Drug Database: Enfuvirtide

What is enfuvirtide?What is enfuvirtide?

What is enfuvirtide?

Enfuvirtide (brand name: Fuzeon) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection 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.

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 with HIV.

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.

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 transmission. 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 taking enfuvirtide?What should I tell my health care provider before taking enfuvirtide?

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 ever had lung problems.
• If you have a low CD4 count.
• If you smoke or use intravenous (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 During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States. Note that the enfuvirtide drug section of the Perinatal HIV Guidelines is no longer being reviewed or updated.
• If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
• If you are using hormone-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 HIV and Birth Control infographic.
• 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?How should I use enfuvirtide?

How should I use enfuvirtide?

Enfuvirtide comes as single-dose vials of powder for injection. Each vial contains 108 mg of enfuvirtide powder. Enfuvirtide is packaged in a monthly convenience kit that contains 60 vials of enfuvirtide powder and supplies needed to prepare each dose of enfuvirtide.

Use enfuvirtide exactly as your health care provider tells you to. Do not miss a dose of enfuvirtide, and do not change your dose or stop using enfuvirtide without first talking with your health care provider.

Enfuvirtide is given by subcutaneous injection only. Never inject enfuvirtide directly into a vein or muscle. See the “Instructions for Use” that come with the enfuvirtide kit for step-by-step instructions on how to properly mix enfuvirtide powder with sterile water, 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 or online) 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?What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of 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?What side effects can enfuvirtide cause?

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 (neuralgia) or numbness, burning, or prickling feeling of your skin (paresthesia) 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 hemophilia or other blood clotting problems may have a higher risk.
• Changes in your immune system (called immune reconstitution inflammatory syndrome 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?How should enfuvirtide be stored?

How should enfuvirtide be stored?

• Store vials of unmixed enfuvirtide powder 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. For information on disposing of needles and other sharps, please refer to these guidelines or ask your health care provider or pharmacist.
• Keep enfuvirtide and all medicines out of reach of children.

Where can I find more information about enfuvirtide?Where can I find more information about enfuvirtide?

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 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 (injection). The Patient Package Insert and Instructions For Use include information for people taking enfuvirtide.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for enfuvirtide injection available from MedlinePlus.
• Enfuvirtide-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)
• A list of FDA-approved HIV medicines, from HIVinfo.