Name of Medicine
- Each film-coated tablet of ONGLYZA contains either 2.5 mg or 5 mg of saxagliptin free base (as saxagliptin hydrochloride).
Key Practice Points
- Treatment of type 2 diabetes in adults where physical activity and dietary management has not resulted in adequate glycaemic targets.
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- The recommended dose of ONGLYZA is 5 mg once daily as add-on dual combination therapy or triple oral therapy. Onglyza must be swallowed whole (do not split or cut) without regard to food.
- Renal impairment: For moderate renal impairment with eGFR < 45 mL/min/1.73 m2, dose should be adjusted to 2.5 mg. Severe renal impairment (eGFR 15-<30 mL/min/1.73 m2) dose should be 2.5mg once a day. Saxagliptin should be used with caution in severe renal impairment. It is not recommended for patients with end-stage renal disease (ESRD), an eGFR <15mL/min/1.73 m2 or requiring either haemodialysis or peritoneal dialysis.
- Hepatic impairment: No dosage adjustment for ONGLYZA is required.
- No dosage adjustment is required based on age alone.
- Hypersensitivity to vildagliptin or any of the excipients.
- Type 1 diabetes
- Diabetic Ketoacidosis
- Acute pancreatitis: Use of DPP4 inhibitors have been associated with a risk of developing acute pancreatitis. If pancreatitis is suspected, Saxagliptin should be discontinued.
- Hypersensitivity Reactions: During post marketing serious hypersensitivity reactions, including anaphylaxis and angioedema were reported. If a serious hypersensitivity reaction suspected, discontinue ONGLYZA, assess for other potential causes for the event, and institute alternative treatment for diabetes.
- Bullous pemphigoid: Post-marketing cases of bullous pemphigoid requiring hospitalisation have been reported with DPP-4 inhibitor use.
- Arthralgia: Joint pain, which may be severe, has been reported in post marketing reports for DPP4 inhibitors.
- Upper respiratory tract infection
- Urinary tract infection
Pharmacokinetic Properties – Summary
- The amount of saxagliptin absorbed following an oral dose is at least 75%.
- The metabolism of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5). The major metabolite of saxagliptin is also a reversible, competitive DPP-4 inhibitor, half as potent as saxagliptin.
- Protein binding of saxagliptin and its major metabolite is negligible
- Saxagliptin is eliminated by both renal and hepatic pathways.