Zavedos

idarubicin hydrochloride

Idamycin PFS, Zavedos (UK)

Pharmacologic class: Anthracycline antibiotic

Therapeutic class: Antineoplastic

Pregnancy risk category D

FDA Box Warning

• Administer slowly I.V.-never I.M. or subcutaneously. Extravasation may cause severe local tissue necrosis.

• Drug may cause myocardial toxicity leading to heart failure, especially in patients who have received prior anthracyclines or have preexisting cardiac disease.

• Severe bone marrow depression can occur when drug is used at effective therapeutic doses.

• Reduce dosage in hepatic or renal impairment.

• Give under supervision of physician experienced in using leukemia chemotherapeutic drugs, in facility with adequate diagnostic and treatment resources.

Action

Inhibits nucleic acid synthesis by disrupting DNA and RNA polymerase, causing cell death

Availability

Injection: 1 mg/ml

Indications and dosages

Acute myeloid leukemia

Adults: 12 mg/m2/day by slow I.V. injection over 10 to 15 minutes for 3 days. As prescribed, give with cytarabine by continuous I.V. infusion for 7 days, or give cytarabine as I.V. bolus followed by 5 days of cytarabine by continuous I.V. infusion. Second course may be given, depending on response.

Dosage adjustment

• Renal or hepatic impairment
• Severe mucositis

Off-label uses

• Acute nonlymphocytic and chronic myelogenous leukemias
• Non-Hodgkin's lymphoma
• Breast cancer

Contraindications

• Hypersensitivity to drug
• Pregnancy or breastfeeding

Precautions

Use cautiously in:
• renal or hepatic impairment
• bone marrow depression
• previous treatment with anthracyclines or cardiotoxic drugs
• cardiac disease.

Administration

When preparing, wear goggles and gloves, because exposure may cause severe skin reaction. If exposure occurs, wash affected area immediately with soap and water. For eye exposure, follow standard eye irrigation procedure.
• Reconstitute 5-, 10-, or 20-mg vial with 5, 10, or 20 ml of normal saline solution, respectively, to yield a concentration of 1 mg/ml.
• Give slowly over 10 to 15 minutes into I.V. tubing that is infusing normal saline solution or dextrose 5% in water.

Don't administer subcutaneously or I.M. (may cause tissue necrosis).
• If severe mucositis occurs, delay second course (if prescribed) until full recovery; then reduce dosage by 25%.

Adverse reactions

CNS: headache, mental status changes, peripheral neuropathy, seizures

CV: chest pain, heart failure, atrial fibrillation, myocardial infarction, arrhythmias

GI: nausea, vomiting, diarrhea, cramps, mucositis, GI hemorrhage

GU: red urine, renal failure

Hematologic: bone marrow depression

Hepatic: hepatic function changes

Metabolic: hyperuricemia

Skin: alopecia, urticaria, bullous erythematous rash on palms and soles, erythema at previously irradiated site, tissue necrosis or urticaria at injection site

Other: fever, infection, hypersensitivity reaction

Interactions

Drug-drug.Alkaline solutions, heparin: incompatibility

Patient monitoring

Evaluate injection site for burning, stinging, and extravasation. If extravasation occurs, stop infusion and restart in another vein. Then rinse area with normal saline solution and apply cold compress. (Local infiltration with corticosteroids may be indicated.)
• Monitor patient's response to therapy regularly.
• Assess serum uric acid level and CBC.
• Monitor hemodynamic status and cardiac output. Assess for S3 heart sound (which signals heart failure).
• Assess fluid intake and output. Make sure patient is adequately hydrated, to prevent hyperuricemia.

Patient teaching

Instruct patient to immediately report unusual bleeding or bruising, difficulty breathing, or sudden weight gain.
• Tell patient to eat small, frequent meals.
• Advise patient to keep follow-up appointments for assessment, regular blood testing, and monitoring of drug effects.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.

Zavedos

A brand name for IDARUBICIN.
Full browser ?