These highlights do not include all the information needed to use DOXORUBICIN HYDROCHLORIDE safely and effectively. See full prescribing information for DOXORUBICIN HYDROCHLORIDE.
DOXORUBICIN HYDROCHLORIDE injection, for intravenous use
DOXORUBICIN HYDROCHLORIDE for injection, for intravenous use
Initial U.S. Approval: 1974
WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION
See full prescribing information for complete boxed warning.
-
Cardiomyopathy: Myocardial damage can occur with doxorubicin HCl with incidences from 1% – 20% for cumulative doses from 300 mg/m2 to 500 mg/m2 when doxorubicin HCl is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with doxorubicin HCl. (5.1)
-
Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin HCl. (5.2)
-
Extravasation and Tissue Necrosis: Extravasation of doxorubicin HCl can result in severe local tissue injury and necrosis requiring wide excision and skin grafting. Immediately terminate the drug, and apply ice to the affected area. (5.3)
-
Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur. (5.4)
INDICATIONS AND USAGE
Doxorubicin hydrochloride (HCl) is an anthracycline topoisomerase II inhibitor indicated:
-
as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer (1.1).
-
for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms' tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma (1.2).
DOSAGE AND ADMINISTRATION
-
Single agent: 60 to 75 mg/m2 given intravenously every 21 days (2.1).
-
In combination therapy: 40 to 75 mg/m2 given intravenously every 21 to 28 days (2.1).
-
Discontinue doxorubicin HCl in patients who develop signs or symptoms of cardiomyopathy (2.2).
-
Reduce dose in patients with hepatic impairment (2.2).
DOSAGE FORMS AND STRENGTHS
-
Doxorubicin HCl injection: Vials contain 10 mg/5 mL, 20 mg/10 mL, 50 mg/25 mL, 150 mg/75 mL, and 200 mg/100 mL as a solution (3)
-
Doxorubicin HCl for injection: Vials contain 10 mg, 20 mg, 50 mg, and 150 mg as a lyophilized powder (3)
CONTRAINDICATIONS
-
Severe myocardial insufficiency (4)
-
Recent myocardial infarction (4)
-
Severe persistent drug-induced myelosuppression (4)
-
Severe hepatic impairment (4)
-
Hypersensitivity to doxorubicin HCl (4)
WARNINGS AND PRECAUTIONS
-
Radiation-induced toxicity can be increased by the administration of doxorubicin HCl. Radiation recall can occur in patients who receive doxorubicin HCl after prior radiation therapy (5.7).
-
Embryofetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus (5.8).
The most common (>10%) adverse drug reactions are alopecia, nausea and vomiting (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
-
Avoid concurrent use of doxorubicin HCl with inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp (7.1).
-
Do not administer doxorubicin HCl in combination with trastuzumab due to increased risk of cardiac dysfunction (5.1, 7.2).
USE IN SPECIFIC POPULATIONS
-
Nursing Mothers: Discontinue drug or nursing taking into consideration importance of drug to mother (8.3).
-
Pediatric Use: Recommend long-term follow-up cardiac eva luations due to risk of delayed cardiotoxicity (8.4).
-
Females and Males of Reproductive Potential: May impair fertility. Counsel female and male patients on pregnancy planning and prevention (8.6).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 1/2014
