Substance / Medication

Topotecan

Overview

Active Ingredient
topotecan
RxNorm CUI
57308

Indications

Topotecan Injection is indicated for the treatment of: Topotecan Injection in combination with cisplatin is indicated for the treatment of: 14 Clinical Studies () [see] small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the Phase 3 study) or at least 90 days (in the Phase 2 studies) after chemother

Labeler: Accord Healthcare Inc.Updated: 2025-12-17T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

3 Do not give Topotecan Injection to patients with baseline neutrophil counts less than 1,500 cells/mm . In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection and death, monitor peripheral blood counts frequently on all pati

Contraindications

When this intervention should not be used

Topotecan Injection is contraindicated in patients who have a history of severe hypersensitivity reactions (e.g., anaphylactoid reactions) to topotecan or to any of its ingredients. Topotecan Injection should not be used in patients with severe bone marrow depression.

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Clinical Trials

12 trials linked to this intervention

12
Total Trials
10
Recruiting
1
With Results

Research Evidence

Published studies and systematic reviews

Sort:
Non-coding RNAs' pivotal importance in modulation of cancer sensitivity to Topotecan: a systematic review.
Rahimi Seyed Mostafa, Bagheri Abouzar · Med Oncol · 2025
PMID: 40944749Meta-Analysis
Topotecan for Relapsed Small-cell Lung Cancer: Systematic Review and Meta-Analysis of 1347 Patients.
Horita Nobuyuki, Yamamoto Masaki, Sato Takashi et al. · Sci Rep · 2015
PMID: 26486755Meta-AnalysisFull text (PMC)
Ocular pharmacology of topotecan and its activity in retinoblastoma.
Schaiquevich Paula, Carcaboso Angel M, Buitrago Emiliano et al. · Retina · 2014
PMID: 25099219Meta-Analysis
Topotecan for relapsed small cell lung cancer: a systematic review and economic evaluation.
Hartwell Debbie, Jones Jeremy, Loveman Emma et al. · Cancer Treat Rev · 2011
PMID: 20709456Meta-Analysis
The clinical effectiveness and cost-effectiveness of topotecan for small cell lung cancer: a systematic review and economic evaluation.
Loveman E, Jones J, Hartwell D et al. · Health Technol Assess · 2010
PMID: 20356561Meta-Analysis
Systematic Review of topotecan (Hycamtin) in relapsed small cell lung cancer.
Riemsma Rob, Simons Jean P, Bashir Zahid et al. · BMC Cancer · 2010
PMID: 20716361Meta-AnalysisFull text (PMC)
Topotecan for ovarian cancer.
Lihua P, Chen X Y, Wu T X · Cochrane Database Syst Rev · 2008
PMID: 18425923Meta-AnalysisFull text (PMC)

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Topotecan (substance)
SNOMED CT
372536007
UMLS CUI
C0146224
RxNorm CUI
57308
Labeler
Accord Healthcare Inc.

Clinical Data

This intervention maps to 5 entities in the Healos knowledge graph.

5
Conditions
0
Biomarkers
0
Specialists
0
Symptoms
12
Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.