Pharmacy Diabetes

D-3.3 formulations-saxagliptin

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
Therapeutic Indications:
  • 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
  • Ketoacidosis due to diabetes
  • 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.
Adverse Effects:
  • Upper respiratory tract infection
  • Urinary tract infection
  • Headache
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.
More Information
For more detailed information on this product, please consult the product information.