• 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)
• 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)
• FUZEON must only be reconstituted with 1 mL of Sterile Water for Injection provided in the Convenience Kit. (2.3)
• Reconstituted FUZEON must be injected immediately or kept refrigerated in the original vial. It must be used within 24 hours. (2.3)

• 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)
• 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)
• 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)
• Hypersensitivity: FUZEON should be discontinued immediately upon signs and symptoms of systemic hypersensitivity reactions. (5.4)
• Immune Reconstitution: Patients treated with combination antiretroviral therapy, including FUZEON, may experience immune reconstitution syndrome requiring further eva luation and treatment. (5.6)

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.

• 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)

• 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)
• Nursing mothers: Do not breast-feed while receiving FUZEON therapy. (8.3)
• 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)
• Geriatric Use: No data available for patients ≥ 65 years of age. (8.5)