Adrim

Doxorubicin HCl

Component of multi-agent adjuvant chemotherapy for women w/ axillary lymph node involvement following resection of primary breast cancer. Acute lymphoblastic leukemia; AML; Hodgkin's & non-Hodgkin's lymphoma; metastatic breast cancer, Wilms tumor & neuroblastoma; metastatic soft tissue & bone sarcoma; metastatic ovarian, transitional cell bladder, thyroid, gastric & bronchogenic carcinoma.

Adjuvant breast cancer 60 mg/m² via IV bolus on day 1 of each 21-day treatment cycle in combination w/ cyclophosphamide for total of 4 cycles. Metastatic disease, leukemia or lymphoma Monotherapy: 60-75 mg/m² IV every 21 days. In combination w/ other chemotherapy drugs: 40-75 mg/m² IV every 21-28 days.

Severe hypersensitivity reaction to doxorubicin HCl including anaphylaxis, or to other anthracyclines or anthracenediones. Severe myocardial insufficiency & persistent drug-induced myelosuppresion. Recent MI (occurring w/in past 4-6 wk). Severe hepatic impairment (Child-Pugh Class C or serum bilirubin level >5 mg/dL).

Not to be administered IM or SC. Not recommended as direct push inj. Discontinue if signs or symptoms of cardiomyopathy develop; burning or stinging sensation or other evidence indicating perivenous infiltration or extravasation occur. Cardiomyopathy including decreased left ventricular ejection fraction & CHF, pericarditis, myocarditis; arrhythmias, tachyarrhythmias including sinus tachycardia, premature ventricular contractions, ventricular tachycardia & bradycardia, non-specific ST-T wave changes, AV & bundle-branch block; severe myelosuppression; tumor lysis syndrome; extravasation. Increased risk of developing secondary acute myelogenous leukemia & myelodysplastic syndrome; radiation-induced toxicity to myocardium, skin mucosa & liver. Radiation-recall after prior RT. Serum bilirubin levels of 1.2-5 mg/dL. Assess left ventricular cardiac function prior to therapy, during treatment to detect acute changes & after treatment to detect delayed cardiotoxicity. Apply ice to the site of extravasation intermittently for 15 min qid for 3 days or administer dexrazoxane as soon as possible & w/in the 1st 6 hr after extravasation. Monitor blood cell counts at baseline & regularly during therapy. Obtain liver tests including SGOT, SGPT, alkaline phosphatase & bilirubin prior to & during therapy. Evaluate blood uric acid levels, K, Ca, phosphate & creatinine after initial treatment. Hydration, urine alkalinization & prophylaxis w/ allopurinol to prevent hyperuricemia. Concomitant use w/ other cardiotoxic agents eg, cyclophosphamide & trastuzumab. Contraindicated in severe hepatic impairment (Child Pugh Class C or serum bilirubin level >5 mg/dL). Males & females of reproductive potential should use highly effective contraception during & for 6 mth after treatment. May cause infertility in both male & female; amenorrhea in females; oligospermia & azoospermia in males. Pregnancy & lactation. Ped (at risk of CV dysfunction especially <5 yr). Pre-pubertal growth failure; temporary gonadal impairment in ped patients. Elderly.

Leukopenia, thrombocytopenia; shock, sepsis; systemic infection; vomiting; alopecia; cardiac dysfunction. Cardiogenic shock; skin & nail hyperpigmentation, onycholysis, rash, itching, photosensitivity, urticaria, acral erythema, palmar plantar erythrodysesthesia; nausea, mucositis, stomatitis, necrotizing colitis, typhlitis, gastric erosions, GIT bleeding, hematochezia, esophagitis, anorexia, abdominal pain, dehydration, diarrhea, hyperpigmentation of oral mucosa; anaphylaxis; increased ALT & AST; peripheral sensory & motor neuropathy, seizures, coma; conjunctivitis, keratitis, lacrimation; phlebosclerosis, phlebitis/thrombophlebitis, hot flashes, thromboembolism; malaise/asthenia, fever, chills, wt gain.

Increased conc & clinical effect w/ CYP3A4 & CYP2D6 inhibitors &/or P-gp inhibitors eg, verapamil. Decreased conc w/ CYP3A4 (eg, phenobarb, phenytoin, St. John's Wort) & P-gp inducers. Increased risk of cardiac dysfunction w/ trastuzumab. Increased plasma conc w/ paclitaxel. Diminished therapeutic effect w/ dexrazoxane. Enhanced hepatotoxicity of mercaptopurine.

Cytotoxic Chemotherapy

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

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