Doxorubicin-Teva

Doxorubicin HCl

In combination w/ other antineoplastic drugs for remission induction therapy of acute lymphocytic leukemia, except acute lymphatic leukemia of low risk in childn; remission induction therapy of AML, early stage Hodgkin lymphomas (stages I-II) in patients w/ unfavorable prognosis, advanced Hodgkin lymphomas (stages III-IV), high-grade non-Hodgkin lymphomas; adjuvant & neoadjuvant therapy for osteosarcoma, Ewing sarcoma, advanced adult soft tissue sarcomas, metastatic breast carcinoma, advanced gastric carcinoma, small-cell lung cancer, advanced neuroblastoma, Wilms tumor [stage II w/ unfavorable histology & advanced stages (stages III-IV)]; systemic therapy of locally advanced or metastatic bladder carcinoma. Intravesical treatment for prophylaxis of disease recurrence of superficial bladder carcinoma following transurethral resection in patients at risk for recurrence.

IV Administer by bolus inj, or as continuous infusion over 3-5 min. As single agent: 60-75 mg/m² once every 3 wk. Alternatively, 20 mg/m² for 3 consecutive days once every 3 wk. In combination w/ other oncolytics: 30-60 mg/m² once every 3-4 wk. Max cumulative dose: 550 mg/m². Childn Max cumulative dose: 450 mg/m². Patient who received mediastinal irradiation, w/ concomitant heart disease, or treated w/ other cardiotoxic, non-anthracycline oncolytics Max cumulative dose: 400 mg/m². Patient w/ bilirubin levels 1.2 to 3 mg/100 mL 50% of normal doxorubicin dose, >3 mg/100 mL 25% of normal doxorubicin dose. Intravesical Superficial bladder carcinoma Initially 50 mg in 50 mL normal saline administered wkly via a sterile catheter, then mthly later on.

Hypersensitivity to doxorubicin or other anthracyclines. Myelosuppression including patients w/ high risk of haemorrhage. Pre-existing heart disease, previous treatment w/ complete cumulative doses of doxorubicin or other anthracyclines, or acute infections. Intravesical treatment of bladder carcinoma in patients w/ urethral stenosis who cannot be catheterised or in patients w/ UTIs.

Must not be used interchangeably w/ liposome formulations of doxorubicin HCl. Do not administer intramuscularly, subcutaneously, orally or intrathecally. Immediately terminate inj if extravasation occurs & restart in another vein. Risk of extremely severe nausea, vomiting & mucositis. Consider treating patients at increased risk for cardiotoxicity w/ a 24-hr continuous infusion, rather than bolus inj. Risk of developing cardiomyopathy gradually increases w/ increasing dosage. Cardiotoxicity may occur at doses lower than the recommended cumulative limit in patients previously treated w/ other anthracyclines or cyclophosphamide, mitomycin C or dacarbazine & those who received RT to the mediastinal area. Reports of acute severe arrhythmias during or w/in a few hr after administration. Assess heart function before, during & after therapy (eg, by ECG, echocardiography, or determination of ejection fraction). High incidence of bone marrow depression. Do not start or continue therapy when polynuclear granulocyte counts are <2,000/mm³. Risk of secondary leukemias after treatment. Myelosuppression may be more pronounced due to additive effects w/ other oncolytics. Patients w/ elevated bilirubin may experience slower clearance w/ increase in overall toxicity. Evaluate hepatic function (SGOT, SGPT, alkaline phosphatase, & bilirubin) before & during therapy. Evaluate risk-benefit of treatment before administration in patients w/ severe hepatic impairment. Reports of severe hepatotoxicity, partially leading to death, in patients w/ previous RT to the mediastinal area. May induce hyperuricemia. May impart red coloration to urine. Do not drive or operate machinery. Not recommended during pregnancy & lactation. Can have genotoxic effects. Men should not father a child during & up to 6 mth after treatment. Women should not become pregnant during & up to 6 mth after treatment.

Transient leukopenia; life-threatening cardiomyopathy; nausea, vomiting; reversible alopecia; red coloration to urine. Mucositis (stomatitis or esophagitis).

Enhanced cardiotoxicity w/ previous or concurrent use of other anthracyclines (eg, mitomycin C, dacarbazine, dactinomycin), paclitaxel, & possibly cyclophosphamide. May exacerbate hemorrhagic cystitis caused by previous cyclophosphamide therapy. Severe hematopoietic disturbances w/ drugs affecting bone marrow function (eg, cytostatic agents, sulfonamides, chloramphenicol, phenytoin, amidopyrine derivates, antiretroviral drugs). Potentiated effect of RT. Increased cardiotoxicity or hepatotoxicity w/ previous, concomitant or subsequent RT. Possible decrease in efficacy w/ CYP450 inducers (eg, rifampicin, barbiturates). Possible increase in toxic effects w/ CYP450 inhibitors (eg, cimetidine). Severe & prolonged haematologic toxicity w/ cyclosporine. Decreased serum levels of phenytoin. Reduced oral bioavailability of digoxin. May be hydrolysed by alkalic soln. Incompatible w/ heparin, 5-fluorouracil, allopurinol, cephalotin, dexamethasone, diazepam, furosemide, gallium nitrate, hydrocortisone, MTX, parenteral nutrition soln, piperacillin, theophylline, vincristine. Avoid contact w/ Al.

Cytotoxic Chemotherapy

L01DB01 - doxorubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.

A