HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TOPOTECAN INJECTION safely and effectively. See full prescribing information for TOPOTECAN INJECTION.
TOPOTECAN injection, for intravenous use
Initial U.S. Approval: 1996
See full prescribing information for complete boxed warning.
Topotecan can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts greater than or equal to 1,500/mm3 and platelet count greater than or equal to 100,000/mm3. Monitor blood cell counts. (2.2, 5.1)
INDICATIONS AND USAGE
Topotecan Injection is a topoisomerase inhibitor indicated for treatment of small cell lung cancer (SCLC) platinum-sensitive disease in patients who progressed at least 60 days after initiation of first-line chemotherapy. (1)
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
Injection: 4 mg/4 mL (1 mg/mL topotecan free base) solution in single-dose vial. (3)
History of severe hypersensitivity reactions to topotecan. (4)
WARNINGS AND PRECAUTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION.