Topotecan (Hycamtin)

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General information

Class/mechanism: Topoisomerase I inhibitor. Topotecan binds to the topoisomerase I-DNA complex and prevents the religation of single strand breaks that were originally created by topoisomerase I. This leads to double strand DNA damage, which results in cell damage and cell death.[1][2]
Route: IV
Extravasation: irritant

For conciseness and simplicity, currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is established (work in progress)

Diseases for which it is used

Patient drug information

History of changes in FDA indication

  • 1996-05-28: Initial FDA approval for metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy. (Based on Bookman et al. 1996 & ten Bokkel Huinink et al. 1997)
  • 1998-11-30: Indication expanded to include 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. (Based on von Pawel et al. 1999)
  • 2006-06-14: Indication expanded to include stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy. (Based on GOG 179)

History of changes in EMA indication

  • 1996-11-12: Initial marketing authorization as Hycamtin.

History of changes in PMDA indication

  • 2011-02-23: New additional indication and a new dosage for the treatment of ovarian cancer which has progressed after cancer chemotherapy.
  • 2013-06-14: New additional indication and a new dosage for the treatment of pediatric malignant solid tumors.
  • 2015-11-20: New additional indication and a new dosage for the treatment of advanced or recurrent cervical cancer.

Also known as

  • Code name: SKF S-104864-A
  • Generic name: nogitecan hydrochloride
  • Brand names: Evotopin, Hycamtin, Potactasol, Topecan, Topotec