Brand and Other Names:Onglyza
Dosing & Uses
Dosage Forms & Strengths
Diabetes Mellitus Type 2
2.5-5 mg PO qDay
Combination therapy: May need to reduce dosage of sulfonylurea or other insulin secretagogues when administered in combination
Coadministration with strong CYP450 3A4/5 inhibitors: Not to exceed 2.5 mg PO qDay
- CrCl ≥50 mL/min: No dose adjustment required
- CrCl <50 mL/min: Not to exceed 2.5 mg PO qDay
- ESRD requiring hemodialysis: Not to exceed 2.5 mg PO qDay administered postdialysis
- ESRD requiring peritoneal dialysis: Not studied
<18 years: Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Urinary tract infection (7%)
Hypersensitivity-related events (<4%; eg, urticaria, facial edema)
Peripheral edema (<4%; increased incidence when coadministered with thiazolidinediones)
Upper respiratory tract infection (3%)
Frequency Not Defined
Increased creatinine phosphokinase
Idiopathic thrombocytopenic purpura rash
Severe and disabling arthralgia
Documented hypersensitivity (eg, anaphylaxis, angioedema, exfoliative skin conditions)
Decrease dose with strong CYP450 3A4/5 inhibitors
Coadministration with thiazolidinediones (eg, rosiglitazone, pioglitazone) increases risk for peripheral edema
Pancreatitis reported with saxagliptin; monitor for signs and symptoms and discontinue if pancreatitis suspected
Serious hypersensitivity reactions with saxagliptin reported (typically within the first 3 months of therapy)
History of angioedema
Coadministration with a sulfonylurea or with insulin may increase hypoglycemia; monitor closely and adjust sulfonylurea and/or insulin dose accordingly
Severe and disabling arthralgia reported in patients taking DPP-4 inhibitors; consider as a possible cause for severe joint pain and discontinue drug if appropriate
Congestive heart failure (CHF) risks
- In the SAVOR-TIMI 53 trial (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) 16,492 patients with type 2 diabetes mellitus and a history of, or at risk of, cardiovascular events were randomized to saxagliptin or placebo
- A higher incidence of hospitalization for CHF was observed in patients treated with saxagliptin compared with those treated with placebo (3.5% vs 2.8%; P=0.007); this increased risk was highest among patients with elevated levels of natriuretic peptides, previous heart failure, or chronic kidney disease
- Circulation. 2014 Oct 28;130(18):1579-88
- Observe patients for signs and symptoms of heart failure during therapy; inform patients of characteristic symptoms of heart failure and advice patients to immediately report them; if heart failure develops, evaluate and manage according to current standards of care and consider discontinuation of therapy
Pregnancy & Lactation
Pregnancy category: B
Lactation: Not known whether distributed in breast milk; caution advised
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Dipeptidyl peptidase IV (DPP-4) inhibition that results in increased incretin hormones and enhanced glycemic control
Peak plasma time: 2hr (saxagliptin); 4 hr (5-hyroxy saxagliptin)
Hepatic by CYP450 3A4/5 to active metabolite (50% potency of parent compound)
Half-life (elimination): 2.5 hr (saxagliptin); 3.1 hr (5-hydroxy saxagliptin)
Renal clearance: 7.2 L/hr
Excretion: Urine (75%); feces (22%)
May administer with or without food
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