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

For patient information regarding Doxorubicin liposome, click here.

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Black Box Warning

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. Acute infusion-related reactions consisting of, but not limited to, flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension occurred in 11% of patients with solid tumors treated with DOXIL. Serious, life-threatening and fatal infusion reactions have been reported.

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

Ovarian Cancer

DOXIL is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.

AIDS-Related Kaposi's Sarcoma

DOXIL is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.

Multiple Myeloma

DOXIL, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.

Dosage

Important Use Information

Do not substitute DOXIL for doxorubicin HCl injection.

Do not administer as an undiluted suspension or as an intravenous bolus.

Ovarian Cancer

The recommended dose of DOXIL is 50 mg/m2 intravenously over 60 minutes every 28 days until disease progression or unacceptable toxicity.

AIDS-Related Kaposi's Sarcoma

The recommended dose of DOXIL is 20 mg/m2 intravenously over 60 minutes every 21 days until disease progression or unacceptable toxicity.

Multiple Myeloma

The recommended dose of DOXIL is 30 mg/m2 intravenously over 60 minutes on day 4 of each 21-day cycle for eight cycles or until disease progression or unacceptable toxicity. Administer DOXIL after bortezomib on day 4 of each cycle.

Dose Modifications for Adverse Reactions

Do not increase DOXIL after a dose reduction for toxicity.

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

For neuropathic pain or peripheral neuropathy, no dosage adjustments are required for DOXIL. Refer to bortezomib manufacturer's prescribing information.

Preparation and Administration

Preparation

Dilute DOXIL doses up to 90 mg in 250 mL of 5% Dextrose Injection, USP prior to administration. Dilute doses exceeding 90 mg in 500 mL of 5% Dextrose Injection, USP prior to administration. Refrigerate diluted DOXIL at 2°C to 8°C (36°F to 46°F) and administer within 24 hours.

Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if a precipitate or foreign matter is present.

Do not use with in-line filters.

Administer the first dose of DOXIL at an initial rate of 1 mg/min. If no infusion-related adverse reactions are observed, increase the infusion rate to complete the administration of the drug over one hour. Do not rapidly flush the infusion line.

Do not mix DOXIL with other drugs.

Management of Suspected Extravasation

Discontinue DOXIL for burning or stinging sensation or other evidence indicating perivenous infiltration or extravasation. Manage confirmed or suspected extravasation as follows:

• Do not remove the needle until attempts are made to aspirate extravasated fluid

• Do not flush the line

• Avoid applying pressure to the site

• Apply ice to the site intermittently for 15 min 4 times a day for 3 days

• If the extravasation is in an extremity, elevate the extremity

Procedure for Proper Handling and Disposal

Handle and dispose of DOXIL in accordance with recommendations for the handling and disposal of hazardous drugs.

If DOXIL comes into contact with skin or mucosa, immediately wash thoroughly with soap and water.

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

Mycosis fungoides

• Dosing Information

• In observational, single-arm studies, pegylated liposomal DOXOrubicin 20 to 40 mg/m(2) IV every 4 weeks was administered for patients with refractory mycosis fungoides.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

The safety and effectiveness of DOXIL in pediatric patients have not been established.

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

• 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

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Mechanism of Action

mechanismofaction

Structure

File:Doxorubicin liposome01.png

This image is provided by the National Library of Medicine.

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

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This image is provided by the National Library of Medicine.

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This image is provided by the National Library of Medicine.

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.