An Overview of Fuzeon (Enfuvirtide, T-20)

en-FYOO-vir-tide

Brand Name: Fuzeon
Other Name(s): DP 178, DP178, Pentafuside, T 20, T-20, T20
Drug Class: Entry and Fusion Inhibitors

Patient Information

FUZEON^® (few′-zee-on)
enfuvirtide
Injection

This leaflet contains important information for patients and their caregivers about FUZEON. Please read this leaflet and FUZEON Injection Instructions carefully before you start using FUZEON. Always read this leaflet each time you get your FUZEON prescription refilled. There may be new important information about the use of FUZEON.

This information does not take the place of talking with your healthcare provider about your medical conditions or treatment.

What is FUZEON?

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 your immune system healthy, so it can help fight infection.

Does FUZEON cure HIV and AIDS?

FUZEON does not cure HIV infection or AIDS. 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.

Does FUZEON lower the chance of passing HIV to other people?

FUZEON does not lower your chance of passing HIV to other people through unprotected sex, sharing needles or being exposed to your blood. For your own health and the health of others, it is important to continue to practice safer sex. Use a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions or blood. Never use dirty needles or share needles. Ask your healthcare provider if you have any questions about safer sex or how to prevent passing HIV to other people.

Who should not use FUZEON?

Do not use FUZEON if you are allergic to any of the ingredients in FUZEON. See the end of this leaflet for a list of ingredients in FUZEON.

Tell your healthcare provider:

• if you are pregnant or plan to become pregnant. We do not know if FUZEON can harm your unborn child. You and your healthcare provider will need to decide if FUZEON is right for you. If you use FUZEON while you are pregnant, talk to your healthcare provider about how you can be in the Antiretroviral Pregnancy Registry.
• if you are breast-feeding. You should not breast-feed if you are HIV-positive because of the chance of passing the HIV virus to your baby. Also, it is not known if FUZEON can pass into your breast milk and if it can harm your baby.
• about all your medical conditions.
• about all the medicines you use, including prescription and non-prescription medicines, vitamins, and herbal supplements. FUZEON has not been tested with all medicines. FUZEON does not affect other anti-HIV medicines or the medicine rifampin (also known as rifampicin, Rifadin^® or Rimactane^®). You can take FUZEON at the same times or at different times than your other anti-HIV medicines.

How should I use FUZEON?

Before you use FUZEON, make sure you understand all of the information in this leaflet and the FUZEON Injection Instructions that come with your medicine. You or your caregiver should be trained by a healthcare provider before injecting it. If you do not understand all the information or are having a hard time mixing or injecting FUZEON, talk with your healthcare provider.

• Use FUZEON with other anti-HIV medicines. You can take FUZEON at the same time or at a different time than your other anti-HIV medicines.
• Do not use FUZEON as your only anti-HIV medicine.
• FUZEON must be injected. FUZEON does not work if the medicine is swallowed.
• Do not mix other medicines in the same syringe with FUZEON.
• FUZEON is given under the skin by injection (a "shot") in the upper arm, upper leg or stomach two times a day. See the FUZEON Injection Instructions that come with your medicine for step-by-step instructions about how to inject FUZEON.
• Do not inject FUZEON in the same area as you did the time before. Do not inject FUZEON into the following areas: near the elbow, knee, groin, the lower or inner buttocks, directly over a blood vessel, around the navel (belly button), scar tissue, a bruise, a mole, a surgical scar, tattoo or burn site, or where there is an injection site reaction.
• If the FUZEON is foamy or jelled, allow more time for it to dissolve. Do not inject FUZEON if you see particles floating in the FUZEON vial after you mix it up.
• You can use FUZEON whether you have eaten or not. Food does not affect FUZEON. However, you must keep taking your other medicines the way you did before.
• Do not change your dose or stop taking FUZEON without first talking with your healthcare provider.
• See your healthcare provider regularly while using FUZEON.
• When your FUZEON supply runs low, be sure to have it refilled. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. If you miss or skip doses of FUZEON, HIV may develop resistance to FUZEON and become harder to treat.
• If you miss a dose of FUZEON, take the missed dose as soon as you can and then take your next dose as scheduled. If you have missed a dose of FUZEON and it is close to the time when you are supposed to take your next dose, wait and take the next dose as regularly scheduled. Do not take two doses of FUZEON at the same time.
• If you take too much FUZEON, call your healthcare provider right away. We do not know what can happen if you take too much FUZEON. You will be watched very carefully if you take too much FUZEON.
• It is important that you put your used syringes into a special sharps container after injecting FUZEON. Your healthcare provider will give you more instructions about the safe disposal of your used syringes. Do not put them in a trash can. If you do not have a sharps container, call your healthcare provider or pharmacist to get one before using FUZEON.