Doxorubicin liposome

Doxorubicin liposome
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Steven Bellm, M.D. [2]

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Black Box Warning

TITLE See full prescribing information for complete Boxed Warning. Condition Name: (Content)

Overview

Doxorubicin liposome is an anthracycline that is FDA approved for the treatment of metastatic breast cancer, non-small cell lung cancer, and adenocarcinoma of the pancreas. There is a Black Box Warning for this drug as shown here. Common adverse reactions include alopecia, neutropenia, sensory neuropathy, arrhythmia, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, and infections.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Doxorubicin liposome FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Doxorubicin liposome in adult patients.

Non–Guideline-Supported Use

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)

There is limited information regarding Doxorubicin liposome FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Doxorubicin liposome in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Doxorubicin liposome in pediatric patients.

Contraindications

There is limited information regarding Doxorubicin liposome Contraindications in the drug label.

Warnings

TITLE See full prescribing information for complete Boxed Warning. Condition Name: (Content)

There is limited information regarding Doxorubicin liposome Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Doxorubicin liposome Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Doxorubicin liposome Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Doxorubicin liposome Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Doxorubicin liposome in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Doxorubicin liposome in women who are pregnant.

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 in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Doxorubicin liposome in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Doxorubicin liposome in geriatric settings.

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

There is limited information regarding Doxorubicin liposome Administration in the drug label.

Monitoring

There is limited information regarding Doxorubicin liposome Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Doxorubicin liposome and IV administrations.

Overdosage

There is limited information regarding Doxorubicin liposome overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Doxorubicin liposome Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Doxorubicin liposome Mechanism of Action in the drug label.

Structure

There is limited information regarding Doxorubicin liposome Structure in the drug label.

Pharmacodynamics

There is limited information regarding Doxorubicin liposome Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Doxorubicin liposome Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Doxorubicin liposome Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Doxorubicin liposome Clinical Studies in the drug label.

How Supplied

There is limited information regarding Doxorubicin liposome How Supplied in the drug label.

Storage

There is limited information regarding Doxorubicin liposome Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Doxorubicin liposome Patient Counseling Information 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

There is limited information regarding Doxorubicin liposome Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Doxorubicin liposome Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.