Saxagliptin

FDA label

Read the full label on DailyMed ↗

Renal CrCl ≤50 mL/min (moderate/severe or ESRD on hemodialysis): 2.5 mg QD, given after hemodialysis; mild (CrCl >50): no adjustment. Assess renal function before starting and periodically.

Hepatic No adjustment needed

Limit to 2.5 mg once daily when coadministered with strong CYP3A4/5 inhibitors.

Instructions

• Take once daily regardless of meals; do not split or cut tablets
• Assess renal function before initiation and periodically
• When used with an insulin secretagogue (e.g., sulfonylurea) or insulin, a lower dose of that agent may be needed to reduce hypoglycemia risk

Contraindications

• History of a serious hypersensitivity reaction (anaphylaxis, angioedema, or exfoliative skin conditions) to saxagliptin.

Cautions

• Acute pancreatitis — discontinue if suspected
• Hypoglycemia when used with a sulfonylurea or insulin
• Serious hypersensitivity reactions (anaphylaxis, angioedema, exfoliative skin conditions)
• No conclusive evidence of macrovascular risk reduction

Adverse reactions

• upper respiratory tract infection
• urinary tract infection
• headache
• peripheral edema (with a thiazolidinedione)
• hypoglycemia (with sulfonylurea or insulin)

Pregnancy Pregnancy Category B; no adequate human studies. Not teratogenic in animals. Use during pregnancy only if clearly needed.

Lactation Secreted in the milk of lactating rats; unknown whether secreted in human milk. Exercise caution when administering to a nursing woman.