Frequently Asked Questions about FUZEON

FUZEON is the first anti-HIV drug that is taken as an injection under the skin. FUZEON needs to be injected because, if taken by mouth, it would be digested in your stomach and would not work. Your doctor or nurse will teach you how to find the correct sites for injecting FUZEON. The sites for injection are the abdomen, upper thighs, or upper arms because there is enough fatty tissue under the skin to allow you to give the injection correctly.

FUZEON comes in a 30-day kit containing 60 doses of supplies (twice-daily injections).

No. FUZEON has not been studied in patients who have never been on anti-HIV treatment. Please contact your healthcare provider for more information.

Resistance testing should be a choice that remains with you and your healthcare provider as treatment decisions are based on each individual case. Please contact your healthcare provider for more information.  

Do not use FUZEON if you are allergic to any of the ingredients in FUZEON (active ingredient: enfuvirtide; inactive ingredients: mannitol, sodium carbonate, sodium hydroxide, and hydrochloric acid).

Before taking FUZEON, tell your healthcare provider:

• About all your medical conditions, including if you have or had bleeding problems, lung problems or a low CD4 count
• If you smoke or use intravenous (IV) street drugs
• 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
• Do not breastfeed.  We do not know if FUZEON can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk
• 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.

FUZEON does not prevent the transmission of HIV. FUZEON is not a cure for 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.

If you miss a dose of FUZEON, contact your healthcare provider for guidance.

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.

Tell your healthcare provider:

• About all your medical conditions, including if you have or had bleeding problems, lung problems or a low CD4 count
• If you smoke or use intravenous (IV) street drugs
• 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 Antiviral Pregnancy Registry
• Do not breastfeed. We do not know if FUZEON can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk
• About all the medicines you use, including prescription and nonprescription medicines, vitamins and herbal supplements. FUZEON has not been tested with all medicines

• Store FUZEON vials that have not been mixed with sterile water at room temperature between 68°F to 77°F (20°C to 25°C)
• Store FUZEON that has been mixed with sterile water in the original vial and in the refrigerator between 36°F to 48°F (2°C to 8°C) for up to 24 hours. Throw away (discard) any unused FUZEON left in the vial after 24 hours

Keep FUZEON and all medicines out of the reach of children.

Yes. 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 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. Do not breastfeed. We do not know if FUZEON can be passed to your baby in your breast milk and whether it could harm your baby.

The majority of patients (98%) receiving FUZEON in randomized, controlled, open-label, multicenter clinical trials had at least one local injection site reaction.

Injection site reactions where FUZEON is injected include: pain and discomfort, redness, rash, itching and bruising.

These reactions generally happen within the first week of FUZEON treatment and may continue throughout treatment with FUZEON. Injection site reactions can be present at more than one injection site.

It is important to familiarize yourself with the FUZEON Injection Instructions in order to know how to inject FUZEON appropriately and how to monitor carefully for signs or symptoms of cellulitis or local infection. Call your healthcare provider right away if you have pain, redness, or swelling around the injection site that does not go away within a few days or gets worse.

In the FUZEON clinical trials, the average duration of individual injection site reactions with FUZEON was between three and seven days in 41% of patients and more than seven days in 24% of patients.  

Call your healthcare provider right away if you have pain, redness, or swelling around the injection site that does not go away within a few days or gets worse.

An injection site can get infected. It is important to follow the FUZEON Instructions for Use that come with your medicine to lower your chances of getting an injection site infection. Oozing, increased heat, swelling, redness, and pain may be signs of an infection and you need to call your healthcare provider.

If the injection site reaction is painful, call your healthcare provider. In clinical trials, 96% of patients felt some degree of pain or discomfort. Of those, 11% needed pain medicine or found that the pain limited their usual activities.   

Nodules (bumps) or cysts (fluid-filled bumps) can form at the injection site. If you have nodules or cysts under your skin, you will be able to feel them with your fingertips.

In clinical trials, 80% of patients on FUZEON had nodules or cysts. Follow up with your healthcare provider if you have any questions or concerns regarding nodules or cysts.

FUZEON can cause hypersensitivity reactions, which are serious allergic reactions. Symptoms of a serious allergic reaction with FUZEON can include hypersensitivity: rash, fever, nausea and vomiting, chills, rigors, low blood pressure, and increased liver enzymes. If you are experiencing any of these symptoms, please contact your healthcare provider immediately and cease taking any more FUZEON until after proper medical evaluation.

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 the use of 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.

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 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.  It is unclear if pneumonia is related to the use of FUZEON. You should contact your healthcare provider right away if you have cough, fever, or trouble breathing.

Yes. 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, and/or swelling of your feet. Call your healthcare provider right away if you get any of these symptoms. Discuss with your healthcare provider if you have previously taken FUZEON and experienced any of these 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, weight decrease, weakness or loss strength, muscle pain, constipation, and pancreas problems.    

Reconstitution (to dissolve) can take up to 45 minutes. After reconstitution, FUZEON can be stored in a refrigerator at 36°F to 46°F. Reconstituted FUZEON must be used within 24 hours. Before injection, it should be allowed to return to room temperature and the vial should be inspected visually again to ensure that the contents are fully dissolved in the solution and that the solution is clear, colorless, and without bubbles or particles. If you have further questions, contact your healthcare provider.    

It is difficult to speed up the mixing of FUZEON. To begin dissolving FUZEON, gently tap the vial with your fingertip. You can also try gently rolling the FUZEON vial in your hands. Never shake the vial or turn it upside down to mix. Note: It is OK to turn the FUZEON vial upside down after FUZEON is completely dissolved.

• If the FUZEON is foamy or jelled, allow more time for it to dissolve
• If the FUZEON liquid is cloudy, discolored, or you see any particles in it once it is completely mixed and you have waited 45 minutes, do not use that vial. Properly throw it away and get a new one
• If you see bubbles, gently tap the vial until they disappear

Never mix FUZEON with anything other than the sterile water provided.

Yes, you can. To save time, you can mix 2 doses of FUZEON at the same time, but you will need to keep the second vial of mixed FUZEON in the refrigerator. If you want to mix 2 doses at the same time, be sure to use new alcohol pads, syringes, medicine, and sterile water when mixing the second dose. Store FUZEON in the vial. Do not store mixed FUZEON in the syringe.

Once sterile water has been added to the FUZEON, the vial can be placed in the refrigerator. The FUZEON will dissolve in time for your next dose.

Write the date and time on the vial when mixed if you are mixing the dose to be used later.

Before using the dose of refrigerated FUZEON, be sure it is clear and allow it to warm to room temperature.

Mixed FUZEON must be used within 24 hours.

Do not store reconstituted FUZEON in the syringe in the refrigerator. Reconstituted FUZEON should be stored in the vial in the refrigerator for up to 24 hours.    

Freezing can cause alteration of the physical and chemical properties of FUZEON. The effect of injecting FUZEON that has been frozen has not been studied and, therefore, cannot be recommended. If your vial of FUZEON has been frozen, please discard the vial.

Before using the dose of refrigerated FUZEON, be sure it is clear and allow it to warm to room temperature. Injecting cold solutions beneath your skin (subcutaneously) could cause discomfort. You can warm it by holding the vial in your hand to help bring it to room temperature before you inject it. Do not microwave the vial or put it in hot water.

The sterile water vials may be stored at room temperature (59°F to 86°F). All vials of sterile water provided in your FUZEON kit are for single-use only. Never enter a sterile water vial provided in your FUZEON kit more than once with the syringe needle.

The expired FUZEON should be returned to the pharmacy that provided it. If you have unused syringes, be sure to safely dispose of them in a sharps container. Do not put either unused or used syringes into the trash.    

The larger (3 cc) syringe is intended for mixing the sterile water for injection with FUZEON, while the Terumo Safety (1 cc) syringe is for injecting FUZEON into the body. The smaller syringe has a much shorter and narrower needle, reducing the amount of discomfort during injection. The smaller volume of the syringe also makes it easier to draw the right amount of FUZEON.

Read the FUZEON Instructions for Use.

If only a few small bubbles are in the syringe, tap the syringe gently to make the air bubbles rise to the top. If extra air gets into the syringe, very gently press the plunger to force any air back into the vial and withdraw the sterile water again, making sure you have 1 cc of sterile water in the syringe.

If only a few small bubbles are in the syringe, tap the syringe gently to make the air bubbles rise to the top. If extra air gets into the syringe, very gently press the plunger to force any air back into the vial and withdraw FUZEON again, making sure you have 1 cc of FUZEON in the syringe. Make sure that foaming or bubbling has not occurred before re-drawing FUZEON.

The best way to prevent air from getting into the syringes is to turn the vial upside down when drawing the sterile water or FUZEON. When turning the FUZEON vial upside down, make sure to do it slowly to prevent foaming or bubbling from occurring. When you draw either the sterile water or FUZEON with the vial upside down, make sure to keep the needle below the surface of the liquid. It is also important to use a smooth, slow motion when drawing the sterile water or FUZEON.