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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 Must be diluted before intravenous infusion Initial U.S. Approval: 1996
Medication labelWhy this: Advisory · dailymed-prescription
Topotecan Injection is indicated for the treatment of: 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 chemotherapy [see Clinical Studies ( 14) ] . Topotecan Injection in combination with cisplatin is indicated for the treatment of: stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.
- generic_name
- topotecan
- product_names
- Topotecan
- ndc
- 16729-243, 16729-243-30, 16729-243-31
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en