reflux disease (heartburn, pain or difficulty swallowing), flatulence/passing wind 
 Joint pain, muscle spasms, back pain, neck pain, pain/discomfort in limbs, decrease of grip 

strength
 Blurred vision, ‘floaters’ (small shapes seen floating in the field of vision)
 Swollen or enlarged lymph nodes 
 Allergic reaction 
 Dehydration 
 Poor control of diabetes 
 Abnormal sense of taste 
 Slow heartbeat
 Fever 
 Swelling in ankles and/or feet 
 Abnormal smelling urine, abnormal blood tests 

 



49

 Infusion reactions (chills, shaking or shivering with fever, muscle pain, swelling of the face, 
weakness, fainting, shortness of breath, chest tightness and angina pectoris).

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not 
listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects you can help provide more information on the safety of this 
medicine.

5. How to store Sivextro

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial label after “EXP”. The expiry 
date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any particles or the solution is cloudy.

Once opened this medicine must be used immediately. If not, the reconstituted and diluted solution 
should be stored at room temperature or in a refrigerator at 2°C to 8°C, and administered within
24 hours after reconstitution.

Any unused medicine or waste material, including materials used for reconstitution, dilution and 
administration, should be disposed of in accordance with local requirements.

6. Contents of the pack and other information

What Sivextro contains 
 The active substance is tedizolid phosphate. Each vial of powder contains disodium tedizolid 

phosphate which is equal to 200 mg of tedizolid phosphate.

 The other ingredients are mannitol, sodium hydroxide (for pH adjustment) and hydrochloric 
acid (for pH adjustment).

What Sivextro looks like and contents of the pack
Sivextro is a white to off-white powder for concentrate for solution for infusion in a glass vial. The 
powder will be reconstituted in the vial with 4 mL of water for injections. The reconstituted solution 
will be withdrawn from the vial and added to an infusion bag of 0.9% sodium chloride in the hospital.

It is available in packs containing 1 or 6 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder 
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

Manufacturer
Laboratoires Merck Sharp & Dohme-Chibret
Route de Marsat, Riom
63963, Clermont-Ferrand Cedex 9
France

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


50

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

Belgique/België/Belgien
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
dpoc_belux@merck.com

Lietuva
UAB Merck Sharp & Dohme
Tel.: +370 5 278 02 47
msd_lietuva@merck.com

България 
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737
info-msdbg@merck.com

Luxembourg/Luxemburg
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
dpoc_belux@merck.com

Česká republika
Merck Sharp & Dohme s.r.o.
Tel.: +420 233 010 111
dpoc_czechslovak@merck.com

Magyarország
MSD Pharma Hungary Kft.
Tel.: +361 888 53 00
hungary_msd@merck.com

Danmark
MSD Danmark ApS
Tlf: +45 4482 4000
dkmail@merck.com

Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558)
malta_info@merck.com

Deutschland
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
e-mail@msd.de

Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000 (+31 23 5153153)
medicalinfo.nl@merck.com

Eesti
Merck Sharp & Dohme OÜ
Tel.: +372 6144 200
msdeesti@merck.com

Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00
msdnorge@ msd.no

Ελλάδα
MSD Α.Φ.Β.Ε.Ε.
Τηλ: +30 210 98 97 300
dpoc_greece@merck.com

Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
msd-medizin@merck.com

España
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00
msd_info@merck.com

Polska
MSD Polska Sp.z o.o.
Tel.: +48 22 549 51 00
msdpolska@merck.com

France
MSD France
Tél: + 33 (0) 1 80 46 40 40

Portugal
Merck Sharp & Dohme, Lda
Tel: +351 21 4465700
inform_pt@merck.com

Hrvatska
Merck Sharp & Dohme d.o.o. 
Tel: + 385 1 6611 333
croatia_info@merck.com

România
Merck Sharp & Dohme Romania S.R.L.
Tel: +40 21 529 29 00
msdromania@merck.com

 



51

Ireland
Merck Sharp & Dohme Ireland (Human Health) 
Limited
Tel: +353 (0)1 299 8700
medinfo_ireland@merck.com

Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: + 386 1 5204 201
msd_slovenia@merck.com

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel.: +421 2 58282010
dpoc_czechslovak@merck.com

Ιtalia
MSD Italia S.r.l.
Tel: +39 06 361911
medicalinformation.it@merck.com

Suomi/Finland
MSD Finland Oy
Puh/Tel: +358 (0) 9 804650
info@msd.fi

Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673 (+357 22866700)
cyprus_info@merck.com 

Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488
medicinskinfo@merck.com

Latvija
SIA Merck Sharp & Dohme Latvija
Tel: +371 67364224
msd_lv@merck.com.

United Kingdom
Merck Sharp & Dohme Limited
Tel: +44 (0) 1992 467272
medicalinformationuk@merck.com

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.
---------------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:

Important: Please refer to the Summary of Product Characteristics (SmPC) before prescribing.

Patients who commence treatment on the parenteral formulation may be switched to the oral 
presentation when clinically indicated.

Sivextro must be reconstituted with water for injections and subsequently diluted in 250 mL of 0.9% 
sodium chloride for infusion.

Only limited data are available on the compatibility of Sivextro with other intravenous substances, 
therefore additives or other medicinal products should not be added to Sivextro single use vials or 
infused simultaneously. If the same intravenous line is used for sequential infusion of several different 
medicinal products, the line should be flushed before and after infusion with 0.9% sodium chloride. 
Do not use Lactated Ringer’s Injection or Hartmann’s Solution.

Reconstitution
Aseptic technique must be followed when preparing the infusion solution. Reconstitute the contents of 
the vial with 4 mL water for injections, and swirl gently until the powder has dissolved entirely. Avoid 
shaking or rapid movement as it may cause foaming.

Dilution
For administration, the reconstituted solution must be further diluted in 250 mL 0.9% sodium chloride. 
Do not shake the bag. The resulting solution is a clear colourless or light-yellow solution.

 



52

Infusion
The reconstituted solution should be inspected visually for particulate matter prior to administration. 
Reconstituted solutions containing visible particles should be discarded.

Sivextro is administered intravenously over approximately 1 hour.

The reconstituted solution must be administered as an intravenous infusion only. It must not be 
administered as an intravenous bolus. Sivextro must not be mixed with other medicinal products.

Each vial is for single use only.

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
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{'Title': '2. what you need to know before you take sivextro', 'Section_Content': 'do not take sivextro if you are allergic to tedizolid phosphate or any of the other ingredients of this medicine (listed in section 6). warnings and precautions your doctor will have decided if sivextro is suitable to treat your infection. talk to your doctor or nurse before taking sivextro if any of the following apply to you: - are suffering from diarrhoea, or have suffered from diarrhoea whilst (or up to 2 months after) taking antibiotics in the past. - are allergic to other medicines belonging to the group "oxazolidinones" (e.g., linezolid, cycloserine). - are taking certain medicines to treat depression, known as tricyclics, ssris (selective serotonin reuptake inhibitors) or maois (monoamine oxidase inhibitors). see other medicines and sivextro for examples. - are taking certain medicines to treat migraine known as "triptans". see other medicines and sivextro for examples. ask your doctor or pharmacist if you are not sure whether you are taking any of these medicines. diarrhoea contact your doctor straight away if you suffer from diarrhoea during or after your treatment. do not take any medicine to treat your diarrhoea without first checking with your doctor. resistance to antibiotics bacteria can become resistant to treatment with antibiotics over time. this is when antibiotics cannot stop the growth of bacteria and treat your infection. your doctor will decide if you should be given sivextro to treat your infection. possible side effects certain side effects have been observed with another member of the oxazolidinone class when administered over a duration exceeding that recommended for sivextro. tell your doctor straight away if you suffer from any of the following while taking sivextro: a low white blood cell count anaemia (low red blood cells) bleeding or bruising easily loss of sensitivity in your hands or feet (such as numbness, prickling/tingling, or sharp pains) any problems with your eyesight such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted. children this medicine should not be used in children under 12 years of age as it has not been studied enough in this population. other medicines and sivextro tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. it is especially important that you tell your doctor if you are also taking: amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, isocarboxazid, lofepramine, moclobemide, paroxetine, phenelzine, selegiline and sertraline (used to treat depression) sumatriptan, zolmitriptan (used to treat migraine) imatinib, lapatinib (used to treat cancer) methotrexate (used to treat cancer, rheumatoid arthritis or psoriasis) sulfasalazine (used to treat inflammatory bowel diseases) topotecan (used to treat cancer) statins such as pitavastatin, rosuvastatin (used to lower blood cholesterol) sivextro can interfere with the effects of these medicines. your doctor will explain more. pregnancy and breast-feeding if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. it is not known if sivextro passes into breast milk in humans. ask your doctor for advice before breast-feeding your baby. driving and using machines do not drive or use machines if you feel dizzy or tired after taking this medicine.', 'Entity_Recognition': [{'Text': 'sivextro', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 2, 'BeginOffset': 12, 'EndOffset': 20, 'Score': 0.9863383173942566, 'Text': 'sivextro', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.8464428782463074}]}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 32, 'EndOffset': 40}, {'Id': 3, 'BeginOffset': 44, 'EndOffset': 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{'Title': '3. how to take sivextro', 'Section_Content': 'always take this medicine exactly as your doctor or pharmacist has told you. check with your doctor or pharmacist if you are not sure. the recommended dose is one 200 mg tablet once a day for 6 days. the tablets are swallowed whole and can be taken with or without food or drink. talk to a doctor if you do not feel better, or if you feel worse after 6 days. if you take more sivextro than you should contact your doctor, pharmacist or nearest hospital casualty department as soon as possible if you have taken more tablets than you should, and take your medicine with you. if you forget to take sivextro if you forget to take your medicine, take the dose as soon as possible anytime up to 8 hours prior to the next scheduled dose. if less than 8 hours remains before the next dose, then wait until the next scheduled dose. do not take a double dose to make up for a forgotten dose. if in any doubt, contact your pharmacist for advice. you should take all 6 tablets to complete your course of treatment, even if you have missed a dose. if you stop taking sivextro if you stop taking sivextro without the advice of your doctor, your symptoms may get worse. talk to your doctor or pharmacist before you stop taking your medicine. if you have any further questions on the use of this medicine, ask your doctor or pharmacist.', 'Entity_Recognition': [{'Text': 'sivextro', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 12, 'EndOffset': 25}, {'Text': '200', 'Type': 'NUMBER', 'BeginOffset': 163, 'EndOffset': 166}, {'Text': '6', 'Type': 'NUMBER', 'BeginOffset': 192, 'EndOffset': 193}, {'Text': '6', 'Type': 'NUMBER', 'BeginOffset': 351, 'EndOffset': 352}, {'Id': 4, 'BeginOffset': 376, 'EndOffset': 384, 'Score': 0.956061840057373, 'Text': 'sivextro', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Id': 5, 'BeginOffset': 596, 'EndOffset': 604, 'Score': 0.9859383702278137, 'Text': 'sivextro', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'your medicine', 'Type': 'TREATMENT', 'BeginOffset': 627, 'EndOffset': 640}, {'Text': '8', 'Type': 'NUMBER', 'BeginOffset': 690, 'EndOffset': 691}, {'Text': '8', 'Type': 'NUMBER', 'BeginOffset': 745, 'EndOffset': 746}, {'Text': 'a double dose', 'Type': 'TREATMENT', 'BeginOffset': 836, 'EndOffset': 849}, {'Text': '6', 'Type': 'NUMBER', 'BeginOffset': 956, 'EndOffset': 957}, {'Text': 'treatment', 'Type': 'TREATMENT', 'BeginOffset': 993, 'EndOffset': 1002}, {'Id': 6, 'BeginOffset': 1055, 'EndOffset': 1063, 'Score': 0.9881854057312012, 'Text': 'sivextro', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.4383464455604553}]}, {'Id': 7, 'BeginOffset': 1083, 'EndOffset': 1091, 'Score': 0.9886761903762817, 'Text': 'sivextro', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.5042559504508972}]}, {'Text': 'your symptoms', 'Type': 'PROBLEM', 'BeginOffset': 1127, 'EndOffset': 1140}, {'Text': 'your medicine', 'Type': 'TREATMENT', 'BeginOffset': 1213, 'EndOffset': 1226}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 1276, 'EndOffset': 1289}]}
{'Title': '4. possible side effects', 'Section_Content': "like all medicines, this medicine can cause side effects, although not everybody gets them. contact your doctor straight away if you suffer from diarrhoea during or after your treatment. other side effects may include: common side effects (may affect up to 1 in 10 people) nausea vomiting headache itching all over the body tiredness dizziness uncommon side effects (may affect up to 1 in 100 people) fungal infections of skin, mouth and vagina (oral / vaginal thrush) itching (including itching due to allergic reaction), hair loss, acne, red and/or itchy rash or hives, excessive sweating decrease or loss of skin sensitivity, tingling/prickling skin sensation hot flush or blushing/redness in the face, neck or upper chest abscess (swollen, pus-filled lump) vaginal infection, inflammation or itching anxiety, irritability, shaking or trembling respiratory tract (sinuses, throat and chest) infection dryness in the nose, congestion in the chest, cough sleepiness, abnormal sleep pattern, difficulty sleeping, nightmares (unpleasant/disturbing dreams) dry mouth, constipation, indigestion, pain/discomfort in the belly (abdomen), retching, dry heaving, bright red blood in the stool acid reflux disease (heartburn, pain or difficulty swallowing), flatulence/passing wind joint pain, muscle spasms, back pain, neck pain, pain/discomfort in limbs, decrease of grip strength 43 blurred vision, 'floaters' (small shapes seen floating in the field of vision) swollen or enlarged lymph nodes allergic reaction dehydration poor control of diabetes abnormal sense of taste slow heartbeat fever swelling in ankles and/or feet abnormal smelling urine, abnormal blood tests reporting of side effects if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side 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fever swelling in ankles and/or feet abnormal smelling urine', 'Type': 'PROBLEM', 'BeginOffset': 1568, 'EndOffset': 1643}, {'Id': 112, 'BeginOffset': 1645, 'EndOffset': 1691, 'Score': 0.5884062051773071, 'Text': 'abnormal blood tests reporting of side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.8843485713005066}]}, {'Id': 113, 'BeginOffset': 1707, 'EndOffset': 1719, 'Score': 0.923925518989563, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.8339008688926697}]}, {'Id': 114, 'BeginOffset': 1783, 'EndOffset': 1795, 'Score': 0.9593688249588013, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7569478154182434}]}, {'Id': 115, 'BeginOffset': 1844, 'EndOffset': 1856, 'Score': 0.8867183923721313, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 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{'Title': '5. how to store sivextro', 'Section_Content': 'keep this medicine out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the carton or blister label after "exp". the expiry date refers to the last day of that month. this medicinal product does not require any special storage conditions. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. these measures will help protect the environment.', 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': "what sivextro contains the active substance is tedizolid phosphate. each film-coated tablet contains 200 mg of tedizolid phosphate. the other ingredients are microcrystalline cellulose, mannitol, povidone, crospovidone and magnesium stearate within the tablet core. the film coat of the tablet contains polyvinyl alcohol, titanium dioxide (e171), macrogol, talc and yellow iron oxide (e172). what sivextro looks like and contents of the pack sivextro is an oval, yellow film-coated tablet imprinted with 'tzd' on one side and '200' on the other side. it is available in 6 × 1 tablets in perforated unit-dose blisters.", 'Entity_Recognition': [{'Text': 'sivextro', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 5, 'EndOffset': 13, 'Score': 0.8020591139793396, 'Text': 'sivextro', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Id': 1, 'BeginOffset': 47, 'EndOffset': 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