ONGLYZA® (saxagliptin)

How do you choose the right DPP-4 inhibitor for your patients with type 2 diabetes?

Clinical considerations1

General

Onglyza should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Onglyza is not a substitute for insulin in insulin-requiring patients.

The safety and efficacy of Onglyza in children aged birth to <18 years have not yet been established. No data are available. 

Renal impairment

No dose adjustment is recommended for patients with mild renal impairment. The dose should be reduced to 2.5 mg once daily in patients with moderate or severe renal impairment. Onglyza is not recommended for use in patients with end-stage renal disease (ESRD) requiring haemodialysis. Assessment of renal function is recommended prior to initiation of Onglyza, and, in keeping with routine care, renal assessment should be done periodically thereafter.

Hepatic impairment

No dose adjustment is necessary in mild or moderate hepatic impairment. Use with caution in patients with moderate hepatic impairment. Not recommended for use in patients with severe hepatic impairment.

Older people (≥65 years)

No dose adjustment is recommended based solely on age.

Pancreatitis

In post-marketing experience there have been spontaneously reported adverse reactions of acute pancreatitis. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of saxagliptin. If pancreatitis is suspected, Onglyza should be discontinued.

Use with medicinal products known to cause hypoglycaemia

Sulphonylureas and insulin are known to cause hypoglycaemia. Therefore, a lower dose of sulphonylurea or insulin may be required to reduce the risk of hypoglycaemia when used in combination with Onglyza.

Use with potent CYP 3A4/5 inducers

Using CYP3A4/5 inducers like carbamazepine, dexarnethasone, phenobarbital, phenytoin, and rifampicin may reduce the glycaemic lowering effect of Onglyza. Glycaernic control should be carefully assessed when used with potent CYP3A4/5 inducers.

Hypersensitivity reactions

Onglyza should not be used in patients who have had any serious hypersensitivity reaction to a dipeptidyl peptidase 4 (DPP4) inhibitor. If a serious hypersensitivity reaction to saxagliptin is suspected, discontinue Onglyza, assess for other potential causes for the event, and institute alternative treatment for diabetes.

Cardiac failure

Cardiac failure Experience in NYHA class III-IV is still limited. Therefore, caution is warranted in these patients. In the SAVOR trial a small increase in the rate for hospitalisation for heart failure was observed in the Onglyza treated patients compared to placebo. Additional analysis did not indicate a differential effect among NYHA classes.

See Onglyza SmPC for full prescribing information.

1. ONGLYZA® Summary of Product Characteristics. http://www.medicines.org.uk/emc/medicine/22315 (Last accessed August 2017).