Mitoxantrone Baxter: Dosing, Side Effect & Interaction

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing Local Product Insert

Concise Prescribing Info

Contents

Mitoxantrone HCl

Indications/Uses

Breast, primary liver cell & ovarian carcinoma. Malignant lymphomas. Acute leukaemias.

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Dosage/Direction for Use

Individualized dosage. IV Administer slowly as infusion over 15-30 min. Mammary, primary liver cell & ovarian carcinoma, non-Hodgkin's lymphoma 14 mg/m² as initial dose for 1st cycle. Repeat after 21 days. Patient w/ diminished bone marrow reserves as result of previous radiation &/or chemotherapy or those in general poor state of health Reduce initial dose to 12 mg/m² or corresponding to haematological parameters. Combination w/ other myelotoxic acting cytostatic agents Reduce initial dose by 2-4 mg/m². Acute leukemias Adult Induction treatment: 10-12 mg/m² daily for 5 consecutive days (total dose of 50-60 mg/m²). Intrapleural instillation Pleural metastases in cases of breast cancer & non-Hodgkin's lymphoma Single dose of 20-30 mg. Retention time of 1st dose in pleural cavity: 48 hr. Further instillation of 30 mg after 48 hr if vol is >200 mL. Max dose for 1 treatment cycle: 60 mg.

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Overdosage

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Contraindications

Hypersensitivity. Intraarterial, SC, IM or intrathecal administration. Pregnancy & lactation.

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Warnings

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Special Precautions

Secondary acute myelocytic leukemia. Patients w/ severe CV disease or risk factors; prior treatment w/ anthracyclines &/or mediastinal RT; suffering from myelosuppression &/or pancytopenia or severe infections. Closely monitor cardiac functions. Check CBC & liver function parameters before each administration & at least once during each treatment cycle. Concomitant use w/ other cardiotoxic drugs; other DNA-damaging antineoplastic agents &/or RT; high doses of cytotoxic drugs. Severe renal & hepatic impairment. May be genotoxic. Women should not become pregnant & men should not father childn during treatment & for up to 6 mth after treatment, & both should use effective methods of contraception during this period. Risk of irreversible infertility. Discontinue breastfeeding before starting treatment. Ped. Elderly (monitor for toxicities).

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Use In Pregnancy & Lactation

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Adverse Reactions

Sepsis, infection; AML, myelodysplastic syndrome; bone marrow failure, pancytopenia, thrombocytopenia, febrile neutropenia, neutropenia, leukopenia, anemia; hypersensitivity reactions; tumor lysis syndrome; confusional state; cardiomyopathy, cardiac & left ventricular failure, MI, ECG alterations, arrhythmia; phlebitis; interstitial pneumonitis, dyspnea; nausea, vomiting, stomatitis, abdominal pain & tenderness, diarrhea; hepatotoxicity; alopecia, nail disorder, onycholysis including nail discoloration; fetal growth restriction; amenorrhea, oligospermia; inj site necrosis, discoloration, erythema, pain & warmth, asthenia, chest pain, mucosal inflammation, pain, pyrexia; decreased ejection fraction, increased hepatic enzyme & blood bilirubin.

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Drug Interactions

Increased myelotoxic & cardiotoxic effects w/ antineoplastic drugs. Concomitant use w/ cytostatic drugs &/or RT. Reduced response w/ live vaccines. Reduced clearance w/ cyclosporine in patients w/ AML.

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Caution For Usage

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Storage

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Description

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Action

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MIMS Class

Cytotoxic Chemotherapy

ATC Classification

L01DB07 - mitoxantrone ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.

Thai FDA Category

Presentation/Packing

Form

Mitoxantrone Baxter soln for inj 10 mg/5 mL

Packing/Price

1's

Form

Mitoxantrone Baxter soln for inj 20 mg/10 mL

Packing/Price

1's

Mitoxantrone Baxter

mitoxantrone

Manufacturer:

Baxter International

Distributor:

Zuellig Pharma