Frequently Asked Questions about FUZEON


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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:

  • 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.

Site Reactions and Hypersensitivity FAQs

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.    

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.

  • 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.

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 Instructions for Use.

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 Instructions for Use.

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 Instructions for Use.

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 any prior injection sites where any obvious reactions have occurred.

Do not inject:

  • into areas where the skin is tender, bruised, burned or areas with moles, scars or tattoos
  • over a blood vessel
  • within 2 inches of the belly-button (navel)

View the FUZEON Instructions for Use.

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.

Do not inject:

  • into areas where the skin is tender, bruised, burned or areas with moles, scars or tattoos
  • over a blood vessel
  • near the elbow, knee, groin, or the lower or inner buttocks

View the FUZEON Instructions for Use.

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 Instructions for Use.

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 Instructions for Use.

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 most of the way in. Gently let go of the skin. Make sure the needle stays in place.

View the FUZEON Instructions for Use.

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

View the FUZEON Instructions for Use.

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.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal.

Phone assistance

GET ASSISTANCE

For assistance with any of the items in the FUZEON package, call 1-877-4 FUZEON (1-877-438-9366)

Indication
What is FUZEON?

FUZEON is a prescription medicine used in combination with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in people who have taken other antiretroviral medicines and whose HIV-1 levels have continued to increase while on treatment.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

It is not known if FUZEON is safe and effective for use in children under 6 years of age.

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

Before using FUZEON, tell your healthcare provider about all your medical conditions, including if you:

  • have bleeding problems
  • have or had lung problems
  • have a low CD4 count
  • smoke or use intravenous (IV) street drugs
  • are pregnant or plan to become pregnant. It is not known if FUZEON can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with FUZEON.
    • Pregnancy Registry: There is a pregnancy registry for women who use antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you use FUZEON.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
    • It is not known if FUZEON passes into your breast milk. 
    • Talk to your healthcare provider about the best way to feed your baby during treatment with FUZEON.
  • are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take medicines that affect blood clotting. Some medicines interact with FUZEON. Keep a list of your medicines to show to your healthcare provider and pharmacist when you get a new medicine.
Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to use FUZEON with other medicines.

What are the possible side effects of FUZEON?
FUZEON may cause serious side effects, including:

  • Injection site reactions. Injection site reactions including pain and discomfort, redness, rash, itching and bruising have happened in people who use FUZEON. 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.
  • Nerve pain (neuralgia) or numbness, burning, or prickling feeling of your skin (paresthesia) have happened in people who use the Biojector 2000 needle-free device to give their FUZEON dose. These symptoms can last up to 6 months.
  • Bleeding after your injection. People who take medicines that affect blood clotting (anticoagulants) or people with hemophilia or other blood clotting problems may have a higher risk.
  • Allergic reactions. Stop using FUZEON and call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of these signs and symptoms of an allergic reaction:
    • rash
    • fever
    • chills
    • trouble breathing
    • hives
    • nausea and vomiting
    • swelling of your face, eyes, lips or mouth
    • low blood pressure
  • Pneumonia. Pneumonia which can be serious and cause hospitalization and death has happened in people who use FUZEON. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of these signs or symptoms of pneumonia:
    • cough with fever
    • fast breathing
    • shortness of breath
  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when an HIV-1 infected person starts taking antiretroviral medicines including FUZEON. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting FUZEON.

The most common side effects of FUZEON include local injection site reactions, diarrhea, nausea, tiredness, weight loss, sinus problems, stomach pain, cough, herpes simplex, decreased appetite, pancreas problems, pain in arms and legs, pneumonia, pain and numbness in feet or legs, flu-like symptoms, infected hair follicle, dry mouth, and eye infection.
These are not all the possible side effects of FUZEON.

What should I avoid while using FUZEON?

  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how FUZEON affects you.

Call your doctor for medical advice about side effects.  You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or to Genentech at 1-888-835-2555.

Please see full Prescribing Information, including Patient Information and Instructions for Use, for additional Important Safety Information.