GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Lumateperone capsules (Caplyta)

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

Caplyta

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Official source

Lumateperone capsules (Caplyta) - selected U.S. label sections

Product / population
CAPLYTA oral capsules.
Renal measure
eGFR in mL/min/1.73 m2; single-dose PK study

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 study

The selected label describes a single 14 mg dose in patients with varying renal function. Moderate impairment (eGFR 30-59) did not change measured exposure. In severe impairment (eGFR at or below 29), the reported mean AUC and peak-concentration ratios versus normal renal function were 1.5 and 1.4.

Interpretation limit

These are pharmacokinetic observations, not instructions to divide the clinical dose by an exposure ratio. This entry does not create a renal or dialysis dosing schedule.

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=db730b06-6351-47fd-8183-e61e61bbead5

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

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Official product label

Lumateperone capsules (Caplyta) - selected U.S. label sections

CAPLYTA oral capsules.

Renal method: eGFR in mL/min/1.73 m2; single-dose PK study
Retrieved: 2026-09-05

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Original content / product scopeLumateperone capsules (Caplyta) - 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=db730b06-6351-47fd-8183-e61e61bbead5

Product and population scope

CAPLYTA oral capsules.

RDM32-lumateperone-caplyta-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

Lumateperone capsules (Caplyta) - selected U.S. label sections

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U.S. product labeling / DailyMed · CAPLYTA oral capsules.

Renal method: eGFR in mL/min/1.73 m2; single-dose PK study
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 study

The selected label describes a single 14 mg dose in patients with varying renal function. Moderate impairment (eGFR 30-59) did not change measured exposure. In severe impairment (eGFR at or below 29), the reported mean AUC and peak-concentration ratios versus normal renal function were 1.5 and 1.4.

RDM32-lumateperone-caplyta-1 · Source locator: 12.3, Table 8

Interpretation limit

These are pharmacokinetic observations, not instructions to divide the clinical dose by an exposure ratio. This entry does not create a renal or dialysis dosing schedule.

RDM32-lumateperone-caplyta-2 · Source locator: 12.3, Table 8

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=db730b06-6351-47fd-8183-e61e61bbead5
Retrieved
2026-09-05
DailyMed Set ID
db730b06-6351-47fd-8183-e61e61bbead5
Renal-function method
eGFR in mL/min/1.73 m2; single-dose PK study
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
e2e6b8ba08f615aeaaaabfc9afc2c5e2135f4cbf3ea87e6c81a9d935bb0a96ad

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=db730b06-6351-47fd-8183-e61e61bbead5
Source retrieval
2026-09-05. This is not the source publication or label revision date.
Original source type
multisource addition
Local text SHA-256
4ee3f167e37bc0792be56086c2edf052e3b78dcbdd7f15bdc86aac807492cc47
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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