Enfuvirtide Solution for injection

What is this medicine?

ENFUVIRTIDE (en FYOO vir tide) is an antiretroviral drug. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. It will not stop the spread of HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• lung or breathing disease, like asthma

• take medicines that treat or prevent blood clots

• an unusual or allergic reaction to enfuvirtide, mannitol, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin or into a muscle. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

This medicine causes injection site reactions. The reactions are usually mild to moderate, but can be severe. They usually happen within the first week of using the medicine and happen again as you keep using it. Each injection site reaction usually does not last longer than 7 days. The reactions may be worse when injections are given in the same place on the body or when the injection is given deeper than it should be (for example, into the muscle). Sometimes an injection site can get infected. Be sure to follow the instructions you get with this medicine. Following the instructions may help to lower your chance of getting an infection.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• an injections site reaction that is severe, infected, or in any way worrisome to you

• breathing problems

• cough

• fever or chills

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• depressed mood

• constipation

• difficulty sleeping

• mild or moderate injection site reaction, like bumps, hardened skin, or itching

• muscle pain or weakness

• pain or numbness in the feet or legs

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store the vials of medicine and the vials of water that have not been mixed at room temperature, between 15 and 30 degrees C (59 and 86 degrees F). After the medicine and water have been mixed together, you can store the vial in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F) for up to 24 hours. Throw away any unused medicine after the expiration date.