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 |
|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|
|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%).
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
- 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
- STEGLATRO Summary of Product Characteristics.
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
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