MITOXANTRON EBEWE
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Package:
VIALS: 1 x 20 mg.
Dosage:
I.V. infusion: Dosage to be adjusted according to the indication, general condition and the blood counts. See prescribing information for full details.
Prescribing Restrictions:
Indications:
Advanced breast cancer, non-Hodgkin's lymphoma, adult acute non-lymphocytic leukemia (ANLL), palliation of non-resectable primary hepatocellular carcinoma. In combination with corticosteroids as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer. Reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e. patients whose neurologic status is significantly abnormal between relapses) for ages 18-55 years only. Not indicated in the treatment of patients with primary progressive multiple sclerosis.
Contra-Indications:
Hypersensitivity to the ingredients, bone marrow depression. Not for intrathecal use, pregnancy and lactation.
Special Precautions:
If life-threatening non-hematological toxicity is observed during the first induction course, withhold second induction course until toxicity clears. Women with multiple sclerosis should have a pregnancy test before receiving each dose. When used for leukemia, severe myelosuppression will occur. Only physicians experienced in the chemotherapy of this disease should administer treatment. Laboratory and supportive services must be available for hematologic and chemistry monitoring and adjunctive therapies. Particular care should be given to assuring full hematological recovery before undertaking consolidation therapy (if used) and patients should be monitored closely during this phase. Regular monitoring of clinical hematological and biochemical parameters should be performed. Dosage adjustments may be necessary. Patients with myelosuppression, poor general condition, who have had prior treatment with anthracycline derivatives, prior mediastinal/thoracic radiotherapy, or with pre-existing heart disease. Cardiac examinations should be performed in patients during therapy exceeding a cumulative dose of 160 mg/m
2. Patients with severe hepatic insufficiency. Prehistory of asthma or allergy. Immunization with live virus vaccines is generally not recommended. Treat systemic infections concomitantly with or just prior to commencing therapy. A complete blood count, including platelets, and liver function tests should be performed prior to each course of therapy.
Pregnancy and lactation: May cause fetal harm when administered to a pregnant woman.
Pediatric patients: Safety and effectiveness have not been established.
Side Effects:
The major toxic effects occur in normal, rapidly proliferating tissues, particularly bone marrow and the GI tract. Alopecia, infection, menstrual disorders, stomatitis, amenorrhea, leucopenia, arrhythmia, gamma-glutamyltranspeptidase (GGT) increased. May color the urine blue-green for up to 24 hours after administration. See prescribing information for full details.
Drug Interactions:
Combination with other myelosuppressive drugs. Combination with other antineoplastic agents and/or X-ray treatment
