Topotecan

In this article, we will discuss Topotecan (Dosage Overview). So, let’s get started.

Indications

Topotecan is indicated for the treatment of:

• metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy.
• 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.
Topotecan 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.

Dosage

Prior to administration of the first course of HYCAMTIN, patients must have a baseline neutrophil count of >1,500 cells/mm³ and a platelet count of >100,000 cells/mm³.

Ovarian Cancer and Small Cell Lung Cancer
Recommended Dosage: The recommended dose of Topotecan is 1.5 mg/m² by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on day 1 of a 21-day course. In the absence of tumor progression, a minimum of 4 courses is recommended because tumor response may be delayed. The median time to response in 3 ovarian clinical trials was 9 to 12 weeks, and median time to response in 4 small cell lung cancer trials was 5 to 7 weeks.

Dosage Modification Guidelines: In the event of severe neutropenia (defined as <500 cells/mm³) during any course, reduce the dose by 0.25 mg/m2 (to 1.25 mg/m²) for subsequent courses. Alternatively, in the event of severe neutropenia, administer G-CSF (granulocyte-colony stimulating factor) following the subsequent course (before resorting to dose reduction) starting from day 6 of the course (24 hours after completion of topotecan administration). In the event the platelet count falls below 25,000 cells/mm³, reduce doses by (0.25 mg/m² to 1.25 mg/m²) for subsequent courses.

Cervical Cancer
Recommended Dosage: The recommended dose of Topotecan is 0.75 mg/m² by intravenous infusion over 30 minutes daily on days 1, 2, and 3; followed by cisplatin 50 mg/m² by intravenous infusion on day 1 repeated every 21 days (a 21-day course).

Dosage Modification Guidelines:
Dosage adjustments for subsequent courses of Topotecan in combination with cisplatin are specific for each drug. See manufacturer’s prescribing information for cisplatin administration and hydration guidelines and for cisplatin dosage adjustment in the event of hematologic toxicity. In the event of severe febrile neutropenia (defined as <1000 cells/mm³ with temperature of 38.0°C or 100.4°F), reduce the dose of Topotecan to 0.60 mg/m² for subsequent courses. Alternatively, in the event of severe febrile neutropenia, administer G-CSF following the subsequent course (before resorting to dose reduction) starting from day 4 of the course (24 hours after completion of administration of Topotecan). If febrile neutropenia occurs despite the use of G-CSF, reduce the dose of Topotecan to 0.45 mg/m² for subsequent courses. In the event the platelet count falls below 25,000 cells/mm³, reduce doses to 0.60 mg/m² for subsequent courses.

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