Ziextenzo
1 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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▼This medicinal product is subject to additional monitoring. This will allow quick identification of new 
safety information. Healthcare professionals are asked to report any suspected adverse reactions. See 
section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Ziextenzo 6 mg solution for injection in pre-filled syringe 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection. The 
concentration is 10 mg/mL based on protein only**. 
 
*Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with 
polyethylene glycol (PEG). 
** The concentration is 20 mg/mL if the PEG moiety is included. 
 
The potency of this product should not be compared to the potency of another pegylated or 
non-pegylated protein of the same therapeutic class. For more information, see section 5.1 
 
Excipients with known effect 
Each pre-filled syringe contains 30 mg sorbitol (E420). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection (injection) 
 
Clear, colourless to slightly yellowish solution for injection. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients 
treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia 
and myelodysplastic syndromes). 
 
4.2 Posology and method of administration 
 
Ziextenzo therapy should be initiated and supervised by physicians experienced in oncology and/or 
haematology. 
 
Posology 
 
One 6 mg dose (a single pre-filled syringe) of Ziextenzo is recommended for each chemotherapy cycle, 
given at least 24 hours after cytotoxic chemotherapy. 
 



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Special populations 
 
Paediatric population 
 
The safety and efficacy of pegfilgrastim in children has not yet been established. Currently available 
data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made. 
 
Patients with renal impairment 
 
No dose change is recommended in patients with renal impairment, including those with end stage renal 
disease. 
 
Method of administration 
 
Ziextenzo is for subcutaneous use. The injections should be given into the thigh, abdomen or upper arm. 
For instructions on handling 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 
 
Traceability 
 
In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the trade name 
of the administered product should be clearly recorded in the patient file. 
 
General warnings and precautions 
 
Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for 
pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (AML) (see section 5.1). 
However, the long-term effects of pegfilgrastim have not been established in AML; therefore, it should 
be used with caution in this patient population. 
 
Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects 
may be seen on some non-myeloid cells in vitro. 
 
The safety and efficacy of pegfilgrastim have not been investigated in patients with myelodysplastic 
syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should 
not be used in such patients. Particular care should be taken to distinguish the diagnosis of blast 
transformation of chronic myeloid leukaemia from AML. 
 
The safety and efficacy of pegfilgrastim administration in de novo AML patients aged < 55 years with 
cytogenetics t(15;17) have not been established. 
 
The safety and efficacy of pegfilgrastim have not been investigated in patients receiving high dose 
chemotherapy. This medicinal product should not be used to increase the dose of cytotoxic 
chemotherapy beyond established dosage regimens. 
 
Pulmonary adverse events 
 
Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF 
administration. Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher 
risk (see section 4.8). 
 



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The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs 
of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count 
may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS). In such circumstances 
pegfilgrastim should be discontinued at the discretion of the physician and the appropriate treatment 
given (see section 4.8). 
 
Glomerulonephritis 
 
Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim. Generally, 
events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim. 
Urinalysis monitoring is recommended. 
 
Capillary leak syndrome 
 
Capillary leak syndrome has been reported after granulocyte-colony stimulating factor administration 
and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. Patients who 
develop symptoms of capillary leak syndrome should be closely monitored and receive standard 
symptomatic treatment, which may include a need for intensive care (see section 4.8). 
 
Splenomegaly and splenic rupture 
 
Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, 
have been reported following administration of pegfilgrastim (see section 4.8). Therefore, spleen size 
should be carefully monitored (e.g. clinical examination, ultrasound). A diagnosis of splenic rupture 
should be considered in patients reporting left upper abdominal pain or shoulder tip pain. 
 
Thrombocytopenia and anaemia 
 
Treatment with pegfilgrastim alone does not preclude thrombocytopenia and anaemia because full dose 
myelosuppressive chemotherapy is maintained on the prescribed schedule. Regular monitoring of 
platelet count and haematocrit is recommended. Special care should be taken when administering single 
or combination chemotherapeutic agents which are known to cause severe thrombocytopenia. 
 
Sickle cell anaemia 
 
Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell trait or 
sickle cell disease (see section 4.8). Therefore, physicians should use caution when prescribing 
pegfilgrastim in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical 
parameters and laboratory status and be attentive to the possible association of this medicine with 
splenic enlargement and vaso-occlusive crisis. 
 
Leukocytosis 
 
White blood cell (WBC) counts of 100 x 109/L or greater have been observed in less than 1% of patients 
receiving pegfilgrastim. No adverse events directly attributable to this degree of leukocytosis have been 
reported. Such elevation in white blood cells is transient, typically seen 24 to 48 hours after 
administration and is consistent with the pharmacodynamic effects of this medicine. Consistent with the 
clinical effects and the potential for leukocytosis, a WBC count should be performed at regular intervals 
during therapy. If leukocyte counts exceed 50 x 109/L after the expected nadir, this medicine should be 
discontinued immediately. 
 
Hypersensitivity 
 
Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment has been 
reported in patients treated with pegfilgrastim. Permanently discontinue pegfilgrastim in patients with 
clinically significant hypersensitivity. Do not administer pegfilgrastim to patients with a history of 



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hypersensitivity to pegfilgrastim or filgrastim. If a serious allergic reaction occurs, appropriate therapy 
should be administered, with close patient follow-up over several days. 
 
Stevens-Johnson syndrome 
 
Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in 
association with pegfilgrastim treatment. If the patient has developed SJS with the use of pegfilgrastim, 
treatment with pegfilgrastim must not be restarted in this patient at any time.  
 
Immunogenicity 
 
As with all therapeutic proteins, there is a potential for immunogenicity. Rates of generation of 
antibodies against pegfilgrastim are generally low. Binding antibodies do occur as expected with all 
biologics; however, they have not been associated with neutralising activity at present. 
 
Aortitis 
 
Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients. The 
symptoms experienced included fever, abdominal pain, malaise, back pain and inflammatory markers 
(e.g. C-reactive protein and white blood cell count) were raised. In most cases aortitis was diagnosed by 
CT scan and generally resolved after withdrawal of G-CSF. See also section 4.8. 
 
Other warnings 
 
The safety and efficacy of pegfilgrastim for the mobilisation of blood progenitor cells in patients or 
healthy donors have not been adequately evaluated. 
 
Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been 
associated with transient positive bone-imaging findings. This should be considered when interpreting 
bone-imaging results. 
 
 
This medicinal product contains 30 mg sorbitol in each pre-filled syringe which is equivalent to 
50 mg / mL. The additive effect of concomitantly administered products containing sorbitol (or fructose) 
and dietary intake of sorbitol (or fructose) should be taken into account. 
 
This medicinal product contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say 
essentially ‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ 
pegfilgrastim should be administered at least 24 hours after administration of cytotoxic chemotherapy. In 
clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy. Concomitant 
use of pegfilgrastim with any chemotherapy agent has not been evaluated in patients. In animal models 
concomitant administration of pegfilgrastim and 5-fluorouracil (5-FU) or other antimetabolites has been 
shown to potentiate myelosuppression. 
 
Possible interactions with other haematopoietic growth factors and cytokines have not been specifically 
investigated in clinical trials. 
 
The potential for interaction with lithium, which also promotes the release of neutrophils, has not been 
specifically investigated. There is no evidence that such an interaction would be harmful. 
 
The safety and efficacy of pegfilgrastim have not been evaluated in patients receiving chemotherapy 
associated with delayed myelosuppression e.g. nitrosoureas. 
 



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Specific interaction or metabolism studies have not been performed, however, clinical trials have not 
indicated an interaction of pegfilgrastim with any other medicinal products. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of pegfilgrastim in pregnant women. Studies in 
animals have shown reproductive toxicity (see section 5.3). Pegfilgrastim is not recommended during 
pregnancy and in women of childbearing potential not using contraception. 
 
Breast-feeding 
 
There is insufficient information on the excretion of pegfilgrastim/metabolites in human milk, a risk to 
the newborns/infants cannot be excluded. A decision must be made whether to discontinue 
breast-feeding or to discontinue/abstain from pegfilgrastim therapy taking into account the benefit of 
breast-feeding for the child and the benefit of therapy for the woman. 
 
Fertility 
 
Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative 
weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body 
surface area) (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Pegfilgrastim has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and 
musculoskeletal pain (common [≥ 1/100 to < 1/10]). Bone pain was generally of mild to moderate 
severity, transient and could be controlled in most patients with standard analgesics. 
 
Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, 
flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon 
[≥ 1/1,000 to < 1/100]). Serious allergic reactions, including anaphylaxis can occur in patients receiving 
pegfilgrastim (uncommon) (see section 4.4). 
 
Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported as 
uncommon (≥ 1/1,000 to < 1/100) in cancer patients undergoing chemotherapy following administration 
of granulocyte colony-stimulating factors; see section 4.4 and section “Description of selected adverse 
reactions” below. 
 
Splenomegaly, generally asymptomatic, is uncommon. 
 
Splenic rupture including some fatal cases is uncommonly reported following administration of 
pegfilgrastim (see section 4.4). 
 
Uncommon pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema, 
pulmonary infiltrates and pulmonary fibrosis have been reported. Uncommonly, cases have resulted in 
respiratory failure or ARDS, which may be fatal (see section 4.4). 
 
Isolated cases of sickle cell crises have been reported in patients with sickle cell trait or sickle cell 
disease (uncommon in sickle cell patients) (see section 4.4). 



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Tabulated summary of adverse reactions 
 
The data in the table below describe adverse reactions reported from clinical trials and spontaneous 
reporting. Within each frequency grouping, undesirable effects are presented in order of decreasing 
seriousness. 
 
MedDRA 
system organ 
class 

Adverse reactions 
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) 

Blood and 
lymphatic 
system 
disorders 

 Thrombocytopenia1 
Leukocytosis1 

Sickle cell crisis2;  
Splenomegaly2; 
Splenic rupture2 

  

Immune system 
disorders 

  Hypersensitivity 
reactions; 
Anaphylaxis 

  

Metabolism 
and nutrition 
disorders 

  Elevations in uric 
acid 

  

Nervous system 
disorders 

Headache1     

Vascular 
disorders 

  Capillary leak 
syndrome1 

Aortitis  

Respiratory, 
thoracic and 
mediastinal 
disorders 

  Acute respiratory 
distress syndrome2; 
Pulmonary adverse 
reactions 
(interstitial 
pneumonia, 
pulmonary oedema, 
pulmonary 
infiltrates and 
pulmonary fibrosis) 
Haemoptysis 

Pulmonary 
haemorrhage 

 

Gastrointestinal 
disorders 

Nausea1     

Skin and 
subcutaneous 
tissue disorders 

  Sweet’s syndrome 
(acute febrile 
dermatosis)1,2; 
Cutaneous 
vasculitis1,2 

Stevens-
Johnson 
syndrome 

 

Musculoskeletal 
and connective 
tissue disorders 

Bone pain  
 

Musculoskeletal 
pain (myalgia, 
arthralgia, pain in 
extremity, back 
pain, musculo-
skeletal pain, neck 
pain) 

   

Renal and 
urinary 
disorders 

  Glomerulonephritis2    

General 
disorders and 

 Injection site pain1 
Non-cardiac chest 

Injection site 
reactions2  

  



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MedDRA 
system organ 
class 

Adverse reactions 
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) 

administrative 
site conditions 

pain  

Investigations   Elevations in lactate 
dehydrogenase and 
alkaline 
phosphatase1; 
Transient elevations 
in LFT's for ALT or 
AST1 

  

1 See section “Description of selected adverse reactions” below. 
2 This adverse reaction was identified through post-marketing surveillance but not observed in 
randomised, controlled clinical trials in adults. The frequency category was estimated from a statistical 
calculation based upon 1,576 patients receiving pegfilgrastim in nine randomised clinical trials. 
 
Description of selected adverse reactions 
 
Uncommon cases of Sweet’s syndrome have been reported, although in some cases underlying 
haematological malignancies may play a role. 
 
Uncommon events of cutaneous vasculitis have been reported in patients treated with pegfilgrastim. The 
mechanism of vasculitis in patients receiving pegfilgrastim is unknown. 
 
Injection site reactions, including injection site erythaema (uncommon) as well as injection site pain 
(common) have occurred on initial or subsequent treatment with pegfilgrastim. 
 
Common cases of leukocytosis (White Blood Count [WBC] > 100 x 109/L) have been reported (see 
section 4.4). 
 
Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical 
effects, were uncommon; reversible, mild to moderate elevations in lactate dehydrogenase, with no 
associated clinical effects, were uncommon in patients receiving pegfilgrastim following cytotoxic 
chemotherapy. 
 
Nausea and headaches were very commonly observed in patients receiving chemotherapy. 
 
Uncommon elevations in liver function tests (LFTs) for alanine aminotransferase (ALT) or aspartate 
aminotransferase (AST), have been observed in patients after receiving pegfilgrastim following 
cytotoxic chemotherapy. These elevations are transient and return to baseline. 
 
Common cases of thrombocytopenia have been reported. 
 
Cases of capillary leak syndrome have been reported in the post-marketing setting with granulocyte 
colony-stimulating factor use. These have generally occurred in patients with advanced malignant 
diseases, sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see 
section 4.4). 
 
Paediatric population 
 
The experience in children is limited. A higher frequency of serious adverse reactions in younger 
children aged 0-5 years (92%) has been observed compared to older children aged 6-11 and 12-21 years 
respectively (80% and 67%) and adults. The most common adverse reaction reported was bone pain (see 
section 5.1 and 5.2). 



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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 
 
Single doses of 300 mcg/kg have been administered subcutaneously to a limited number of healthy 
volunteers and patients with non-small cell lung cancer without serious adverse reactions. The adverse 
events were similar to those in subjects receiving lower doses of pegfilgrastim. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: immunostimulants, colony stimulating factor; ATC Code: L03AA13 
 
Ziextenzo is a biosimilar medicinal product. Detailed information is available on the website of the 
European Medicines Agency http://www.ema.europa.eu. 
 
Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production 
and release of neutrophils from the bone marrow. Pegfilgrastim is a covalent conjugate of recombinant 
human G-CSF (r-metHuG-CSF) with a single 20 kd polyethylene glycol (PEG) molecule. Pegfilgrastim 
is a sustained duration form of filgrastim due to decreased renal clearance. 
Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked 
increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes 
and/or lymphocytes. Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show 
normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function. As with 
other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human 
endothelial cells. G-CSF can promote growth of myeloid cells, including malignant cells, in vitro and 
similar effects may be seen on some non-myeloid cells in vitro. 
 
In two randomised, double-blind, pivotal studies in patients with high-risk stage II-IV breast cancer 
undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of 
pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of 
febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 
11 daily administrations). In the absence of growth factor support, this regimen has been reported to 
result in a mean duration of grade 4 neutropenia of 5 to7 days, and a 30-40% incidence of febrile 
neutropenia. In one study (n = 157), which used a 6 mg fixed dose of pegfilgrastim the mean duration of 
grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim 
group (difference 0.23 days, 95% CI -0.15, 0.63). Over the entire study, the rate of febrile neutropenia 
was 13% of pegfilgrastim-treated patients compared with 20% of filgrastim-treated patients (difference 
7%, 95% CI of -19%, 5%). In a second study (n = 310), which used a weight-adjusted dose (100 µg/kg), 
the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 
1.8 days in the filgrastim group (difference 0.03 days, 95% CI-0.36, 0.30). The overall rate of febrile 
neutropenia was 9% of patients treated with pegfilgrastim and 18% of patients treated with filgrastim 
(difference 9%, 95% CI of -16.8%, -1.1%). 
 
In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on 
the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen 
associated with a febrile neutropenia rate of 10-20% (docetaxel 100 mg/m2 every 3 weeks for 4 cycles). 
Nine hundred and twenty eight patients were randomised to receive either a single dose of pegfilgrastim 
or placebo approximately 24 hours (day 2) after chemotherapy in each cycle. The incidence of febrile 
neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1% 



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versus 17%, p < 0.001). The incidence of hospitalisations and IV anti-infective use associated with a 
clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo 
(1% versus 14%, p < 0.001; and 2% versus 10%, p < 0.001). 
 
A small (n = 83), Phase II, randomised, double-blind study in patients receiving chemotherapy for de 
novo acute myeloid leukaemia compared pegfilgrastim (single dose of 6 mg) with filgrastim, 
administered during induction chemotherapy. Median time to recovery from severe neutropenia was 
estimated as 22 days in both treatment groups. Long term outcome was not studied (see section 4.4). 
 
In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 
100 mcg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide 
(VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 x 109) was 
observed in younger children aged 0-5 years (8.9 days) compared to older children aged 6-11 years and 
12-21 years (6 days and 3.7 days, respectively) and adults. Additionally a higher incidence of febrile 
neutropenia was observed in younger children aged 0-5 years (75%) compared to older children aged 
6-11 years and 12-21 years (70% and 33%, respectively) and adults (see sections 4.8 and 5.2). 
 
5.2 Pharmacokinetic properties 
 
After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim occurs 
at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the 
period of neutropenia after myelosuppressive chemotherapy. The elimination of pegfilgrastim is 
non-linear with respect to dose; serum clearance of pegfilgrastim decreases with increasing dose. 
Pegfilgrastim appears to be mainly eliminated by neutrophil mediated clearance, which becomes 
saturated at higher doses. Consistent with a self-regulating clearance mechanism, the serum 
concentration of pegfilgrastim declines rapidly at the onset of neutrophil recovery (see Figure 1). 
 

Figure 1. Profile of median pegfilgrastim serum concentration and absolute neutrophil count 
(ANC) in chemotherapy treated patients after a single 6 mg injection 

 
 
Due to the neutrophil-mediated clearance mechanism, the pharmacokinetics of pegfilgrastim is not 
expected to be affected by renal or hepatic impairment. In an open-label, single dose study (n = 31) 
various stages of renal impairment, including end-stage renal disease, had no impact on the 
pharmacokinetics of pegfilgrastim. 
 



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Elderly 
 
Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects (> 65 years) is 
similar to that in adults. 
 
Paediatric population 
 
The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who 
received 100 mcg/kg pegfilgrastim after the completion of VAdriaC/IE chemotherapy. The youngest age 
group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) 
(47.9 ± 22.5 mcg·hr/ml) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 mcg hr/ml and 
29.3 ± 23.2 mcg·hr/ml, respectively) (see section 5.1). With the exception of the youngest age group 
(0-5 years), the mean AUC in paediatric subjects appeared similar to that for adult patients with 
high-risk stage II-IV breast cancer and receiving 100 mcg/kg pegfilgrastim after the completion of 
doxorubicin/docetaxel (see sections 4.8 and 5.1). 
 
5.3 Preclinical safety data 
 
Preclinical data from conventional studies of repeated dose toxicity revealed the expected 
pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, 
extramedullary haematopoiesis and splenic enlargement. 
 
There were no adverse effects observed in offspring from pregnant rats given pegfilgrastim 
subcutaneously, but in rabbits pegfilgrastim has been shown to cause embryo/foetal toxicity (embryo 
loss) at cumulative doses approximately 4 times the recommended human dose, which were not seen 
when pregnant rabbits were exposed to the recommended human dose. In rat studies, it was shown that 
pegfilgrastim may cross the placenta. Studies in rats indicated that reproductive performance, fertility, 
oestrous cycling, days between pairing and coitus, and intrauterine survival were unaffected by 
pegfilgrastim given subcutaneously. The relevance of these findings for humans is not known. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Glacial acetic acid 
Sorbitol (E420) 
Polysorbate 20 
Sodium hydroxide (for pH adjustment) 
Water for injections 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products, particularly with sodium 
chloride solutions. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2 °C–8 °C). 
 
Ziextenzo may be exposed to room temperature (not above 35 °C) for a maximum single period of up to 
120 hours. Ziextenzo left at room temperature for more than 120 hours should be discarded. 
 



12 
 

Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours 
does not adversely affect the stability of Ziextenzo. 
 
Keep the container in the outer carton in order to protect from light. 
 
6.5 Nature and contents of container 
 
Pre-filled syringe (Type I glass), with a rubber plunger stopper, a plunger rod, a stainless steel needle 
and a rubber needle cap with an automatic needle guard. 
 
Each pre-filled syringe contains 0.6 ml of solution for injection. 
Pack size of one pre-filled syringe in a blistered packaging. 
 
6.6 Special precautions for disposal and other handling 
 
Before use, Ziextenzo solution should be inspected visually for particulate matter. Only a solution that is 
clear and colourless to slightly yellowish should be injected. 
 
Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive.  
 
Allow the pre-filled syringe to reach room temperature before injecting. 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestr. 10 
6250 Kundl 
Austria 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/18/1327/001 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 22 November 2018 
 
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. 



13 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 

 
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER 

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 



14 
 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

Name and address of the manufacturers of the biological active substance 

LEK Pharmaceuticals d.d. 
Kolodvorska Cesta 27 
1234 Menges 
Slovenia 
 
Sandoz GmbH 
Biochemiestr. 10 
6250 Kundl 
Austria 
 
Name and address of the manufacturer responsible for batch release 

Sandoz GmbH 
Schaftenau 
Biochemiestr. 10 
6336 Langkampfen 
Austria 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION  

 

• Periodic safety update reports  

The requirements for submission of periodic safety update reports 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 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 agreeed subsequent 
updates of the RMP. 



15 
 

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.  



16 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



17 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



18 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Ziextenzo 6 mg solution for injection in pre-filled syringe 
pegfilgrastim 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: glacial acetic acid, sorbitol (E420), polysorbate 20, sodium hydroxide, water for injections. 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
1 pre-filled syringe with automatic needle guard containing 0.6 mL solution for injection. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Important: Read the package leaflet before handling the pre-filled syringe. 
Single use. 
Subcutaneous 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 
 
Avoid vigorous shaking. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



19 
 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Keep the container in the outer carton in order to protect from light. 
 
 
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 
 
Sandoz GmbH 
Biochemiestr. 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/18/1327/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Ziextenzo 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 
 



20 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS 
 
BLISTER  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Ziextenzo 6 mg injection 
pegfilgrastim 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
SC 
 

 



21 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SYRINGE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Ziextenzo 6 mg injection  
pegfilgrastim 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
6. OTHER 
 
 



22 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



23 
 

 
Package leaflet: Information for the user 

 
Ziextenzo 6 mg solution for injection in pre-filled syringe 

pegfilgrastim 
 
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety 
information. You can help by reporting any side effects you may get. See the end of section 4 for how to 
report side effects. 
 
Read all of this leaflet carefully before you start using 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, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

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

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Ziextenzo is and what it is used for 
2. What you need to know before you use Ziextenzo 
3. How to use Ziextenzo 
4. Possible side effects 
5. How to store Ziextenzo 
6. Contents of the pack and other information 
 
 
1. What Ziextenzo is and what it is used for 
 
Ziextenzo contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by 
biotechnology in bacteria called E. coli. It belongs to a group of proteins called cytokines, and is very 
similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body. 
 
Ziextenzo is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence 
of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of 
cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are important 
as they help your body fight infection. These cells are very sensitive to the effects of chemotherapy 
which can cause the number of these cells in your body to decrease. If white blood cells fall to a low 
level there may not be enough left in the body to fight bacteria and you may have an increased risk of 
infection. 
 
Your doctor has given you Ziextenzo to encourage your bone marrow (part of the bone which makes 
blood cells) to produce more white blood cells that help your body fight infection. 
 
 
2. What you need to know before you use Ziextenzo 
 
Do not use Ziextenzo  
 
• if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine 

(listed in section 6). 
 



24 
 

Warnings and precautions 
Talk to your doctor, pharmacist or nurse before using Ziextenzo: 
 
• if you experience an allergic reaction including weakness, drop in blood pressure, difficulty 

breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the skin 
that itch. 

• if you experience a cough, fever and difficulty breathing. This can be a sign of Acute Respiratory 
Distress Syndrome (ARDS). 

• if you have any of the following or combination of the following side effects: 
- swelling or puffiness, which may be associated with passing water less frequently, 

difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of 
tiredness 

 These could be symptoms of condition called “Capillary Leak Syndrome” which causes blood to 
leak from the small blood vessels into your body. See section 4. 

• if you get left upper abdominal pain or pain at the tip of your shoulder. This may be a sign of a 
problem with your spleen (splenomegaly). 

• if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary 
oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung 
infiltration). 

• if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or 
decreased blood platelet counts, which reduces the ability of your blood to clot 
(thrombocytopenia). Your doctor may want to monitor you more closely. 

• if you have sickle cell anaemia. Your doctor may monitor your condition more closely. 
• if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, 

lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing these 
could be signs of a severe allergic reaction. 

• Inflammation of the aorta (the large blood vessel which transports blood from the heart to the 
body) has been reported rarely in cancer patients and healthy donors. The symptoms can include 
fever, abdominal pain, malaise, back pain and increased inflammatory markers. Tell your doctor 
if you experience these symptoms. 

 
Your doctor will check your blood and urine regularly as pegfilgrastim can harm the tiny filters inside 
your kidneys (glomerulonephritis). 
 
Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Ziextenzo. Stop 
using Ziextenzo and seek medical attention immediately if you notice any of the symptoms described in 
section 4. 
 
You should talk to your doctor about your risks of developing cancers of the blood. If you develop or 
are likely to develop cancers of the blood, you should not use Ziextenzo, unless instructed by your 
doctor. 
 
Loss of response to pegfilgrastim 
 
If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your 
doctor will investigate the reasons why, including whether you have developed antibodies which 
neutralise pegfilgrastim’s activity. 
 
Other medicines and Ziextenzo 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
 



25 
 

Pregnancy and breast-feeding 
 
Ask your doctor or pharmacist for advice before taking any medicine. Pegfilgrastim has not been tested 
in pregnant women. It is important to tell your doctor if you: 
• are pregnant; 
• think you may be pregnant; or 
• are planning to have a baby. 
 
If you become pregnant during Ziextenzo treatment, please inform your doctor.  
 
Unless your doctor directs you otherwise, you must stop breast-feeding if you use Ziextenzo. 
 
Driving and using machines 
 
Ziextenzo has no or negligible effect on the ability to drive or use machines. 
 
Ziextenzo contains sorbitol (E420) and sodium 
 
This medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / mL. 
 
This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially 
‘sodium-free’. 
 
 
3. How to use Ziextenzo 
 
Ziextenzo is for use in adults aged 18 and over. 
 
Always use Ziextenzo exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are unsure. The usual dose is one 6 mg subcutaneous injection (injection under your 
skin) using a pre-filled syringe and it should be given at least 24 hours after your last dose of 
chemotherapy at the end of each chemotherapy cycle. 
 
Injecting Ziextenzo yourself 
 
Your doctor may decide that it would be more convenient for you to inject Ziextenzo yourself. Your 
doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been 
trained. 
 
For further instructions on how to inject yourself with Ziextenzo, please read the section at the end of 
this leaflet. 
 
Do not shake Ziextenzo vigorously as this may affect its activity. 
 
If you use more Ziextenzo than you should 
 
If you use more Ziextenzo than you should contact your doctor, pharmacist or nurse. 
 
If you forget to inject Ziextenzo 
 
If you are injecting yourself and have forgotten a dose of Ziextenzo, you should contact your doctor to 
discuss when you should inject the next dose. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 



26 
 

4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Please tell your doctor immediately if you have any of the following or combination of the following 
side effects: 
• swelling or puffiness, which may be associated with passing water less frequently, difficulty 

breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. These 
symptoms generally develop in a rapid fashion. 

 
These could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called 
“Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body and 
needs urgent medical attention. 
 
Very common side effects (may affect more than 1 in 10 people): 
• bone pain. Your doctor will tell you what you can take to ease the bone pain. 
• nausea and headaches. 
 
Common side effects (may affect up to 1 in 10 people): 
• pain at the site of injection. 
• general aches and pains in the joints and muscles. 
• some changes may occur in your blood, but these will be detected by routine blood tests. Your 

white blood cell count may become high for a short period of time. Your platelet count may 
become low which might result in bruising. 

 
Uncommon side effects (may affect up to 1 in 100 people): 
• allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin that 

itch. 
• serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty 

breathing, swelling of the face). 
• increased spleen size. 
• spleen rupture. Some cases of splenic rupture were fatal. It is important that you contact your 

doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder 
pain since this may relate to a problem with your spleen. 

• breathing problems. If you have a cough, fever and difficulty breathing please tell your doctor. 
• Sweet’s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face 

and neck with fever) has occurred but other factors may play a role. 
• cutaneous vasculitis (inflammation of the blood vessels in the skin). 
• damage to the tiny filters inside your kidneys (glomerulonephritis). 
• redness at the site of injection. 
• coughing up blood (haemoptysis) 
 
Rare side effects (may affect up to 1 in 1,000 people): 
• inflammation of the aorta (the large blood vessel which transports blood from the heart to the 

body), see section 2. 
• bleeding from the lung (pulmonary haemorrhage). 
• Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with 

central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can 
be preceded by fever and flu-like symptoms. Stop using Ziextenzo if you develop these symptoms 
and contact your doctor or seek medical attention immediately. See also section 2. 

 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist 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. 
 



27 
 

 
5. How to store Ziextenzo 
 
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 and on the syringe label after 
EXP. The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2 °C – 8 °C). 
 
You may take Ziextenzo out of the refrigerator and keep it at room temperature (not above 35 °C) for no 
longer than 120 hours. Once a syringe has been removed from the refrigerator and has reached room 
temperature (not above 35 °C) it must either be used within 120 hours or disposed of. 
 
Do not freeze. Ziextenzo may be used if it is accidentally frozen for a single period of less than 24 
hours. 
 
Keep the container in the outer carton in order to protect from light. 
 
Do not use this medicine if you notice it is cloudy or there are particles in it. 
 
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 to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Ziextenzo contains 
- The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 

0.6 mL of solution. 
- The other ingredients are glacial acetic acid, sorbitol (E420), polysorbate 20, sodium hydroxide 

and water for injections. See section 2 “Ziextenzo contains sorbitol (E420) and sodium”. 
 
What Ziextenzo looks like and contents of the pack 
Ziextenzo is a clear, colourless to slightly yellowish solution for injection in a pre-filled syringe 
(6 mg/0.6 mL). 
 
Each pack contains 1 glass pre-filled syringe with a rubber plunger stopper, a plunger rod, an attached 
stainless steel needle and needle cap. The syringes are provided with an automatic needle guard. 
 
Marketing Authorisation Holder  
 
Sandoz GmbH 
Biochemiestr. 10 
6250 Kundl 
Austria 
 
Manufacturer 
 
Sandoz GmbH 
Biochemiestr. 10 
6336 Langkampfen 
Austria 
 
 
This leaflet was last revised in {MM/YYYY}. 
 



28 
 

Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
This leaflet is available in all EU/EEA languages on the European Medicines Agency website. 



29 
 

Instructions for use of Ziextenzo pre-filled syringe 
 
To help avoid possible infections and to ensure that you use the medicine correctly, it is important that 
you follow these instructions. 
 
Read ALL the way through these instructions before injecting. It is important not to try to inject yourself 
until you have been trained by your doctor, nurse or pharmacist. The carton contains the pre-filled 
syringe individually sealed in a plastic blister. 
 
Your Ziextenzo pre-filled syringe with needle guard 

 
After the medicine has been injected, the needle guard will be activated to cover the needle. The needle 
guard is intended to protect healthcare professionals, caregivers and patients from accidental needle 
sticks after the injection. 
 
What you additionally need for 
your injection: 
• Alcohol swab. 
• Cotton ball or gauze. 
• Sharps disposal container. 

 
Important safety information 
Caution: Keep the pre-filled syringe out of the sight and reach of children. 
1. Do not open the carton until you are ready to use the pre-filled syringe. 
2. Do not use the pre-filled syringe if the seal of the blister is broken, as it may not be safe for you to 

use. 
3. Never leave the pre-filled syringe unattended where others might tamper with it. 
4. Do not shake the pre-filled syringe. 
5. Be careful not to touch the needle guard wings before use. By touching them, the needle guard 

may be activated too early. 
6. Do not remove the needle cap until just before you give the injection. 
7. The pre-filled syringe cannot be re-used. Dispose of the used pre-filled syringe immediately after 

use in a sharps container. 
 



30 
 

Storage of the Ziextenzo pre-filled syringe 
1. Store the blistered pre-filled syringe in its carton to protect it from light.  
2. Store in the refrigerator between 2 °C and 8 °C. Do not freeze. 
3. Prior to use‚ remove the pre-filled syringe from the refrigerator and allow Ziextenzo to reach 

room temperature (up to a maximum of 35 °C) for approximately 15-30 minutes. 
4. Do not use the pre-filled syringe after the expiry date which is stated on the carton or syringe 

label. If it has expired, return the entire pack to the pharmacy. 
 
The injection site 

 

The injection site is the place on the body where you are 
going to use the pre-filled syringe. 
• The recommended site is the front of your thighs. You 

may also use the lower abdomen, but not the area 
5 centimetres around the navel (belly button).  

• Choose a different site each time you give yourself an 
injection. 

• Do not inject into areas where the skin is tender, 
bruised, red, scaly or hard. Avoid areas with scars or 
stretch marks. 

 

If a caregiver is giving you the injection, the outer upper 
arms may also be used. 

 
Preparing the Ziextenzo pre-filled syringe ready for use 
1. Take the carton containing the blistered pre-filled syringe out of the refrigerator and leave it 

unopened for approximately 15-30 minutes so that it reaches room temperature. 
2. When you are ready to use the pre-filled syringe, open the blister and wash your hands thoroughly 

with soap and water. 
3. Clean the injection site with an alcohol swab. 
4. Remove the pre-filled syringe from the blister. Check to ensure the plastic transparent needle 

guard is situated over the barrel of the glass syringe. If the transparent needle guard is covering 
the needle cap (as shown below) the syringe has been activated, DO NOT use this syringe and 
take a new syringe. The figure below shows a ready to use syringe.  

5. Inspect the pre-filled syringe. The liquid should be clear. Its colour may vary from colourless to 
slightly yellowish. You may see a small air bubble in the liquid. This is normal. Do not use the 
pre-filled syringe if any other particulates and/or discolouration are observed.  

6. Do not use if the syringe is broken or activated. Return the Ziextenzo pre-filled syringe and the 
package to your pharmacy. 

 
Device ACTIVATED – DO NOT USE 

 

In this configuration the needle guard is 
ACTIVATED – DO NOT USE the pre-filled syringe 

 

Device READY TO BE USED 

 

In this configuration the needle guard is NOT 
ACTIVATED and the pre-filled syringe is ready for 
use 



31 
 

 
 

How to use the Ziextenzo pre-filled syringe 

1 

 

Carefully pull the needle cap straight off. You may 
see a drop of liquid at the end of the needle. This 
is normal.  

2 

 

Gently pinch the skin at the injection site and insert 
the needle as shown. Push the needle all the way in 
to ensure that the medicine can be fully 
administered. 

3 

 

Holding the pre-filled syringe as shown, slowly depress 
the plunger as far as it will go so that the plunger head 
is completely between the needle guard wings. 
Keep the plunger pressed fully down while you hold the 
syringe in place for 5 seconds.  

 

4 

 

Keep the plunger fully depressed while you carefully 
pull the needle straight out from the injection site and 
let it go off your skin. 

 



32 
 

5 

 

Slowly release the plunger and allow the syringe needle 
guard to automatically cover the exposed needle.  
 
There may be a small amount of blood at the injection 
site. You can press a cotton ball or gauze onto the 
injection site and hold it for 10 seconds. Do not rub the 
injection site. You may cover the injection site with a 
small adhesive bandage, if needed. 

 
6 

 

 
Healthcare providers only 
The trade name of the administered product 
should be clearly recorded in the patient file. 
Remove and save the pre-filled syringe label. 
Turn the plunger to move the label into a position 
where you can remove the syringe label. 

 
Disposal instructions 
 

 

Dispose of the used syringe in a sharps container 
(closable, puncture resistant container). 
 
Do not throw away any medicines via wastewater or 
household waste. Ask your doctor or pharmacist how to 
throw away medicines you no longer use. These 
measures will help protect the environment. Any unused 
product or waste material should be disposed of in 
accordance with local requirements. 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER 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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'EndOffset': 521, 'Score': 0.911335289478302, 'Text': 'cytotoxic chemotherapy', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Text': 'medicines', 'Type': 'TREATMENT', 'BeginOffset': 523, 'EndOffset': 532}, {'Id': 18, 'BeginOffset': 570, 'EndOffset': 587, 'Score': 0.4147479832172394, 'Text': 'white blood cells', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Text': 'your body fight infection', 'Type': 'PROBLEM', 'BeginOffset': 615, 'EndOffset': 640}, {'Text': 'these cells', 'Type': 'PROBLEM', 'BeginOffset': 642, 'EndOffset': 653}, {'Id': 19, 'BeginOffset': 691, 'EndOffset': 703, 'Score': 0.9233075380325317, 'Text': 'chemotherapy', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Id': 20, 'BeginOffset': 775, 'EndOffset': 792, 'Score': 0.39078885316848755, 'Text': 'white blood cells', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TEST_NAME', 'Traits': [], 'Attributes': [{'Type': 'TEST_VALUE', 'Score': 0.5621477961540222, 'RelationshipScore': 0.9999687671661377, 'RelationshipType': 'TEST_VALUE', 'Id': 21, 'BeginOffset': 803, 'EndOffset': 806, 'Text': 'low', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Traits': []}]}, {'Text': 'fight bacteria', 'Type': 'PROBLEM', 'BeginOffset': 857, 'EndOffset': 871}, {'Id': 12, 'BeginOffset': 910, 'EndOffset': 919, 'Score': 0.9828333854675293, 'Text': 'infection', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.7978677153587341}]}, {'Id': 6, 'BeginOffset': 947, 'EndOffset': 956, 'Score': 0.767083466053009, 'Text': 'ziextenzo', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'your bone marrow', 'Type': 'PROBLEM', 'BeginOffset': 970, 'EndOffset': 986}, {'Id': 1, 'BeginOffset': 1000, 'EndOffset': 1004, 'Score': 0.774682879447937, 'Text': 'bone', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 23, 'BeginOffset': 1017, 'EndOffset': 1028, 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{'Title': '2. what you need to know before you use ziextenzo', 'Section_Content': 'do not use ziextenzo if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine (listed in section 6). warnings and precautions talk to your doctor, pharmacist or nurse before using ziextenzo: if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the skin that itch. if you experience a cough, fever and difficulty breathing. this can be a sign of acute respiratory distress syndrome (ards). if you have any of the following or combination of the following side effects: - swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness these could be symptoms of condition called "capillary leak syndrome" which causes blood to leak from the small blood vessels into your body. see section 4. if you get left upper abdominal pain or pain at the tip of your shoulder. this may be a sign of a problem with your spleen (splenomegaly). if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration). if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or decreased blood platelet counts, which reduces the ability of your blood to clot (thrombocytopenia). your doctor may want to monitor you more closely. if you have sickle cell anaemia. your doctor may monitor your condition more closely. if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing these could be signs of a severe allergic reaction. inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors. the symptoms can include fever, abdominal pain, malaise, back pain and increased inflammatory markers. tell your doctor if you experience these symptoms. your doctor will check your blood and urine regularly as pegfilgrastim can harm the tiny filters inside your kidneys (glomerulonephritis). severe skin reactions (stevens-johnson syndrome) have been reported with the use of ziextenzo. stop using ziextenzo and seek medical attention immediately if you notice any of the symptoms described in section 4. you should talk to your doctor about your risks of developing cancers of the blood. if you develop or are likely to develop cancers of the blood, you should not use ziextenzo, unless instructed by your doctor. loss of response to pegfilgrastim if you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your doctor will investigate the reasons why, including whether you have developed antibodies which neutralise pegfilgrastim\'s activity. other medicines and ziextenzo tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. pregnancy and breast-feeding ask your doctor or pharmacist for advice before taking any medicine. pegfilgrastim has not been tested in pregnant women. it is important to tell your doctor if you: are pregnant; think you may be pregnant; or are planning to have a baby. if you become pregnant during ziextenzo treatment, please inform your doctor. unless your doctor directs you otherwise, you must stop breast-feeding if you use ziextenzo. driving and using machines ziextenzo has no or negligible effect on the ability to drive or use machines. ziextenzo contains sorbitol (e420) and sodium this medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / ml. this 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{'Title': '3. how to use ziextenzo', 'Section_Content': 'ziextenzo is for use in adults aged 18 and over. always use ziextenzo exactly as your doctor has told you. you should check with your doctor or pharmacist if you are unsure. the usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle. injecting ziextenzo yourself your doctor may decide that it would be more convenient for you to inject ziextenzo yourself. your doctor or nurse will show you how to inject yourself. do not try to inject yourself if you have not been trained. for further instructions on how to inject yourself with ziextenzo, please read the section at the end of this leaflet. do not shake ziextenzo vigorously as this may affect its activity. if you use more ziextenzo than you should if you use more ziextenzo than you should contact your doctor, pharmacist or nurse. if you forget to inject ziextenzo if you are injecting yourself and have forgotten a dose of ziextenzo, you should contact your doctor to discuss when you should inject the next dose. if you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.', 'Entity_Recognition': [{'Text': 'ziextenzo', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 1, 'BeginOffset': 0, 'EndOffset': 9, 'Score': 0.7498564124107361, 'Text': 'ziextenzo', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': '18', 'Type': 'NUMBER', 'BeginOffset': 36, 'EndOffset': 38}, {'Text': '6', 'Type': 'NUMBER', 'BeginOffset': 196, 'EndOffset': 197}, {'Id': 0, 'BeginOffset': 246, 'EndOffset': 250, 'Score': 0.9413186311721802, 'Text': 'skin', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': 'a pre-filled syringe', 'Type': 'TREATMENT', 'BeginOffset': 258, 'EndOffset': 278}, {'Text': '24', 'Type': 'NUMBER', 'BeginOffset': 311, 'EndOffset': 313}, {'Id': 7, 'BeginOffset': 344, 'EndOffset': 356, 'Score': 0.8585302233695984, 'Text': 'chemotherapy', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Text': 'each chemotherapy cycle', 'Type': 'TREATMENT', 'BeginOffset': 371, 'EndOffset': 394}, {'Text': 'ziextenzo', 'Type': 'TREATMENT', 'BeginOffset': 694, 'EndOffset': 703}, {'Id': 4, 'BeginOffset': 974, 'EndOffset': 983, 'Score': 0.44832712411880493, 'Text': 'ziextenzo', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 5, 'BeginOffset': 1043, 'EndOffset': 1052, 'Score': 0.8499672412872314, 'Text': 'ziextenzo', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 1182, 'EndOffset': 1195}]}
{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. please tell your doctor immediately if you have any of the following or combination of the following side effects: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. these symptoms generally develop in a rapid fashion. these could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called "capillary leak syndrome" which causes blood to leak from the small blood vessels into your body and needs urgent medical attention. very common side effects (may affect more than 1 in 10 people): bone pain. your doctor will tell you what you can take to ease the bone pain. nausea and headaches. common side effects (may affect up to 1 in 10 people): pain at the site of injection. general aches and pains in the joints and muscles. some changes may occur in your blood, but these will be detected by routine blood tests. your white blood cell count may become high for a short period of time. your platelet count may become low which might result in bruising. uncommon side effects (may affect up to 1 in 100 people): allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin that itch. serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face). increased spleen size. spleen rupture. some cases of splenic rupture were fatal. it is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen. breathing problems. if you have a cough, fever and difficulty breathing please tell your doctor. sweet\'s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred but other factors may play a role. cutaneous vasculitis (inflammation of the blood vessels in the skin). damage to the tiny filters inside your kidneys (glomerulonephritis). redness at the site of injection. coughing up blood (haemoptysis) rare side effects (may affect up to 1 in 1,000 people): inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2. bleeding from the lung (pulmonary haemorrhage). stevens-johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. stop using ziextenzo if you develop these symptoms and contact your doctor or seek medical attention immediately. see also section 2. reporting of side effects if you get any side effects, talk to your doctor, pharmacist or nurse. this 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{'Title': '5. how to store ziextenzo', '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 and on the syringe label after exp. the expiry date refers to the last day of that month. store in a refrigerator (2 8 ). you may take ziextenzo out of the refrigerator and keep it at room temperature (not above 35 ) for no longer than 120 hours. once a syringe has been removed from the refrigerator and has reached room temperature (not above 35 ) it must either be used within 120 hours or disposed of. do not freeze. ziextenzo may be used if it is accidentally frozen for a single period of less than 24 hours. keep the container in the outer carton in order to protect from light. do not use this medicine if you notice it is cloudy or there are particles in it. 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 to protect the environment.', 'Entity_Recognition': [{'Text': 'ziextenzo', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 83}, {'Text': '8', 'Type': 'NUMBER', 'BeginOffset': 253, 'EndOffset': 254}, {'Text': 'ziextenzo', 'Type': 'TREATMENT', 'BeginOffset': 271, 'EndOffset': 280}, {'Text': '35', 'Type': 'NUMBER', 'BeginOffset': 348, 'EndOffset': 350}, {'Text': '120', 'Type': 'NUMBER', 'BeginOffset': 372, 'EndOffset': 375}, {'Text': 'a syringe', 'Type': 'TREATMENT', 'BeginOffset': 388, 'EndOffset': 397}, {'Text': '35', 'Type': 'NUMBER', 'BeginOffset': 481, 'EndOffset': 483}, {'Text': '120', 'Type': 'NUMBER', 'BeginOffset': 516, 'EndOffset': 519}, {'Text': 'ziextenzo', 'Type': 'TREATMENT', 'BeginOffset': 557, 'EndOffset': 566}, {'Text': '24', 'Type': 'NUMBER', 'BeginOffset': 641, 'EndOffset': 643}, {'Text': 'the outer carton', 'Type': 'TREATMENT', 'BeginOffset': 673, 'EndOffset': 689}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 733, 'EndOffset': 746}, {'Text': 'cloudy', 'Type': 'PROBLEM', 'BeginOffset': 767, 'EndOffset': 773}, {'Text': 'these measures', 'Type': 'TREATMENT', 'BeginOffset': 938, 'EndOffset': 952}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what ziextenzo contains - the active substance is pegfilgrastim. each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution. - the other ingredients are glacial acetic acid, sorbitol (e420), polysorbate 20, sodium hydroxide and water for injections. see section 2 "ziextenzo contains sorbitol (e420) and sodium". what ziextenzo looks like and contents of the pack ziextenzo is a clear, colourless to slightly yellowish solution for injection in a pre-filled syringe (6 mg/0.6 ml). each pack contains 1 glass pre-filled syringe with a rubber plunger stopper, a plunger rod, an attached stainless steel needle and needle cap. the syringes are provided with an automatic needle guard.', 'Entity_Recognition': [{'Text': 'ziextenzo', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 50, 'EndOffset': 63, 'Score': 0.9857485890388489, 'Text': 'pegfilgrastim', 'Category': 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