Full Prescribing Information (204K/PDF)
Important Patient Information (68K/PDF)

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

Fuzeon® (enfuvirtide) is a medicine called an HIV (human immunodeficiency virus) fusion inhibitor. Fuzeon is always used with other anti-HIV medicines to treat adults and children ages 6 years and older with HIV infection.

Fuzeon blocks HIV's ability to infect healthy CD4 cells. When used with other anti-HIV medicines, Fuzeon can reduce the amount of HIV in the blood and increase the number of CD4 cells. This may keep the immune system healthy, so it can help fight infection.

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 Allergic Reactions Fuzeon can cause serious allergic reactions. Symptoms of a serious allergic reaction with Fuzeon can include: trouble breathing, fever with vomiting and a skin rash, blood in the urine, and swelling of the feet. Patients should call their healthcare provider right away if they get any of those symptoms.

Injection Site Reactions Fuzeon causes injection site reactions. Almost all people get injection site reactions with Fuzeon. Reactions are usually mild to moderate but occasionally may be severe. Reactions on the skin where Fuzeon is injected include: itching, swelling, redness, pain or tenderness, hardened skin, or bumps.

These reactions generally happen within the first week of Fuzeon treatment and usually happen again as patients keep using Fuzeon. A reaction at one skin injection site usually lasts for less than 7 days. Injection site reactions may be worse when injections are given again in the same place on the body or when the injection is given deeper than it should be (for example, into the muscle).

Patients who are worried about the reaction they are having should call their healthcare provider to help them decide if they need medical care. If the patient's injection site reaction is severe, they should call their healthcare provider right away. Patients with an injection site reaction can discuss ways to help the symptoms with their healthcare provider.

An injection site can get infected. It is important to follow the Fuzeon Injection Instructions that come with the medicine to lower a patient's chances of getting an injection site infection. Patients should call their healthcare provider right away if there are signs of infection at the injection site such as oozing, increasing heat, swelling, redness or pain.

Injection Using Biojector® 2000 Shooting nerve pain and tingling lasting up to 6 months from injecting close to large nerves or near joints, and bruising and/or collections of blood under the skin have been reported with use of the Biojector 2000 needle-free device to inject Fuzeon. Patients taking any blood thinners, or who have hemophilia or any other bleeding disorder may be at higher risk of bruising or bleeding after using the Biojector.

Pneumonia Patients with HIV get bacterial pneumonia more often than patients without HIV. Patients with HIV are more likely to get bacterial pneumonia if they have any of the following: a low number of CD4 cells, increased amount of HIV in the blood, intravenous (injected into the vein) drug use, smoking or had experienced lung disease in the past. Patients taking Fuzeon with other HIV medicines may get bacterial pneumonia more often than patients not receiving Fuzeon. It is unclear if this is related to the use of Fuzeon.

Patients should contact their healthcare provider right away if they have a cough, fever, or trouble breathing. If patients have previously taken Fuzeon and have experienced any of these reactions, they should discuss this with their healthcare provider.

Other Side Effects The following side effects were seen more often in patients using Fuzeon with their other anti-HIV medicines than in patients not using Fuzeon with their other anti-HIV medicines: pain and numbness in the feet or legs, loss of sleep, depression, decreased appetite, sinus problems, enlarged lymph nodes, weight decrease, weakness or loss of strength, muscle pain, constipation, pancreas problems.

These are not all the side effects of Fuzeon. For more information, patients should ask their healthcare provider or pharmacist. If patients have questions about side effects, they should ask their healthcare provider.

View full prescribing information for additional safety information.