Saxagliptin
ONGLYZA
Pronunciation: SAX-a-glip-tin (on-GLYE-za)
“Sax on Liza”
DPP-4 inhibitor tea bag theme → gliptin → Lipton sweet tea (although opposite effect on blood glucose)
What it isDPP-4 inhibitor enhancing endogenous incretin action; type 2 diabetes.
Why this oneUnlike linagliptin, it needs renal adjustment and CYP3A4 review, with no offsetting cardiovascular advantage.
What limits itA heart-failure hospitalization signal distinguishes it adversely from other gliptins; pancreatitis and severe joint pain can occur.
FDA-approved for
- type 2 diabetes (2009)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Type 2 diabetes mellitus (adjunct to diet and exercise) | Adult | 2.5 mg or 5 mg QD | 5 mg/day |
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
Available strengths
- tab 2.5, 5 mg
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.
Cost
Generic entry2023
NO BOXED WARNINGS
Principal riskHeart-failure hospitalization signal
Classes and tags
Clinical profile
Legacy pregnancy categoryMultiple / indication-, trimester- or formulation-dependent
Defining liabilityAgent-specific hypoglycemia, ketoacidosis, volume, renal or gastrointestinal toxicity.
Open Saxagliptin in the interactive console ↗
Memory aids: interaction avatars
