Macitentan / tadalafil - OPSYNVI | GlobalRPh Renal Dosing Master

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OPSUMIT versus OPSYNVI: the combination changes renal restrictions

A macitentan pharmacokinetic statement does not establish eligibility for the macitentan/tadalafil combination.

Before applying: Check all ingredients and the combination-specific severe-impairment and dialysis restrictions.

Also check: OPSUMIT versus OPSYNVI: the combination changes renal restrictions

Rxlist source

GlobalRPh RX List - OPSYNVI

Product / population: Macitentan / tadalafil - OPSYNVI; selected renal source sections only, not a complete prescribing monograph.
Renal measure: Creatinine clearance (CrCl), mL/min; selected passage does not establish an estimating equation.

RX mirror: this is not independent corroboration of its underlying label. Check dated-label and formulation limitations.

Renal dosing, restrictions and evidence limits

Avoid OPSYNVI with severe renal impairment (CrCl 15-29 mL/min), and use is not recommended in dialysis. For the printed mild (51-80) and moderate (30-50) CrCl bands, use the adult dosing instructions. The tadalafil component contributes increased exposure, and hemodialysis removes little tadalafil or metabolite. Do not replace these combination restrictions with the macitentan-alone pharmacokinetic assessment. No unprinted low-function band is assigned a safe regimen.

Source revision: RX page prints April 2025. | Retrieved: 2026-09-08. Retrieval date is not the revision date.

Source: https://globalrph.com/rx-list/opsynvi-drug/

Scope: Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph. GlobalRPh v6.6.

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Read 1 source difference / applicability notes

GlobalRPh RX List

GlobalRPh RX List - OPSYNVI

Restriction or avoidance guidance. Read the specific threshold, age, formulation and dialysis exclusions; do not generalize across products.

Macitentan / tadalafil - OPSYNVI; selected renal source sections only, not a complete prescribing monograph.

Renal method: Creatinine clearance (CrCl), mL/min; selected passage does not establish an estimating equation.
Retrieved: 2026-09-08

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Source-specific review points

OPSUMIT versus OPSYNVI: the combination changes renal restrictions

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Jump to renal guidance Read 1 difference / caution notes Clinician guide

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Renal-context checklist: population, kidney trend and dialysis

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Population Kidney-function trend Renal replacement setting

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See source-specific renal methods and the clinical interpretation guide for the supporting context.

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Source differences and product cautions

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These are specific issues found during source review, not an automated judgment that one source is universally correct. A label mirror and its original label are not independent evidence.

formulation scope

OPSUMIT versus OPSYNVI: the combination changes renal restrictions

A macitentan pharmacokinetic statement does not establish eligibility for the macitentan/tadalafil combination.

How to use this: Check all ingredients and the combination-specific severe-impairment and dialysis restrictions.

GlobalRPh RX List - OPSYNVI Macitentan - OPSUMIT

Source-specific interpretation; independent clinician adjudication pending.

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Renal dosing and precautions

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New source summary - independent clinical review pending. Summaries of the identified label sections are included locally. Source import and numeric transcription checks are not independent two-reference validation. Do not treat this card as an approved institutional dosing protocol.

Rxlist source

GlobalRPh RX List - OPSYNVI

Macitentan / tadalafil - OPSYNVI; selected renal source sections only, not a complete prescribing monograph.

Method: Creatinine clearance (CrCl), mL/min; selected passage does not establish an estimating equation.

Renal dosing, restrictions and evidence limits Read this complete source summary

No dialysis or renal heading shown? Read the complete source summary. Absence of a heading is not evidence that dose adjustment is unnecessary.

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Original content / product scope GlobalRPh RX List - OPSYNVI

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://globalrph.com/rx-list/opsynvi-drug/

Exact product and population

Macitentan / tadalafil - OPSYNVI; selected renal source sections only, not a complete prescribing monograph.

RDM47-SCOPE-macitentan-tadalafil-opsynvi · Source section: Selected source product scopeRenal section finder

Locally imported selected renal sections

GlobalRPh RX List renal information

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GlobalRPh RX List - OPSYNVI

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GlobalRPh-hosted RX List · Macitentan / tadalafil - OPSYNVI; selected renal source sections only, not a complete prescribing monograph.

Renal method: Creatinine clearance (CrCl), mL/min; selected passage does not establish an estimating equation.
Source date: RX page prints April 2025.
Retrieved: 2026-09-08

Label mirror, not independent corroboration. This is selected locally stored RX List content. Full monograph import and current official-label review are not implied.

Restriction or avoidance guidance. Read the specific threshold, age, formulation and dialysis exclusions; do not generalize across products.

Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.

Renal dosing, restrictions and evidence limits

RDM47-rxlist-macitentan-tadalafil-opsynvi-2675894b8b-C1 · Source locator: Renal Impairment, lines 373-375; pharmacokinetics lines 489-497.

Source identity and provenance

Source family: product_label_mirror
Source: https://globalrph.com/rx-list/opsynvi-drug/
Retrieved: 2026-09-08
Renal-function method: Creatinine clearance (CrCl), mL/min; selected passage does not establish an estimating equation.
Source date/version: RX page prints April 2025.
Hash meaning: SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256: 6eef30f3dd7f546bac48cdd6cd08e6e75f80d6ff9c6d2d6d063224904e0c038d

Provenance and preservation

Additional summaries stored on this page: 0 official-label, 1 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://globalrph.com/rx-list/opsynvi-drug/
Source retrieval: 2026-09-08. This is not the source publication or label revision date.
Original source type: rxlist summary
Local text SHA-256: fec33a2a6efe10b6cf3811ff1dd3f7e0ef96f7c6049e57179d1d9294664c980e
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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