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topotecan injection
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topotecan injection Quick Finder
Highlights
Boxed Warning
WARNING: MYELOSUPPRESSION
Topotecan can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm3...
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Indications and Usage
1 INDICATIONS AND USAGE
Topotecan Injection is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line...
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Dosage and Administration
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2 DOSAGE AND ADMINISTRATION
2.1 Important Safety Information
Verify dosage using body surface area. Do not exceed a single dose of 4 mg intravenously.
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Injection: 4 mg/4 mL (1 mg/mL topotecan free base) clear, yellow to yellow-green solution in single-dose vial.
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Contraindications
4 CONTRAINDICATIONS
Topotecan Injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. Reactions have included anaphylactoid reactions [see...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Myelosuppression
Topotecan can cause severe myelosuppression.
Grade 4 neutropenia occurred in 78% of 879 patients, with a median...
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Adverse Reactions
6 ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
- Myelosuppression [see Warnings and Precautions (5.1)]...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on animal data...
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Overdosage
10 OVERDOSAGE
Overdoses (up to 10-fold of the recommended dose) have occurred in patients receiving intravenous topotecan. The primary complication of overdosage is myelosuppression. Elevated hepatic enzymes, mucositis,...
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Description
11 DESCRIPTION
Topotecan is a semi-synthetic derivative of camptothecin and a topoisomerase inhibitor. The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Topoisomerase I relieves torsional strain in DNA by inducing reversible single-strand breaks. Topotecan binds to the...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity testing of topotecan has not been performed. Topotecan is known to...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Small Cell Lung Cancer
The efficacy of topotecan was studied in 426 patients with recurrent or progressive SCLC in a randomized, comparative...
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References
15 REFERENCES
1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Topotecan Injection is supplied in 4 mg/4 mL (1 mg/mL topotecan free base) single-dose vials. Each vial contains 4 mL of the sterile, clear, yellow to yellow-green solution.
NDC...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Myelosuppression
Inform patients that topotecan decreases blood cell counts such as white blood cells,...
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