Topotecan

Indications & Dose:

Treatment of patients with metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy and small cell lung cancer sensitive disease after failure of first-line chemotherapy.

DOSE

Initial dose: The recommended dose is 1.5mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on day one of a 21-day course. A minimum of four courses is recommended. Prior to administration of the first course of, patients must have a baseline neutrophil count of at least 1,500 cells/mm3 and a platelet count of at least 100,000 cells/mm3 and a haemoglobin level of 9 mg/dl. Subsequent doses: should not be readministered unless the neutrophil count recovers to >1,000 cells/mm3 , platelets recover to >100,000 cells/mm3 and haemoglobin levels recover to 9.0 mg/ dl (with transfusion if necessary). Patients who experience severe neutropenia (neutrophil count 1,500 cells/mm3) for 7 days or more, or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, should be treated as follows: either dosage reduced by 0.25 mg/m2 for subsequent courses or given GCSF prophylactically in subsequent courses to maintain dose intensity starting from day six of the course (the day after completion of the administration). If neutropenia is not adequately managed with G-CSF administration, doses should be reduced. Use in children is not recommended as only limited clinical data are available. Dosage in renally impaired. No dosage adjustment appears to be required for treating patients with mild renal impairment (CIcr 40 to 60 ml/min). Dosage adjustment to 0.75 mg/m2 is recommended for patients with moderate renal impairment (20 to 39 ml/min). Insufficient data are available in patients with severe renal impairment to provide a dosage recommen-dation. Dosage in hepatically impaired: No dosage adjustment appears to be required for treating patients with impaired hepatic function (plasma bilirubin >1.5 to <10 mg/dl). Elderly Patients: No dosage adjustment is needed in the elderly, other than adjust-ments related to renal function.

Contraindications:

Hypersensitivity reactions to topotecan and/or its excipients, are pregnant or breast-feeding, or those with severe bone marrow depression. Pregnancy and breast-feeding

Side Effects:

Haematological: Severe neutropenia; with fever or infection, sepsis, severe thrombocytopenia, moderate to severe anaemia, severe leukopenia. Non-haematological: Nausea, vomiting, diarrhoea, constipation, abdominal pain, stomatitis, anorexia, fatigue, asthenia, alopecia, hyperbilirubinaemia, dyspnea, amalise, arthralgia, asthenia, headache, myalgia, pain, rash. Drug interactions: If G-CSF is to be used, it should not be initiated until day 6 of the course of therapy, 24 hours after completion of treatment.

Cautions:

Precautions:

Administered under the direction of a physician experienced in the use of cytotoxic agents. Not be given to patients with baseline neutrophil counts of less than 1,500 cells/mm3 and platelet count of less than 100,000 cells/mm3 . Bone marrow suppression is the dose limiting toxicity of topotecan. Full blood count including platelets should be monitored regularly.

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