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Doxorubicin

    DEA Class; Rx

    Common Brand Names; Adriamycin, Caelyx, Rubex, Doxil, Lipodox, Myocet

    • Antineoplastics, Anthracycline

    A cytotoxic anthracycline antibiotic that inhibits nucleotide replication and repair
    Approved for use in certain types of leukemias, lymphomas, and solid tumors
    Cardiotoxicity including congestive heart failure has been reported; use is contraindicated in patients with severe myocardial insufficiency or recent myocardial infarction

    Cancer of breast, ovary, prostate, stomach, thyroid; small cell cancer of lung, liver; squamous cell cancer of head and neck; multiple myeloma, Hodgkin’s disease, lymphomas, ALL, AML

    Indicated for AIDS-related Kaposi’s sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy

    Indicated for ovarian cancer in patients whose disease has progressed or recurred after platinum-based chemotherapy

    Indicated in combination with bortezomib for multiple myeloma in patients who have not previously received bortezomib and have received at least 1 prior therapy

    Hypersensitivity

    Active infection

    Severe hepatic impairment

    Baseline neutrophil count <1500/mm³

    Recent MI or severe myocardial insufficiency

    Prior treatment max dose of doxorubicin, daunorubicin, idarubicin, or other anthracyclines

    Cardiomyopathy, CHF, impaired cardiac function

    IM/SC administration

    • Neutropenia (52%)
    • Anemia (52%)
    • Leukopenia (42%)
    • Pruritus (37%)
    • Nausea (37%)
    • Stomatitis (37%)
    • Fatigue (33%)
    • CHF (30%)
    • Thrombocytopenia (24%)
    • Vomiting (22%)
    • Rash (21%)
    • Alopecia (15%)
    • Anorexia (12%)
    • Constipation (12%)
    • Diarrhea (10%)
    • Cardiomyopathy (0.5-9%)

    Vesicant

    Pericarditis and myocarditis reported during or following treatment; assess left ventricular cardiac function (eg, MUGA or echocardiogram) prior to initiation of doxorubicin; discontinue in patients who develop signs or symptoms of cardiomyopathy; consider use of dexrazoxane to reduce incidence and severity of cardiomyopathy due to administration in patients who have received a cumulative doxorubicin hydrochloride dose of 300 mg/m2 and who will continue to receive doxorubicin hydrochloride

    The risk of developing secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) is increased following treatment with doxorubicin hydrochloride. Cumulative incidences ranged from 0.2% at five years to 1.5% at 10 years in two separate trials involving the adjuvant treatment of women with breast cancer. These leukemias generally occur within 1 to 3 years of treatment

    Drug clearance of doxorubicin is decreased in patients with elevated serum bilirubin with increased risk of toxicity; reduce dose in patients with serum bilirubin levels of 1.2 to 5 mg/dL; obtain liver tests including ALT, AST, alkaline phosphatase, and bilirubin prior to and during therapy

    Doxorubicin hydrochloride can induce tumor lysis syndrome in patients with rapidly growing tumors; evaluate blood uric acid levels, potassium, calcium, phosphate, and creatinine after initial treatment; hydration, urine alkalinization, and prophylaxis with allopurinol to prevent hyperuricemia may minimize potential complications of tumor lysis syndrome

    Therapy can increase radiation-induced toxicity to myocardium, mucosa, skin, and liver; radiation recall, including but not limited to cutaneous and pulmonary toxicity, can occur in patients who receive drug after prior radiation therapy

    Secondary oral cancers, primarily squamous cell carcinoma, reported with long-term (ie, >1 yr)

    Use caution in the elderly, liver impairment, and concomitant radiotherapy

    Not effective in malignant melanoma, kidney CA, bowel CA, brain tumors, CNS metastasis

    Therapy can cause myelosuppression; a dose-dependent, reversible neutropenia is predominant manifestation of myelosuppression from therapy; obtain complete blood counts prior to each treatment and carefully monitor patients during treatment for possible clinical complications due to myelosuppression; delay next dose if severe myelosuppression has not improved; consider dose reduction for patients with prolonged myelosuppression based on severity of reaction

    Based on findings in animals and its mechanism of action, drug can cause fetal harm when administered to a pregnant woman; avoid use during 1st trimester

    Data are not available regarding effects on breastfed children or milk production

    The suggested maximum tolerated dose (MTD) for doxorubicin, which is dependent on performance status, other chemotherapy agents or radiation given in combination, and disease state, is as follows:
    NOTE: The correct dose of doxorubicin will vary from protocol to protocol. Clinicians should consult the appropriate references to verify the dose.

    Adults

    Maximum lifetime cumulative dosage of doxorubicin is 550 mg/m2 IV; 450 mg/m2 IV in patients who have received previous mediastinal radiation.

    Geriatric

    Maximum lifetime cumulative dosage of doxorubicin is 550 mg/m2 IV; 450 mg/m2 IV in patients who have received previous mediastinal radiation.

    Adolescents

    Maximum lifetime cumulative dosage of doxorubicin is 550 mg/m2 IV; 450 mg/m2 IV in patients who have received previous mediastinal radiation.

    Children

    Maximum lifetime cumulative dosage of doxorubicin is 550 mg/m2 IV; 450 mg/m2 IV in patients who have received previous mediastinal radiation. The dose should be based on body weight for children with a BSA < 0.5 m2. Children are more susceptible to cardiotoxicity and require long term follow-up.

    Doxorubicin hydrochloride

    injectable solution

    • 2mg/mL

    powder for injection

    • 10mg
    • 50mg