Olanzapine / samidorphan tablets (Lybalvi) | GlobalRPh Renal Dosing Master

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Official source

Olanzapine / samidorphan tablets (Lybalvi) - selected U.S. label sections

Product / population: Adult LYBALVI combination oral tablets, not single-agent olanzapine.
Renal measure: eGFR in mL/min/1.73 m2

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 restrictions for the combination

No adjustment is required with eGFR 15-89, despite higher exposures observed in severe impairment. ESRD below 15 was not studied and use is not recommended. Do not substitute the single-agent olanzapine renal statement for this combination.

Other safety requirements

The samidorphan component creates opioid-related restrictions that require separate review. Renal eligibility is not a substitute for checking the full contraindications.

Source revision: 1/2026 | Retrieved: 2026-09-05. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=32ffddd1-4e2b-45d9-9b36-bb730167ec80

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

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Official product label

Olanzapine / samidorphan tablets (Lybalvi) - selected U.S. label sections

Adult LYBALVI combination oral tablets, not single-agent olanzapine.

Renal method: eGFR in mL/min/1.73 m2
Retrieved: 2026-09-05

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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

Olanzapine / samidorphan tablets (Lybalvi) - selected U.S. label sections

Adult LYBALVI combination oral tablets, not single-agent olanzapine.

Method: eGFR in mL/min/1.73 m2

Renal restrictions for the combination Read this complete source summary

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Original content / product scope Olanzapine / samidorphan tablets (Lybalvi) - 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=32ffddd1-4e2b-45d9-9b36-bb730167ec80

Product and population scope

Adult LYBALVI combination oral tablets, not single-agent olanzapine.

RDM32-olanzapine-samidorphan-lybalvi-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

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Olanzapine / samidorphan tablets (Lybalvi) - selected U.S. label sections

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U.S. product labeling / DailyMed · Adult LYBALVI combination oral tablets, not single-agent olanzapine.

Renal method: eGFR in mL/min/1.73 m2
Source date: 1/2026
Retrieved: 2026-09-05

Local label summary; independent clinical review pending. Not a two-source validated protocol.

Renal restrictions for the combination

RDM32-olanzapine-samidorphan-lybalvi-1 · Source locator: 8.7

Other safety requirements

The samidorphan component creates opioid-related restrictions that require separate review. Renal eligibility is not a substitute for checking the full contraindications.

RDM32-olanzapine-samidorphan-lybalvi-2 · Source locator: 4

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=32ffddd1-4e2b-45d9-9b36-bb730167ec80
Retrieved: 2026-09-05
DailyMed Set ID: 32ffddd1-4e2b-45d9-9b36-bb730167ec80
Label revision: 1/2026
Renal-function method: eGFR in mL/min/1.73 m2
Source date/version: 1/2026
Hash meaning: SHA-256 identifies this local summary, not original SPL XML or a label PDF.
Local summary SHA-256: 47f6e04a95b171d09e8d34229069e2985a1337f7e6165b606e9bf6a594398b9d

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=32ffddd1-4e2b-45d9-9b36-bb730167ec80
Source retrieval: 2026-09-05. This is not the source publication or label revision date.
Original source type: multisource addition
Local text SHA-256: 82279d9a432bd8d1fb7705c2a4a46d976d0594508962cdfd750afe7cad43a31c
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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