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DOXIL ® (doxorubicin hydrochloride liposome injection)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use DOXIL safely and effectively. See full prescribing information for DOXIL.
DOXIL ® (doxorubicin hydrochloride liposome injection), for intravenous use
Initial U.S. Approval: 1995
WARNING: CARDIOMYOPATHY and INFUSION-RELATED REACTIONS
See full prescribing information for complete boxed warning.
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Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin HCl approaches 550 mg/m2. The risk of cardiomyopathy may be increased at lower cumulative doses with mediastinal irradiation (5.1).
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Acute infusion-related reactions occurred in 11% of patients with solid tumors. Serious, life-threatening, and fatal infusion reactions have been reported. Medications/emergency equipment to treat such reactions should be available for immediate use (5.2).
RECENT MAJOR CHANGES
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Boxed Warning |
01/2015 |
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Dosage and Administration (2) |
01/2015 |
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Contraindications (4) |
01/2015 |
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Warnings and Precautions (5) |
01/2015 |
INDICATIONS AND USAGE
DOXIL is an anthracycline topoisomerase II inhibitor indicated for:
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Ovarian cancer (1.1)
After failure of platinum-based chemotherapy.
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AIDS-related Kaposi's Sarcoma (1.2)
After failure of prior systemic chemotherapy or intolerance to such therapy.
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Multiple Myeloma (1.3)
In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy.
DOSAGE AND ADMINISTRATION
Administer DOXIL at an initial rate of 1 mg/min to minimize the risk of infusion reactions. If no infusion related reactions occur, increase rate of infusion to complete administration over 1 hour. Do not administer as bolus injection or undiluted solution (2).
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Ovarian cancer: 50 mg/m2 IV every 4 weeks (2.2)
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AIDS-related Kaposi's Sarcoma: 20 mg/m2 IV every 3 weeks (2.3)
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Multiple Myeloma: 30 mg/m2 IV on day 4 following bortezomib (2.4)
DOSAGE FORMS AND STRENGTHS
Doxorubicin hydrochloride (HCl) liposomal injection: Single use vials: 20 mg/10 mL and 50 mg/25 mL (3)
CONTRAINDICATIONS
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Hypersensitivity reactions to doxorubicin HCl or the components of DOXIL (4, 5.2)
WARNINGS AND PRECAUTIONS
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Hand-Foot Syndrome may occur. Dose modification or discontinuation may be required (5.3)
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Embryofetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus. Use effective contraception (5.5, 8.1, 8.3)
ADVERSE REACTIONS
Most common adverse reactions (>20%) are asthenia, fatigue, fever, anorexia, nausea, vomiting, stomatitis, diarrhea, constipation, hand-foot syndrome, rash, neutropenia, thrombocytopenia, and anemia (6).
To report SUSPECTED ADVERSE REACTIONS contact Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
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Lactation: Discontinue breastfeeding (8.2).
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 4/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Ovarian Cancer
DOXIL is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
1.2 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.
1.3 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.
2 DOSAGE AND ADMINISTRATION
2.1 Important Use Information
Do not substitute DOXIL for doxorubicin HCl injection.
Do not administer as an undiluted suspension or as an intravenous bolus [see Warnings and Precautions (5.2)].
2.2 Ovarian Cancer
The recommended dose of DOXIL is 50 mg/m2 intravenously over 60 minutes every 28 days until disease progression or unacceptable toxicity.
2.3 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.
2.4 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 [see Clinical Studies (14.3)].
2.5 Dose Modifications for Adverse Reactions
Do not increase DOXIL after a dose reduction for toxicity.
For neuropathic pain or peripheral neuropathy, no dosage adjustments are required for DOXIL. Refer to bortezomib manufacturer's prescribing information.
2.6 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
Inspect parenteral drug products 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 [see Warnings and Precautions (5.2)]. Do not rapidly flush the infusion line.
Do not mix DOXIL with other drugs.
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