Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
HYCAMTIN capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
HYCAMTIN capsules should only be prescribed and therapy supervised by a physician experienced in the use of chemotherapeutic agents.
Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥1.5 × 109/l, a platelet count of ≥100 × 109/l and a haemoglobin level of ≥9 g/dl (after transfusion if necessary).
The recommended dose of HYCAMTIN capsules is 2.3 mg/m² body surface area per day administered for five consecutive days with a three-week interval between the start of each course. If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1).
The capsule(s) must be swallowed whole, and must not be chewed crushed or divided. Hycamtin capsules may be taken with or without food (see section 5.2).
Topotecan should not be re-administered unless the neutrophil count is 1 × 109/l, the platelet count is 100 × 109/l, and the haemoglobin level is ≥9 g/dl (after transfusion if necessary).
Standard oncology practice for the management of neutropenia is either to administer topotecan with other medicinal products (e.g. G-CSF) or to reduce the dose to maintain neutrophil counts.
If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count <0.5 × 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 mg/m²/day to 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 × 109/l. In clinical studies, topotecan was discontinued if the dose needed to be reduced below 1.5 mg/m²/day.
For patients who experience Grade 3 or 4 diarrhoea, the dose should be reduced by 0.4 mg/m²/day for subsequent courses (see section 4.4). Patients with Grade 2 diarrhoea may need to follow the same dose modification guidelines.
Proactive management of diarrhoea with anti-diarrhoeal agents is important. Severe cases of diarrhoea may require administration of oral or intravenous electrolytes and fluids, and interruption of topotecan therapy (see sections 4.4 and 4.8).
The recommended monotherapy dose of oral topotecan in patients with small cell lung carcinoma with creatinine clearance between 30 and 49 ml/min is 1.9 mg/m²/day for five consecutive days. If well tolerated, the dose may be increased to 2.3 mg/m²/day in subsequent cycles (see section 5.2).
Limited data in Korean patients with creatinine clearance less than 50 ml/min suggest a further lowering of dose may be required (see section 5.2).
Insufficient data are available to make a recommendation for patients with a creatinine clearance <30 ml/min.
Pharmacokinetics of HYCAMTIN capsules have not been specifically studied in patients with impaired hepatic function. There are insufficient data available with HYCAMTIN capsules to make a dose recommendation for this patient group (see section 4.4).
Currently available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
No overall differences in effectiveness were observed between patients aged over 65 years and younger adult patients. However in the two studies in which both oral and intravenous topotecan were administered, patients over 65 years old receiving oral topotecan experienced an increase in drugrelated diarrhoea compared to those younger than 65 years of age (see section 4.4 and 4.8).
Overdoses have been reported in patients being treated with topotecan capsules (up to 5 fold of the recommended dose) and intravenous topotecan (up to 10 fold of the recommended dose). The signs and symptoms observed following overdose were consistent with the known undesirable events associated with topotecan (see section 4.8). The primary complications of overdose are bone marrow suppression and mucositis. In addition, elevated hepatic enzymes have been reported with intravenous topotecan overdose.
There is no known antidote for topotecan overdose. Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
3 years.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the blister in the outer carton in order to protect from light.
White polyvinyl chloride / polychlorotrifluoroethylene blister sealed with aluminium / Polyethylenterephtalate (PET) / paper foil lidding. The blisters are sealed with a peel-push child resistant opening feature.
Each blister contains 10 capsules.
HYCAMTIN capsules should not be opened or crushed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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