Full Prescribing Information (255K/PDF)
Important Patient Information (114K/PDF)

04-30-2008 Fuzeon® 60's Convenience Kit (enfuvirtide) Shipping Label Change (125K/PDF)

Fuzeon® (enfuvirtide) 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 patients.

Injection Site Reactions (ISRs) ISRs were the most frequently reported adverse event (98%). Few patients (4%) discontinued treatment because of ISRs. Signs/symptoms may include pain and discomfort, induration, erythema, nodules and cysts, puritus, ecchymosis and infection. 11% of patients had local reactions that required analgesics or limited usual activities.

Important Safety Information Pneumonia An increased rate of bacterial pneumonia was observed in subjects treated with Fuzeon in the Phase III clinical trials compared to the control arm. It is unclear if the increased incidence of pneumonia is related to Fuzeon use. However, because of this finding, patients with HIV infection should be monitored for signs and symptoms of pneumonia, especially if they have underlying conditions that may predispose them to pneumonia. Risk factors for pneumonia included low initial CD4 cell count, high initial viral load, intravenous drug use, smoking and a prior history of lung disease.

Hypersensitivity Reactions Fuzeon is contraindicated in patients with known hypersensitivity to Fuzeon or any of its components. Systemic hypersensitivity reactions have been associated with Fuzeon therapy and may recur on rechallenge. Hypersensitivity reactions have occurred in <1% of patients and have included combinations of rash, fever, nausea and vomiting, chills, rigors, hypotension and elevated serum liver transaminases. Other adverse events that may be immune-mediated and have been reported in subjects receiving Fuzeon include primary immune complex reaction, respiratory distress, glomerulonephritis and Guillain-Barre syndrome. Patients developing signs and symptoms suggestive of a systemic hypersensitivity reaction should discontinue Fuzeon treatment and should seek medical evaluation immediately. Therapy with Fuzeon should not be restarted following systemic signs and symptoms consistent with a hypersensitivity reaction. Risk factors that may predict the occurrence or severity of hypersensitivity to Fuzeon have not been identified.

Immune Reconstitution Syndrome Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Fuzeon.

Administration with Biojector 2000 Nerve pain (neuralgia and/or paresthesia) lasting up to 6 months associated with administration at anatomical sites where large nerves course close to the skin, bruising and hematomas have occurred with use of the Biojector 2000 needle-free device for administration of Fuzeon. Patients receiving anticoagulants or persons with hemophilia, or other coagulation disorders, may have a higher risk of post-injection bleeding.

Other Adverse Events Excluding ISRs, the events most frequently reported in patients receiving Fuzeon plus a background regimen were diarrhea (38 per 100 patient-years, or 32%), nausea (27 per 100 patient-years, or 23%) and fatigue (24 per 100 patient-years, or 20%). These events were seen at a lower incidence than in patients receiving a background regimen without Fuzeon: diarrhea (73 per 100 patient-years), nausea (50 per 100 patient-years) and fatigue (38 per 100 patient-years).

Fuzeon is not a cure for HIV infection or AIDS. Fuzeon does not prevent the transmission of HIV.

For more information on Fuzeon, please see package insert, go to www.FUZEON.COM OR CALL 1-877-4-FUZEON (1-877-438-9366).

View full prescribing information for additional safety information.