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

Effects of ertugliflozin on the pharmacokinetics of other medicinal products

Pharmacodynamic interactions

Diuretics

Insulin and insulin secretagogues

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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