Onglyza

/ Astra Zeneca

The recommended dose of ONGLYZA is 2.5 mg or 5 mg once daily taken regardless of meals.
Posology: Monotherapy and Add-On Combination Therapy The recommended dose of Onglyza is 5 mg once daily as monotherapy or as add-on combination therapy with metformin, insulin , or a sulfonylurea. Onglyza can be taken with or without food.
Initial Combination Therapy: The recommended starting doses of Onglyza and metformin when used as initial combination therapy is 5 mg Onglyza plus 500 mg metformin once daily. Patients with inadequate glycemic control on this starting dose should further have their metformin dose increased according to approved local label guidelines. The safety and efficacy of saxagliptin as triple oral therapy in combination with metformin and a thiazolidinedione, or with metformin and a sulphonylurea, has not been established.
Special Populations: 
Renal impairment: No dosage adjustment is recommended for patients with mild renal impairment (creatinine clearance [CrCl] >50 mL/min).
The dose  is 2.5 mg once daily for patients with moderate or severe renal impairment. Because the dose should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation and periodically thereafter. Renal function can be estimated from serum creatinine using the Cockcroft-Gault formula or Modification of Diet in Renal Disease formula. (see sections 5.2).
Hepatic impairment: No dose adjustment is necessary for patients with mild or moderate hepatic impairment. Saxagliptin should be used with caution in patients with moderate hepatic impairment, and is not recommended for use in patients with severe hepatic impairment (see section 4.4).
Elderly (≥65 years): No dose adjustment is recommended based solely on age. Experience in patients aged 75 years and older is very limited and caution should be exercised when treating this population (see also sections 4.4, 5.1 and 5.2).
Paediatric population: The safety and efficacy of Onglyza in children aged birth to < 18 years have not yet been established: No data are available.
Method of administration: Onglyza can be taken with or without a meal at any time of the day. If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.

Monotherapy: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
Combination therapy: Add-on combination: In patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin, a thiazolidinedione (TZD), or a sulfonylurea (SU), when the single agent alone, with diet and exercise, does not provide adequate glycemic control. Initial combination: As initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus when dual saxagliptin and metformin therapy is appropriate.Should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. The product has not been studied in combination with insulin.

Hypersensitivity to the active substance or to any of the excipients.

Should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Saxagliptin has not been studied in combination with insulin. Renal impairment: Use is not recommended in patients with moderate to severe renal impairment. Hepatic impairment: Should be used with caution in patients with moderate hepatic impairment, and is not recommended for use in patients with severe hepatic impairment. Use with sulphonylureas: Sulphonylureas are known to cause hypoglycemia. Therefore, a lower dose of sulphonylurea may be required to reduce the risk of hypoglycemia when used in combination with Onglyza. Should not be used in patients who have had any serious hypersensitivity reaction to a dipeptidyl peptidase 4 (DPP4) inhibitor. Elderly patients: Experience in patients aged 75 years and older is very limited and caution should be exercised when treating this population. Immunocompromised patients: Immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodeficiency syndrome, have not been studied in the Onglyza clinical program. Therefore, the efficacy and safety profile of saxagliptin in these patients has not been established. Lactose: The tablet contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicdbinal product.Pregnancy and lactation: Should not be used during pregnancy unless clearly necessary. A decision must be made whether to discontinue breast-feeding or to discontinue therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy to the woman. The effect of saxagliptin on fertility in humans has not been studied.
See prescribing information for full details.

Upper respiratory infection, urinary tract infection, gastroenteritis, sinusitis, nasopharyngitis. Hypoglycemia, headache, vomiting, peripheral edema.
See prescribing information for full details.

Use with potent CYP 3A4 inducers like carbamazepine, dexamethasone, phenobarbital, phenytoin, and rifampicin may reduce the glycemic lowering effect of Onglyza.
See prescribing information for full details.

Onglyza has been shown to be safe and well-tolerated with no clinically meaningful effect on QTc interval or heart rate at oral doses up to 400 mg daily for 2 weeks (80 times the recommended dose). In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s clinical status.
Saxagliptin and its major metabolite can be removed by haemodialysis (23% of dose over 4 hours).