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Doxil (doxil)
Doxorubicin binds DNA, inhibits nucleic acid synthesis, and induces mutagenesis and chromosomal aberrations.
At a glance
| Generic name | doxil |
|---|---|
| Sponsor | Pfizer Inc. |
| Target | DNA |
| Therapeutic area | Other |
| Phase | FDA-approved |
Mechanism of action
Doxorubicin works by penetrating cells quickly and binding to DNA near the nucleus. This binding disrupts the synthesis of nucleic acids, halts cell division, and causes genetic mutations and chromosomal abnormalities.
Approved indications
Boxed warnings
- WARNING: CARDIOMYOPATHY and INFUSION-RELATED REACTIONS • 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/m 2 to 550 mg/m 2 . 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) ] . WARNING: CARDIOMYOPATHY and INFUSION- RELATED REACTIONS See full prescribing information for complete 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/m 2 to 550 mg/m 2 . Assess left ventricular cardiac function prior to initiation of DOXIL liposomal infusion, during treatment, and after treatment ( 5.1 ). • Serious, life-threatening, and fatal infusion‑related reactions can occur. 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 ( 5.2 ).
Common side effects
- Neutropenia 500 – <1000/mm 3
- Neutropenia <500/mm 3
- Anemia 6.5 – <8 g/dL
- Anemia < 6.5 g/dL
- Thrombocytopenia 10,000 – <50,000/mm 3
- Thrombocytopenia <10,000/mm 3
- Asthenia
- Fever
- Mucous Membrane Disorder
- Back Pain
- Infection
- Headache
Key clinical trials
- Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial (PHASE2)
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (PHASE3)
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (PHASE2, PHASE3)
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Doxil CI brief — competitive landscape report
- Doxil updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI