(doxorubicin hydrochloride)

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

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
Initial U.S. Approval: 1974

WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION

See full prescribing information for complete boxed warning.

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Cardiomyopathy: Myocardial damage can occur with doxorubicin hydrochloride with incidences from 1%–20% for cumulative doses from 300 mg/m2 to 500 mg/m2 when doxorubicin hydrochloride 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 hydrochloride. (5.1)
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Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin hydrochloride. (5.2)
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Extravasation and Tissue Necrosis: Extravasation of doxorubicin hydrochloride 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)
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Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur. (5.4)

INDICATIONS AND USAGE

Doxorubicin Hydrochloride Injection is an anthracycline topoisomerase inhibitor indicated:

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as a component of multi‑agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer (1.1)
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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

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Single agent: 60 to 75 mg/m2 given intravenously every 21 days (2.2)
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In combination: 40 to 75 mg/m2 given intravenously every 21 to 28 days (2.2)
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Discontinue Doxorubicin Hydrochloride Injection in patients who develop signs or symptoms of cardiomyopathy (2.3)
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Reduce dose in patients with hepatic impairment (2.4)

DOSAGE FORMS AND STRENGTHS

Injection:

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10 mg/5 mL, 20 mg/10 mL, 50 mg/25 mL in single-dose vial (3)
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150 mg/75 mL, and 200 mg/100 mL in multiple-dose vial (3)

CONTRAINDICATIONS

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Severe myocardial insufficiency (4)
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Recent myocardial infarction (4)
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Severe persistent drug-induced myelosuppression (4)
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Severe hepatic impairment (4)
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Severe hypersensitivity to doxorubicin hydrochloride (4)

WARNINGS AND PRECAUTIONS

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Radiation-Induced Toxicity: Can be increased by the administration of Doxorubicin Hydrochloride Injection. Radiation recall can occur in patients who receive Doxorubicin Hydrochloride Injection after prior radiation therapy. (5.7)
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Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and on the use of effective contraception. Advise males with female partners of reproductive potential to use effective contraception. Advise males with pregnant partners to use condoms. (5.8, 8.1, 8.3)

ADVERSE REACTIONS

The most common (>10%) adverse 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

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Avoid concomitant use of doxorubicin hydrochloride with inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp (7.1)
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Do not administer doxorubicin hydrochloride in combination with trastuzumab due to increased risk of cardiac dysfunction (5.1, 7.2)

USE IN SPECIFIC POPULATIONS

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Lactation: Advise not to breastfeed (8.2)
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Females and Males of Reproductive Potential: May impair fertility (8.3)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 7/2024

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