FUZEON FAQs

Please choose from the following categories to view frequently asked questions (FAQs) about FUZEON: (click on each question to reveal the answer)

General FUZEON FAQs

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 T cells (CD4). When used with other anti-HIV medicines, FUZEON can reduce the amount of HIV in the blood and increase the number of T cells.

FUZEON is not a cure for HIV infection or AIDS, and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using 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:

  • 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 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.

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.

FUZEON in combination with other anti-HIV medicines has lowered the amount of HIV in the blood (viral load) and increased T cell counts in clinical studies. Results at 48 weeks showed that treatment-experienced patients who took FUZEON plus other anti-HIV medicines:

  • Were twice as likely to achieve undetectable viral loads compared with patients taking anti-HIV medicines without FUZEON
  • Had twice the increase in T cell counts compared with patients taking anti-HIV medicines without FUZEON

FUZEON is not a cure for HIV infection or AIDS, and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using FUZEON.

If you miss a dose of FUZEON, talk to your healthcare provider, 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 2 doses of FUZEON at the same time.    

View the FUZEON Patient Dosing Guide.

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.

Food does not affect FUZEON. You can take your FUZEON injection whether you have eaten recently or not. However, you must keep taking your other medicines as your healthcare provider has directed.    

Tell your doctor:

  • 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 your medical conditions
  • About all the medicines you use, including prescription and nonprescription medicines, vitamins and herbal supplements. FUZEON has not been tested with all medicines

FUZEON vials that have not been mixed with sterile water can be stored at room temperature (59°F to 86°F). FUZEON should be refrigerated if it cannot be stored at room temperature. The Sterile Water for Injection (diluent) may be stored at room temperature (59°F to 86°F). After FUZEON has been mixed with sterile water, the vial can be stored in a refrigerator for up to 24 hours. Do not use FUZEON or sterile water after the expiration date on the vials. Do not keep FUZEON that is out of date or that you no longer need.

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.

Site Reactions and Hypersensitivity FAQs

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 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 Patient Dosing Guide 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.

With 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.

If you feel the injection site reaction you are having is severe, call your healthcare provider right away.

Itchiness at the injection site was experienced by 65% of patients in clinical trials. Call your healthcare provider if the itching does not go away with topical creams (like hydrocortisone or diphenhydramine) or if the amount of itching continues to increase.

This could be a sign of infection. Call your healthcare provider if the area is warm to the touch or oozing fluid.    

An injection site can get infected. It is important to follow the FUZEON Patient Dosing Guide 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. They can vary in size, but 77% of them were less than 1 inch in diameter. Be sure not to inject into nodules or cysts. Call your healthcare provider if the nodules or cysts become larger than 1 inch across or if the cysts begin to ooze fluid.

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.    

FUZEON Preparation FAQs

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.

FUZEON can take up to 45 minutes to fully reconstitute. Do not shake your vial of FUZEON because it might take even longer to dissolve. If you have waited the appropriate amount of time and still see bubbles, foam or gel in your FUZEON, put the vial in the refrigerator and mix another vial. When you are ready to give your next dose, and still see bubbles, contact your pharmacy or the Genentech Patient Resource Center at 1-877-4-FUZEON (1-877-438-9366).  

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.

It is recommended that you let reconstituted FUZEON reach room temperature before giving the injection. Injecting cold solutions beneath your skin (subcutaneously) could cause discomfort. You can warm it by holding the vial in your hand for about 5 minutes.

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 Patient Dosing Guide.

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.

FUZEON Injection FAQs

If you are rotating your injection sites properly and have a choice of sites, you may find it easier to inject into an area where there is more subcutaneous fat. Remember, there are several injection sites within each area. Rotate between your upper arm, abdomen, and upper thigh.

If you are very thin or have trouble finding areas with subcutaneous fat for injection sites, talk to your healthcare provider.

The following sites are recommended for injection of your medicine: upper arms, abdomen, and upper thighs. Remember that there are several injection areas within each site. Remember not to inject into 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 you still can’t find an injection site, contact your healthcare provider.

View the FUZEON Patient Dosing Guide.

Always change injection sites. Even if you find one particular site easier to use than others, it is important to give your injection at a different site each time. Be sure to rotate your injection sites, so that no one spot becomes too tender. This also helps you avoid developing injection site reactions (ISRs) that are too close to each other.

FUZEON should be injected under a pinched fold of skin into the fatty layer beneath the surface. The pinch helps gather the fatty tissue to ensure the injection goes into the fatty layer. The pinch also helps you avoid giving the injection too deep or into muscles or veins.    

View the FUZEON Patient Dosing Guide.

Talk to your healthcare provider team about proper injection technique. If you are injecting into your abdomen (and you are right-handed) the plunger should be angled between 1 o’clock and 2 o’clock, it would be a 45-degree angle. If the plunger was pointing at 3 o’clock, it would be at a 90-degree angle.

View the FUZEON Patient Dosing Guide.

The tissue below the skin of the abdomen absorbs medicine readily. When using this site, squeeze the skin between your fingers before the injection and release the skin once the needle is inserted. Be sure to avoid injecting FUZEON in the area closely surrounding the navel (belly button) or beltline, as well as any prior injection sites where any obvious reactions have occurred.

View the FUZEON Patient Dosing Guide.

The front or outer thigh is another site that provides a fatty layer of tissue under the skin to absorb the medicine, as well as enough skin to pinch for the injection. It is important to pinch the skin to avoid giving the injection into the muscle of the thigh. Squeeze the skin between your fingers before the injection and release the skin once the needle is inserted. Be sure to avoid injecting FUZEON in any prior injection sites where any obvious reactions have occurred.

View the FUZEON Patient Dosing Guide.

The back of the arm can be a tricky injection site. A friend or caregiver may be helpful in reaching injection areas that are difficult for you to personally reach. That person will need to learn how to give the injections correctly to reduce the risk of reactions and infections at the injection site. Your caregiver will also need to know how to protect himself from contact with blood. Your caregiver should meet with a healthcare provider to learn the safe way to give an injection.

View the FUZEON Patient Dosing Guide.

If you accidentally inject into a vein or muscle, contact your healthcare provider, then cover the area with a bandage if any bleeding occurs. Light pressure might help to stop any bleeding.

View the FUZEON Patient Dosing Guide.

It is possible that the needle was not properly inserted into the skin. When giving the FUZEON injection, it is recommended to pinch the skin and insert the needle at a 45-degree angle. The needle should be inserted ¾ of the way into the injection site.

View the FUZEON Patient Dosing Guide.

It is recommended that you use different injection sites for FUZEON and your other injectable medications.

View the FUZEON Patient Dosing Guide.

Used syringes are always considered medical waste and must be disposed of properly to avoid accidental needle-stick injury. If you cannot obtain a sharps container, please contact 1-877-4-FUZEON and we can provide one for you.

Each locality has different regulations regarding sharps disposal. You should contact your healthcare provider or local health department regarding disposal options. Sharps containers should not be discarded with normal household waste.

IMPORTANT SAFETY INFORMATION & INDICATION

INDICATION

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.

Who should not use FUZEON?

Do not use FUZEON if you are allergic to any of the ingredients in FUZEON.

What are the possible side effects of FUZEON?

Injection Site Reactions (ISRs)

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 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 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 had 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:

  • 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. Discuss with your healthcare provider if you have previously taken FUZEON and experienced any of these reactions.

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 possible side effects of FUZEON. For more information, ask your healthcare provider or pharmacist. If you have questions about side effects, ask your healthcare provider.

As with other anti-HIV medicines, FUZEON may strengthen the body’s immune response which could uncover hidden infections. 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.

FUZEON is not a cure for HIV infection or AIDS; FUZEON does not prevent the transmission of HIV. For complete details on FUZEON, please see the Patient Information, or call 1-877-4-FUZEON (1-877-438-9366).