Doxorubicin Hydrochloride (5 brand names, 2 dosage forms, 1 route)
Available dosage forms: INJECTABLE, INJECTABLE, LIPOSOMAL.
Routes of administration: INJECTION.
Brand Names
- ADRIAMYCIN PFS
- DOXIL (LIPOSOMAL)
- DOXORUBICIN HYDROCHLORIDE
- DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
- RUBEX
Boxed Warning
• DOXIL liposomal infusion can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 mg/m2 to 550 mg/m2. Assess left ventricular cardiac function prior to initiation of DOXIL liposomal infusion and during and after treatment [see Warnings and Precautions (5.1)]. • Serious, life-threatening, and fatal infusion-related reactions can occur with DOXIL liposomal infusion Acute infusion-related reactions occurred in 11% of patients with solid tumors. Withhold DOXIL liposomal infusion for infusion-related reactions and resume at a reduced rate. Discontinue DOXIL liposomal infusion for serious or life-threatening infusion-related reactions [see Warnings and Precautions (5.2)].
Contraindications
DOXIL liposomal infusion is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see Warnings and Precautions (5.2)].
Adverse Reactions
The following adverse reactions are discussed in more detail in other sections of the labeling. •Cardiomyopathy [see Warnings and Precautions (5.1)] •Infusion-Related Reactions [see Warnings and Precautions (5.2)] •Hand-Foot Syndrome [see Warnings and Precautions (5.3)] •Secondary Oral Neoplasms [see Warnings and Precautions (5.4)]
Drug Interactions
No formal drug interaction studies have been conducted with DOXIL liposomal infusion.
Mechanism of Action
The active ingredient of DOXIL liposomal infusion is doxorubicin hydrochloride. The mechanism of action of doxorubicin hydrochloride is thought to be related to its ability to bind DNA and inhibit nucleic acid synthesis. Cell structure studies have demonstrated rapid cell penetration and perinuclear chromatin binding, rapid inhibition of mitotic activity and nucleic acid synthesis, and induction of mutagenesis and chromosomal aberrations.
Overdosage
Acute overdosage with doxorubicin hydrochloride causes increased risk of severe mucositis, leukopenia, and thrombocytopenia.