Generic Medicine Info
Neutrophil counts of <1, 500 cells/mm3 (except if used in acute myeloid leukaemia [AML]). Hepatic impairment (when used for multiple sclerosis [MS]). Pregnancy and lactation. Concurrent administration with live virus vaccines.
Special Precautions
Patient with predisposing factors for therapy-induced cardiotoxicity (e.g. history or current CV disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, prior anthracycline or anthracenedione therapy), diabetes. Not indicated for the treatment of primary progressive MS. Not recommended in patients with pre-existing myelosuppression as a result of previous chemotherapy. Not recommended when baseline LVEF below the lower limit of normal or if clinically significant reduction in LVEF is observed during therapy (when used for MS). Hepatic impairment. Patient Counselling This drug may cause confusion and fatigue, if affected, do not drive or operate machinery. Use effective contraceptive method during therapy and for at least 4 months (for women) or 6 months (for men) following cessation of therapy. Monitoring Parameters Perform pregnancy test before therapy in females of reproductive potential or before each dose (when used for MS). Evaluate cardiac-related signs and symptoms (e.g. history, ECG, physical exam) before starting therapy or before each dose (when used for MS); LVEF with echocardiogram, multiple-gated acquisition (MUGA) or MRI before initial dose and periodically during therapy, or before each dose (when used for MS); perform annual evaluation of LVEF after discontinuing therapy (when used for MS). When used for MS: Screen for latent infections (e.g. TB, hepatitis) before starting therapy (in high-risk population or countries with high TB burden). Monitor CBC with differentials, uric acid (when used for leukaemia), electrolytes, urea, LFTs; injection site for extravasation; hypersensitivity reactions, myelosuppression.
Adverse Reactions
Significant: Acute CHF (when used for AML or MS), functional cardiac changes, severe myelosuppression, secondary AML, myelodysplastic syndrome (MDS), increased risk of transitory or persistent amenorrhoea, hyperuricaemia, tumour lysis syndrome; blue-green colouration of urine, saliva, sweat, tears (for 24 hours after infusion); blue-green tinged sclera; extravasation resulting in erythema, burning, swelling, pain and skin discolouration (blue). Blood and lymphatic system disorders: Anaemia, leucopenia, neutropenia, thrombocytopenia, granulocytopenia. Cardiac disorders: Arrhythmia. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, stomatitis. General disorders and administration site conditions: Lethargy, asthenia, fatigue, pyrexia, oedema. Investigations: Abnormal ECG, elevated AST. Metabolism and nutrition disorders: Anorexia, hyperglycaemia. Nervous system disorders: Headache. Renal and urinary disorders: UTI. Respiratory, thoracic and mediastinal disorders: Dyspnoea, upper respiratory tract infection. Skin and subcutaneous tissue disorders: Alopecia.
Potentially Fatal: Myocardial toxicity, CHF, infection; AML (when used for MS).
Drug Interactions
May increase risk of cardiac toxicity with other cardiotoxic drugs (e.g. anthracyclines). May increase risk of developing secondary AML or MDS with other antineoplastic and/or radiotherapy. May increase risk of myelosuppression with other myelosuppressive agents (e.g. drugs used for treatment of breast cancer). May increase risk of excessive immunodepression and lymphoproliferative syndrome with other immunosuppressive agents. May increase risk of bleeding with vitamin K antagonists. May result in increased bioavailability with BCRP transporter inhibitors (e.g. eltrombopag, gefitinib). May result in decreased exposure with BCRP transporter inducers.
CIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01DB07 - mitoxantrone ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
Disclaimer: This information is independently developed by CIMS based on mitoxantrone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 CIMS. All rights reserved. Powered by
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