Mitoxantrone is indicated for treatment of patients with highly active relapsing multiple sclerosis associated with rapidly evolving disability where no alternative therapeutic options exist.
For this indication, competent medicine agencies globally authorize below treatments:
12 - 12 mg per m² of body surface area (BSA)
From 12 To 12 mg per m² of body surface area (BSA) once every day
The treatment with mitoxantrone should be administered under the supervision of a physician experienced in the use of cytotoxic chemotherapeutic agents for the treatment of multiple sclerosis.
This treatment should be used only after assessment of the benefit-risk, particularly concerning the haematological and cardiac risks.
The treatment must not be initiated in patients who have been previously treated with mitoxantrone.
The recommended dosage of mitoxantrone is usually 12 mg/m² body surface area given as a short (approximately 5 to 15 minutes) intravenous infusion that may be repeated every 1-3 months. The maximum lifetime cumulative dose should not exceed 72 mg/m².
If mitoxantrone is administered repeatedly dosing adjustments should be guided by extent and duration of bone marrow suppression.
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.