YERVOY - renal function versus immune-mediated renal toxicity
- Product / population
- Adults; named product and route only. Selected dosing and renal summary, not the full prescribing information.
- Renal measure
- GFR >=15 mL/min/1.73 m2 in population PK; CTCAE grading for immune toxicity.
Dosing / renal protocol and limits
Adult unresectable/metastatic melanoma monotherapy: 3 mg/kg IV every 3 weeks, at most 4 doses. The current label specifies a 30-minute infusion. Combination and adjuvant regimens are different and are not interchangeable with this example.
In population pharmacokinetics, renal impairment with GFR >=15 mL/min/1.73 m2 had no clinically important effect on clearance. This does not establish dosing for GFR <15 or dialysis. Renal immune toxicity is a separate issue: withhold for grade 2-3 creatinine elevation from nephritis and permanently discontinue for grade 4; follow full-label resumption criteria and specialist management. Routine dose reduction is not the toxicity-management strategy.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2265ef30-253e-11df-8a39-0800200c9a66