Omarigliptin is indicated for the treatment of type 2 diabetes mellitus in adults.

Omarigliptin is a long-acting inhibitor of dipeptidyl peptidase-4 (DPP-4) enzyme. DPP-4 normally breaks down incretin hormones quickly. Incretin hormones help lower blood glucose after meals by increasing insulin secretion and reducing glucagon release in a glucose-dependent way. By inhibiting DPP-4, omarigliptin enhances the action of incretin hormones, leading to improved glycemic control.

Route of administration: Omarigliptin tablets should be taken in oral route.

Recommended dosage: The recommended dose of Omarigliptin is 25 mg once weekly as monotherapy or as add-on therapy for optimisation of glycemic control. If patient misses a dose, advice to take the missed dose as soon as possible and then follow the regular weekly dosing schedule. Never take two doses at one time.

Renal impairment: The dosage in patients with severe renal dysfunction or with end-stage renal failure or in those requiring hemodialysis or peritoneal dialysis should be according to the following:

• Severe end-stage kidney failure
• Men: CrCl >1.9: 12.5 mg once a week
• Women: CrCl >1.4: 12.5 mg once a week.

Use in children and adolescents: Safety and efficacy of omarigliptin in children and adolescents have not been established.

Drug interaction with medication: Omarigliptin may interact with metformin, glimepiride, oral contraceptives, and atorvastatin. Other antidiabetic medicines, especially insulin or sulfonylureas, should be used carefully with omarigliptin because they may increase the risk of hypoglycemia. Caution is required with drugs that enhance blood glucose–lowering effects such as beta-blockers, salicylic acid derivatives, and monoamine oxidase inhibitors. Blood glucose should be closely monitored when using drugs that may reduce the hypoglycemic effect, such as adrenaline, adrenocorticotropic hormone (ACTH), and thyroid hormones.

Omarigliptin is contraindicated in patients with hypersensitivity to omarigliptin or any component of the product. It is also contraindicated in severe ketosis, diabetic coma or precoma in type 1 diabetes. In addition, it should not be used in severe infections where insulin is required for glycemic control, or in patients undergoing surgery or suffering from severe trauma.

Omarigliptin is generally well tolerated. The most common side effects include nasopharyngitis, hypoglycemia, constipation, diarrhea, gastrointestinal disturbances, and skin or subcutaneous tissue disorders.

There are no adequate clinical studies in pregnant women. It should be used during pregnancy only if the potential benefit outweighs the possible risk to the fetus. Breastfeeding is not recommended for mothers taking omarigliptin.

Omarigliptin should be used carefully in patients at risk of hypoglycemia, such as those with pituitary or adrenal insufficiency, malnutrition, fasting, irregular food intake, or debilitated conditions. Caution is also needed in individuals performing intense physical activity, consuming excessive alcohol, or in elderly patients. Special care should be taken in patients who drive vehicles or operate machinery.

There is no specific information available on omarigliptin overdose. In case of overdose, supportive treatment is recommended.

Dipeptidyl peptidase-4 (DPP-4) inhibitor.

Store in a cool (below 30°C), dry place protected from light. Keep out of reach of children.