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DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE is a drug. It is currently FDA-approved (first approved 1974) for Adjuvant Breast Cancer, Acute Lymphoblastic Leukemia, Acute Myeloblastic Leukemia.
Doxorubicin works by intercalating DNA, inhibiting nucleotide replication, and forming DNA-cleavable complexes with topoisomerase II.
At a glance
| Generic name | DOXORUBICIN HYDROCHLORIDE |
|---|---|
| Target | topoisomerase II |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1974 |
Mechanism of action
Doxorubicin exerts its cytotoxic effects by inserting itself between DNA base pairs, which prevents DNA and RNA replication. It also binds to topoisomerase II, leading to DNA damage and cell death.
Approved indications
- Adjuvant Breast Cancer
- 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 Sarcoma
- Metastatic Ovarian Carcinoma
- Metastatic Transitional Cell Bladder Carcinoma
- Metastatic Thyroid Carcinoma
- Metastatic Gastric Carcinoma
- Metastatic Bronchogenic Carcinoma
Boxed warnings
- WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION • Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur with doxorubicin hydrochloride. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 1%–20% for cumulative doses ranging from 300 mg/m 2 to 500 mg/m 2 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 [see Warnings and Precautions (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 hydrochloride [see Warnings and Precautions (5.2) ] . • Extravasation and Tissue Necrosis: Extravasation of doxorubicin hydrochloride can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting. Immediately terminate the drug and apply ice to the affected area [see Warnings and Precautions (5.3) ] . • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur [see Warnings and Precautions (5.4) ] . 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 hydrochloride with incidences from 1%–20% for cumulative doses from 300 mg/m 2 to 500 mg/m 2 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 ) • 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 ) • 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 ) • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur. ( 5.4 )
Common side effects
- Alopecia
- Vomiting ≤12 hours
- Vomiting >12 hours
- Intractable Vomiting
- Leukopenia Grade 3 (1,000–1,999 /mm 3)
- Leukopenia Grade 4 (<1000 /mm 3)
- Shock, sepsis
- Systemic infection
- Cardiac dysfunction Asymptomatic
- Cardiac dysfunction Transient
- Cardiac dysfunction Symptomatic
- Thrombocytopenia Grade 3 (25,000–49,999 /mm 3)
Drug interactions
- CYP3A4, CYP2D6, or P-gp inhibitors
- CYP3A4, CYP2D6, or P-gp inducers
- Paclitaxel
- Trastuzumab
- Dexrazoxane
- 6-Mercaptopurine
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- DOXORUBICIN HYDROCHLORIDE CI brief — competitive landscape report
- DOXORUBICIN HYDROCHLORIDE updates RSS · CI watch RSS
Frequently asked questions about DOXORUBICIN HYDROCHLORIDE
What is DOXORUBICIN HYDROCHLORIDE?
DOXORUBICIN HYDROCHLORIDE is a Small molecule drug, indicated for Adjuvant Breast Cancer, Acute Lymphoblastic Leukemia, Acute Myeloblastic Leukemia.
How does DOXORUBICIN HYDROCHLORIDE work?
Doxorubicin works by intercalating DNA, inhibiting nucleotide replication, and forming DNA-cleavable complexes with topoisomerase II.
What is DOXORUBICIN HYDROCHLORIDE used for?
DOXORUBICIN HYDROCHLORIDE is indicated for Adjuvant Breast Cancer, Acute Lymphoblastic Leukemia, Acute Myeloblastic Leukemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma.
When was DOXORUBICIN HYDROCHLORIDE approved?
DOXORUBICIN HYDROCHLORIDE was first approved on 1974.
What development phase is DOXORUBICIN HYDROCHLORIDE in?
DOXORUBICIN HYDROCHLORIDE is FDA-approved (marketed).
What are the side effects of DOXORUBICIN HYDROCHLORIDE?
Common side effects of DOXORUBICIN HYDROCHLORIDE include Alopecia, Vomiting ≤12 hours, Vomiting >12 hours, Intractable Vomiting, Leukopenia Grade 3 (1,000–1,999 /mm 3), Leukopenia Grade 4 (<1000 /mm 3).
What does DOXORUBICIN HYDROCHLORIDE target?
DOXORUBICIN HYDROCHLORIDE targets topoisomerase II.
Related
- Target: All drugs targeting topoisomerase II
- Indication: Drugs for Adjuvant Breast Cancer
- Indication: Drugs for Acute Lymphoblastic Leukemia
- Indication: Drugs for Acute Myeloblastic Leukemia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing