Sitagliptin / metformin immediate-release (Janumet) - selected U.S. label sections
- Product / population
- JANUMET immediate-release combination tablets; not JANUMET XR or separate component tablets.
- Renal measure
- eGFR in mL/min/1.73 m2
Selected renal sections only, not a complete monograph. Exact product, indication, patient population, renal method and all other contraindications/interactions remain controlling.
Second independent renal reference and clinician adjudication remain pending; no all-indication, dialysis or pediatric dose may be inferred from an omitted field.
Renal restrictions - IR combination
Assess renal function before treatment and periodically. JANUMET is contraindicated below eGFR 30. At 30 to below 45, it is not recommended because the fixed combination cannot provide the lower sitagliptin dosage needed.
Iodinated contrast and renal reassessment
For eGFR 30-60, withhold at or before iodinated contrast. Reassess eGFR after 48 hours and restart only when stable. The label also requires withholding for specified liver disease, alcoholism, heart failure or intra-arterial contrast circumstances.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d19c7ed0-ad5c-426e-b2df-722508f97d67