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topotecan injection

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topotecan injection Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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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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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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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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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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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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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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6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

  • Myelosuppression [see

    6.1 Clinical Trials Experience

    ...
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on animal data...

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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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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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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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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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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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15 REFERENCES

1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.

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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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17 PATIENT COUNSELING INFORMATION

Myelosuppression

Inform patients that topotecan decreases blood cell counts such as white blood cells,...

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Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

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