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FUZEON (enfuvirtide) for Injection
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use FUZEON safely and effectively. See full prescribing information for FUZEON.
FUZEON ® (enfuvirtide) for Injection
Initial U.S. Approval: 2003
INDICATIONS AND USAGE
FUZEON is an HIV-1 fusion inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced patients with HIV-1 replication despite ongoing antiretroviral therapy. ( 1)
DOSAGE AND ADMINISTRATION
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Adults: Recommended FUZEON dose of 90 mg (1 mL) twice daily injected subcutaneously into the upper arm, anterior thigh, or abdomen. FUZEON should not be injected near any anatomical areas where large nerves course close to the skin. (2.1)
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Pediatric Patients (6 to 16 years of age): Recommended 2 mg/kg twice daily up to a maximum dose of 90 mg twice daily injected subcutaneously. Weight should be monitored periodically and the FUZEON dose should be adjusted accordingly. (2.2)
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FUZEON must only be reconstituted with 1 mL of Sterile Water for Injection provided in the Convenience Kit. (2.3)
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Reconstituted FUZEON must be injected immediately or kept refrigerated in the original vial. It must be used within 24 hours. (2.3)
DOSAGE FORMS AND STRENGTHS
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Lyophilized powder: 108 mg/vial (3)
CONTRAINDICATIONS
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Hypersensitivity to FUZEON or any of its components. (4)
WARNINGS AND PRECAUTIONS
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Injection Site Reaction: 98% of subjects experienced at least one injection site reaction during FUZEON treatment in randomized, controlled, open-label, multicenter trials. Manifestations included pain and discomfort, erythema, nodules and cysts, and ecchymosis. (5.1)
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Biojector® 2000: Administration of FUZEON with Biojector 2000 may result in neuralgia and/or paresthesia, bruising and hematomas. Patients receiving anticoagulants or persons with hemophilia, or other coagulation disorders, may have a higher risk of post-injection bleeding. (5.2)
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Pneumonia: Monitor for signs and symptoms of pneumonia in HIV-infected patients, especially those predisposed to pneumonia (e.g., low initial CD4 cell count). (5.3)
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Hypersensitivity: FUZEON should be discontinued immediately upon signs and symptoms of systemic hypersensitivity reactions. (5.4)
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Immune Reconstitution: Patients treated with combination antiretroviral therapy, including FUZEON, may experience immune reconstitution syndrome requiring further eva luation and treatment. (5.6)
ADVERSE REACTIONS
Most common adverse reactions are local injection site reactions, diarrhea, nausea, and fatigue. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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No dose adjustments of FUZEON or the co-administered drug is needed when FUZEON is administered concomitantly with other antiretroviral or non-antiretroviral drugs. (7, 12.3)
USE IN SPECIFIC POPULATIONS
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Pregnancy: No evidence of harm to the fetus was observed in animal reproduction studies and FUZEON should be used only if clearly needed. (8.1)
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Nursing mothers: Do not breast-feed while receiving FUZEON therapy. (8.3)
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Pediatric Use: Safety and pharmacokinetics of FUZEON have not been established in pediatric patients < 6 years of age. Limited efficacy data for pediatric patients ≥ 6 years of age. (8.4)
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Geriatric Use: No data available for patients ≥ 65 years of age. (8.5)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 12/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
FUZEON® in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
This indication is based on results from two controlled studies of 48 weeks duration. Subjects enrolled were treatment-experienced adults; many had advanced disease. There are no studies of FUZEON in antiretroviral naive subjects.
2 DOSAGE AND ADMINISTRATION
2.1 Adults
The recommended dose of FUZEON is 90 mg (1 mL) twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen. Each injection should be given at a site different from the preceding injection site, and only where there is no current injection site reaction from an earlier dose. FUZEON should not be injected near any anatomical areas where large nerves course close to the skin, such as near the elbow, knee, groin or the inferior or medial section of the buttocks, skin abnormalities, including directly over a blood vessel, into moles, scar tissue, bruises, or near the navel, surgical scars, tattoos or burn sites. Additional detailed information regarding the administration of FUZEON is described in the FUZEON Injection Instructions.
2.2 Pediatric Patients
Insufficient data are available to establish a dose recommendation of FUZEON in pediatric patients below the age of 6 years. In pediatric patients 6 years through 16 years of age, the recommended dosage of FUZEON is 2 mg/kg twice daily up to a maximum dose of 90 mg twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen. Each injection should be given at a site different from the preceding injection site and only where there is no current injection site reaction from an earlier dose. FUZEON should not be injected into moles, scar tissue, bruises or the navel. Table 1 contains dosing guidelines for FUZEON based on body weight. Weight should be monitored periodically and the FUZEON dose adjusted accordingly.
2.3 Directions for Use
For more detailed instructions, see FUZEON Injection Instructions.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Subcutaneous Administration
FUZEON must only be reconstituted with 1 mL of Sterile Water for Injection provided in the Convenience Kit. After adding sterile water, the vial should be gently tapped for 10 seconds and then gently rolled between the hands to avoid foaming and to ensure all particles of drug are in contact with the liquid and no drug remains on the vial wall. The vial should then be allowed to stand until the powder goes completely into solution, which could take up to 45 minutes. Reconstitution time can be reduced by gently rolling the vial between the hands until the product is completely dissolved. Before the solution is withdrawn for administration, the vial should be inspected visually to ensure that the contents are fully dissolved in solution, and that the solution is clear, colorless and without bubbles or particulate matter. If the FUZEON is foamy or jelled, allow more time for it to dissolve. If there is evidence of particulate matter, the vial must not be used and should be returned to the pharmacy.
FUZEON contains no preservatives. Once reconstituted, FUZEON should be injected immediately or kept refrigerated in the original vial until use. Reconstituted FUZEON must be used within 24 hours. The subsequent dose of FUZEON can be reconstituted in advance and must be stored in the refrigerator in the original vial and used within 24 hours. Refrigerated reconstituted solution should be brought to room temperature before injection and the vial should be inspected visually again to ensure that the contents are fully dissolved in solution and that the solution is clear, colorless, and without bubbles or particulate matter.
A vial is suitable for single use only; unused portions must be discarded (see FUZEON Injection Instructions).
Patients should contact their healthcare provider for any questions regarding the administration of FUZEON. Information about the self-administration of FUZEON may also be obtained by calling th |
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