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topotecan injection
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
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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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.