GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Topotecan capsules - HYCAMTIN

Local official-label summaryBase record retrieved 2026-09-07See the evidence for this drug1 sources available - open source summaries, references and comparisons

HYCAMTIN capsules

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Official source

Topotecan capsules - HYCAMTIN

Product / population
Oral HYCAMTIN capsules; relapsed SCLC with prior response and >=45 days since first-line treatment
Renal measure
Cockcroft-Gault CrCl, mL/min, using ideal body weight

Renal dosing, restrictions and evidence limits

For labeled relapsed small cell lung cancer, usual oral dosing is 2.3 mg/m2/day for five consecutive days starting a 21-day cycle. Using Cockcroft-Gault with ideal body weight, reduce to 1.5 mg/m2/day at CrCl 30-49 mL/min, and 0.6 mg/m2/day below 30.

Round to the nearest 0.25 mg using the minimum number of 1-mg and 0.25-mg capsules; swallow whole. Blood-count eligibility, diarrhea-related holds and toxicity modifications remain separate requirements. The below-30 band is not an independently established dialysis schedule. Do not use the IV product's renal dose or cancer-indication schedule for these capsules.

Source revision: September 2023 | Retrieved: 2026-09-07. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b23b46f5-c276-47f5-8bbd-940680b3f579

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

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Official product label

Topotecan capsules - HYCAMTIN

Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.

Oral HYCAMTIN capsules; relapsed SCLC with prior response and >=45 days since first-line treatment

Renal method: Cockcroft-Gault CrCl, mL/min, using ideal body weight
Retrieved: 2026-09-07

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Original content / product scopeTopotecan capsules - HYCAMTIN
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=b23b46f5-c276-47f5-8bbd-940680b3f579

Exact product and population

Oral HYCAMTIN capsules; relapsed SCLC with prior response and >=45 days since first-line treatment

RDM38-SCOPE-topotecan-hycamtin-capsules · Source section: Selected source product scopeRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

Topotecan capsules - HYCAMTIN

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DailyMed / Sandoz · Oral HYCAMTIN capsules; relapsed SCLC with prior response and >=45 days since first-line treatment

Renal method: Cockcroft-Gault CrCl, mL/min, using ideal body weight
Source date: September 2023
Retrieved: 2026-09-07

Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.

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

Renal dosing, restrictions and evidence limits

For labeled relapsed small cell lung cancer, usual oral dosing is 2.3 mg/m2/day for five consecutive days starting a 21-day cycle. Using Cockcroft-Gault with ideal body weight, reduce to 1.5 mg/m2/day at CrCl 30-49 mL/min, and 0.6 mg/m2/day below 30.

Round to the nearest 0.25 mg using the minimum number of 1-mg and 0.25-mg capsules; swallow whole. Blood-count eligibility, diarrhea-related holds and toxicity modifications remain separate requirements. The below-30 band is not an independently established dialysis schedule. Do not use the IV product's renal dose or cancer-indication schedule for these capsules.

RDM38-official-topotecan-hycamtin-capsules-dc66160907-C1 · Source locator: Sections 1, 2.1, 2.2 and 2.3

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b23b46f5-c276-47f5-8bbd-940680b3f579
Retrieved
2026-09-07
Exact label title
Topotecan capsules - HYCAMTIN
DailyMed Set ID
b23b46f5-c276-47f5-8bbd-940680b3f579
Labeler
Sandoz
Label revision
September 2023
Renal-function method
Cockcroft-Gault CrCl, mL/min, using ideal body weight
Source date/version
September 2023
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
4970ee31a4af0f9de1457a2a870fcc944348de4981aeef6dbcae1927d0651e73

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=b23b46f5-c276-47f5-8bbd-940680b3f579
Source retrieval
2026-09-07. This is not the source publication or label revision date.
Original source type
source summary
Local text SHA-256
8bc10efdaa4efe1d38b1a513b8b4ebdef1b6fc72d0c5291eef9b5ec1737fa5ad
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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