What are the most important things to know about enfuvirtide?
Enfuvirtide can cause serious side effects. These include severe, severe allergic reactions, and .
Almost all people using enfuvirtide have injection site reactions. These reactions are usually mild to moderate but occasionally can be severe. Contact your health care provider right away if you develop possible signs of infection, such as pain, redness, or swelling around the injection site that does not go away within a few days or gets worse.
Contact your health care provider or get medical help right away if you have any of the following symptoms that could be signs of a severe allergic reaction:
- Trouble breathing
- Nausea and vomiting
- Swelling of your face, eyes, lips, or mouth
- Low blood pressure
- Cough with fever
- Trouble breathing, including rapid breathing or shortness of breath
While taking enfuvirtide, it is important to keep all of your appointments with your health care provider.
What is enfuvirtide?
Enfuvirtide (brand name: Fuzeon) is a prescription medicine approved by the U.S.(FDA) for the treatment of HIV in adults and in children 6 years of age and older weighing at least 24 lb (11 kg) whose infection is not well-controlled by ongoing treatment with other HIV medicines. Enfuvirtide is always used in combination with other HIV medicines.
Although enfuvirtide is FDA-approved for use in children, the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection no longer recommend its use as a treatment for HIV in children.
For more information on the use of enfuvirtide in adults and adolescents with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV.
HIV medicines cannot cure HIV/AIDS, but taking medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV. If you are taking HIV medicines, do not cut down on, skip, or stop taking them unless your health care provider tells you to.
What should I tell my health care provider before using enfuvirtide?
Before using enfuvirtide, tell your health care provider:
- If you are allergic to enfuvirtide or any other medicines.
- If you have bleeding problems.
- If you have or have had lung problems.
- If you have a low .
- If you smoke or use (IV) street drugs.
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of using enfuvirtide during pregnancy. For more information on the use of enfuvirtide during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States.
- If you are breastfeeding or plan to breastfeed. For women with HIV in the United States, the Guideline does not recommend breastfeeding. Before your baby is born, or if you are already breastfeeding, talk to your health care provider to discuss alternative options for feeding your baby.
- If you are using HIV and Birth Control infographic. -based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the HIVinfo
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Enfuvirtide may affect the way other medicines or products work, and other medicines or products may affect how enfuvirtide works. Taking enfuvirtide together with certain medicines or products may cause serious side effects.
How should I use enfuvirtide?
Enfuvirtide is given by injection (a shot). The drug comes as a powder that is mixed with sterile water to give as an injection. The enfuvirtide powder, sterile water, and everything else needed to give the injection come in a convenience kit. The kit includes:
- 60 vials of enfuvirtide powder. Each vial contains 108 mg of enfuvirtide powder.
- 60 vials of sterile water.
- 60 syringes for mixing.
- 60 syringes for injecting.
- Instructions for mixing and injecting enfuvirtide ("Instructions for Use").
- and patient information about enfuvirtide.
Use enfuvirtide exactly as your health care provider tells you to.
See the “Instructions for Use” that come with the enfuvirtide kit for step-by-step instructions on how to properly mix and inject enfuvirtide and dispose of used needles and syringes. Your health care provider should teach you how to prepare and inject enfuvirtide before you inject it for the first time. Do not use enfuvirtide until you have learned how to inject enfuvirtide the right way.
- Inject enfuvirtide under the skin of your stomach, outer thigh, or upper arm.
- Change your injection site with each injection.
- Do not inject enfuvirtide into areas with scars, moles, bruises, tattoos, burns, blood vessels, or within 2 inches of your belly button.
Always use enfuvirtide in combination with other HIV medicines.
If you have injected too much enfuvirtide, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.
For more information on how to use enfuvirtide, see the FDA drug label.
What should I do if I forget a dose?
If you miss aof enfuvirtide, inject the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just inject your next dose at the regular time. Do not inject two doses at the same time to make up for a missed dose.
What side effects can enfuvirtide cause?
Enfuvirtide may cause side effects. Some side effects of enfuvirtide can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.
Other possible side effects of enfuvirtide include:
- Mild to moderate injection site reactions, including itching, swelling, redness, pain or discomfort, rash, bruising, hardened skin, or bumps. If the injection site reaction is severe or you have pain, redness, or swelling around the injection site that does not go away within a few days or gets worse, contact your health care provider right away.
- Nerve pain ( ) or numbness, burning, or prickling feeling of your skin ( ) that can last up to 6 months. This is likely caused by injecting enfuvirtide close to large nerves. (This side effect has been reported with use of the Biojector 2000 needle-free device to inject enfuvirtide.)
- Bruising and/or collection of blood under the skin. (This side effect has also been reported with use of the Biojector 2000 needle-free device.)
- Bleeding after your injection. People who take medicines that affect blood clotting (anticoagulants) or people with or other blood clotting problems may have a higher risk.
- Changes in your (called or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of enfuvirtide. To learn more about possible side effects of enfuvirtide, read the drug label or package insert or talk to your health care provider or pharmacist.
You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.
How should enfuvirtide be stored?
- Store unmixed enfuvirtide powder vials at room temperature, 68°F to 77°F (20°C to 25°C).
- Store the mixed enfuvirtide solution in the original vial and keep it refrigerated at 36°F to 46°F (2°C to 8°C). Use the mixed enfuvirtide solution within 24 hours. Throw away (discard) any unused enfuvirtide solution left in the vial after 24 hours.
- Do not use enfuvirtide if the original seal on the convenience kit or any of the kit’s components are broken or missing.
- Throw away enfuvirtide or sterile water vials that are no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep enfuvirtide and all medicines out of reach of children.
Where can I find more information about enfuvirtide?
- For more information on the use of enfuvirtide in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
- This Patient Version drug summary is based on the following FDA label(s): Kit. The Patient Counseling Information section of the label includes information for people taking enfuvirtide.
- Enfuvirtide-related research studies, from .
- A list of FDA-approved HIV medicines, from HIVinfo.
Hoffman-La Roche; Genentech
Main number: 866-422-2377
Patient assistance: 877-436-3683
Last Reviewed: June 13, 2021