What is enfuvirtide (Fuzeon), and what is it used for?

Fuzeon 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 subjects.

What are the side effects of enfuvirtide (Fuzeon)?

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:

These reactions generally happen within the first week of Fuzeon treatment and usually happen again as you 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).

If you are worried about the reaction you are having, call your healthcare provider to help you decide if you need medical care. If the injection site reaction you are having is severe, call your healthcare provider right away. If you have an injection site reaction, you can discuss with your 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 your medicine to lower your chances of getting an injection site infection. Call your 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 needlefree device to inject Fuzeon.

If you are taking any blood thinners, or have hemophilia or any other bleeding disorder, you 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 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.

You should contact your healthcare provider right away if you have a cough, fever or trouble breathing.

Patients are more likely to get bacterial pneumonia if they had 4 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. It is unclear if pneumonia is related to Fuzeon.

Allergic reactions Fuzeon can cause serious allergic reactions. Symptoms of a serious allergic reaction with Fuzeon can include:

Call your healthcare provider right away if you get any of these symptoms. 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:

These are not all the side effects of Fuzeon. For more information, ask your healthcare provider or pharmacist. If you have questions about side effects, ask your healthcare provider. Report any new or continuing symptoms to your healthcare provider. Your healthcare provider will tell you what to do and may be able to help you with these side effects.