Steglatro
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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

Steglatro 5 mg film-coated tablets
Steglatro 15 mg film-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Steglatro 5 mg film-coated tablets
Each tablet contains 5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).

Excipient(s) with known effect
Each tablet contains 28 mg of lactose (as monohydrate).

Steglatro 15 mg film-coated tablets
Each tablet contains 15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).

Excipient(s) with known effect
Each tablet contains 85 mg of lactose (as monohydrate).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablet (tablet).

Steglatro 5 mg film-coated tablets
Pink, 6.4 x 6.6 mm, triangular-shaped, film-coated tablets debossed with “701” on one side and plain 
on the other side.

Steglatro 15 mg film-coated tablets
Red, 9.0 x 9.4 mm, triangular-shaped, film-coated tablets debossed with “702” on one side and plain 
on the other side.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Steglatro is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to 
diet and exercise to improve glycaemic control:
 as monotherapy in patients for whom the use of metformin is considered inappropriate due to 

intolerance or contraindications.
 in addition to other medicinal products for the treatment of diabetes.

(For study results with respect to combinations and effects on glycaemic control see sections 4.4, 4.5, 
and 5.1.)

 



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4.2 Posology and method of administration

Posology
The recommended starting dose of ertugliflozin is 5 mg once daily. In patients tolerating ertugliflozin
5 mg once daily, the dose can be increased to 15 mg once daily if additional glycaemic control is 
needed.

When ertugliflozin is used in combination with insulin or an insulin secretagogue, a lower dose of 
insulin or the insulin secretagogue may be required to reduce the risk of hypoglycaemia (see 
sections 4.4, 4.5, and 4.8).

In patients with volume depletion, correcting this condition prior to initiation of ertugliflozin is 
recommended (see section 4.4).

If a dose is missed, it should be taken as soon as the patient remembers. Patients should not take two 
doses of Steglatro on the same day.

Special populations

Renal impairment
Assessment of renal function is recommended prior to initiation of Steglatro and periodically 
thereafter (see section 4.4).

Initiation of this medicinal product is not recommended in patients with an estimated glomerular 
filtration rate (eGFR) less than 60 ml/min/1.73 m2 or CrCl less than 60 ml/min (see section 4.4). 

Steglatro should be discontinued when eGFR is persistently less than 45 ml/min/1.73 m2 or CrCl is 
persistently less than 45 ml/min.

Steglatro should not be used in patients with severe renal impairment, with end-stage renal disease 
(ESRD), or receiving dialysis, as it is not expected to be effective in these patients.

Hepatic impairment
No dose adjustment of ertugliflozin is necessary in patients with mild or moderate hepatic impairment. 
Ertugliflozin has not been studied in patients with severe hepatic impairment and is not recommended 
for use in these patients (see section 5.2).

Elderly (≥ 65 years old)
No dose adjustment of ertugliflozin is recommended based on age. Renal function and risk of volume 
depletion should be taken into account (see sections 4.4 and 4.8). There is limited experience with 
Steglatro in patients ≥ 75 years of age.

Paediatric population 
The safety and efficacy of ertugliflozin in children under 18 years of age have not been established. 
No data are available.

Method of administration 
Steglatro should be taken orally once daily in the morning, with or without food. In case of 
swallowing difficulties, the tablet could be broken or crushed as it is an immediate-release dosage 
form.

4.3 Contraindications

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

 



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4.4 Special warnings and precautions for use

General
Steglatro should not be used in patients with type 1 diabetes mellitus.

Hypotension/Volume depletion
Ertugliflozin causes an osmotic diuresis, which may lead to intravascular volume contraction. 
Therefore, symptomatic hypotension may occur after initiating Steglatro (see section 4.8), particularly 
in patients with impaired renal function (eGFR less than 60 ml/min/1.73 m2 or CrCl less than 
60 ml/min), elderly patients (≥ 65 years), patients on diuretics, or patients on anti-hypertensive therapy 
with a history of hypotension. Before initiating Steglatro, volume status should be assessed and 
corrected if indicated. Monitor for signs and symptoms after initiating therapy.

Due to its mechanism of action, ertugliflozin induces an osmotic diuresis and increases serum 
creatinine and decreases eGFR. Increases in serum creatinine and decreases in eGFR were greater in 
patients with moderate renal impairment (see section 4.8).

In case of conditions that may lead to fluid loss (e.g., gastrointestinal illness), careful monitoring of
volume status (e.g., physical examination, blood pressure measurements, laboratory tests including
haematocrit) and electrolytes is recommended for patients receiving ertugliflozin. Temporary
interruption of treatment with ertugliflozin should be considered until the fluid loss is corrected.

Diabetic ketoacidosis
Rare cases of DKA, including life-threatening and fatal cases, have been reported in clinical trials and 
post-marketing in patients treated with sodium glucose co-transporter-2 (SGLT2) inhibitors, and cases 
have been reported in clinical trials with ertugliflozin. In a number of cases, the presentation of the 
condition was atypical with only moderately increased blood glucose values, below 14 mmol/l 
(250 mg/dl). It is not known if DKA is more likely to occur with higher doses of ertugliflozin.

The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as
nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual
fatigue or sleepiness. Patients should be assessed for ketoacidosis immediately if these symptoms
occur, regardless of blood glucose level.

In patients where DKA is suspected or diagnosed, treatment with ertugliflozin should be discontinued 
immediately.

Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute
serious medical illnesses. Monitoring of ketones is recommended in these patients. Measurement of 
blood ketone levels is preferred to urine. Treatment with ertugliflozin may be restarted when the 
ketone values are normal and the patient’s condition has stabilised.

Before initiating ertugliflozin, factors in the patient history that may predispose to ketoacidosis should 
be considered.

Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g.,
type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or
patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or
severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin
requirements due to acute medical illness, surgery, or alcohol abuse. SGLT2 inhibitors should be used
with caution in these patients.

Restarting SGLT2 inhibitor treatment in patients with previous DKA while on SGLT2 inhibitor
treatment is not recommended, unless another clear precipitating factor is identified and resolved.

The safety and efficacy of ertugliflozin in patients with type 1 diabetes have not been established and
ertugliflozin should not be used for treatment of patients with type 1 diabetes. Limited data from

 



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clinical trials suggest that DKA occurs with common frequency when patients with type 1 diabetes are
treated with SGLT2 inhibitors.

Lower limb amputations 
In an ongoing clinical study of ertugliflozin added to existing therapy in type 2 diabetes patients with a 
history of established cardiovascular disease, an approximately 1.2-1.6-fold increase in cases of lower 
limb amputation (primarily of the toe) has been observed in patients treated with ertugliflozin. An 
increase in cases of lower limb amputation (primarily of the toe) has also been observed in long-term 
clinical studies with another SGLT2 inhibitor. As an underlying mechanism has not been established, 
risk factors, apart from general risk factors, for amputation are unknown.

Before initiating ertugliflozin, consider factors in the patient history that may increase the risk for 
amputation. As precautionary measures, consideration should be given to carefully monitoring patients 
with a higher risk for amputation events and counselling patients about the importance of routine 
preventative foot care and maintaining adequate hydration. Consideration may also be given to 
stopping treatment with ertugliflozin in patients who develop events which may precede amputation 
such as lower-extremity skin ulcer, infection, osteomyelitis or gangrene.

Impairment in renal function
The efficacy of ertugliflozin is dependent on renal function, and efficacy is reduced in patients who 
have moderate renal impairment and likely absent in patients with severe renal impairment (see 
section 4.2).

Steglatro should not be initiated in patients with an eGFR below 60 ml/min/1.73 m2 or CrCl below
60 ml/min. Steglatro should be discontinued when eGFR is persistently below 45 ml/min/1.73 m2 or 
CrCl is persistently below 45 ml/min due to a reduction of efficacy.

Monitoring of renal function is recommended as follows:
- Prior to ertugliflozin initiation and periodically during treatment (see section 4.2).
- More frequently in patients with an eGFR below 60 ml/min/1.73 m2 or a CrCl below 60 ml/min.

Hypoglycaemia with concomitant use with insulin and insulin secretagogues
Ertugliflozin may increase the risk of hypoglycaemia when used in combination with insulin and/or an 
insulin secretagogue, which are known to cause hypoglycaemia (see section 4.8). Therefore, a lower 
dose of insulin or insulin secretagogue may be required to minimise the risk of hypoglycaemia when 
used in combination with ertugliflozin (see sections 4.2 and 4.5).

Genital mycotic infections
Ertugliflozin increases the risk of genital mycotic infections. In trials with SGLT2 inhibitors, patients 
with a history of genital mycotic infections and uncircumcised males were more likely to develop 
genital mycotic infections (see section 4.8). Patients should be monitored and treated appropriately.

Urinary tract infections
Urinary glucose excretion may be associated with an increased risk of urinary tract infections. The 
incidence of urinary tract infections was not notably different in the ertugliflozin 5 mg and 15 mg 
groups (4.0% and 4.1%) and the placebo group (3.9%). Most of the events were mild or moderate and 
no serious case was reported. Temporary interruption of ertugliflozin should be considered when 
treating pyelonephritis or urosepsis.

Necrotising fasciitis of the perineum (Fournier’s gangrene) 
Post-marketing cases of necrotising fasciitis of the perineum, (also known as Fournier’s gangrene), 
have been reported in female and male patients taking SGLT2 inhibitors. This is a rare but serious and 
potentially life-threatening event that requires urgent surgical intervention and antibiotic treatment. 

Patients should be advised to seek medical attention if they experience a combination of symptoms of 
pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise. Be aware 
that either uro-genital infection or perineal abscess may precede necrotising fasciitis. If Fournier’s 

 



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gangrene is suspected, Steglatro should be discontinued and prompt treatment (including antibiotics 
and surgical debridement) should be instituted. 

Elderly patients
Elderly patients may be at an increased risk of volume depletion. Patients 65 years and older treated 
with ertugliflozin had a higher incidence of adverse reactions related to volume depletion compared to 
younger patients. Ertugliflozin is expected to have diminished efficacy in elderly patients with renal 
impairment (see sections 4.2 and 4.8).

Cardiac failure
Experience in New York Heart Association (NYHA) class I-II is limited, and there is no experience in
clinical studies with ertugliflozin in NYHA class III-IV.

Urine laboratory assessments
Due to its mechanism of action, patients taking Steglatro will test positive for glucose in their urine.
Alternative methods should be used to monitor glycaemic control.

Interference with 1,5-anhydroglucitol (1,5-AG) assay
Monitoring glycaemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are 
unreliable in assessing glycaemic control in patients taking SGLT2 inhibitors. Alternative methods 
should be used to monitor glycaemic control.

Lactose
The tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose 
intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal 
product.

Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 
‘sodium-free’.

4.5 Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions

Diuretics 
Ertugliflozin may add to the diuretic effect of diuretics and may increase the risk of dehydration and 
hypotension (see section 4.4). 

Insulin and insulin secretagogues 
Insulin and insulin secretagogues, such as sulphonylureas, cause hypoglycaemia. Ertugliflozin may 
increase the risk of hypoglycaemia when used in combination with insulin and/or an insulin 
secretagogue. Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce 
the risk of hypoglycaemia when used in combination with ertugliflozin (see sections 4.2, 4.4, and 4.8). 

Pharmacokinetic interactions

Effects of other medicinal products on the pharmacokinetics of ertugliflozin
Metabolism by UGT1A9 and UGT2B7 is the primary clearance mechanism for ertugliflozin. 

Interaction studies conducted in healthy subjects, using a single dose design, suggest that the 
pharmacokinetics of ertugliflozin are not altered by sitagliptin, metformin, glimepiride, or simvastatin.

Multiple-dose administration of rifampin (a UGT and CYP inducer) decreases ertugliflozin AUC and 
Cmax by 39% and 15%, respectively. This decrease in exposure is not considered clinically relevant and 
therefore, no dose adjustment is recommended. A clinically relevant effect with other inducers (e.g., 
carbamazepine, phenytoin, phenobarbital) is not expected. 

 



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The impact of UGT inhibitors on the pharmacokinetics of ertugliflozin has not been studied clinically, 
but potential increase in ertugliflozin exposure due to UGT inhibition is not considered to be clinically 
relevant.

Effects of ertugliflozin on the pharmacokinetics of other medicinal products
Interaction studies conducted in healthy volunteers suggest that ertugliflozin had no clinically relevant 
effect on the pharmacokinetics of sitagliptin, metformin, and glimepiride.

Coadministration of simvastatin with ertugliflozin resulted in a 24% and 19% increase in AUC and 
Cmax of simvastatin, respectively, and 30% and 16% increase in AUC and Cmax of simvastatin acid, 
respectively. The mechanism for the small increases in simvastatin and simvastatin acid is unknown 
and is not perpetrated through OATP inhibition by ertugliflozin. These increases are not considered to 
be clinically meaningful. 

4.6 Fertility, pregnancy and lactation

Pregnancy
There are limited data from the use of ertugliflozin in pregnant women. Based on results from animal 
studies, ertugliflozin may affect renal development and maturation (see section 5.3). Therefore, 
Steglatro should not be used during pregnancy.

Breast-feeding
There is no information regarding the presence of ertugliflozin in human milk, the effects on the 
breast-fed infant, or the effects on milk production. Ertugliflozin is present in the milk of lactating rats 
and caused effects in the offspring of lactating rats. Pharmacologically-mediated effects were observed 
in juvenile rats (see section 5.3). Since human kidney maturation occurs in utero and during the first 
2 years of life when exposure from breast-feeding may occur, a risk to newborns/infants cannot be 
excluded. Steglatro should not be used during breast-feeding.

Fertility
The effect of ertugliflozin on fertility in humans has not been studied. No effects on fertility were 
observed in animal studies (see section 5.3).

4.7 Effects on ability to drive and use machines

Ertugliflozin has no or negligible influence on the ability to drive and use machines. Patients should be 
alerted to the risk of hypoglycaemia when Steglatro is used in combination with insulin or an insulin 
secretagogue and to the elevated risk of adverse reactions related to volume depletion, such as postural 
dizziness (see sections 4.2, 4.4, and 4.8).

4.8 Undesirable effects

Summary of the safety profile

Pool of placebo-controlled trials evaluating Steglatro 5 mg and 15 mg
The primary assessment of safety was conducted in a pool of three 26-week, placebo-controlled trials. 
Ertugliflozin was used as monotherapy in one trial and as add-on therapy in two trials (see 
section 5.1). These data reflect exposure of 1,029 patients to ertugliflozin with a mean exposure 
duration of approximately 25 weeks. Patients received ertugliflozin 5 mg (N=519), ertugliflozin 15 mg 
(N=510), or placebo (N=515) once daily.

The most commonly reported adverse reactions across the clinical program were vulvovaginal mycotic 
infection and other female genital mycotic infections. Serious diabetic ketoacidosis occurred rarely. 
See “Description of selected adverse reactions” for frequencies and see section 4.4.

 



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Tabulated list of adverse reactions
Adverse reactions listed below are classified according to frequency and system organ class (SOC). 
Frequency categories are defined according to the following convention: 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), not known (cannot be estimated from the available data).

Table 1: Adverse reactions 

System Organ Class
Frequency

Adverse Reaction

Infections and infestations

Very common

Common

Not known

Vulvovaginal mycotic infection and other female 
genital mycotic infections*,†

Balanitis candida and other male genital mycotic 
infections*,†

Necrotising fasciitis of the perineum (Fournier’s 
gangrene)*

Metabolism and nutrition disorders

Common

Rare

Hypoglycaemia*,†

Diabetic ketoacidosis*,†

Vascular disorders

Common Volume depletion*,†

Renal and urinary disorders

Common

Uncommon

Increased urination‡

Dysuria, Blood creatinine increased/Glomerular 
filtration rate decreased†

Reproductive system and breast disorders

Common Vulvovaginal pruritus

General disorders and administration site conditions

Common Thirst§

Investigations

Common Serum lipids changed¶, Haemoglobin increased**, 
BUN increased¶¶

* See Section 4.4. 
† See subsections below for additional information.
‡ Includes: pollakiuria, micturition urgency, polyuria, urine output increased, and nocturia.
§ Includes: thirst and polydipsia.
¶ Mean percent changes from baseline for ertugliflozin 5 mg and 15 mg versus placebo, respectively, were LDL-C 5.8% and 

8.4% versus 3.2%; total cholesterol 2.8% and 5.7% versus 1.1%; however, HDL-C 6.2% and 7.6% versus 1.9%. Median 
percent changes from baseline for ertugliflozin 5 mg and 15 mg versus placebo, respectively, were triglycerides -3.9% 
and -1.7% versus 4.5%.

** The proportion of subjects having at least 1 increase in haemoglobin > 2.0 g/dL was higher in the ertugliflozin 5 mg and 
15 mg groups (4.7% and 4.1%, respectively) compared to the placebo group (0.6%).

¶¶ The proportion of subjects having any occurrence of BUN values ≥ 50% increase and value >ULN was numerically higher 
in the ertugliflozin 5 mg group and higher in the 15 mg group (7.9% and 9.8%, respectively) relative to the placebo group 
(5.1%). 

Description of selected adverse reactions

Volume depletion 
Ertugliflozin causes an osmotic diuresis, which may lead to intravascular volume contraction and 
adverse reactions related to volume depletion. In the pool of placebo-controlled studies, the incidence 
of adverse events related to volume depletion (dehydration, dizziness postural, presyncope, syncope, 
hypotension, and orthostatic hypotension) was low (< 2%) and not notably different across the 
ertugliflozin and placebo groups. In the subgroup analyses in the broader pool of Phase 3 studies, 
subjects with eGFR < 60 mL/min/1.73 m2, subjects ≥ 65 years of age and subjects on diuretics had a 
higher incidence of volume depletion in the ertugliflozin groups relative to the comparator group (see 
sections 4.2 and 4.4). In subjects with eGFR < 60 mL/min/1.73 m2, the incidence was 5.1%, 2.6%, and 

 



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0.5% for ertugliflozin 5 mg, ertugliflozin 15 mg, and the comparator group and for subjects with 
eGFR 45 to < 60 mL/min/1.73 m2, the incidence was 6.4%, 3.7%, and 0% respectively.

Hypoglycaemia
In the pool of placebo-controlled studies, the incidence of documented hypoglycaemia was increased 
for ertugliflozin 5 mg and 15 mg (5.0% and 4.5%) compared to placebo (2.9%). In this population, the 
incidence of severe hypoglycaemia was 0.4% in each group. When ertugliflozin was used as 
monotherapy, the incidence of hypoglycaemic events in the ertugliflozin groups was 2.6% in both 
groups and 0.7% in the placebo group. When used as add-on to metformin, the incidence of 
hypoglycaemic events was 7.2% in the ertugliflozin 5 mg group, 7.8% in the ertugliflozin 15 mg 
group and 4.3% in the placebo group.

When ertugliflozin was added to metformin and compared to sulphonylurea, the incidence of 
hypoglycaemia was higher for the sulphonylurea (27%) compared to ertugliflozin (5.6% and 8.2% for 
ertugliflozin 5 mg and 15 mg, respectively). 

In patients with moderate renal impairment taking insulins, SU, or meglitinides as background 
medication, documented hypoglycaemia was 36%, 27% and 36% for ertugliflozin 5 mg, ertugliflozin 
15 mg, and placebo, respectively (see sections 4.2, 4.4, and 4.5).

Diabetic ketoacidosis
Across the clinical program, ketoacidosis was identified in 3 of 3,409 (0.1%) ertugliflozin-treated 
patients and 0.0% of comparator-treated patients (see section 4.4). 

Blood creatinine increased/Glomerular filtration rate decreased and renal-related events
Initial increases in mean creatinine and decreases in mean eGFR in patients treated with ertugliflozin 
were generally transient during continuous treatment. Patients with moderate renal impairment at 
baseline had larger mean changes that did not return to baseline at Week 26; these changes reversed
after treatment discontinuation.

Renal-related adverse reactions (e.g., acute kidney injury, renal impairment, acute prerenal failure) 
may occur in patients treated with ertugliflozin, particularly in patients with moderate renal 
impairment where the incidence of renal-related adverse reactions was 2.5%, 1.3%, and 0.6% in 
patients treated with ertugliflozin 5 mg, ertugliflozin 15 mg, and placebo, respectively.

Genital mycotic infections 
In the pool of three placebo-controlled clinical trials, female genital mycotic infections (e.g., genital 
candidiasis, genital infection fungal, vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal 
mycotic infection, vulvovaginitis) occurred in 9.1%, 12%, and 3.0% of females treated with 
ertugliflozin 5 mg, ertugliflozin 15 mg, and placebo, respectively. In females, discontinuation due to 
genital mycotic infections occurred in 0.6% and 0% of patients treated with ertugliflozin and placebo, 
respectively (see section 4.4).

In the same pool, male genital mycotic infections (e.g., balanitis candida, balanoposthitis, genital 
infection, genital infection fungal) occurred in 3.7%, 4.2%, and 0.4% of males treated with 
ertugliflozin 5 mg, ertugliflozin 15 mg, and placebo, respectively. Male genital mycotic infections 
occurred more commonly in uncircumcised males. In males, discontinuations due to genital mycotic 
infections occurred in 0.2% and 0% of patients treated with ertugliflozin and placebo, respectively. In 
rare instances, phimosis was reported and sometimes circumcision was performed (see section 4.4).

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.

 

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4.9 Overdose

Ertugliflozin did not show any toxicity in healthy subjects at single oral doses up to 300 mg and 
multiple doses up to 100 mg daily for 2 weeks. No potential acute symptoms and signs of overdose 
were identified.

In the event of an overdose, employ the usual supportive measures (e.g., remove unabsorbed material 
from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment) as 
dictated by the patient’s clinical status. Removal of ertugliflozin by haemodialysis has not been 
studied.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, Sodium glucose co-transporter 2 (SGLT2) 
inhibitors, ATC code: A10BK04.

Mechanism of action
SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular 
filtrate back into the circulation. Ertugliflozin is a potent, selective, and reversible inhibitor of SGLT2. 
By inhibiting SGLT2, ertugliflozin reduces renal reabsorption of filtered glucose and lowers the renal 
threshold for glucose, and thereby increases urinary glucose excretion.

Pharmacodynamic effects

Urinary glucose excretion and urinary volume
Dose-dependent increases in the amount of glucose excreted in urine were observed in healthy 
subjects and in patients with type 2 diabetes mellitus following single- and multiple-dose 
administration of ertugliflozin. Dose-response modelling indicates that ertugliflozin 5 mg and 15 mg 
result in near maximal urinary glucose excretion (UGE) in patients with type 2 diabetes mellitus, 
providing 87% and 96% of maximal inhibition, respectively.

Clinical efficacy and safety
The efficacy and safety of ertugliflozin have been studied in 7 multi-centre, randomised, double-blind, 
placebo- or active comparator-controlled, Phase 3 clinical studies involving 4,863 patients with type 2 
diabetes, including a study of 468 patients with moderate renal impairment. The racial distribution was 
76.8% White, 13.3% Asian, 5.0% Black and 4.8% other. Hispanic or Latino patients comprised 24.2% 
of the population. Patients had an average age of 57.8 years (range 21 years to 87 years), with 25.8% 
of patients ≥ 65 years of age and 4.5% ≥ 75 years of age.

Ertugliflozin has been studied as monotherapy and in combination with metformin and/or a dipeptidyl 
peptidase 4 (DPP-4) inhibitor. Ertugliflozin has also been studied in combination with current diabetes 
treatments, including insulin and a sulphonylurea, in patients with type 2 diabetes with moderate renal 
impairment.

Monotherapy
A total of 461 patients with type 2 diabetes inadequately controlled on diet and exercise participated in 
a randomised, double-blind, multi-centre, 26-week, placebo-controlled study to evaluate the efficacy 
and safety of ertugliflozin monotherapy. These patients, who were not receiving any background anti-
hyperglycaemic treatment, were randomised to ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo 
administered once daily (see Table 2).

 



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Table 2: Results at Week 26 from a placebo-controlled monotherapy study of Steglatro*

Steglatro 5 mg Steglatro 15 mg Placebo

HbA1c (%) N = 156 N = 151 N = 153

Baseline (mean) 8.2 8.4 8.1

Change from baseline (LS mean†) -0.8 -1.0 0.2

Difference from placebo (LS mean†, 95% CI) -1.0‡ (-1.2, -0.8) -1.2‡ (-1.4, -0.9)

Patients [N (%)] with HbA1c < 7% 44 (28.2)§ 54 (35.8)§ 20 (13.1)

Body Weight (kg) N = 156 N = 152 N = 153

Baseline (mean) 94.0 90.6 94.2

Change from baseline (LS mean†) -3.2 -3.6 -1.4

Difference from placebo (LS mean†, 95% CI) -1.8‡ (-2.6, -0.9) -2.2‡ (-3.0, -1.3)

* N includes all randomised, treated patients who had at least one measurement of the outcome variable.
† Least squares means adjusted for treatment, time, prior antihyperglycaemic medication, baseline eGFR and the interaction 

of time by treatment.
‡ p< 0.001 compared to placebo.
§ p< 0.001 compared to placebo (based on adjusted odds ratio comparisons from a logistic regression model using multiple 

imputation for missing data values).

Ertugliflozin as add-on combination therapy with metformin
A total of 621 patients with type 2 diabetes inadequately controlled on metformin monotherapy 
(≥ 1,500 mg/day) participated in a randomised, double-blind, multi-centre, 26-week, placebo-
controlled study to evaluate the efficacy and safety of ertugliflozin in combination with metformin. 
Patients were randomised to ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo administered once 
daily in addition to continuation of background metformin therapy (see Table 3).

Table 3: Results at Week 26 from a placebo-controlled study for Steglatro used in combination 
with metformin*

Steglatro 5 mg Steglatro 15 mg Placebo

HbA1c (%) N = 207 N = 205 N = 209

Baseline (mean) 8.1 8.1 8.2

Change from baseline (LS mean†) -0.7 -0.9 -0.0

Difference from placebo (LS mean†, 95% CI) -0.7‡ (-0.9, -0.5) -0.9‡ (-1.1, -0.7)

Patients [N (%)] with HbA1c < 7% 73 (35.3)§ 82 (40.0)§ 33 (15.8)

Body Weight (kg) N = 207 N = 205 N = 209

Baseline (mean) 84.9 85.3 84.5

Change from baseline (LS mean†) -3.0 -2.9 -1.3

Difference from placebo (LS mean†, 95% CI) -1.7‡ (-2.2, -1.1) -1.6‡ (-2.2, -1.0)

* N includes all randomised, treated patients who had at least one measurement of the outcome variable.
† Least squares means adjusted for treatment, time, prior antihyperglycaemic medication (metformin monotherapy or 

metformin + another AHA), baseline eGFR (continuous), menopausal status randomisation stratum (men, premenopausal 
women, women who are perimenopausal or < 3 years postmenopausal, women who are  3 years postmenopausal) and the 
interaction of time by treatment.

‡ p 0.001 compared to placebo.
§ p< 0.001 compared to placebo (based on adjusted odds ratio comparisons from a logistic regression model using multiple 

imputation for missing data values).

Active-controlled study of ertugliflozin versus glimepiride as add-on combination therapy with 
metformin 
A total of 1,326 patients with type 2 diabetes inadequately controlled on metformin monotherapy 
participated in a randomised, double-blind, multi-centre, 52-week, active comparator-controlled study 

 



12

to evaluate the efficacy and safety of ertugliflozin in combination with metformin. These patients, who 
were receiving metformin monotherapy (≥ 1,500 mg/day), were randomised to ertugliflozin 5 mg, 
ertugliflozin 15 mg, or glimepiride administered once daily in addition to continuation of background 
metformin therapy. Glimepiride was initiated at 1 mg/day and titrated up to a maximum dose of 6 or 
8 mg/day (depending on maximum approved dose in each country) or a maximum tolerated dose or 
down-titrated to avoid or manage hypoglycaemia. The mean daily dose of glimepiride was 3.0 mg (see 
Table 4).

Table 4: Results at Week 52 from an active-controlled study comparing Steglatro to glimepiride 
as add-on therapy in patients inadequately controlled on metformin*

Steglatro 5 mg Steglatro 15 mg Glimepiride

HbA1c (%) N = 448 N = 440 N = 437

Baseline (mean) 7.8 7.8 7.8

Change from baseline (LS mean†) -0.6 -0.6 -0.7

Difference from glimepiride (LS mean†, 95% CI) 0.2 (0.1, 0.3) 0.1‡ (-0.0, 0.2)

Patients [N (%)] with HbA1c < 7% 154 (34.4) 167 (38.0) 190 (43.5)

Body Weight (kg) N = 448 N = 440 N = 437

Baseline (mean) 87.9 85.6 86.8

Change from baseline (LS mean†) -3.0 -3.4 0.9

Difference from glimepiride (LS mean†, 95% CI) -3.9 (-4.4, -3.4) -4.3§ (-4.8, -3.8)

* N includes all randomised, treated patients who had at least one measurement of the outcome variable.
† Least squares means adjusted for treatment, time, prior antihyperglycaemic medication (monotherapy or dual therapy), 

baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
‡ Non-inferiority is declared when the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is 

less than 0.3%.
§ p< 0.001 compared to glimepiride.

Factorial study with ertugliflozin and sitagliptin as add-on combination therapy with metformin
A total of 1,233 patients with type 2 diabetes participated in a randomised, double-blind, multi-centre, 
26-week, active-controlled study to evaluate the efficacy and safety of ertugliflozin 5 mg or 15 mg in 
combination with sitagliptin 100 mg compared to the individual components. Patients with type 2 
diabetes inadequately controlled on metformin monotherapy (≥ 1,500 mg/day) were randomised to one 
of five active-treatment arms: ertugliflozin 5 mg or 15 mg, sitagliptin 100 mg, or sitagliptin 100 mg in 
combination with 5 mg or 15 mg ertugliflozin administered once daily in addition to continuation of 
background metformin therapy (see Table 5).

 



13

Table 5: Results at Week 26 from a factorial study with Steglatro and sitagliptin as add-on 
combination therapy with metformin compared to individual components alone*

Steglatro
5 mg

Steglatro
15 mg

Sitagliptin 
100 mg

Steglatro 5 mg +
Sitagliptin 100 mg

Steglatro 15 mg + 
Sitagliptin 100 mg

HbA1c (%) N = 250 N = 248 N = 247 N = 243 N = 244

Baseline (mean) 8.6 8.6 8.5 8.6 8.6

Change from baseline (LS mean†) -1.0 -1.1 -1.1 -1.5 -1.5

Difference from

Sitagliptin 

Steglatro 5 mg

-0.4‡ (-0.6, -0.3)

-0.5‡ (-0.6, -0.3)

-0.5‡ (-0.6, -0.3)

Steglatro 15 mg

(LS mean†, 95% CI)

-0.4‡ (-0.6, -0.3)

Patients [N (%)] with HbA1c < 7% 66 (26.4) 79 (31.9) 81 (32.8) 127§ (52.3) 120§ (49.2)

Body Weight (kg) N = 250 N = 248 N = 247 N = 243 N = 244

Baseline (mean) 88.6 88.0 89.8 89.5 87.5

Change from baseline (LS mean†) -2.7 -3.7 -0.7 -2.5 -2.9

Difference from Sitagliptin

(LS mean†, 95% CI)

-1.8‡ (-2.5, -1.2) -2.3‡ (-2.9, -1.6)

* N includes all randomised, treated patients who had at least one measurement of the outcome variable.
† Least squares means adjusted for treatment, time, baseline eGFR and the interaction of time by treatment.
‡ p< 0.001 compared to control group.
§ p< 0.001 compared to corresponding dose of ertugliflozin or sitagliptin (based on adjusted odds ratio comparisons from a logistic

regression model using multiple imputation for missing data values).

Ertugliflozin as add-on combination therapy with metformin and sitagliptin
A total of 463 patients with type 2 diabetes inadequately controlled on metformin (≥ 1,500 mg/day) 
and sitagliptin 100 mg once daily participated in a randomised, double-blind, multi-centre, 26-week, 
placebo-controlled study to evaluate the efficacy and safety of ertugliflozin. Patients were randomised 
to ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo administered once daily in addition to 
continuation of background metformin and sitagliptin therapy (see Table 6).

Table 6: Results at Week 26 from an add-on study of Steglatro in combination with metformin 
and sitagliptin*

Steglatro 5 mg Steglatro 15 mg Placebo

HbA1c (%) N = 156 N = 153 N = 153

Baseline (mean) 8.1 8.0 8.0

Change from baseline (LS mean†) -0.8 -0.9 -0.1

Difference from placebo (LS mean†, 95% CI) -0.7‡ (-0.9, -0.5) -0.8‡ (-0.9, -0.6)

Patients [N (%)] with HbA1c < 7% 50 (32.1)‡ 61 (39.9)‡ 26 (17.0)

Body Weight (kg) N = 156 N = 153 N = 153

Baseline (mean) 87.6 86.6 86.5

Change from baseline (LS mean†) -3.3 -3.0 -1.3

Difference from placebo (LS mean†, 95% CI) -2.0‡ (-2.6, -1.4) -1.7‡ (-2.3, -1.1)

* N includes all randomized, treated patients who had at least one measurement of the outcome variable.
† Least squares means adjusted for treatment, time, prior antihyperglycaemic medication.
‡ p< 0.001 compared to placebo.

 



14

Combination therapy of ertugliflozin and sitagliptin
A total of 291 patients with type 2 diabetes inadequately controlled on diet and exercise participated in 
a randomised, double-blind, multi-centre, placebo-controlled 26-week study to evaluate the efficacy 
and safety of ertugliflozin in combination with sitagliptin. These patients, who were not receiving any 
background anti-hyperglycaemic treatment, were randomised to ertugliflozin 5 mg or ertugliflozin
15 mg in combination with sitagliptin (100 mg) or to placebo once daily (see Table 7).

Table 7: Results at Week-26 from a combination therapy study of ertugliflozin and sitagliptin*

Ertugliflozin 5 mg

+ Sitagliptin

Ertugliflozin 

15 mg

+ Sitagliptin

Placebo

HbA1c (%) N = 98 N = 96 N = 96

Baseline (mean) 8.9 9.0 9.0

Change from baseline (LS mean†) -1.6 -1.7 -0.4

Difference from placebo (LS mean† and 95% 

CI)

-1.2‡ (-1.5, -0.8) -1.2‡ (-1.6, -0.9)

Patients [N (%)] with HbA1c <7% 35 (35.7)§ 30 (31.3)§ 8 (8.3)

Body Weight (kg) N = 98 N = 96 N = 97

Baseline (mean) 90.8 91.3 95.0

Change from baseline (LS mean†) -2.9 -3.0 -0.9

Difference from placebo (LS mean†, 95% CI) -2.0‡ (-3.0, -1.0) -2.1‡ (-3.1, -1.1)
* N includes all patients who received at least one dose of study medication and had at least one measurement of the 

outcome variable.
† Least squares means adjusted based on a longitudinal model including terms for treatment, time, and the interaction of 

time by treatment.
‡ p< 0.001 compared to placebo.
§ p< 0.001 compared to placebo (based on adjusted odds ratio comparisons from a logistic regression model using 

multiple imputation for missing data values).

Moderate renal impairment
The efficacy of ertugliflozin was also assessed separately in a dedicated study of diabetic patients with 
moderate renal impairment (468 patients with eGFR ≥ 30 to < 60 ml/min/1.73 m2).

The LS mean (95% CI) changes from baseline in HbA1c were -0.26 (-0.42, -0.11), -0.29 
(-0.44, -0.14), and -0.41 (-0.56, -0.27) in the placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg 
groups, respectively. The HbA1c reductions in the ertugliflozin arms were not significantly different 
from placebo. The pre-specified analysis of glycaemic efficacy was confounded by use of a prohibited 
concomitant antihyperglycaemic medication. In a subsequent analysis excluding those subjects who 
used the prohibited medication, ertugliflozin 5 mg and 15 mg were associated with placebo-corrected 
reductions in HbA1c of -0.14 (-0.36, 0.08) and -0.33 (-0.55, -0.11)

Fasting plasma glucose
In three placebo-controlled studies, ertugliflozin resulted in statistically significant reductions in FPG. 
For ertugliflozin 5 mg and 15 mg, respectively, the placebo-corrected reductions in FPG were 1.92 and 
2.44 mmol/l as monotherapy, 1.48 and 2.12 mmol/l as add-on to metformin, and 1.40 and 1.74 mmol/l 
as add-on to metformin and sitagliptin. 

The combination of ertugliflozin and sitagliptin resulted in significantly greater reductions in FPG 
compared to sitagliptin or ertugliflozin alone or placebo. The combination of ertugliflozin 5 or 15 mg 
and sitagliptin resulted in incremental FPG reductions of 0.46 to 0.65 mmol/l compared to the 
ertugliflozin alone or 1.02 to 1.28 mmol/l compared to sitagliptin alone. The placebo-corrected 
reductions of ertugliflozin 5 or 15 mg in combination with sitagliptin were 2.16 and 2.56 mmol/l.

 



15

Efficacy in patients with baseline HbA1c ≥ 8%
In the monotherapy study conducted on a background of diet and exercise in patients with baseline 
HbA1c from 7-10.5%, the subgroup of patients in the study with a baseline HbA1c ≥ 8% had 
placebo-corrected reductions in HbA1c of 1.11% and 1.52% with ertugliflozin 5 or 15 mg, 
respectively.

In the study of ertugliflozin added-on to metformin in patients with baseline HbA1c from 7.0-10.5%, 
the placebo-corrected reductions in HbA1c for the subgroup of patients in the study with baseline 
HbA1c ≥ 9% were 1.31% and 1.43% with ertugliflozin 5 and 15 mg, respectively.

In the study of patients inadequately controlled on metformin with baseline HbA1c from 7.5-11.0%, 
among the subgroup of patients with a baseline HbA1c ≥ 10%, the combination of ertugliflozin 5 mg 
or 15 mg with sitagliptin resulted in reductions of HbA1c of 2.35% and 2.66% compared to 2.10%, 
1.30%, and 1.82% for ertugliflozin 5 mg, ertugliflozin 15 mg and sitagliptin alone, respectively.

Post-prandial glucose
In the monotherapy study, ertugliflozin 5 and 15 mg resulted in statistically significant placebo-
corrected reductions in 2-hour PPG of 3.83 and 3.74 mmol/l.

Blood pressure
In three 26-week, placebo-controlled studies, ertugliflozin reduced systolic blood pressure (SBP). For 
ertugliflozin 5 mg and 15 mg, the statistically significant placebo-corrected reductions in SBP ranged 
from 2.9 mmHg to 3.7 mmHg and 1.7 mmHg to 4.5 mmHg, respectively. 

In a 52-week, active-controlled study versus glimepiride, reductions from baseline in SBP were 
2.2 mmHg and 3.8 mmHg for ertugliflozin 5 mg and 15 mg respectively, while subjects treated with 
glimepiride had an increase in SBP from baseline of 1.0 mmHg.

Subgroup analysis
In patients with type 2 diabetes treated with ertugliflozin, clinically meaningful reductions in HbA1c 
were observed in subgroups defined by age, sex, race, ethnicity, geographic region, baseline BMI, 
baseline HbA1c, and duration of type 2 diabetes mellitus.

Paediatric population
The European Medicines Agency has deferred the obligation to submit the results of studies with 
ertugliflozin in one or more subsets of the paediatric population in Type II diabetes mellitus (see 
section 4.2 for information on paediatric use).

5.2 Pharmacokinetic properties

General introduction
The pharmacokinetics of ertugliflozin are similar in healthy subjects and patients with type 2 diabetes. 
The steady state mean plasma AUC and Cmax were 398 ng∙hr/ml and 81 ng/ml, respectively, with 5 mg 
ertugliflozin once daily treatment, and 1,193 ng∙hr/ml and 268 ng/ml, respectively, with 15 mg 
ertugliflozin once daily treatment. Steady-state is reached after 4 to 6 days of once-daily dosing with 
ertugliflozin. Ertugliflozin does not exhibit time-dependent pharmacokinetics and accumulates in 
plasma up to 10-40% following multiple dosing.

Absorption
Following single-dose oral administration of 5 mg and 15 mg of ertugliflozin, peak plasma 
concentrations (median Tmax) of ertugliflozin occur at 1 hour postdose under fasted conditions. Plasma 
Cmax and AUC of ertugliflozin increase in a dose-proportional manner following single doses from 
0.5 mg to 300 mg and following multiple doses from 1 mg to 100 mg. The absolute oral bioavailability 
of ertugliflozin following administration of a 15-mg dose is approximately 100%. 

Administration of ertugliflozin with a high-fat and high-calorie meal decreases ertugliflozin Cmax by 
29% and prolongs Tmax by 1 hour, but does not alter AUC as compared with the fasted state. The 

 



16

observed effect of food on ertugliflozin pharmacokinetics is not considered clinically relevant, and 
ertugliflozin may be administered with or without food. In Phase 3 clinical trials, ertugliflozin was 
administered without regard to meals.

Ertugliflozin is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) 
transporters.

Distribution
The mean steady-state volume of distribution of ertugliflozin following an intravenous dose is 86 l. 
Plasma protein binding of ertugliflozin is 93.6% and is independent of ertugliflozin plasma 
concentrations. Plasma protein binding is not meaningfully altered in patients with renal or hepatic 
impairment. The blood-to-plasma concentration ratio of ertugliflozin is 0.66.

Ertugliflozin is not a substrate of organic anion transporters (OAT1, OAT3), organic cation 
transporters (OCT1, OCT2), or organic anion transporting polypeptides (OATP1B1, OATP1B3) in 
vitro.

Biotransformation
Metabolism is the primary clearance mechanism for ertugliflozin. The major metabolic pathway for 
ertugliflozin is UGT1A9 and UGT2B7-mediated O-glucuronidation to two glucuronides that are 
pharmacologically inactive at clinically relevant concentrations. CYP-mediated (oxidative) 
metabolism of ertugliflozin is minimal (12%).

Elimination
The mean systemic plasma clearance following an intravenous 100 µg dose was 11 l/hr. The mean 
elimination half-life in type 2 diabetic patients with normal renal function was estimated to be 
17 hours based on the population pharmacokinetic analysis. Following administration of an oral 
[14C]-ertugliflozin solution to healthy subjects, approximately 41% and 50% of the drug-related 
radioactivity was eliminated in faeces and urine, respectively. Only 1.5% of the administered dose was 
excreted as unchanged ertugliflozin in urine and 34% as unchanged ertugliflozin in faeces, which is 
likely due to biliary excretion of glucuronide metabolites and subsequent hydrolysis to parent.

Special populations

Renal impairment
In a Phase 1 clinical pharmacology study in patients with type 2 diabetes and mild, moderate, or 
severe renal impairment (as determined by eGFR), following a single-dose administration of 15 mg 
ertugliflozin, the mean increases in AUC of ertugliflozin were ≤ 1.7-fold, compared to subjects with 
normal renal function. These increases in ertugliflozin AUC are not considered clinically relevant. 
There were no clinically meaningful differences in the ertugliflozin Cmax values among the different 
renal function groups. The 24-hour urinary glucose excretion declined with increasing severity of renal 
impairment (see section 4.4). The plasma protein binding of ertugliflozin was unaffected in patients 
with renal impairment.

Hepatic impairment
Moderate hepatic impairment (based on the Child-Pugh classification) did not result in an increase in 
exposure of ertugliflozin. The AUC of ertugliflozin decreased by approximately 13%, and Cmax
decreased by approximately 21% compared to subjects with normal hepatic function. This decrease in 
ertugliflozin exposure is not considered clinically meaningful. There is no clinical experience in 
patients with Child-Pugh class C (severe) hepatic impairment. The plasma protein binding of 
ertugliflozin was unaffected in patients with moderate hepatic impairment.

Paediatric population
No studies with ertugliflozin have been performed in paediatric patients.

 



17

Effects of age, body weight, gender, and race
Based on a population pharmacokinetic analysis, age, body weight, gender, and race do not have a 
clinically meaningful effect on the pharmacokinetics of ertugliflozin.

Drug interactions

In vitro assessment of ertugliflozin
In in vitro studies, ertugliflozin and ertugliflozin glucuronides did not inhibit or inactivate CYPs 1A2, 
2C9, 2C19, 2C8, 2B6, 2D6, or 3A4, and did not induce CYPs 1A2, 2B6, or 3A4. Ertugliflozin and 
ertugliflozin glucuronides did not inhibit the activity of UGTs 1A6, 1A9 or 2B7 in vitro. Ertugliflozin 
was a weak inhibitor of UGTs 1A1 and 1A4 in vitro at higher concentrations that are not clinically 
relevant. Ertugliflozin glucuronides had no effect on these isoforms. Overall, ertugliflozin is unlikely 
to affect the pharmacokinetics of concurrently administered drugs eliminated by these enzymes.

Ertugliflozin or ertugliflozin glucuronides do not meaningfully inhibit P-gp, OCT2, OAT1, or OAT3 
transporters or transporting polypeptides OATP1B1 and OATP1B3 at clinically relevant 
concentrations in vitro. Overall, ertugliflozin is unlikely to affect the pharmacokinetics of concurrently 
administered medications that are substrates of these transporters.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, acute toxicity, repeated dose toxicity, genotoxicity, and carcinogenic potential.

General toxicity
Repeat-dose oral toxicity studies were conducted in mice, rats, and dogs for up to 13, 26, and 
39 weeks, respectively. Signs of toxicity that were considered adverse were generally observed at 
exposures greater than or equal to 77 times the human unbound exposure (AUC) at the maximum 
recommended human dose (MRHD) of 15 mg/day. Most toxicity was consistent with pharmacology 
related to urinary glucose loss and included decreased body weight and body fat, increased food 
consumption, diarrhoea, dehydration, decreased serum glucose and increases in other serum 
parameters reflective of increased protein metabolism, gluconeogenesis and electrolyte imbalances, 
and urinary changes such as polyuria, glucosuria, and calciuria. Microscopic changes related to 
glucosuria and/or calciuria observed only in rodents included dilatation of renal tubules, hypertrophy 
of zona glomerulosa in adrenal glands (rats), and increased trabecular bone (rats). Except for emesis, 
there were no adverse toxicity findings in dogs at 379 times the human unbound exposure (AUC) at 
the MRHD of 15 mg/day.

Carcinogenesis
In the 2-year mouse carcinogenicity study, ertugliflozin was administered by oral gavage at doses of 5, 
15, and 40 mg/kg/day. There were no ertugliflozin-related neoplastic findings at doses up to 
40 mg/kg/day (approximately 41 times human unbound exposure at the MRHD of 15 mg/day based on 
AUC). In the 2-year rat carcinogenicity study, ertugliflozin was administered by oral gavage at doses 
of 1.5, 5, and 15 mg/kg/day. Ertugliflozin-related neoplastic findings included an increased incidence 
of benign adrenal medullary pheochromocytoma in male rats at 15 mg/kg/day. This finding was 
attributed to carbohydrate malabsorption leading to altered calcium homeostasis and was not 
considered relevant to human risk. The no-observed-effect level (NOEL) for neoplasia was
5 mg/kg/day (approximately 16 times human unbound exposure at the MRHD of 15 mg/day).

Mutagenesis
Ertugliflozin was not mutagenic or clastogenic with or without metabolic activation in the microbial 
reverse mutation, in vitro cytogenetic (human lymphocytes), and in vivo rat micronucleus assays.

Reproductive toxicology
In the rat fertility and embryonic development study, male and female rats were administered 
ertugliflozin at 5, 25, and 250 mg/kg/day. No effects on fertility were observed at 250 mg/kg/day 
(approximately 386 times human unbound exposure at the MRHD of 15 mg/day based on AUC 

 



18

comparisons). Ertugliflozin did not adversely affect developmental outcomes in rats and rabbits at 
maternal exposures that were 239 and 1,069 times, respectively, the human exposure at the maximum 
clinical dose of 15 mg/day, based on AUC. At a maternally toxic dose in rats (250 mg/kg/day), lower 
foetal viability and a higher incidence of a visceral malformation were observed at maternal exposure 
that was 510 times the maximum clinical dose of 15 mg/day.

In the pre- and postnatal development study, decreased postnatal growth and development were 
observed in rats administered ertugliflozin gestation day 6 through lactation day 21 at 
≥ 100 mg/kg/day (estimated 239 times the human exposure at the maximum clinical dose of 
15 mg/day, based on AUC). Sexual maturation was delayed in both sexes at 250 mg/kg/day (estimated 
620 times the MRHD at 15 mg/day, based on AUC).

When ertugliflozin was administered to juvenile rats from postnatal day (PND) 21 to PND 90, a period 
of renal development corresponding to the late second and third trimesters of human pregnancy, 
increased kidney weights, dilatation of the renal pelvis and tubules, and renal tubular mineralization 
were seen at an exposure 13 times the maximum clinical dose of 15 mg/day, based on AUC. Effects 
on bone (shorter femur length, increased trabecular bone in the femur) as well as effects of delayed 
puberty were observed at an exposure 817 times the MRHD of 15 mg/day based on AUC. The effects 
on kidney and bone did not fully reverse after the 1-month recovery period.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core
Microcrystalline cellulose (E460)
Lactose monohydrate
Sodium starch glycolate (Type A)
Magnesium stearate (E470b)

Film coating
Hypromellose 2910/6 (E464)
Lactose monohydrate
Macrogol 3350 (E1521)
Triacetin (E1518)
Titanium dioxide (E171)
Iron oxide red (E172)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container 

Alu/PVC/PA/Alu blisters.
Packs of 14, 28, 30, 84, 90 and 98 film-coated tablets in non-perforated blisters.
Packs of 30x1 film-coated tablets in perforated unit dose blisters.

 



19

Not all pack sizes may be marketed.

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) 

Steglatro 5 mg film-coated tablets
EU/1/18/1267/001
EU/1/18/1267/002
EU/1/18/1267/003
EU/1/18/1267/004
EU/1/18/1267/005
EU/1/18/1267/006
EU/1/18/1267/013

Steglatro 15 mg film-coated tablets
EU/1/18/1267/007
EU/1/18/1267/008
EU/1/18/1267/009
EU/1/18/1267/010
EU/1/18/1267/011
EU/1/18/1267/012
EU/1/18/1267/014

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 21 March 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.

 

http://www.ema.europa.eu/


20

ANNEX II

A. MANUFACTURER(S) 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

 



21

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer(s) responsible for batch release
Schering-Plough Labo NV
Industriepark 30
2220 Heist-op-den-Berg
BELGIUM

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. The marketing authorisation 
holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.

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. 

 



22

ANNEX III

LABELLING AND PACKAGE LEAFLET

 



23

A. LABELLING

 



24

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR STEGLATRO 5 mg

1. NAME OF THE MEDICINAL PRODUCT

Steglatro 5 mg film-coated tablets
ertugliflozin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).

3. LIST OF EXCIPIENTS

Contains lactose. See the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets
28 film-coated tablets
30 film-coated tablets
30x1 film-coated tablets
84 film-coated tablets
90 film-coated tablets
98 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

 



25

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/1/18/1267/001 (14 film-coated tablets)
EU/1/18/1267/002 (28 film-coated tablets)
EU/1/18/1267/003 (30 film-coated tablets)
EU/1/18/1267/004 (30x1 film-coated tablets)
EU/1/18/1267/005 (84 film-coated tablets)
EU/1/18/1267/006 (90 film-coated tablets)
EU/1/18/1267/013 (98 film-coated tablets)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Steglatro 5 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN

 



26

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER FOR STEGLATRO 5 mg

1. NAME OF THE MEDICINAL PRODUCT

Steglatro 5 mg tablets
ertugliflozin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

 



27

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR STEGLATRO 15 mg

1. NAME OF THE MEDICINAL PRODUCT

Steglatro 15 mg film-coated tablets
ertugliflozin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).

3. LIST OF EXCIPIENTS

Contains lactose. See the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets
28 film-coated tablets
30 film-coated tablets
30x1 film-coated tablets
84 film-coated tablets
90 film-coated tablets
98 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

 



28

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/1/18/1267/007 (14 film-coated tablets)
EU/1/18/1267/008 (28 film-coated tablets)
EU/1/18/1267/009 (30 film-coated tablets)
EU/1/18/1267/010 (30x1 film-coated tablets)
EU/1/18/1267/011 (84 film-coated tablets)
EU/1/18/1267/012 (90 film-coated tablets)
EU/1/18/1267/014 (98 film-coated tablets)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Steglatro 15 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN

 



29

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER FOR STEGLATRO 15 mg

1. NAME OF THE MEDICINAL PRODUCT

Steglatro 15 mg tablets
ertugliflozin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

 



30

B. PACKAGE LEAFLET

 



31

Package leaflet: Information for the patient

Steglatro 5 mg film-coated tablets
Steglatro 15 mg film-coated tablets

ertugliflozin

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 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, 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 signs of illness are the same as yours.
 If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any 

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Steglatro is and what it is used for

What Steglatro is
Steglatro contains the active substance ertugliflozin.

Steglatro is a member of a group of medicines called sodium glucose co-transporter-2 (SGLT2) 
inhibitors.

What Steglatro is used for
 Steglatro lowers blood sugar levels in adult patients (aged 18 years and older) with type 2 

diabetes.
 Steglatro can be used alone or with some other medicines that lower blood sugar.
 You need to keep following your food and exercise plan while taking Steglatro.

How Steglatro works
Ertugliflozin works by blocking the SGLT2 protein in your kidneys. This causes blood sugar to be 
removed in your urine.

What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough insulin or the insulin that 
your body produces does not work as well as it should. Your body can also make too much sugar. 
When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems
like heart disease, kidney disease, blindness and poor circulation.

 



32

2. What you need to know before you take Steglatro

Do not take Steglatro
 if you are allergic to ertugliflozin or any of the other ingredients of this medicine (listed in 

section 6).

Warnings and precautions 
Talk to your doctor, pharmacist, or nurse before and while taking Steglatro if you:
 have kidney problems.
 have or have had yeast infections of the vagina or penis.
 have ever had serious heart disease or if you have had a stroke.
 have type 1 diabetes. Steglatro should not be used to treat this condition.
 take other diabetes medicines; you are more likely to get low blood sugar with certain 

medicines.
 might be at risk of dehydration (for example, if you are taking medicines that increase urine 

production [diuretics] or lower blood pressure or if you are over 65 years old). Ask about ways 
to prevent dehydration.

 experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and 
deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet 
or metallic taste in your mouth or a different odour to your urine or sweat contact a doctor or the 
nearest hospital straight away. These symptoms could be a sign of “diabetic ketoacidosis” – a 
problem you can get with diabetes because of increased levels of “ketone bodies” in your urine 
or blood, seen in tests. The risk of developing diabetic ketoacidosis may be increased with 
prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin 
dose, or a higher need of insulin due to major surgery or serious illness.

 have had a lower limb amputation.

It is important to check your feet regularly and adhere to any other advice regarding foot care and 
adequate hydration given by your healthcare professional. You should notify your doctor immediately 
if you notice any wounds or discolouration, or if you experience any tenderness or pain in your feet. 
Some studies indicate that taking ertugliflozin may have contributed to an increase in cases of lower 
limb amputation (mainly of the toe).

Talk to your doctor immediately if you develop a combination of symptoms of pain, tenderness, 
redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling 
generally unwell. These symptoms could be a sign of a rare but serious or even life-threatening 
infection, called necrotising fasciitis of the perineum or Fournier’s gangrene which destroys the tissue 
under the skin. Fournier’s gangrene has to be treated immediately.

When this medicine is used in combination with insulin or medicines that increase insulin release from 
the pancreas, low blood sugar (hypoglycaemia) can occur. Your doctor may reduce the dose of your 
insulin or other medicine.

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

Urine glucose
Because of how this medicine works, your urine will test positive for sugar (glucose) while you are on
this medicine.

Children and adolescents
Children and adolescents below 18 years should not take this medicine. It is not known if this 
medicine is safe and effective when used in children and adolescents under 18 years of age.

Other medicines and Steglatro
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 

 



33

In particular, tell your doctor: 
 if you are taking medicines which increase urine production (diuretics). 
 if you are taking other medicines that lower the sugar in your blood, such as insulin or

medicines that increase insulin release from the pancreas. 
If any of the above apply to you (or you are not sure), tell your doctor.

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 Steglatro can harm your unborn baby. If you are pregnant, talk with your doctor 
about the best way to control your blood sugar while you are pregnant. Do not use Steglatro if you are
pregnant.

It is not known if Steglatro passes into breast milk. Talk with your doctor about the best way to feed 
your baby if you take Steglatro. Do not use Steglatro if you are breast-feeding.

Driving and using machines
This medicine has no or negligible influence on the ability to drive and use machines. Taking this 
medicine in combination with insulin or medicines that increase insulin release from the pancreas can 
cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as 
shaking, sweating and change in vision, and may affect your ability to drive and use machines. Do not 
drive or use any tools or machines if you feel dizzy while taking Steglatro.

Steglatro contains lactose
Steglatro contains lactose (milk sugar). If you have been told by your doctor that you have an 
intolerance to some sugars, contact your doctor before taking this medicine.

Steglatro contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 
‘sodium-free’.

3. How to take Steglatro

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

How much to take
 The starting dose of Steglatro is one 5-mg tablet each day. Your doctor will decide whether to 

increase your dose to 15 mg.
 Your doctor will prescribe the right dose for you. Do not change your dose unless your doctor 

has told you to.

Taking this medicine
 Swallow the tablet; if you have difficulties with swallowing, the tablet can be broken or 

crushed.
 Take one tablet every morning. Try to take it at the same time; this will help you remember to 

take it.
 You can take your tablet with or without food. 
 You need to keep following your food and exercise plan while taking Steglatro.

If you take more Steglatro than you should
If you take too much Steglatro, talk to a doctor or pharmacist straight away.

 



34

If you forget to take Steglatro
If you forget a dose, take it as soon as you remember. However, if it is nearly time for your next dose, 
skip the missed dose and go back to your regular schedule. 

Do not take a double dose (two doses on the same day) to make up for a forgotten dose.

If you stop taking Steglatro
Do not stop taking this medicine without talking to your doctor. Your blood sugar levels may increase
if you stop the medicine.

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

4. Possible side effects

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

Contact a doctor or the nearest hospital straight away if you have any of the following serious 
side effects:

Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people)

These are the signs of diabetic ketoacidosis (see also section “Warnings and precautions”): 
 increased levels of “ketone bodies” in your urine or blood 
 rapid weight loss 
 feeling sick or being sick 
 stomach pain 
 excessive thirst 
 fast and deep breathing 
 confusion 
 unusual sleepiness or tiredness 
 a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your 

urine or sweat 
This may occur regardless of blood glucose level. Your doctor may decide to temporarily or 
permanently stop your treatment with Steglatro.

Necrotising fasciitis of the perineum or Fournier’s gangrene (not known, cannot be estimated 
from the available data)
A serious soft tissue infection of the genitals or the area between the genitals and the anus (see section 
“Warnings and precautions” for symptoms).

If you notice any of the side effects above, contact a doctor or the nearest hospital straight away.

Contact your doctor as soon as possible if you notice the following side effects:

Dehydration (losing too much water from your body; common, may affect up to 1 in 10 people)
Symptoms of dehydration include:
 dry mouth
 feeling dizzy, light-headed, or weak, especially when you stand up
 fainting

You may be more likely to get dehydrated if you:
 have kidney problems
 take medicines that increase your urine production (diuretics) or lower blood pressure
 are 65 years or older

 



35

Low blood sugar (hypoglycaemia; common) 
Your doctor will tell you how to treat low blood sugar and what to do if you have any of the symptoms 
or signs below. The doctor may lower the dose of your insulin or other diabetes medicine.

Signs and symptoms of low blood sugar may include:
 headache
 drowsiness
 irritability
 hunger
 dizziness
 confusion
 sweating
 feeling jittery
 weakness
 fast heart beat

If you notice any of the side effects above, contact your doctor as soon as possible.

Other side effects when taking Steglatro:
Very common
 vaginal yeast infection (thrush)

Common
 yeast infections of the penis
 changes in urination, including urgent need to urinate more often, in larger amounts, or at night
 thirst
 vaginal itching
 blood tests may show changes in the amount of urea in your blood
 blood tests may show changes in the amount of total and bad cholesterol (called LDL - a type of 

fat in your blood)
 blood tests may show changes in the amount of red blood cells in your blood (called 

haemoglobin)

Uncommon (may affect up to 1 in 100 people)
 blood tests may show changes related to kidney function (such as ‘creatinine’)
 painful urination

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

5. How to store Steglatro

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 blister and the carton 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 the packaging is damaged or shows signs of tampering.

 

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


36

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 Steglatro contains 
 The active substance is ertugliflozin.

o Each Steglatro 5 mg film-coated tablet contains 5 mg ertugliflozin (as ertugliflozin 
L-pyroglutamic acid).

o Each Steglatro 15 mg film-coated tablet contains 15 mg ertugliflozin (as ertugliflozin 
L-pyroglutamic acid).

 The other ingredients are:
o Tablet core: microcrystalline cellulose (E460), lactose monohydrate (see section 2), 

sodium starch glycolate (Type A), magnesium stearate (E470b).
o Film coating: hypromellose 2910/6 (E464), lactose monohydrate (see section 2), 

macrogol 3350 (E1521), triacetin (E1518), titanium dioxide (E171), iron oxide red 
(E172).

What Steglatro looks like and contents of the pack
 Steglatro 5 mg film-coated tablets (tablets) are pink, 6.4 x 6.6 mm, triangular-shaped, with 

“701” on one side and plain on the other side. 
 Steglatro 15 mg film-coated tablets (tablets) are red, 9.0 x 9.4 mm, triangular-shaped, with 

“702” on one side and plain on the other side.

Steglatro is available in Alu/PVC/PA/Alu blisters. The pack sizes are 14, 28, 30, 84, 90 and 98 film-
coated tablets in non-perforated blisters and 30x1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Manufacturer
Merck Sharp & Dohme B.V. Schering-Plough Labo NV
Waarderweg 39 Industriepark 30 - Zone A
2031 BN Haarlem 2220 Heist-op-den-Berg
The Netherlands Belgium

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

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

Lietuva
UAB Merck Sharp & Dohme
Tel: + 370 5 2780247
msd_lietuva@merck.com

България
Мерк Шарп и Доум България ЕООД
Teл.: + 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.: + 36 1 888-5300
hungary_msd@merck.com

 



37

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

Malta
Merck Sharp and 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

Ireland
Merck Sharp & Dohme Ireland (Human Health) 
Limited
Tel: +353 (0)1 2998700
medinfo_ireland@merck.com

Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: + 386 1 5204201
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

Italia
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

 



38

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

Sverige
Merck Sharp & Dohme (Sweden) AB
Tfn: + 46 (0)77 570 04 88
medicinskinfo@merck.com

Latvija
SIA Merck Sharp & Dohme Latvija
Tel: + 371 67 364224
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.

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) 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 steglatro', 'Section_Content': 'do not take steglatro if you are allergic to ertugliflozin or any of the other ingredients of this medicine (listed in section 6). warnings and precautions talk to your doctor, pharmacist, or nurse before and while taking steglatro if you: have kidney problems. have or have had yeast infections of the vagina or penis. have ever had serious heart disease or if you have had a stroke. have type 1 diabetes. steglatro should not be used to treat this condition. take other diabetes medicines; you are more likely to get low blood sugar with certain medicines. might be at risk of dehydration (for example, if you are taking medicines that increase urine production [diuretics] or lower blood pressure or if you are over 65 years old). ask about ways to prevent dehydration. experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat contact a doctor or the nearest hospital straight away. these symptoms could be a sign of "diabetic ketoacidosis" a problem you can get with diabetes because of increased levels of "ketone bodies" in your urine or blood, seen in tests. the risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness. have had a lower limb amputation. it is important to check your feet regularly and adhere to any other advice regarding foot care and adequate hydration given by your healthcare professional. you should notify your doctor immediately if you notice any wounds or discolouration, or if you experience any tenderness or pain in your feet. some studies indicate that taking ertugliflozin may have contributed to an increase in cases of lower limb amputation (mainly of the toe). talk to your doctor immediately if you develop a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling generally unwell. these symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotising fasciitis of the perineum or fournier\'s gangrene which destroys the tissue under the skin. fournier\'s gangrene has to be treated immediately. when this medicine is used in combination with insulin or medicines that increase insulin release from the pancreas, low blood sugar (hypoglycaemia) can occur. your doctor may reduce the dose of your insulin or other medicine. if you have any further questions on the use of this medicine, ask your doctor or pharmacist. urine glucose because of how this medicine works, your urine will test positive for sugar (glucose) while you are on this medicine. children and adolescents children and adolescents below 18 years should not take this medicine. it is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age. other medicines and steglatro tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. in particular, tell your doctor: if you are taking medicines which increase urine production (diuretics). if you are taking other medicines that lower the sugar in your blood, such as insulin or medicines that increase insulin release from the pancreas. if any of the above apply to you (or you are not sure), tell your doctor. 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 steglatro can harm your unborn baby. if you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant. do not use steglatro if you are pregnant. it is not known if steglatro passes into breast milk. talk with your doctor about the best way to feed your baby if you take steglatro. do not use steglatro if you are breast-feeding. driving and using machines this medicine has no or negligible influence on the ability to drive and use machines. taking this medicine in combination with insulin or medicines that increase insulin release from the pancreas can cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines. do not drive or use any tools or machines if you feel dizzy while taking steglatro. steglatro contains lactose steglatro contains lactose (milk sugar). if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. steglatro contains sodium 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{'Title': '3. how to take steglatro', '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. how much to take the starting dose of steglatro is one 5-mg tablet each day. your doctor will decide whether to increase your dose to 15 mg. your doctor will prescribe the right dose for you. do not change your dose unless your doctor has told you to. taking this medicine swallow the tablet; if you have difficulties with swallowing, the tablet can be broken or crushed. take one tablet every morning. try to take it at the same time; this will help you remember to take it. you can take your tablet with or without food. you need to keep following your food and exercise plan while taking steglatro. if you take more steglatro than you should if you take too much steglatro, talk to a doctor or pharmacist straight away. if you forget to take steglatro if you forget a dose, take it as soon as you remember. however, if it is nearly time for your next dose, skip the missed dose and go back to your regular schedule. do not take a double dose (two doses on the same day) to make up for a forgotten dose. if you stop taking steglatro do not stop taking this medicine without talking to your doctor. your blood sugar levels may increase if you stop the medicine. if you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.', 'Entity_Recognition': [{'Text': 'steglatro', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 12, 'EndOffset': 25}, {'Id': 0, 'BeginOffset': 173, 'EndOffset': 182, 'Score': 0.8517503142356873, 'Text': 'steglatro', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.7860186696052551, 'RelationshipScore': 0.9968212842941284, 'RelationshipType': 'DOSAGE', 'Id': 1, 'BeginOffset': 186, 'EndOffset': 194, 'Text': 'one 5-mg', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FORM', 'Score': 0.9844039082527161, 'RelationshipScore': 0.9750810861587524, 'RelationshipType': 'FORM', 'Id': 2, 'BeginOffset': 195, 'EndOffset': 201, 'Text': 'tablet', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FREQUENCY', 'Score': 0.8387047052383423, 'RelationshipScore': 0.999213457107544, 'RelationshipType': 'FREQUENCY', 'Id': 3, 'BeginOffset': 202, 'EndOffset': 210, 'Text': 'each day', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.9002906084060669, 'RelationshipScore': 0.5198379755020142, 'RelationshipType': 'DOSAGE', 'Id': 4, 'BeginOffset': 269, 'EndOffset': 275, 'Text': '15 mg.', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '15', 'Type': 'NUMBER', 'BeginOffset': 269, 'EndOffset': 271}, {'Text': 'this medicine swallow', 'Type': 'TREATMENT', 'BeginOffset': 394, 'EndOffset': 415}, {'Id': 11, 'BeginOffset': 440, 'EndOffset': 468, 'Score': 0.5659197568893433, 'Text': 'difficulties with swallowing', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7907870411872864}]}, {'Id': 7, 'BeginOffset': 726, 'EndOffset': 735, 'Score': 0.7889237999916077, 'Text': 'steglatro', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 8, 'BeginOffset': 754, 'EndOffset': 763, 'Score': 0.6723282337188721, 'Text': 'steglatro', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 9, 'BeginOffset': 880, 'EndOffset': 889, 'Score': 0.7096453309059143, 'Text': 'steglatro', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'a double dose', 'Type': 'TREATMENT', 'BeginOffset': 1066, 'EndOffset': 1079}, {'Id': 10, 'BeginOffset': 1160, 'EndOffset': 1169, 'Score': 0.7898989319801331, 'Text': 'steglatro', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.8266012072563171}]}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 1189, 'EndOffset': 1202}, {'Text': 'your blood sugar levels', 'Type': 'TEST', 'BeginOffset': 1235, 'EndOffset': 1258}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 1346, 'EndOffset': 1359}]}
{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. contact a doctor or the nearest hospital straight away if you have any of the following serious side effects: diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) these are the signs of diabetic ketoacidosis (see also section "warnings and precautions"): increased levels of "ketone bodies" in your urine or blood rapid weight loss feeling sick or being sick stomach pain excessive thirst fast and deep breathing confusion unusual sleepiness or tiredness a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat this may occur regardless of blood glucose level. your doctor may decide to temporarily or permanently stop your treatment with steglatro. necrotising fasciitis of the perineum or fournier\'s gangrene (not known, cannot be estimated from the available data) a serious soft tissue infection of the genitals or the area between the genitals and the anus (see section "warnings and precautions" for symptoms). if you notice any of the side effects above, contact a doctor or the nearest hospital straight away. contact your doctor as soon as possible if you notice the following side effects: dehydration (losing too much water from your body; common, may affect up to 1 in 10 people) symptoms of dehydration include: dry mouth feeling dizzy, light-headed, or weak, especially when you stand up fainting you may be more likely to get dehydrated if you: have kidney problems take medicines that increase your urine production (diuretics) or lower blood pressure are 65 years or older 35 low blood sugar (hypoglycaemia; common) your doctor will tell you how to treat low blood sugar and what to do if you have any of the symptoms or signs below. the doctor may lower the dose of your insulin or other diabetes medicine. signs and symptoms of low blood sugar may include: headache drowsiness irritability hunger dizziness confusion sweating feeling jittery weakness fast heart beat if you notice any of the side effects above, contact your doctor as soon as possible. other side effects when taking steglatro: very common vaginal yeast infection (thrush) common yeast infections of the penis changes in urination, including urgent need to urinate more often, in larger amounts, or at night thirst vaginal itching blood tests may show changes in the amount of urea in your blood blood tests may show changes in the amount of total and bad cholesterol (called ldl - a type of fat in your blood) blood tests may show changes in the amount of red blood cells in your blood (called haemoglobin) uncommon (may affect up to 1 in 100 people) blood tests may show changes related to kidney function (such as \'creatinine\') painful urination reporting of side effects if you get any side effects, talk to your doctor or, pharmacist or nurse. this includes any possible side effects 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{'Title': '5. how to store steglatro', '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 blister and the carton 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 the packaging is damaged or shows signs of tampering. 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 steglatro contains the active substance is ertugliflozin. o each steglatro 5 mg film-coated tablet contains 5 mg ertugliflozin (as ertugliflozin l-pyroglutamic acid). o each steglatro 15 mg film-coated tablet contains 15 mg ertugliflozin (as ertugliflozin l-pyroglutamic acid). the other ingredients are: o tablet core: microcrystalline cellulose (e460), lactose monohydrate (see section 2), sodium starch glycolate (type a), magnesium stearate (e470b). o film coating: hypromellose 2910/6 (e464), lactose monohydrate (see section 2), macrogol 3350 (e1521), triacetin (e1518), titanium dioxide (e171), iron oxide red (e172). what steglatro looks like and contents of the pack steglatro 5 mg film-coated tablets (tablets) are pink, 6.4 x 6.6 mm, triangular-shaped, with "701" on one side and plain on the other side. steglatro 15 mg film-coated tablets (tablets) are red, 9.0 x 9.4 mm, triangular-shaped, with "702" on one side and plain on the other side. steglatro is available in alu/pvc/pa/alu blisters. the pack sizes are 14, 28, 30, 84, 90 and 98 film- coated tablets in non-perforated blisters and 30x1 film-coated tablets in perforated unit dose blisters. not all pack sizes may be marketed.', 'Entity_Recognition': [{'Text': 'steglatro', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 48, 'EndOffset': 61, 'Score': 0.9818587899208069, 'Text': 'ertugliflozin', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.9101022481918335, 'RelationshipScore': 0.9535825252532959, 'RelationshipType': 'FORM', 'Id': 3, 'BeginOffset': 85, 'EndOffset': 89, 'Text': 'film', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FORM', 'Score': 0.7406833171844482, 'RelationshipScore': 0.5268688201904297, 'RelationshipType': 'FORM', 'Id': 4, 'BeginOffset': 90, 'EndOffset': 103, 'Text': 'coated tablet', 'Category': 'MEDICATION', 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