Zavedos Dosage & Drug Information

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

Concise Prescribing Info

Contents

Idarubicin HCl

Indications/Uses

Acute non-lymphocytic leukemia (ANLL) in adult for remission induction in untreated, relapsed or refractory patients; acute lymphocytic leukemia (ALL) as 2nd-line treatment in adult & childn.

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Dosage/Direction for Use

Adult ANLL 12 mg/m² IV daily for 3 days in combination w/ cytarabine or 8 mg/m² IV daily for 5 days as single agent or in combination. ALL Adult 12 mg/m² single dose IV daily for 3 days. Childn 10 mg/m² single dose IV daily for 3 days.

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Overdosage

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Contraindications

Hypersensitivity to idarubicin, other anthracyclines or anthracenediones. Severe myocardial insufficiency & arrhythmias; recent MI; persistent myelosuppression. Previous treatment w/ max cumulative doses of idarubicin &/or other anthracyclines & anthracenediones. Severe hepatic & renal impairment.

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Special Precautions

Early/delayed cardiotoxicity; active or dormant CV disease, prior or concomitant RT to mediastinal/pericardial area, previous therapy w/ other anthracyclines or anthracenediones; severe myelosuppression; secondary leukemia; mucositis, stomatitis; tumor lysis syndrome, thrombophlebitis & thromboembolic phenomena. Inj site effects, extravasation. Assess cardiac function, hematologic profile before & during treatment. Evaluate blood uric acid, K, Ca phosphate & creatinine levels after initial treatment. Avoid use w/ live vaccine. Concomitant use of drugs w/ ability to suppress cardiac contractility or cardiotoxic drugs eg, trastuzumab. Hepatic &/or renal impairment. May affect fertility. Women of childbearing potential should use effective contraception during & at least 6.5 mth after last dose. Pregnancy. Not to be used during lactation. Infants & childn.

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Use In Pregnancy & Lactation

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Adverse Reactions

Infection, sepsis/septicemia; secondary leukemias; anemia, leukopenia, neutropenia, thrombocytopenia; anaphylaxis; anorexia, dehydration, hyperuricemia; cardiac, vascular, GI & skin & subcutaneous tissue disorders; red color urine 1-2 days after administration; fever; asymptomatic reductions in left ventricular ejection fraction, ECG abnormalities, elevation of liver enzymes & bilirubin.

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Drug Interactions

Monitor cardiac function w/ other potentially cardiotoxic drugs & cardioactive compd eg, Ca-channel blockers. Additive myelosuppressant effect w/ RT.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Zavedos detailed prescribing information

Storage

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Description

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Action

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MIMS Class

Cytotoxic Chemotherapy

ATC Classification

L01DB06 - idarubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.

Regulatory Classification

Presentation/Packing

Form

Zavedos soln for inj 1 mg/mL

Packing/Price

1's

Zavedos

idarubicin

Manufacturer:

Pfizer

Distributor:

DKSH