Zavedos

Zavedos

idarubicin

Manufacturer:

Pfizer

Distributor:

Zuellig
Concise Prescribing Info
Contents
Idarubicin HCl
Indications/Uses
AML in adults for remission induction in untreated patients or in relapsed or refractory patients. 1st-line treatment of AML in childn in combination w/ cytarabine for remission induction. 2nd-line treatment of relapsed acute lymphoblastic leukemia (ALL) in adults & childn.
Dosage/Direction for Use
IV Adult AML 12 mg/m2 daily for 3 days in combination w/ cytarabine or 8 mg/m2 daily for 5 days w/ or w/o combination. ALL 12 mg/m2 daily for 3 days as single agent. Childn AML 10-12 mg/m2 daily for 3 days in combination w/ cytarabine. ALL 10 mg/m2 daily for 3 days as single agent. Patient who develop severe mucositis Delay administration of 2nd course until recovery & dose reduction of 25% is recommended.
Contraindications
Hypersensitivity to idarubicin HCl, other anthracyclines or anthracenediones. Uncontrolled infections. Severe cardiomyopathy. Recent MI. Severe arrhythmias. Persistent myelosuppression. Previous treatment w/ max cumulative doses of idarubicin HCl &/or other anthracyclines & anthracenediones. Severe hepatic & renal impairment. Discontinue breast-feeding during therapy.
Special Precautions
Discontinue use should signs or symptoms of extravasation occur. Not for intrathecal use. Secondary leukemia w/ or w/o a preleukemic phase. Cardiotoxicity that may be manifested by early (ie, acute) or late (ie, delayed) events. Mucositis early after administration which, if severe, may progress over a few days to mucosal ulcerations. Potential phlebosclerosis from inj into a small vessel or previous inj into the same vein. Tumor lysis syndrome. Thrombophlebitis & thromboembolic phenomena including pulmonary embolism. May cause red coloration of urine for 1-2 days after administration. Assess hematological profiles prior to & during each cycle of therapy including differential WBC counts. Avoid vaccination w/ live vaccine during treatment. Response to concomitant killed or inactivated vaccines may be diminished. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Evaluate liver & kidney function w/ conventional clinical lab tests (using serum bilirubin & creatinine as indicators) prior to & during treatment. Males should use effective contraception during & for at least 3.5 mth after treatment. Possibility of irreversible infertility on men. Women of childbearing potential should adopt adequate contraception during therapy. Pregnancy. Infants & childn.
Adverse Reactions
Infections; anemia, severe leukopenia & neutropenia, thrombocytopenia; anorexia; nausea, vomiting, mucositis/stomatitis, diarrhea, abdominal pain or burning sensation; alopecia; red coloration of urine for 1-2 days after treatment; fever, headache, chills. Bradycardia, sinus tachycardia, tachyarrhythmia, asymptomatic reduction of left ventricular ejection fraction, CHF, cardiomyopathies; local phlebitis, thrombophlebitis, hemorrhages; GIT bleeding, bellyache; elevation of liver enzymes & bilirubin; rash, itch, hypersensitivity of irradiated skin (radiation recall reaction).
Drug Interactions
May induce additive myelosuppressive effects in combination chemotherapy regimens including other agents w/ similar action. Monitor cardiac function throughout treatment in combination chemotherapy w/ other potentially cardiotoxic drugs & cardioactive compd eg, Ca channel blockers. Potential additive myelosuppressant effect w/ RT when given concomitantly or w/in 2-3 wks prior to treatment. Risk of possibly fatal systemic disease w/ live attenuated vaccines eg, yellow fever. Increased frequency of INR w/ oral anticoagulants. Increased AUC w/ cyclosporin A.
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.
Presentation/Packing
Form
Zavedos powd for inj 5 mg
Packing/Price
1's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in