Rubicin

Rubicin

doxorubicin

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Doxorubicin HCl
Indications/Uses
Monotherapy or in combination w/ other cancer chemotherapeutic agents in the treatment of solid tumors & hematologic malignancies eg, acute lymphocytic-lymphoblastic & acute myeloblastic leukemias; Wilm's tumor, neuroblastoma, soft tissue sarcomas, osteosarcoma; breast, ovarian, thyroid & gastric carcinoma; malignant lymphoma, Hodgkin's disease, non-Hodgkin's lymphoma, transitional cell bladder carcinoma, bronchogenic carcinoma in which the small cell histologic type is the most responsive & squamous cell carcinoma of the head & neck. Antitumor activity in adult & ped malignancies eg, endometrial, primary hepatocellular carcinoma, non-seminomatous carcinoma of the testis, carcinoma of the prostate, Ewing's sarcoma, rhabdomyosarcoma, multiple myeloma & chronic leukemias. Component of adjuvant therapy in women w/ evidence of axillary lymph node involvement following resection of primary breast cancer & by instillation in the bladder for the topical treatment of superficial bladder tumors.
Dosage/Direction for Use
Adult Total cumulative dose: 550 mg/m2. Monotherapy 60-75 mg/m2 as single IV inj every 21 days. Alternatively, 20 mg/m2 as single IV inj in wkly doses (to reduce the incidence of CHF) or 30 mg/m2 as single IV inj on each of 3 successive days repeated every 4 wk. Combination therapy IV inj 40-60 mg/m2 every 21-28 days.
Contraindications
Hypersensitivity to doxorubicin, other anthracyclines or anthracenediones eg, epirubicin, daunorubicin, mitoxantrone or mitomycin C. Marked persistent myelosuppression induced by previous treatment w/ other antitumor agents or radiotherapy (baseline neutrophil count <1,500 cells/mm3). Severe hepatic impairment, myocardial insufficiency & arrhythmias; recent MI; history of severe cardiac disease. Patients who received previous treatment w/ max cumulative doses of doxorubicin, daunorubicin, idarubicin &/or other anthracyclines & anthracenediones. Pregnancy & lactation.
Special Precautions
Do not administer IM or SC. Risk of myocardial, cardiac & hematologic toxicity; secondary acute myelogenous leukemia or myelodysplastic syndrome w/ or w/o preleukemic phase; severe myelosuppression. Patients w/ hepatic impairment. Perform determination of hepatic, hematopoietic & cardiac function prior to & at regular intervals during therapy. Effects at inj site, extravasation. Concomitant use w/ live or live attenuated vaccines. Consider prophylactic use of antiemetics before administration particularly when given in conjunction w/ other emetogenic drugs. May potentiate toxicities of antineoplastic drugs; impart red urine color 1-2 days after administration. Abnormalities in hepatic function may occur. May induce "tumor-lysis syndrome" & hyperuricemia in patients w/ rapidly growing tumors. Men undergoing treatment should use effective contraceptive methods. May impair female fertility during therapy. Do not undergo dental work during treatment. Childn. Elderly.
Adverse Reactions
Cardiotoxicity, myelosuppression. Cardiac, hematologic, GI, dermatological, local, vascular, neurological, endocrine/metabolic, ocular, hepatic & urological effects. Hypersensitivity reactions; malaise/asthenia, shock.
Drug Interactions
Additive bone marrow depression w/ bone marrow depressants or radiation therapy. Increased risk of cardiotoxicity w/ other cardiotoxic agents (eg trastuzumab); DVT w/ thalidomide. Exacerbation of cyclophosphamide-induced hemorrhagic cystitis. Increased AUC w/ ciclosporin. Decreased clearance & increase in severity of neutropenia & stomatitis w/ paclitaxel. Increased plasma conc w/ daunorubicin, idarubicin, mitoxantrone & irradiation of the cardiac region. Increased elimination w/ phenobarb. Decreased phenytoin levels. Increased systemic exposure w/ sorafenib. Enhanced hepatotoxicity of 6-mercaptopurine. Possible inhibition of hepatic metabolism w/ streptozocin, methotrexate & valspodar. Risk of recall acute pneumonitis (at variable times after local radiation therapy in childn) w/ dactinomycin. Dexrazoxane, cytarabine, thalidomide. Potentiated doxorubicin-induced cardiotoxicity w/ Ca channel blockers. Exacerbation of doxorubicin-induced neutropenia & thrombocytopenia w/ high doses of progesterone. Increased mucosal toxicity in HIV-associated, non-Hodgkin's lymphoma in saquinavir in combination w/ cyclophosphamide, doxorubicin, etoposide. Seizures &/or coma may occur in concomitant use w/ vincristine. Concurrent use w/ a live virus vaccine may potentiate virus replication.
ATC Classification
L01DB01 - doxorubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
Presentation/Packing
Form
Rubicin inj (lyo) for soln 50 mg
Packing/Price
50 mL x 1's
Form
Rubicin inj (lyo) for soln 10 mg
Packing/Price
1's
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