Concise Prescribing Info
Doxorubicin HCl
Leukaemia, lymphoma, sarcoma, neuroblastoma, Wilm's tumour & malignant neoplasms of the bladder, breast, lung, ovary, & thyroid; other tumours including those of the brain, cervix, endometrium, liver, stomach, pancreas, & thymus, gestational trophoblastic tumours, retinoblastoma, & myeloma.
Dosage/Direction for Use
Monotherapy 60-75 mg/m2 as single IV inj at 21-day intervals. Combination therapy 40-60 mg/m2 as single IV inj every 21-28 days.
Hypersensitivity to doxorubicin, or other anthracyclines or anthracenediones. Baseline neutrophil count <1,500 cells/mm3; recent MI; severe myocardial insufficiency; severe arrhythmias; previous treatment w/ complete cumulative doses of doxorubicin, daunorubicin, idarubicin, &/or other anthracyclines & anthracenediones. Severe hepatic impairment.
Special Precautions
Do not give IM or SC due to severe local tissue necrosis. Risk of developing cardiac toxicity in active or dormant CV disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy w/ other anthracyclines or anthracenediones, concomitant use of cardiotoxic drugs, doxorubicin & Ca channel entry blockers, those w/ long t½ (eg, trastuzumab). Probable toxicity of doxorubicin & other anthracyclines or anthracenediones is additive. Cardiomyopathy &/or congestive heart failure may be encountered several mth or yr after discontinuation of doxorubicin therapy. Secondary acute myelogenous leukemia or myelodysplastic syndrome. Impaired hepatic function. Severe myelosuppression. Acute life-threatening arrhythmias. Phlebosclerosis resulting from an inj into a small vessel or repeated inj into the same vein. Extravasation. Perform a MUGA or an ECHO scan, particularly w/ higher, cumulative anthracycline doses. Total & differential WBC, RBC, & platelet counts should be assessed before & during each cycle of therapy. Hepatic impairment. Pregnancy & lactation. Childn.
Adverse Reactions
Cardiotoxicity; reversible complete alopecia; hyperpigmentation of nailbeds & dermal creases; onycholysis; rash, itching, or photosensitivity; acute nausea & vomiting; mucositis w/in 5-10 days of beginning therapy; ulceration & necrosis of the colon, especially to the cecum; anorexia, abdominal pain, dehydration, diarrhea, hyperpigmentation of the oral mucosa; myelosuppression; reversible leukopenia; granulocytopenia; thrombocytopenia; anemia; consequences of severe myelosuppression include fever, infections, sepsis/septicemia, septic shock, hemorrhage, tissue hypoxia, or death; fever, chills, urticaria; anaphylaxis; apparent cross sensitivity to lincomycin; peripheral neurotoxicity; seizures & coma; conjunctivitis, keratitis, lacrimation; malaise/asthenia.
Drug Interactions
Decreased clearance w/ paclitaxel. Enhanced doxorubicin-induced neutropenia & thrombocytopenia w/ progesterone. Higher initial peak conc w/ verapamil. Lower tumor response rate w/ dexrazoxane. Possibility of necrotizing colitis w/ cytarabine. Exacerbate cyclophosphamide-induced hemorrhagic cystitis w/ cyclophosphamide. Increased elimination w/ phenobarb. Decreased phenytoin levels. Inhibited hepatic metabolism w/ streptomycin. Increased mucosal toxicity in patients w/ HIV-associated non-Hodgkin's lymphoma in combination w/ saquinavir. Live vaccines to immunosuppressed patients including those undergoing cytotoxic chemotherapy.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01DB01 - doxorubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
Adrosal lyo powd for inj 10 mg
Adrosal lyo powd for inj 50 mg
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