Doxorubicin Hydrochloride

What it is and how it works

Mechanism of Action The cytotoxic effect of doxorubicin hydrochloride on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding activities of doxorubicin. Intercalation inhibits nucleotide replication and action of DNA and RNA polymerases. The interaction of doxorubicin with topoisomerase II to form DNA-cleavable complexes appears to be an important mechanism of doxorubicin hydrochloride cytocidal activity.

Indications

Doxorubicin Hydrochloride Injection is an anthracycline topoisomerase inhibitor indicated: • as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer • 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 Adjuvant Breast Cancer Doxorubicin Hydrochloride Injection is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer .

Dosage and administration (summary)

• Single agent : 60 to 75 mg/m 2 given intravenously every 21 days • In combination : 40 to 75 mg/m 2 given intravenously every 21 to 28 days • Discontinue Doxorubicin Hydrochloride Injection in patients who develop signs or symptoms of cardiomyopathy • Reduce dose in patients with hepatic impairment Recommended Dosage for Adjuvant Breast Cancer The recommended dosage of Doxorubicin Hydrochloride Injection is 60 mg/m 2 administered as an intravenous bolus on day 1 of each 21-day treatment cycle, in combination with cyclophosphamide, for a total of four cycles .

Contraindications

Doxorubicin Hydrochloride Injection are contraindicated in patients with: • Severe myocardial insufficiency • Recent (occurring within the past 4–6 weeks) myocardial infarction • Severe persistent drug-induced myelosuppression • Severe hepatic impairment (defined as Child Pugh Class C or serum bilirubin level greater than 5 mg/dL) • Severe hypersensitivity reaction to doxorubicin hydrochloride, including anaphylaxis • Severe myocardial insufficiency • Recent myocardial infarction • Severe persis…

Warnings and precautions

• 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. • 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.

Pregnancy

Pregnancy Risk Summary Based on findings in animals and its mechanism of action, Doxorubicin Hydrochloride Injection can cause fetal harm when administered to a pregnant woman; avoid the use of Doxorubicin Hydrochloride Injection during the 1 st trimester.

Storage and supply

Storage Store all vials at 2°C to 8°C (36°F to 46°F). Protect from light. Storage of Doxorubicin Hydrochloride Injection under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15°C to 30°C (59°F to 86°F)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution.

Source: Doxorubicin Hydrochloride (Doxorubicin Hydrochloride) — US FDA prescribing information, 2026-04-30, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.