Information for Healthcare Providers / Patients

Fuzeon® (enfuvirtide)

Side Effect Reporting

You may report side effects to the FDA at (800) FDA-1088 or

You may also report side effects to Genentech at (888) 835-2555.

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 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.

Important Safety Information

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

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.

  • about all the medicines they use, including prescription and non-prescription medicines, vitamins, and herbal supplements. FUZEON has not been tested with all medicines.
  • trouble breathing
  • blood in the urine

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:

  • swelling
  • pain or tenderness
  • bumps

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.

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.

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.

  • pain and numbness in feet or legs
  • depression
  • sinus problems
  • weight decrease
  • muscle pain
  • pancreas problems

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 or

For more information on FUZEON, go to or call 1.877.4.FUZEON (1.877.438.9366).