Doxorubicin liposome: Difference between revisions
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* 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 | * 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. | * 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. | ||
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Do not use with in-line filters. | 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 | 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. | Do not mix DOXIL with other drugs. | ||
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Discontinue DOXIL for burning or stinging sensation or other evidence indicating perivenous infiltration or extravasation. Manage confirmed or suspected extravasation as follows: | 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 remove the needle until attempts are made to aspirate extravasated fluid | ||
Do not flush the line | * Do not flush the line | ||
Avoid applying pressure to the site | * Avoid applying pressure to the site | ||
Apply ice to the site intermittently for 15 min 4 times a day for 3 days | * 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 | * If the extravasation is in an extremity, elevate the extremity | ||
=====Procedure for Proper Handling and Disposal===== | =====Procedure for Proper Handling and Disposal===== | ||
Handle and dispose of DOXIL in accordance with recommendations for the handling and disposal of hazardous drugs. | 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. | If DOXIL comes into contact with skin or mucosa, immediately wash thoroughly with soap and water. | ||
Revision as of 18:15, 25 February 2015
For patient information regarding Doxorubicin liposome, click here.
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.Black Box Warning
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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.
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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
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.
xx
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
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)
The safety and effectiveness of DOXIL in pediatric patients have not been established.
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.