Mitoxantrone


Full Generic Medicine Info
Dosage/Direction for Use

Intravenous
Acute myeloid leukaemia
Adult: 12 mg/m2 daily for 5 days to induce remission. Alternatively, 12 mg/m2 for 3 days in combination with cytarabine.
Reconstitution: Dilute to at least 50 ml in sodium chloride 0.9% or glucose 5% solution and inj over at least 3 min into a freely running IV infusion of either solution.
Incompatibility: Do not mix in the same infusion as heparin.

Intravenous
Breast cancer
Adult: Initially, 14 mg/m2, then repeat every 3 wk. Adjust subsequent dose according to degree of myelosuppression. Debilitated patients or those who had previous chemotherapy: May reduce initial dose to 12 mg/m2. As part of a combination regimen: May reduce initial dose to 10-12 mg/m2.
Reconstitution: Dilute to at least 50 ml in sodium chloride 0.9% or glucose 5% solution and inj over at least 3 min into a freely running IV infusion of either solution.
Incompatibility: Do not mix in the same infusion as heparin.

Intravenous
Prostate cancer
Adult: Initially, 14 mg/m2, then repeat every 3 wk. Adjust subsequent dose according to degree of myelosuppression. Debilitated patients or those who had previous chemotherapy: May reduce initial dose to 12 mg/m2. As part of a combination regimen: May reduce initial dose to 10-12 mg/m2.
Reconstitution: Dilute to at least 50 ml in sodium chloride 0.9% or glucose 5% solution and inj over at least 3 min into a freely running IV infusion of either solution.
Incompatibility: Do not mix in the same infusion as heparin.

Intravenous
Lymphoma
Adult: Initially, 14 mg/m2, then repeat every 3 wk. Adjust subsequent dose according to degree of myelosuppression. Debilitated patients or those who had previous chemotherapy: May reduce initial dose to 12 mg/m2. As part of a combination regimen: May reduce initial dose to 10-12 mg/m2.
Reconstitution: Dilute to at least 50 ml in sodium chloride 0.9% or glucose 5% solution and inj over at least 3 min into a freely running IV infusion of either solution.
Incompatibility: Do not mix in the same infusion as heparin.

Intravenous
Liver cancer
Adult: Initially, 14 mg/m2, then repeat every 3 wk. Adjust subsequent dose according to degree of myelosuppression. Debilitated patients or those who had previous chemotherapy: May reduce initial dose to 12 mg/m2. As part of a combination regimen: May reduce initial dose to 10-12 mg/m2.
Reconstitution: Dilute to at least 50 ml in sodium chloride 0.9% or glucose 5% solution and inj over at least 3 min into a freely running IV infusion of either solution.
Incompatibility: Do not mix in the same infusion as heparin.

Intravenous
Multiple sclerosis
Adult: 12 mg/m2 by IV infusion over 5-15 min. Initially, dose may be given once every 3 mth provided neutrophil count is >1500 cells/mm3 and LVEF >50%.
Reconstitution: Dilute to at least 50 ml in sodium chloride 0.9% or glucose 5% solution and inj over at least 3 min into a freely running IV infusion of either solution.
Incompatibility: Do not mix in the same infusion as heparin.
Contraindications
Pregnancy and lactation. Multiple sclerosis with LVEF <50% or clinically significant reduction in LVEF.
Special Precautions
Preexisting myelosuppression. Perform periodic blood counts. Monitor cardiac function, especially after a cumulative dose of >160 mg/m2 and in patients with prior radiotherapy of the chest and concomitant cytotoxic therapy. Hepatic impairment. Discontinue admin if extravasation occurs. May impair ability to drive or operate machinery.
Adverse Reactions
Arrhythmia, oedema, ECG changes; pain, fatigue, fever, headache; alopecia, nail bed changes; amenorrhoea, menstrual disorder, hyperglycaemia; abdominal pain, anorexia, nausea, constipation, diarrhoea, GI bleeding, mucositis, stomatitis, dyspepsia, vomiting, wt gain/loss; abnormal urine, UTI; haematologic disorders; elevated LFTs; weakness; increased BUN and creatinine, haematuria; cough, dyspnoea, upper respiratory tract infection; fungal infection, infection, sepsis.
Potentially Fatal: Myelosuppression; cardiotoxicity.
Overdosage
Symptoms: Leucopenia, tachycardia, marrow hypoplasia, infection. Management: No known antidote; symptom-directed and supportive.
Drug Interactions
Impaired immune response to vaccines may occur; infection after admin of live vaccines in patients on immunosuppressants is also possible.
Lab Interference
Blue-green discolouration of urine for 24 hr after dosing may interfere with urine tests.
Action
Mitoxantrone, an analogue of the anthracyclines, intercalates DNA and inhibits topoisomerase II causing DNA strand breakage which leads to decreased cell replication.
Absorption: Poor (oral).
Distribution: Rapidly and extensively distributed to body tissues; does not appear to cross the blood-brain barrier; distributes into breast milk.
Metabolism: Hepatic.
Excretion: Via urine and bile (as unchanged drug and metabolites). 5-18 days (elimination half-life).
Storage
Intravenous: Store at 15-25°C (59-77°F); do not freeze. Store opened vials at room temperature for 7 days or under refrigeration for up to 14 days.
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 © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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