Daunorubicin liposome: Difference between revisions

Daunorubicin 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

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Revision as of 16:14, 25 February 2015

For patient information regarding Daunorubicin liposome, click here.

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

Disclaimer

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Black Box Warning

WARNINGS

See full prescribing information for complete Boxed Warning.

* Cardiac function should be monitored regularly in patients receiving DaunoXome (daunorubicin citrate liposome injection) because of the potential risk for cardiac toxicity and congestive heart failure. Cardiac monitoring is advised especially in those patients who have received prior anthracyclines or who have pre-existing cardiac disease or who have had prior radiotherapy encompassing the heart.

Severe myelosuppression may occur.
DaunoXome should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
Dosage should be reduced in patients with impaired hepatic function.
A triad of back pain, flushing, and chest tightness has been reported in 13.8% of the patients (16/116) treated with DaunoXome in the Phase III clinical trial, and in 2.7% of treatment cycles (27/994). This triad generally occurs during the first five minutes of the infusion, subsides with interruption of the infusion, and generally does not recur if the infusion is then resumed at a slower rate.

Overview

Daunorubicin liposome is an anthracycline that is FDA approved for the treatment of advanced HIV-associated Kaposi's sarcoma. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Cardiotoxicity, Myelosuppression.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Colon cancer

In a phase II clinical trial, DAUNOrubicin citrate liposome in doses of 100 milligrams/square meter every 3 weeks was not associated with significant antitumor activity in patients with metastatic ADENOCARCINOMA OF THE COLON progressing after 5-fluorouracil Do not mix DaunoXome with other drugs.

Kaposi's sarcoma, First line therapy; in patients with advanced HIV-related Kaposi's sarcoma

Important note: The dose OF Daunorubicin citrate liposome is different than that of conventional Daunorubicin and the two formulations are not interchangeable. Consult the drug evaluation monograph entitled "daunorubicin" for clinical use of this formulation.
Daunorubicin citrate liposome is indicated as a first-line cytotoxic therapy for advanced HIV-associated Kaposi's sarcoma. It is not recommended in patients with less than advanced Kaposi's sarcoma. The dose of DAUNOrubicin citrate liposome is 40 milligrams/square meter, administered intravenously over 60 minutes, every 2 weeks. Blood counts should be repeated prior to each dose, and therapy withheld if the absolute granulocyte count is less than 750 cells/cubic millimeter. Treatment should be continued until there is evidence of progressive disease (eg, based on best response achieved: new visceral sites of involvement, or progression of visceral disease; development of 10 or more new cutaneous lesions or a 25% increase in the number of lesions compared to baseline; a change in the character of 25% or more of all previously counted flat lesions to raised; increase in the surface area the indicator lesions), or until other complications of HIV disease require discontinuation of therapy.
In the treatment of AIDS-related Kaposi's sarcoma, the recommended dose of DAUNOrubicin citrate liposome is 40 milligrams/square meter every 14 days. The median duration of response in one study was 12 weeks.
Important Note: The dose of DAUNOrubicin CITRATE LIPOSOME is different than that of conventional DAUNOrubicin and the two formulations are not interchangeable. Consult the Drug Evaluation monograph entitled "DAUNOrubicin" for clinical use of this formulation.
Infiltration: Care should be given to avoid extravasation.
Intravenous rate of administration: DAUNOrubicin citrate liposome should be administered diluted in 5% Dextrose in Water for Injection in volumes of 100 mL and administered via intravenous infusion over 60 minutes. The manufacturer of DAUNOrubicin citrate liposome emphasizes that an inline filter should NOT be used.
Intravenous solution preparation

DAUNOrubicin citrate liposome should be diluted 1:1 with 5% Dextrose Injection (D5W) before administration. Each vial of DaunoXome(R) contains DAUNOrubicin citrate equivalent to 50 milligrams DAUNOrubicin base, at a concentration of 2 mg/mL. The recommended concentration after dilution is 1 mg/mL. The only fluid which may be mixed with DaunoXome(R) is 5% Dextrose Injection; the drug must not be mixed with saline, bacteriostatic agents such as benzyl alcohol, or any other solution. Strictly observe aseptic technique in all handling. Do not use an inline filter for intravenous infusion of DaunoXome.
The calculated volume of DAUNOrubicin citrate liposome should be drawn from the vial into a sterile syringe, and transferred into a sterile infusion bag containing an equivalent volume of 5% Dextrose Injection (D5W). Diluted DAUNOrubicin citrate liposome should be administered immediately; if not used immediately, the dose should be stored refrigerated at 2 to 8 degrees Centigrade (36 to 46 degrees Fahrenheit) for a maximum of 6 hours.

Dosage in Renal Failure

There is limited clinical experience in treating patients with renal impairment with DAUNOrubicin citrate liposome. Thus, based on experience with conventional DAUNOrubicin hydrochloride, it is recommended that the dose of DAUNOrubicin citrate liposome be reduced if the serum creatinine is elevated as follows: For serum creatinine greater than 3 mg/dL, give one-half the normal dose.

Dosage in Hepatic Insufficiency

There is limited clinical experience in treating patients with hepatic impairment with DAUNOrubicin citrate liposome. Thus, based on experience with DAUNOrubicin hydrochloride, it is recommended that the dose of DAUNOrubicin citrate liposome be reduced if the serum bilirubin is elevated as follows: For serum bilirubin 1.2 to 3 milligrams/deciliter, give three-fourths the normal dose; for serum bilirubin greater than 3 mg/dL, give one-half the normal dose.

Geriatric Use

The safety and efficacy of DAUNOrubicin citrate liposome in the elderly have not been established

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

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

{{{offLabelAdultGuideSupport}}}

Non–Guideline-Supported Use

Condition1

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

Safety and effectiveness in pediatric patients have not been established

Condition2

There is limited information regarding FDA-Labeled Use of Daunorubicin liposome in pediatric patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

{{{fdaLIADPed}}}

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

Developed by:

Class of Recommendation:

Strength of Evidence:

Dosing Information

Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

Dosing Information

Dosage

Condition2

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

Contraindications

Condition1

Warnings

Description

Precautions

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Daunorubicin liposome in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

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

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

Drug

Description

Use in Specific Populations

Pregnancy

Pregnancy Category

Labor and Delivery

There is no FDA guidance on use of Daunorubicin liposome during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Daunorubicin liposome with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Daunorubicin liposome with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Daunorubicin liposome with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Daunorubicin liposome with respect to specific gender populations.

Race

There is no FDA guidance on the use of Daunorubicin liposome with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Daunorubicin liposome in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Daunorubicin liposome in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Daunorubicin liposome in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Daunorubicin liposome in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

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

Description

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Daunorubicin liposome in the drug label.

Pharmacology

Mechanism of Action

Structure

File:Daunorubicin liposome01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Images

Package and Label Display Panel

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Daunorubicin liposome in the drug label.

Precautions with Alcohol

Alcohol-Daunorubicin liposome interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

®^[1]

Look-Alike Drug Names

A® — B®^[2]

Drug Shortage Status

References

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

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[1]

[2]

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-* Strength of Evidence:
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