Apremilast extended-release tablets (Otezla XR, adults)

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Official source

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

Product / population: Adult OTEZLA XR extended-release tablets only.
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 restriction - extended-release product

OTEZLA XR is not recommended when adult Cockcroft-Gault CrCl is below 30 mL/min because an appropriate XR dose has not been established. Mild or moderate impairment does not require a renal adjustment.

Do not substitute an IR schedule into XR

The separate immediate-release page contains the labeled reduced IR regimen. Do not split or invent an XR regimen from that recommendation.

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 extended-release tablets (Otezla XR, adults) - selected U.S. label sections

Adult OTEZLA XR extended-release tablets only.

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 extended-release tablets (Otezla XR, adults) - selected U.S. label sections

Adult OTEZLA XR extended-release tablets only.

Method: Cockcroft-Gault creatinine clearance in mL/min

Renal restriction - extended-release product Read this complete source summary

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Original content / product scope Apremilast extended-release tablets (Otezla XR, adults) - 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=f6b1f516-4972-4d82-bced-113e47b41cc5

Product and population scope

Adult OTEZLA XR extended-release tablets only.

RDM32-apremilast-otezla-xr-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 extended-release tablets (Otezla XR, adults) - selected U.S. label sections

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U.S. product labeling / DailyMed · Adult OTEZLA XR extended-release tablets only.

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 restriction - extended-release product

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

Do not substitute an IR schedule into XR

The separate immediate-release page contains the labeled reduced IR regimen. Do not split or invent an XR regimen from that recommendation.

RDM32-apremilast-otezla-xr-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: 670274bd6a767f9d5923daae84dc749a5a0973639e13997703fa4357f6870a87

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: 8192e2c5f13c6c2c422952b82563ac76994e06d49993c91524dcd8d0f06d9bad
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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