Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
Whenever intravenous idarubicin hydrochloride cannot be employed e.g. for medical, psychological or social reasons, oral idarubicin can be used for remission induction in patients with previously untreated, relapsed or refractory acute non-lymphocytic leukaemia.
Zavedos may be used in combination chemotherapy regimens involving other cytotoxic agents.
As a single agent in the treatment of advanced breast cancer after failure of front line chemotherapy not including anthracyclines.
Oral.
Dosage is usually calculated on the basis of body surface area.
In adult acute non-lymphocytic leukaemia (ANLL) also referred to as acute myelogenous leukaemia (AML), the recommended dose schedule suggested is 30 mg/m² orally given daily for 3 days as a single agent, or between 15 and 30 mg/m² orally daily for 3 days in combination with other anti-leukemic agents.
In advanced breast cancer the recommended dose schedule as single agent is 45 mg/m² orally given either on a single day or divided over 3 consecutive days, to be repeated every 3 or 4 weeks based on the haematological recovery.
A maximum cumulative dose of 400 mg/m² is recommended.
These dosage schedules should, however, take into account the haematological status of the patient and the dosages of other cytotoxic drugs when used in combination.
In patients with hepatic impairment a dose reduction of Zavedos should be considered. (See section 4.4).
The capsules should be swallowed whole with some water and should not be sucked, bitten or chewed. Zavedos Capsules may also be taken with a light meal.
Very high doses of idarubicin may be expected to cause acute myocardial toxicity within 24 hours and severe myelosuppression within one to two weeks.
Delayed cardiac failure has been seen with anthracyclines for up to several months after the overdose.
Patients treated with oral idarubicin should be observed for possible gastrointestinal haemorrhage and severe mucosal damage.
Shelf life: 3 years.
Store in a dry place.
Type III amber glass bottles closed with an aluminium screw cap with a polyethylene gasket and a polyethylene cover cap. Aluminium/aluminium strips.
Pack size: 1.
None stated.
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