Cabotegravir / rilpivirine - CABENUVA intramuscular kit

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Renal guidance at a glance

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Retain the increased-monitoring instruction in severe renal disease

CABENUVA specifies additional adverse-effect monitoring in severe impairment and ESRD. The RX retrieval failed; this addition is official-label content.

Before applying: Confirm HIV-treatment eligibility and injection schedule; do not replace this instruction with APRETUDE wording.

Evidence for this qualification

Source-specific qualification; independent clinician review pending.

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Official source

Cabotegravir / rilpivirine - CABENUVA intramuscular kit

Product / population: CABENUVA intramuscular cabotegravir plus rilpivirine kit for eligible virologically suppressed HIV-1 patients; not PrEP.
Renal measure: CrCl, mL/min; source subsection does not name an equation

Selected sections only; not a complete prescribing monograph or independent clinician approval.

Exact DailyMed HTML identity and named sections checked. Raw SPL XML, original document hash and complete revision history were not obtained.

Renal dosing, restrictions and evidence limits

No adjustment is needed at CrCl 30 to below 90 mL/min. At CrCl 15 to below 30 or below 15, the label recommends increased monitoring for adverse effects. ESRD without dialysis has unknown PK; high protein binding makes dialysis unlikely to change exposure.

Use only within the full HIV-treatment eligibility, resistance and injection-schedule requirements. The renal finding differs in scope from APRETUDE monotherapy for prevention. The GlobalRPh CABENUVA mirror failed retrieval in this pass; this locally stored content is from the exact official label, not an imported RX monograph.

Source revision: Source revision date not established in selected retrieval. | Retrieved: 2026-09-10. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1698baf3-f895-4c42-a1b1-e9ee3f20da36

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

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Evidence sources and renal implications

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Official product label

Cabotegravir / rilpivirine - CABENUVA intramuscular kit

Qualified no-adjustment statement. Apply only to the population, product and renal range described in this source.

CABENUVA intramuscular cabotegravir plus rilpivirine kit for eligible virologically suppressed HIV-1 patients; not PrEP.

Renal method: CrCl, mL/min; source subsection does not name an equation
Retrieved: 2026-09-10

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Source-specific review points

Retain the increased-monitoring instruction in severe renal disease

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Population Kidney-function trend Renal replacement setting

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Source differences and product cautions

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product and indication

Retain the increased-monitoring instruction in severe renal disease

CABENUVA specifies additional adverse-effect monitoring in severe impairment and ESRD. The RX retrieval failed; this addition is official-label content.

How to use this: Confirm HIV-treatment eligibility and injection schedule; do not replace this instruction with APRETUDE wording.

Cabotegravir / rilpivirine - CABENUVA intramuscular kit Cabotegravir - APRETUDE intramuscular injection

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.

Official source

Cabotegravir / rilpivirine - CABENUVA intramuscular kit

CABENUVA intramuscular cabotegravir plus rilpivirine kit for eligible virologically suppressed HIV-1 patients; not PrEP.

Method: CrCl, mL/min; source subsection does not name an 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.

Compare or copy source versions

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Original content / product scope Cabotegravir / rilpivirine - CABENUVA intramuscular kit

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=1698baf3-f895-4c42-a1b1-e9ee3f20da36

Exact product and population

CABENUVA intramuscular cabotegravir plus rilpivirine kit for eligible virologically suppressed HIV-1 patients; not PrEP.

RDM57-SCOPE-cabotegravir-rilpivirine-cabenuva · Source section: Selected source product scopeRenal section finder

Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official Compare this source

Cabotegravir / rilpivirine - CABENUVA intramuscular kit

Open original reference

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DailyMed / ViiV Healthcare Company · CABENUVA intramuscular cabotegravir plus rilpivirine kit for eligible virologically suppressed HIV-1 patients; not PrEP.

Renal method: CrCl, mL/min; source subsection does not name an equation
Source date: Source revision date not established in selected retrieval.
Retrieved: 2026-09-10

Qualified no-adjustment statement. Apply only to the population, product and renal range described in this source.

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

Renal dosing, restrictions and evidence limits

RDM57-official-cabotegravir-rilpivirine-cabenuva-5b49d66b05-C1 · Source locator: Sections 1, 8.6 and 12.3

Source-specific limits

Selected sections only; not a complete prescribing monograph or independent clinician approval.

Exact DailyMed HTML identity and named sections checked. Raw SPL XML, original document hash and complete revision history were not obtained.

Source identity and provenance

Source family: product_label
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1698baf3-f895-4c42-a1b1-e9ee3f20da36
Retrieved: 2026-09-10
Exact label title: Cabotegravir / rilpivirine - CABENUVA intramuscular kit
DailyMed Set ID: 1698baf3-f895-4c42-a1b1-e9ee3f20da36
Labeler: ViiV Healthcare Company
Renal-function method: CrCl, mL/min; source subsection does not name an equation
Source date/version: Source revision date not established in selected retrieval.
Hash meaning: SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256: e4284c385c5a56ec366ef6b250230ba34cb9763b374a02b1325f187a89a1b716

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=1698baf3-f895-4c42-a1b1-e9ee3f20da36
Source retrieval: 2026-09-10. This is not the source publication or label revision date.
Original source type: source summary
Local text SHA-256: 61c98bb983f3703565234b264cafa177b1d201a197509418528d8f27483e4080
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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