Enfuvirtide is an antiviral medication that prevents human immunodeficiency virus (HIV) from infecting healthy cells in your body.

Enfuvirtide is used together with other medications to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Enfuvirtide is not a cure for HIV or AIDS.

Enfuvirtide may also be used for purposes not listed in this medication guide.

Some people using enfuvirtide have developed pneumonia. It is not clear whether enfuvirtide is the cause of pneumonia, but using this medicine may increase your risk. You may also be more likely to have pneumonia if you smoke, if you've ever had lung disease, or if you have a history of intravenous (IV) drug use.

Call your doctor if you have a fever, chills, cough with mucus, chest pain, of shortness of breath.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Enfuvirtide must be given in combination with other antiviral medications and it should not be used alone.

Enfuvirtide is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use enfuvirtide if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Enfuvirtide must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine. Do not shake the mixed medicine or it may foam.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Do not mix enfuvirtide with other medications in the same syringe.

Your care provider will show you where on your body to inject enfuvirtide. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses may increase the risk of your virus becoming resistant to medication.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

You will need frequent medical tests.

Store unmixed enfuvirtide powder in the refrigerator, or at room temperature away from moisture and heat.

Store the diluent at room temperature.

Store mixed medicine in the refrigerator and use it within 24 hours. Do not freeze.

Each single-use vial (bottle) of this medicine is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for HIV Infection:

90 mg subcutaneously twice daily administered into the upper arm, abdomen, or anterior thigh

Usual Pediatric Dose for HIV Infection:

6 years through 16 years: 2 mg/kg subcutaneously twice daily administered into the upper arm, abdomen, or anterior thigh
Maximum dose: 90 mg subcutaneously twice daily

17 years or older: 90 mg subcutaneously twice daily administered into the upper arm, abdomen, or anterior thigh

You should not use enfuvirtide if you are allergic to it.

Tell your doctor if you have ever had:

• breathing problems; or

• a bleeding or blood clotting disorder such as hemophilia.

Having HIV makes it easier for you to get other infections. Some people using enfuvirtide have developed pneumonia. It is not clear whether enfuvirtide is the cause of pneumonia, but using enfuvirtide may increase your risk. You may also be more likely to have pneumonia if you smoke, if you've ever had lung disease, or if you have a history of intravenous (IV) drug use.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Enfuvirtide is not approved for use by anyone younger than 6 years old.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid injecting enfuvirtide near your elbow, knee, groin, navel, or buttocks. Do not inject into moles, scars, tattoos, burns, bruises, or skin that is not otherwise healthy.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have signs of an allergic reaction: skin rash or hives; fever with vomiting; blood in your urine; difficulty breathing; fainting; swelling of your feet, face, lips, tongue, or throat.

Enfuvirtide may cause serious side effects. Call your doctor at once if you have:

• shortness of breath;

• fever, chills, chest congestion, cough with yellow or green mucus, stabbing chest pain, wheezing;

• fever with vomiting and skin rash;

• severe pain in your upper stomach spreading to your back, nausea and vomiting;

• blood in your urine;

• swelling in your feet;

• a skin reaction (itching, redness, swelling, pain, or a hard lump) where the medicine is injected; or

• pain, warmth, oozing, or redness where an injection was given, especially if these symptoms get worse or last longer than 7 days.

Enfuvirtide affects your immune system, which may cause certain side effects (even weeks or months after you've taken enfuvirtide). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of enfuvirtide may include:

• nausea, loss of appetite, constipation, diarrhea;

• numbness or pain in your legs or feet;

• muscle pain or weakness;

• depressed mood;

• swollen glands, runny or stuffy nose;

• weight loss;

• tiredness, trouble sleeping, tired; or

• pain, swelling, burning, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• a blood thinner--warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may affect enfuvirtide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.