Active Ingredient: Mitoxantrone
Mitoxantrone is indicated for the treatment of acute myeloid leukaemia (AML) in adults.
For this indication, competent medicine agencies globally authorize below treatments:
6 - 12 mg per m² of body surface area (BSA)
From 6 To 12 mg per m² of body surface area (BSA) once every 21 day(s)
Single Agent Therapy in Relapse: The recommended dosage for remission induction is 12 mg/m² of body surface area, given as a single intravenous dose daily for five consecutive days (total of 60 mg/m²). In clinical studies with a dosage of 12 mg/m² daily for 5 days, patients who achieved a complete remission did so as a result of the first induction course.
Combination Therapy: For induction, the recommended dosage is 12 mg/m² of mitoxantrone daily on Days 1 to 3 given as an intravenous infusion, and 100 mg/m² of cytarabine for 7 days given as a continuous 24-hour infusion on Days 1 to 7.
Most complete remissions will occur following the initial course of induction therapy. In the event of an incomplete antileukaemic response, a second induction course may be given with mitoxantrone given for 2 days and cytarabine for 5 days, using the same daily dosage levels. If severe or life-threatening non-haematological toxicity is observed during the first induction course, the second induction course should be withheld until toxicity resolves.
Consolidation therapy, which was used in two large randomised multicentre trials, consists of mitoxantrone 12 mg/m² given by intravenous infusion daily on Days 1 and 2, and cytarabine, 100 mg/m² for 5 days given as a continuous 24-hour infusion on Days 1 to 5. The first course was given approximately 6 weeks after the final induction course; the second was generally administered 4 weeks after the first.
A single course of mitoxantrone 6 mg/m² intravenous (IV) bolus, etoposide 80 mg/m² intravenous for a period of 1 hour, and cytarabine (Ara-C) 1 g/m² intravenous for a period of 6 hours daily for 6 days (MEC) showed antileukaemic activity as salvage therapy for refractory AML.
Mitoxantrone concentrate should be slowly injected into a free flow lowing intravenous infusion of isotonic saline or 5% glucose solution over a period of not less than 3 to 5 minutes. The tubing should be inserted preferably into a large vein. If possible, avoid veins over joints or in extremities with compromised venous or lymphatic drainage.
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