Topotecan

Topotecan

Topotecan Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

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

Uses

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.

History

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.]

Login To Your Free Account