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Clinical context remains essential
Independent clinical review is pending. Confirm indication, exact formulation/route, population, renal measure and units, kidney-function stability, dialysis prescription, interacting drugs, monitoring and source revision. An RX mirror and its original label are not independent corroboration. Missing disagreement notes do not certify agreement.
The current selected U.S. label and historical handbook differ in administration and available renal evidence. Immune-mediated nephritis requires toxicity management, not an automatic routine renal-dose reduction.
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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 method
GFR >=15 mL/min/1.73 m2 in population PK; CTCAE grading for immune toxicity.
Source revision
DailyMed updated 2026-08-20.
Retrieved
2026-09-05
Local review status
Locally included source-specific summary. Regimen differences are not automatically resolved.
Documented differences and cautions on this drug
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Immune nephritis requires toxicity management, not a calculated dose reduction
The new RX section describes withholding or stopping treatment for immune-mediated creatinine toxicity. These CTCAE grades are not the baseline kidney-function categories used in pharmacokinetic assessment.
What to reconcile: Use the oncology toxicity-management protocol for treatment-emergent nephritis, including the combination-treatment rules. Do not reinterpret a baseline no-adjustment statement as permission to continue through significant immune toxicity.
NIH/NLM DailyMed - U.S. product labeling · Adults; named product and route only. Selected dosing and renal summary, not the full prescribing information.
Renal method: GFR >=15 mL/min/1.73 m2 in population PK; CTCAE grading for immune toxicity. Source date: DailyMed updated 2026-08-20. Retrieved: 2026-09-05
Locally included source-specific summary. Regimen differences are not automatically resolved.
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.
RDM30-085-ipilimumab-1 · Source locator: YERVOY - renal function versus immune-mediated renal toxicity; renal/dosing sections and stated qualifiers
This reference does not select a regimen. Complete the indication, measured/estimated renal function and trend, dialysis setting, source rationale, monitoring and reassessment plan in your institution's approved documentation system. Confirm the complete current source before adopting its regimen.
GlobalRPh v6.6 | RDM66-DIRECT-PHP-20260911 | Local library date 2026-09-11. Selected-card identity does not imply clinical verification.