GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Sotatercept-csrk injection (Winrevair)

Local official-label summaryBase record retrieved 2026-09-05See the evidence for this drug1 sources available - open source summaries, references and comparisons

Winrevair / sotatercept

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Official source

Sotatercept-csrk injection (Winrevair) - selected U.S. label sections

Product / population
Adult WINREVAIR subcutaneous injection for pulmonary arterial hypertension.
Renal measure
eGFR categories in PK section, including hemodialysis

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 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.

Clinical limit

These PK findings do not replace weight-based dosing, hemoglobin and platelet monitoring, or dose holds. Do not invent a post-dialysis supplemental dose.

Source revision: Revision not captured; retrieval date is not the revision date. | Retrieved: 2026-09-05. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7

Scope: Local label summary; independent clinical review pending. Not a two-source validated protocol. GlobalRPh v6.6.

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Official product label

Sotatercept-csrk injection (Winrevair) - selected U.S. label sections

Adult WINREVAIR subcutaneous injection for pulmonary arterial hypertension.

Renal method: eGFR categories in PK section, including hemodialysis
Retrieved: 2026-09-05

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Original content / product scopeSotatercept-csrk injection (Winrevair) - selected U.S. label sections
Exact product and population matter. This added page contains locally stored, source-specific clinical summaries. Historical handbook information, when present, is identified separately and may conflict with U.S. labeling. Confirm indication, population, kidney-function method, monitoring and the full prescribing information before applying a regimen.
Locally stored source content

Exact product and population

Product identity selected for the separately displayed source protocols below. Reference: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7

Product and population scope

Adult WINREVAIR subcutaneous injection for pulmonary arterial hypertension.

RDM32-sotatercept-winrevair-scope · Source section: Editorial scope for the selected U.S. labelRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

Sotatercept-csrk injection (Winrevair) - selected U.S. label sections

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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.

RDM32-sotatercept-winrevair-1 · Source locator: 12.3

Clinical limit

These PK findings do not replace weight-based dosing, hemoglobin and platelet monitoring, or dose holds. Do not invent a post-dialysis supplemental dose.

RDM32-sotatercept-winrevair-2 · Source locator: 2; 12.3

Source-specific limits

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.

Source identity and provenance
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7
Retrieved
2026-09-05
DailyMed Set ID
21693ee2-cd23-4137-ac67-066bb3a4a9b7
Renal-function method
eGFR categories in PK section, including hemodialysis
Source date/version
Revision not captured; retrieval date is not the revision date.
Hash meaning
SHA-256 identifies this local summary, not original SPL XML or a label PDF.
Local summary SHA-256
72f08bf57697a0cad2667af7d029320a834b08ff22f74d7212f82c2da88c7864

Provenance and preservation

Additional summaries stored on this page: 1 official-label, 0 RX List, 0 professional, 0 handbook. Empty additional-source groups are not shown. A missing layer is not a no-adjustment recommendation.

Original source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7
Source retrieval
2026-09-05. This is not the source publication or label revision date.
Original source type
multisource addition
Local text SHA-256
986cb3310f82396a955bcef31e73d96891bce7b438d47af15248fd2d9cc6c30b
Import versus clinical validation
Source-section locators identify where retained content came from. A source-section identifier does not assert that every numeric statement has been independently corroborated. The local text hash is not a hash of original HTML, an FDA PDF or SPL XML.

This page is an additional exact-product entry, not a recovered GlobalRPh monograph. Its primary scope text and separately attributed clinical summaries are locally included.

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