WARNING:
Enfuvirtide causes injection site reactions. Almost all people get injection site reactions with enfuvirtide, which usually are mild to moderate but occasionally can be severe. Reactions on the skin where enfuvirtide is injected include:
- Itching.
- Swelling.
- Redness.
- Pain or tenderness.
- Hardened skin.
- Bumps.
Contact your health care provider right away if you have signs of infection at an injection site (oozing, increasing heat, swelling, redness, and 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 that may signal severe allergic reaction:
- Trouble breathing.
- Fever with vomiting and a skin rash.
- Blood in the urine.
- Swelling of the feet.
Contact your health care provider right away if you have any of the following symptoms that may signal pneumonia:
- Cough.
- Fever.
- Trouble breathing.
While taking enfuvirtide, it is important to keep all of your appointments with your health care provider.
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 adults and children 6 years of age and older. Enfuvirtide is for people who have not responded well enough to treatment with other anti-HIV medicines. Enfuvirtide is always used in combination with other anti-HIV medicines.
Enfuvirtide is a type of anti-HIV medicine called a fusion inhibitor. Fusion inhibitors work by blocking HIV’s ability to merge with and infect healthy cells. When used with other anti-HIV medicines, enfuvirtide may lower the amount of HIV in the blood.
Enfuvirtide does not cure HIV/AIDS. It is not known if enfuvirtide reduces the risk of passing HIV to other people.
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 any other medical conditions.
- If you are pregnant or plan to become pregnant. Whether enfuvirtide can harm an unborn baby is unknown.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking enfuvirtide.
- 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.
How should I take enfuvirtide?
Enfuvirtide comes in powder form and is given as an injection (a shot). Each vial contains 108 mg of enfuvirtide powder. The enfuvirtide powder and everything needed to give the injection come in a convenience kit. The kit includes:
- 60 vials of enfuvirtide powder.
- 60 vials of sterile water for injection.
- 60 syringes for mixing.
- 60 syringes for injecting.
- Alcohol pads.
- Injection instructions.
- 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 on how to mix and inject enfuvirtide before injecting it. If you are having a hard time mixing or injecting enfuvirtide, contact your health care provider.
Enfuvirtide should be injected under the skin in the upper arm, upper leg, or stomach. 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, scar tissue, a bruise, a mole, a surgical scar, a tattoo, or a burn site; or where there is an injection site reaction.
If enfuvirtide is foamy or jelly, allow more time for it to dissolve. Do not inject enfuvirtide if you see particles floating in the vial after it has been mixed. Enfuvirtide can be taken with or without food. Do not swallow enfuvirtide; it must be injected.
Place used syringes into a special sharps container after injecting enfuvirtide. Do not place used syringes in a trash can.
Always take enfuvirtide in combination with other anti-HIV medicines.
If you take too much enfuvirtide, contact your local poison control center (1-800-222-1222) or go to the nearest hospital emergency room right away.
For more information on how to take enfuvirtide, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)
What should I do if I forget a dose?
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?
Enfuvirtide can cause serious side effects. These include severe allergic reaction and possibly pneumonia. (See the WARNING above.)
Other possible side effects of enfuvirtide include:
- Injection site reactions, including itching, swelling, redness, pain or tenderness, hardened skin, or bumps. If the injection site reaction is severe, contact your health care provider right away. If you have signs of infection at an injection site (oozing, increasing heat, swelling, redness, and pain), contact your health care provider right away.
- Shooting nerve pain or tingling that lasts up to 6 months. This is likely caused by injecting close to large nerves or near joints. (Reported with use of the Biojector 2000 needle-free device.)
- Bruising and/or collection of blood under the skin. (Reported with use of the Biojector 2000 needle-free device.)
- Changes in the immune system (immune reconstitution inflammatory syndrome).
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. Ask your health care provider or pharmacist for more information on possible side effects of enfuvirtide.
How should enfuvirtide be stored?
- Enfuvirtide vials that are not mixed with sterile water can be stored at room temperature, 59°F to 86°F (15°C to 30°C).
- The sterile water can be stored at room temperature, 59°F to 86°F (15°C to 30°C).
- After enfuvirtide has been mixed with sterile water, the vial can be stored in a refrigerator for up to 24 hours.
- Safely throw away enfuvirtide or sterile water that is no longer needed or expired (out of date).
- Keep enfuvirtide and all medicines out of reach of children.
Where can I find more information about enfuvirtide?
More information about enfuvirtide is available:
Manufacturer Information
Hoffman-La Roche
888-835-2555
Last Reviewed: September 13, 2012
Last Updated: September 12, 2012