Brand Name: Fuzeon Other Names: T20 Drug Class: Fusion Inhibitor

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What are the most important things to know about enfuvirtide?

What are the most important things to know about enfuvirtide?

Enfuvirtide must be given as an injection (a shot). Almost all people taking the medicine have a reaction at the location where the shot is given (called an injection site reaction). Injection site reactions with enfuvirtide are usually mild to moderate but occasionally can be severe. Reactions on the skin where enfuvirtide is injected include:

  • Itching
  • Swelling
  • Redness
  • Pain or discomfort
  • Rash
  • Bruising
  • Hardened skin
  • Bumps

Contact your health care provider right away if you have signs of infection at an injection site (swelling, redness, or pain).

Enfuvirtide can cause serious side effects. These include severe allergic reaction and possibly pneumonia.

Contact your health care provider right away if you have any of the following symptoms, alone or in combination, that could be signs of a severe allergic reaction:
  • Rash
  • Fever
  • Chills
  • Trouble breathing
  • Hives
  • Nausea and vomiting
  • Swelling of your face, eyes, lips, or mouth
  • Low blood pressure
Contact your health care provider right away if you have any of the following symptoms that could be signs of pneumonia:
  • 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?

What is enfuvirtide?

Enfuvirtide is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in people whose infection is not well controlled by ongoing treatment with other HIV medicines. It is not known if enfuvirtide is safe and effective for use in children under 6 years of age.

Enfuvirtide belongs to a group of HIV drugs called fusion inhibitors. Fusion inhibitors block HIV from getting into and infecting certain cells of the immune system. This prevents HIV from multiplying and can reduce the amount of HIV in the body.

HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV treatment regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission.

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

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

Before taking 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 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 taking enfuvirtide during pregnancy.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking enfuvirtide.
  • 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 AIDSinfo 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 take enfuvirtide?

How should I take enfuvirtide?

Enfuvirtide can only be 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.
  • Patient information about enfuvirtide.

Take enfuvirtide according to your health care provider’s instructions. You or your caregiver should be trained by a health care provider before injecting enfuvirtide. Your health care provider should show you how to prepare and inject enfuvirtide before you inject it for the first time. Do not use enfuvirtide until you have been shown how to inject enfuvirtide the right way.

Mixing enfuvirtide
  • Use the syringes provided to prepare enfuvirtide for injection. Do not use the same syringe to both mix and inject enfuvirtide. Do not mix other medicines in the same syringe with enfuvirtide. If enfuvirtide is foamy or jelled after mixing, give it more time to dissolve. Do not inject enfuvirtide if you see particles floating in the vial after the medicine has been mixed.
Injecting enfuvirtide
  • Inject enfuvirtide under the skin in the upper arm, outer thigh, or stomach two times a day. Do not inject enfuvirtide in the same area as you did the time before. Do not inject enfuvirtide into the following areas: near the elbow, knee, groin, or lower or inner buttocks; directly over a blood vessel; around the belly button; into scar tissue, a bruise, a mole, a surgical scar, a tattoo, or a burn site; or where there is a reaction at an injection site.
  • After injecting enfuvirtide, safely dispose of the used syringes in a special container called a sharps container. Your health care provider or pharmacist can give you a sharps container. Do not place used syringes in a trash can.

Always take enfuvirtide in combination with other HIV medicines.

If you take 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 take enfuvirtide, see the FDA drug label.

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, take 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 take your next dose at the regular time. Do not take 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?

Enfuvirtide may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.

Some side effects of enfuvirtide can be serious. Serious side effects of enfuvirtide include infection at the injection site, severe allergic reaction, and possibly pneumonia. (See section above: What are the most important things to know about enfuvirtide?)

Other possible side effects of enfuvirtide include:

  • 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 signs of infection (swelling, redness, or pain), contact your health care provider right away.
  • Nerve pain (neuralgia) or numbness, burning, or prickling feeling of your skin (paresthesia) that lasts up to 6 months. This is likely caused by injecting enfuvirtide close to large nerves or near joints. (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.)
  • 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?

  • Store unmixed enfuvirtide powder vials at room temperature, 68°F to 77°F (20°C to 25°C). If you cannot store unmixed enfuvirtide powder at room temperature, keep it refrigerated, 36°F to 46°F (2°C to 8°C).
  • Store the sterile water 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.
  • Do not use enfuvirtide or sterile water after the expiration date on the vials. 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?

Where can I find more information about enfuvirtide?

More information about enfuvirtide is available:

Manufacturer Information

Hoffman-La Roche; Genentech
Main number: 866-422-2377
Patient assistance: 877-436-3683

The above Patient Version drug summary is based on the following FDA label(s): Kit.

Last Reviewed: June 27, 2019