Alogliptin

FDA label

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Renal CrCl ≥60: no adjustment. CrCl ≥30 to <60: 12.5 mg QD. CrCl <30 or ESRD/hemodialysis: 6.25 mg QD (give without regard to dialysis timing; peritoneal dialysis not studied)

Hepatic Mild–moderate (Child-Pugh A/B): no adjustment. Severe (Child-Pugh C): not studied — use caution in liver disease

Instructions

• May take with or without food
• Do not split tablets
• If a dose is missed, do not double the next dose
• Assess renal function before initiation and periodically thereafter

Cautions

• Acute pancreatitis (postmarketing and trials) — discontinue promptly if suspected
• Heart failure — weigh risks/benefits in patients at risk (prior HF, renal impairment); consider discontinuation if HF develops
• Serious hypersensitivity: anaphylaxis, angioedema, severe cutaneous reactions incl. Stevens-Johnson syndrome; caution if prior angioedema on another DPP-4 inhibitor
• Hepatic effects — postmarketing hepatic failure (sometimes fatal); interrupt if liver injury detected, do not restart if confirmed without alternative etiology
• Hypoglycemia — consider lowering insulin/secretagogue dose when initiating
• Severe and disabling arthralgia (DPP-4 class) — discontinue if appropriate
• Bullous pemphigoid (DPP-4 class) — discontinue if suspected

Adverse reactions

• Nasopharyngitis (5%)
• Headache (4%)
• Upper respiratory tract infection (4%)
• Hypoglycemia (higher when added to insulin or sulfonylurea)

Pregnancy Limited human data insufficient to determine drug-associated risk; no adverse developmental effects in animals at 149–180x clinical exposure; poorly controlled diabetes itself carries maternal/fetal risk

Lactation No human data; present in rat milk — weigh benefits of breastfeeding against potential infant risk