Adriblastina RD

Adriblastina RD





Concise Prescribing Info
Doxorubicin HCl
Acute lymphoblastic/myelogenous leukemia; chronic leukemia; Hodgkin's & non-Hodgkin's lymphoma; multiple myeloma; osteosarcoma; Ewing's & soft tissue sarcoma; neuroblastoma; rhabdomyosarcoma; Wilm's tumor; breast cancer, including as a component of adjuvant therapy in women w/ evidence of axillary lymph node involvement following resection of primary breast cancer; endometrial, ovarian, non-seminatous testicular, prostate, transitional cell bladder, lung, stomach (gastric), primary hepatocellular, head, neck & thyroid cancer.
Dosage/Direction for Use
IV Dose/cycle differ according to its use w/in specific treatment regimen. Administer IV infusion for not <3 min & not >10 min to minimize the risk of thrombosis or perivenous extravasation. Standard starting dose regimen: Adult 60-90 mg/m2 as single agent; total starting dose may be given as a single dose or divided over 3 successive days or given on days 1 & 8. Each treatment cycle may be repeated every 3-4 wk under conditions of normal recovery from drug-induced toxicity. May also administer in a wkly regimen of 10-20 mg/m2. In combination w/ other cytotoxic drugs 30-60 mg/m2. Adjuvant therapy Combination of doxorubicin 60 mg/m2 & cyclophosphamide 600 mg/m2 administered IV on day 1 of each 21-day treatment cycle. Hepatic dysfunction bilirubin >3 mg/dL ¼ of starting dose, 1.2-3 mg/dL ½ of starting dose. Intravesical Superficial bladder tumors or as prophylaxis to reduce recurrence after transurethral resection Instillations of 30-50 mg in 25-50 mL of saline soln for 1-2 hr in wkly to mthly interval. Intra-arterial Hepatocellular carcinoma 30-150 mg/m2 by infusion into the main hepatic artery at 3-wk to 3-mth intervals.
Hypersensitivity to doxorubicin & other anthracyclines or anthracenediones; methyl p-hydroxybenzoate, lactose monohydrate. IV: Persistent myelosuppression; severe hepatic impairment, myocardial insufficiency & arrhythmias; recent MI; previous treatment w/ max cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin &/or other anthracyclines & anthracenediones. Intravesical: UTI, inflammation of bladder & hematuria.
Special Precautions
Patient should recover from acute toxicities of prior cytotoxic treatment before beginning therapy. Obese patients. Risk of cardiotoxicity. Assess cardiac function before undergoing treatment & monitor throughout therapy to minimize the risk of incurring severe cardiac impairment. May produce myelosuppression; assess hematological profiles including differential WBC before & during each cycle of therapy. Secondary leukemia w/ or w/o a pre-leukemic phase. Mucositis/stomatitis. Evaluate serum total bilirubin before & during treatment; blood uric acid, K, Ca phosphate, creatinine levels after initial therapy. Phlebosclerosis. Stop immediately if signs or symptoms of extravasation occurs. Avoid use of live vaccine. May potentiate toxicity w/ other anticancer therapies. Severe hepatic impairment. Infertility in men & women. May impair ability to drive or use machinery. Pregnancy & lactation.
Adverse Reactions
Infection; leukopenia, neutropenia, anemia, thrombocytopenia; decreased appetite; mucosal inflammation/stomatitis, diarrhea, vomiting, nausea; palmar-plantar erythrodysesthesia syndrome, alopecia; pyrexia, asthenia, chills; decreased ejection fraction, abnormal ECG & transaminases, increased wt.
Drug Interactions
Increased conc & clinical effect w/ CYP3A4, CYP2D6 &/or P-gp (eg, verapamil) inhibitors. May decrease conc w/ CYP3A4 inducers (eg, phenobarb, phenytoin, St. John's wort) & P-gp inducers. May increase AUC of doxorubicin & doxorubicinol w/ cyclosporine. Additive toxicity may occur w/ other cytotoxic drugs. Increased plasma conc w/ paclitaxel.
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.
Adriblastina RD powd for inj 10 mg
((+ 5-mL solvent)) 1's
Adriblastina RD powd for inj 50 mg
((+ 25-mL solvent)) 1's
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