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HYCAMTIN CAPSULES

Package(a):
HARD CAPSULES: 10 x 0.25 mg.
Dosage(a):
The recommended dose is 2.3 mg/m² 1 x daily for five consecutive days every 21 days. The capsules must be swallowed whole, and must not be chewed, crushed or divided. May be taken with or without food. 
Subsequent doses: For patients who experience Grade 3 or 4 diarrhea, the dose should be reduced by 0.4 mg/m²/day for subsequent courses. Patients with Grade 2 diarrhea may need to follow the same dose modification guidelines. Should not be re-administered unless the neutrophil count is more than or equal to 1 x 10⁹/L, the platelet count is more than or equal to 100 x 10⁹/L, and the hemoglobin level is more than or equal to 9 G/dL (after transfusion if necessary). Standard oncology practice for the management of neutropenia is either to administer topotecan with other medications (e.g. G-CSF) or to dose-reduce to maintain neutrophil counts. If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count less than or equal to 0.5 x 10⁹/L) for seven days or more, or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.4-1.9 mg/m²/day (or subsequently down to 1.5 mg/m²/day if necessary). Doses should be similarly reduced if the platelet count falls below 25 x 10⁹/L.
Prescribing Restrictions:  None

Package(b):
HARD CAPSULES: 10 x 1 mg.
Dosage(b):
The recommended dose is 2.3 mg/m² 1 x daily for five consecutive days every 21 days. The capsules must be swallowed whole, and must not be chewed, crushed or divided. May be taken with or without food. 
Subsequent doses: For patients who experience Grade 3 or 4 diarrhea, the dose should be reduced by 0.4 mg/m²/day for subsequent courses. Patients with Grade 2 diarrhea may need to follow the same dose modification guidelines. Should not be re-administered unless the neutrophil count is more than or equal to 1 x 10⁹/L, the platelet count is more than or equal to 100 x 10⁹/L, and the hemoglobin level is more than or equal to 9 G/dL (after transfusion if necessary). Standard oncology practice for the management of neutropenia is either to administer topotecan with other medications (e.g. G-CSF) or to dose-reduce to maintain neutrophil counts. If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count less than or equal to 0.5 x 10⁹/L) for seven days or more, or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.4-1.9 mg/m²/day (or subsequently down to 1.5 mg/m^2/day if necessary). Doses should be similarly reduced if the platelet count falls below 25 x 10⁹/L.
Prescribing Restrictions:  None


Indications:
Treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.
Contra-Indications:
History of severe hypersensitivity reactions to topotecan and excipients. Pregnancy and lactation. Severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils less than 1.5 x 10⁹/L, and/or platelet count of less than 100 x 10⁹/L.
Special Precautions:
Prior to administration, patients must have a baseline neutrophil count of more than or equal to 1.5 x 10⁹/L, a platelet count of more than or equal to 100 x 10⁹/L and a hemoglobin level of more than or equal to 9g/dL (after transfusion if necessary). Should be initiated under the direction of a physician experienced in the use of cytotoxic agents. Hematological toxicity is dose-related and full blood count including platelets should be monitored regularly. Can cause severe myelosuppression. Can cause neutropenic colitis. Has been associated with reports of interstitial lung disease (ILD). Dose adjustment may be necessary if administered in combination with other cytotoxics. See prescribing information for full details.
Side Effects:
Very common: Infection, anemia, febrile neutropenia, leucopenia, neutropenia, thrombocytopenia, anorexia (may be severe), diarrhea, nausea and vomiting (may be severe), alopecia, fatigue. Common: Sepsis, pancytopenia, hypersensitivity, including rash, abdominal pain, constipation, stomatitis, asthenia, pyrexia, malaise. See prescribing information for full details.
Drug Interactions:
Other cytotoxic agents, platinum agents. See prescribing information for full details.