Safety Information

Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]

Adverse event summary of STEGLATRO®▼ (ertugliflozin)

System organ class	Frequency	Adverse reaction
Infections and infestations	Very Common	Vulvovaginal mycotic infection and other female genital mycotic infections^*
Infections and infestations	Common	Balanitis candida and other male genital mycotic infections^*
Infections and infestations	Not known	Necrotising fasciitis of the perineum (Fournier’s gangrene)^*
Metabolism and nutrition disorders	Common	Hypoglycaemia^*
Metabolism and nutrition disorders	Rare	Diabetic ketoacidosis^*
Vascular disorders	Common	Volume depletion^*
Renal and urinary disorders	Common	Increased urination^‡
Renal and urinary disorders	Uncommon	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 of Summary of Product Characteristics for STEGLATRO.

^‡ Includes: pollakiurio, 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 LOL-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%).

Pharmacokinetic interactions

Effects of other medicinal products on the pharmacokinetics of ertugliflozin

Metabolism by UGTlA9 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
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 small increases in simvastatin. These increases are not considered to be clinically meaningful

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 of the Summary of Product Characteristics)

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 of the Summary of Product Characteristics)

Please refer to the Summary of Product Characteristics for a full list of safety information

Reference

STEGLATRO Summary of Product Characteristics.

Supporting documentation

Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
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