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enfuvirtide (cont.)

What should I discuss with my healthcare provider before using enfuvirtide (Fuzeon)?

You should not use this medication if you are allergic to enfuvirtide.

To make sure you can safely use enfuvirtide, tell your doctor if you have any of these other conditions:

  • a bleeding or blood clotting disorder such as hemophilia; or
  • a history of breathing problems.

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

FDA pregnancy category B. Enfuvirtide is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

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.

Do not give this medicine to a child younger than 6 years old without medical advice.

How should I use enfuvirtide (Fuzeon)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use enfuvirtide as your only medication to treat HIV. Enfuvirtide must be used in combination with other HIV medications. Your disease may become resistant to enfuvirtide if you do not use it in combination with other medicines your doctor has prescribed.

Enfuvirtide is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Enfuvirtide is usually injected twice a day. Follow your doctor's instructions.

Enfuvirtide is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

After mixing the powder and the liquid, gently tap the vial for 10 seconds and then slowly roll it between your hands. Let the vial stand until the powder completely dissolves (up to 45 minutes). If the mixture is foamy or gel-like, allow more time for it to dissolve.

Do not shake the mixed medicine or it may foam. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

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

Use a different place on your stomach, thigh, or upper arm each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Carefully follow all instructions about giving yourself an enfuvirtide injection. Most people using this medication have a skin reaction (itching, redness, swelling, pain, bruising, tenderness) where the medicine is injected. Your caregivers can tell you what type of skin reactions are serious and when to call your doctor.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

Use enfuvirtide regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store unmixed enfuvirtide powder and the liquid diluent separately at room temperature away from moisture and heat.

You may also store unmixed enfuvirtide powder in the refrigerator, do not freeze.

After mixing enfuvirtide with a diluent, store in the refrigerator and use it within 24 hours. Do not freeze.

You may take the mixed medicine out of the refrigerator and allow it to reach room temperature before giving the injection. Do not heat the medicine before using.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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