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General Information

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IMPORTANT NOTICE:

Enfuviritide injection has been discontinued in the US. Because this drug is no longer available in the US market, the material in this monograph is no longer updated If this drug is used in countries other than the U. S., it is essential that the manufacturers' labeling be consulted for more recently available information.

Use

WHY is this medicine prescribed?

Enfuvirtide injection is used along with other medications to treat human immunodeficiency virus (HIV) infection in adults and children who weigh at least 24 pounds (11 kg) who have been treated with several other HIV medications in the past and whose HIV could not be successfully be treated with other medications, including their current therapy. Enfuvirtide is in a class of medications called HIV entry and fusion inhibitors. It works by decreasing the amount of HIV in the blood. Although enfuvirtide does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other life-style changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

HOW should this medicine be used?

Enfuvirtide injection comes as a powder to be mixed with sterile water and injected subcutaneously (under the skin). It is usually injected twice a day. To help you remember to inject enfuvirtide, inject it at about the same times each day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use enfuvirtide injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Enfuvirtide injection controls HIV but does not cure it. Continue to use enfuvirtide injection even if you feel well. Do not stop using enfuvirtide injection without talking to your doctor. If you miss doses or stop using enfuvirtide injection, your condition may become more difficult to treat.

Your doctor or nurse will show you or a caregiver how to mix and inject a dose of enfuvirtide injection at home. Before you use enfuvirtide injection for the first time, you and the person who will be giving the injections should read the manufacturer's information for the patient that comes with it. These instructions describe how to mix and inject a dose of enfuvirtide. Be sure that you understand these directions. Ask your healthcare provider if you have any questions about when you should use the medication, where on your body you should inject the medication, how to give the injection, or what type of syringe and needle to use.

You can inject enfuvirtide anywhere in the front of your thighs or in your lower stomach except for the 2-inch (5-centimeter) area around the navel (belly button). If someone else is giving you the injection, it can be injected into the outer area of your upper arms. Do not inject enfuvirtide in any area directly under a belt or waistband; near the elbow, knee, groin, the lower or inner buttocks; or directly over a blood vessel. To reduce the chances of soreness, choose a different area for each injection. Keep track of the areas where you inject enfuvirtide, and do not give an injection into the same area two times in a row. Use your fingertips to check your chosen area for hard bumps under the skin. Do not inject enfuvirtide into an area of skin that has a tattoo, scar, bruise, mole, a burn site, or has had a reaction to a previous injection of enfuvirtide.

Never reuse needles, syringes, vials of enfuvirtide, or vials of sterile water. Dispose of used needles and syringes in a puncture-resistant container. Do not put them in a trash can. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container. Ask your doctor how to dispose of used alcohol pads and vials.

Before preparing an enfuvirtide dose, wash your hands with soap and water. After you wash your hands, do not touch anything except the medication, supplies, and the area where you will inject the medication.

Ask your pharmacist or doctor for a copy of the manufacturer's injection information for the patient. Carefully read the manufacturer's instructions to learn how to prepare and inject your dose. Ask your doctor or pharmacist if you have questions about how to inject enfuvirtide.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special

What SPECIAL PRECAUTIONS should I follow?

Before using enfuvirtide,

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Inject the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

Side Effects

What SIDE EFFECTS can this medicine cause?

Enfuvirtide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical help:

Enfuvirtide may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Overdose

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Storage

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication and the sterile water that comes with it in the containers they came in, tightly closed, and out of reach of children. Store them at room temperature and away from excess heat and moisture (not in the bathroom). If they cannot be stored at room temperature, put them in the refrigerator. If you mix the medication and sterile water in advance, store the mixture in the vial in the refrigerator for up to 24 hours. Never store mixed medication in the syringe.

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

Miscellaneous

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to enfuvirtide injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using enfuvirtide injection.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS® Patient Medication Information Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 15, 2025.