Sitagliptin / metformin extended-release (Janumet XR) - selected U.S. label sections
- Product / population
- JANUMET XR extended-release combination tablets only.
- 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 initiation and continuation
Below eGFR 30, JANUMET XR is contraindicated and must be discontinued. Initiation is not recommended between eGFR 30 and 45. If eGFR falls below 45 during treatment, reassess the benefit-risk balance and limit the sitagliptin component to 50 mg once daily.
Contrast precautions
At eGFR 30-60, stop at or before iodinated contrast; re-evaluate after 48 hours and restart only with stable renal function. Other label-based contrast exclusions also apply. Do not substitute the IR combination recommendation for the XR continuation rule.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50