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Fuzeon (enfuvirtide)

Articles on Fuzeon
Full US Prescribing Information

FUZEONŽ is the first in a class of anti-HIV drugs called fusion inhibitors. FUZEON is different from existing antiviral treatments because it works outside of T cells (CD4) to help prevent HIV from infecting these cells.

Patient Information

Important Safety Information
www.fuzeon.com


Articles on Fuzeon (enfvirtide)

Genentech Warns of Infection Risk from Alcohol Pads Packaged with Fuzeon and Pegasys
1-18-2011

Short-term Enfuvirtide (Fuzeon) May Promote Long-term CD4 Cell Recovery in Patients Who Start Treatment Late
10-02-2009


Raltegravir (Isentress) Found to Be Effective Substitute for Enfuvirtide (Fuzeon)
6-9-2009


Raltegravir (Isentress) Found to Be Effective Substitute for Enfuvirtide (Fuzeon)
6-9-2009


Experimental Fusion Inhibitor TRI-1144
May Permit Less Frequent Dosing and Cause Fewer Injection Site Reactions than Enfuvirtide (Fuzeon)
9-15-2009

Patients with Multidrug-resistant HIV Achieve Good Results after Switching from Enfuvirtide (Fuzeon)
to Raltegravir (Isentress)
7-15-2009




IMPORTANT SAFETY INFORMATION

FUZEON (enfuvirtide) is used with other anti-HIV medicines to treat HIV-1 infection in patients who are treatment-experienced and have detectable viral loads even though they are taking anti-HIV medicines. This indication is based on results from 2 studies that lasted 48 weeks each. Patients in the studies were treatment-experienced adults, and many of them had advanced HIV disease. There are no studies of FUZEON in patients who haven’t taken anti-HIV medicines.

What are the possible side effects of 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:

itching
swelling
redness
pain or tenderness
hardened skin
bumps

These reactions usually happen within the first week of FUZEON treatment and can 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 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 needle-free 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 have a low number of CD4 cells, have a high viral load, use intravenous (injected into the vein) drugs, smoke or have had 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:

trouble breathing
fever with vomiting and a skin rash
blood in your urine
swelling of your feet

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:

pain and numbness in 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. FUZEON is still being studied in children. The safety of FUZEON in children under 6 years of age is not known. The side effects of FUZEON for HIV-positive children aged 6 through 16 years were similar to those seen in adult patients.

If you have questions about side effects, ask your healthcare provider. Report any new or worsening 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.

FUZEON is not a cure for HIV infection or AIDS. FUZEON does not prevent the transmission of HIV. People taking FUZEON may still get opportunistic infections or other conditions that can happen with HIV infection. For these reasons it is very important that you remain under the care of your healthcare provider while taking FUZEON.

View the Patient Product Information.

Source
Roche Laboratories Inc. & Trimeris, Inc.