Topotecan Recall

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


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.


There is currently no drug history available for this drug.

Other Information

Topotecan is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity.

The chemical name for topotecan free base is (S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3’,4’:6,7]indolizino[1,2-b]quinoline-3,14-(4H,12H)-dione. It has the molecular formula C23H23N3O5 and a molecular weight of 421.45.

Topotecan has three pKa values: pKa1 = 10.50 corresponding to the benzyldimethylamino group, pKa2 = 6.99 corresponding to the phenol group and pKa3 = 0.60 corresponding to the quinoline group.

As formulated in Topotecan Injection, topotecan has the following structural formula:

structural formula

where n is >1, corresponding to HCl added to adjust the pH to approximately 2.0 to 2.5.

Topotecan Injection is supplied as a sterile, non-pyrogenic, clear, yellow solution at a topotecan free base concentration of 4 mg/4 mL (1 mg/mL), 3 mg/3 mL (1 mg/mL), and 1 mg/mL available in multiple dose vials. Each mL of Topotecan Injection contains topotecan hydrochloride equivalent to 1 mg of topotecan as free base, 5 mg tartaric acid, NF, and water for injection, USP. Hydrochloric acid and/or sodium hydroxide may be used to adjust the pH.. The hydrochloride salt of topotecan is soluble in water and melts with decomposition at 213°C to 218°C.

The solution must be diluted before administration by intravenous infusion.

Topotecan Manufacturers

  • Sandoz Inc
    Topotecan Injection [Sandoz Inc]
  • Teva Parenteral Medicines, Inc.
    Topotecan Injection, Solution, Concentrate [Teva Parenteral Medicines, Inc.]
  • Hospira, Inc.
    Topotecan (Topotecan Hydrochloride) Injection, Solution, Concentrate [Hospira, Inc.]
  • Hospira, Inc.
    Topotecan (Topotecan Hydrochloride) Injection, Solution, Concentrate [Hospira, Inc.]

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