Apremilast immediate-release tablets (Otezla, adults)

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Official source

Apremilast immediate-release tablets (Otezla, adults) - selected U.S. label sections

Product / population: Adult immediate-release OTEZLA tablets only; not OTEZLA XR.
Renal measure: Cockcroft-Gault creatinine clearance in mL/min

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 dosing - immediate-release product

No adjustment is required for mild or moderate renal impairment. For adult Cockcroft-Gault CrCl below 30 mL/min, reduce the maintenance dose to 30 mg orally once daily. During initial titration, use only the morning doses in the labeled titration schedule and omit the afternoon doses.

Formulation safety

The extended-release formulation has a different severe-impairment recommendation and is listed separately. This entry does not infer a dialysis schedule or a pediatric dose.

Source revision: 12/2025 | Retrieved: 2026-09-05. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f6b1f516-4972-4d82-bced-113e47b41cc5

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

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Official product label

Apremilast immediate-release tablets (Otezla, adults) - selected U.S. label sections

Adult immediate-release OTEZLA tablets only; not OTEZLA XR.

Renal method: Cockcroft-Gault creatinine clearance in mL/min
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

Apremilast immediate-release tablets (Otezla, adults) - selected U.S. label sections

Adult immediate-release OTEZLA tablets only; not OTEZLA XR.

Method: Cockcroft-Gault creatinine clearance in mL/min

Renal dosing - immediate-release product Read this complete source summary

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Original content / product scope Apremilast immediate-release tablets (Otezla, adults) - selected U.S. label sections

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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=f6b1f516-4972-4d82-bced-113e47b41cc5

Product and population scope

Adult immediate-release OTEZLA tablets only; not OTEZLA XR.

RDM32-apremilast-otezla-ir-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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Apremilast immediate-release tablets (Otezla, adults) - selected U.S. label sections

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U.S. product labeling / DailyMed · Adult immediate-release OTEZLA tablets only; not OTEZLA XR.

Renal method: Cockcroft-Gault creatinine clearance in mL/min
Source date: 12/2025
Retrieved: 2026-09-05

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

Renal dosing - immediate-release product

RDM32-apremilast-otezla-ir-1 · Source locator: 2, renal dosage modification; 8.6

Formulation safety

The extended-release formulation has a different severe-impairment recommendation and is listed separately. This entry does not infer a dialysis schedule or a pediatric dose.

RDM32-apremilast-otezla-ir-2 · Source locator: 2; 8.6

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=f6b1f516-4972-4d82-bced-113e47b41cc5
Retrieved: 2026-09-05
DailyMed Set ID: f6b1f516-4972-4d82-bced-113e47b41cc5
Label revision: 12/2025
Renal-function method: Cockcroft-Gault creatinine clearance in mL/min
Source date/version: 12/2025
Hash meaning: SHA-256 identifies this local summary, not original SPL XML or a label PDF.
Local summary SHA-256: b385ac6364776b5dd6d246a2a4495e0ee312fb6762070a2322c93d3de279bc7a

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=f6b1f516-4972-4d82-bced-113e47b41cc5
Source retrieval: 2026-09-05. This is not the source publication or label revision date.
Original source type: multisource addition
Local text SHA-256: 85446d3765c527209a99bb05fffd648c8f42148da0a4134e2f400a84a03bf2ca
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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