Classes
DEA Class; Rx
Common Brand Names; Adriamycin, Caelyx, Rubex, Doxil, Lipodox, Myocet
- Antineoplastics, Anthracycline
Description
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
Indications
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
Contraindications
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
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
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.
Maximum lifetime cumulative dosage of doxorubicin is 550 mg/m2 IV; 450 mg/m2 IV in patients who have received previous mediastinal radiation.
Maximum lifetime cumulative dosage of doxorubicin is 550 mg/m2 IV; 450 mg/m2 IV in patients who have received previous mediastinal radiation.
Maximum lifetime cumulative dosage of doxorubicin is 550 mg/m2 IV; 450 mg/m2 IV in patients who have received previous mediastinal radiation.
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.
How supplied
Doxorubicin hydrochloride
injectable solution
- 2mg/mL
powder for injection
- 10mg
- 50mg