Information for Healthcare Providers / Patients

Fuzeon® (enfuvirtide)

• Full Prescribing Information
• Medication Guide
• Patient Injection Guide

What it Treats

FUZEON 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 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.

Important Safety Information

Important Safety Information

Patients should not use FUZEON if they are allergic to any of the ingredients in FUZEON. 

Patients should tell their healthcare provider:

• if they are pregnant or plan to become pregnant. We do not know if FUZEON can harm the unborn child. Patients and their healthcare provider will need to decide if FUZEON is right for them. If patients use FUZEON while pregnant, they must talk to their healthcare provider about how they can be in the Antiretroviral Pregnancy Registry.
• if they are breast-feeding. Patients should not breastfeed. We do not know if Fuzeon can be passed to an unborn baby in a patient’s breast milk and whether it could harm the patient’s baby.  Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.  
• about all their medical conditions.
• about all the medicines they use, including prescription and non-prescription medicines, vitamins, and herbal supplements. FUZEON has not been tested with all medicines.

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
• swelling of the feet

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
• bumps

These reactions generally happen within the first week of FUZEON treatment and usually happen again as a patient keeps 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 reactions they are having should call their healthcare provider to help decide if they need medical care. If the injection site reaction they are having is severe, patients must call their healthcare provider right away. If patients have an injection site reaction, they can discuss with their healthcare provider ways to help the symptoms.

An injection site can get infected. It is important to follow the FUZEON Injection Instructions that come with the medicine to lower the 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.

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. If patients are taking any blood thinners, or have hemophilia or any other bleeding disorder, they may be at higher risk of bruising or bleeding after using the Biojector.

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. Three patients in the clinical trials who took FUZEON died of pneumonia.

It is unclear if the increased incidence of pneumonia is related to the use of FUZEON. Patients should contact their healthcare provider right away if they have a cough, fever or trouble breathing.  Patients must call their healthcare provider right away if they get any of these symptoms. Patients must discuss with their healthcare provider if they have previously taken FUZEON and experienced any of those reactions.

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 feet or legs
• loss of sleep
• depression
• decreased appetite
• sinus problems
• enlarged lymph nodes
• 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.

FUZEON is not a cure for HIV infection or AIDS, and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections.  Patients should remain under the care of a doctor when using Fuzeon.  

Report side effects to the FDA at (800) FDA-1088 orwww.fda.gov/medwatch. Patients and caregivers may also report side effects to Genentech at (888) 835-2555. For more information on FUZEON, go to www.FUZEON.com or call 1.877.4.FUZEON (1.877.438.9366).