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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.
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Sotatercept-csrk injection (Winrevair) - selected U.S. label sections
Product / population
Adult WINREVAIR subcutaneous injection for pulmonary arterial hypertension.
Renal method
eGFR categories in PK section, including hemodialysis
Source revision
Revision not captured; retrieval date is not the revision date.
Retrieved
2026-09-05
Local review status
Local label summary; independent clinical review pending. Not a two-source validated protocol.
Official
Sotatercept-csrk injection (Winrevair) - selected U.S. label sections
U.S. product labeling / DailyMed · Adult WINREVAIR subcutaneous injection for pulmonary arterial hypertension.
Renal method: eGFR categories in PK section, including hemodialysis Source date: Revision not captured; retrieval date is not the revision date. Retrieved: 2026-09-05
Local label summary; independent clinical review pending. Not a two-source validated protocol.
Renal pharmacokinetic comments
The label reports no clinically significant PK differences with eGFR 30-89 mL/min or ESRD below 15 on dialysis. Evidence in the severe-impairment group was limited to three patients. Sotatercept is not dialyzable.
These PK findings do not replace weight-based dosing, hemoglobin and platelet monitoring, or dose holds. Do not invent a post-dialysis supplemental dose.
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.
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.