Doxorubicin liposome
For patient information regarding Doxorubicin liposome, click here.
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
Disclaimer
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WARNING: CARDIOMYOPATHY AND INFUSION-RELATED REACTIONS
See full prescribing information for complete Boxed Warning.
* DOXIL (doxorubicin HCl liposome injection) can cause myocardial damage, including congestive heart failure, as the total cumulative dose of doxorubicin HCl approaches 550 mg/m2. In a clinical study of 250 patients with advanced cancer who were treated with DOXIL, the risk of cardiotoxicity was 11% when the cumulative anthracycline dose was between 450–550 mg/m2. Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dosage. The risk of cardiomyopathy may be increased at lower cumulative doses in patients with prior mediastinal irradiation [see WARNINGS AND PRECAUTIONS (5.1)].
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Overview
Doxorubicin liposome is an anthracycline that is FDA approved for the treatment of ovarian cancer, AIDS-related Kaposi's sarcoma, and multiple myeloma. There is a Black Box Warning for this drug as shown here. Common adverse reactions include asthenia, fatigue, fever, stomatitis, nausea, vomiting, diarrhea, constipation, anorexia, hand-foot syndrome, rash, neutropenia, thrombocytopenia, and anemia.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
There is limited information regarding Off-Label Guideline-Supported Use of Doxorubicin liposome in adult patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
There is limited information regarding Off-Label Non–Guideline-Supported Use of Doxorubicin liposome in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Indications
Dosage
There is limited information regarding FDA-Labeled Use of Doxorubicin liposome in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
There is limited information regarding Off-Label Guideline-Supported Use of Doxorubicin liposome in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
There is limited information regarding Off-Label Non–Guideline-Supported Use of Doxorubicin liposome in pediatric patients.
Contraindications
- Content
Warnings
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Doxorubicin liposome in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Doxorubicin liposome in the drug label.
Drug Interactions
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category: ABCDXN
- Description
Labor and Delivery
There is no FDA guidance on use of Doxorubicin liposome during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Doxorubicin liposome with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Doxorubicin liposome with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Doxorubicin liposome with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Doxorubicin liposome with respect to specific gender populations.
Race
There is no FDA guidance on the use of Doxorubicin liposome with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Doxorubicin liposome in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Doxorubicin liposome in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Doxorubicin liposome in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Doxorubicin liposome in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
- Description
There is limited information regarding Monitoring of Doxorubicin liposome in the drug label.
Overdosage
- Description
There is limited information regarding Chronic Overdose of Doxorubicin liposome in the drug label.
Pharmacology
drugbox2
Mechanism of Action
mechanismofaction
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Doxorubicin liposome in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Doxorubicin liposome in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Doxorubicin liposome in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Doxorubicin liposome in the drug label.
How Supplied
- Description
There is limited information regarding How Supplied of Doxorubicin liposome in the drug label.
Images
Package and Label Display Panel
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Doxorubicin liposome in the drug label.
Precautions with Alcohol
Alcohol-Doxorubicin liposome interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Doxil, Lipodox
Look-Alike Drug Names
Drug Shortage Status
References
The contents of this FDA label are provided by the National Library of Medicine.