Enfuvirtide, Injection en-FYOO-vir-tide

What are other names for this medicine?

Type of medicine: antiretroviral (anti-HIV)

Generic and brand names: enfuvirtide, injection; Fuzeon Injection; T-20

What is this medicine used for?

This medicine is given by subcutaneous injection (a shot just under the skin) to treat HIV infection. It must be used with other anti-HIV medicines prescribed by your healthcare provider. This medicine does not cure HIV infection or AIDS.

What should my healthcare provider know before I use this medicine?

Tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• bleeding problems such as hemophilia
• pneumonia or other lung disease
• problems with substance abuse, especially IV drugs

Also tell your provider if you smoke. Smoking increases your risk of developing serious side effects while taking this medicine.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant while receiving this treatment. If you become pregnant during treatment, contact your healthcare provider right away. Do not breast-feed during this treatment without your healthcare provider's approval.

How do I use it?

The shots are given just under the skin. Do not inject into your veins or into your muscles. Do not inject this medicine into the following areas: near the elbow, knee, groin, lower or inner buttocks, directly over a blood vessel, around the belly button, or into a scar, bruise, mole, or tattoo.

You can give yourself these shots or have someone at home give them to you. Check the label on the medicine for directions about your specific dose. Be sure you know how to prepare the medicine, when to have shots, and how much medicine to use. Read and follow the patient instruction leaflet that comes in the medicine package.

Before injecting the medicine, check the medicine for any floating particles, foam, or bubbles. If the medicine is not clear, do not inject it. Do not mix any other medicines in the same syringe with this medicine.

Wash your hands before using this medicine. Follow these steps to give yourself the shots:

1. Your healthcare provider will tell you where you can give yourself the shots (abdomen, thigh, upper arm, or other sites). If you are giving the shot in your abdomen, choose a site away from the belly button. Each day, choose a different spot for the shot to lessen irritation.
2. Use an alcohol swab to clean the skin where you will give yourself the shot.
3. Gently pinch up the skin and insert the needle into the skin at a 45° angle. After you insert the needle three-quarters of the way in, release your grasp of the skin.
4. Inject all of the solution by gently and steadily pushing down the plunger.
5. The needle will automatically pull out of the skin and spring back into the syringe when you have pushed the plunger all the way into the syringe. This prevents accidental needlesticks and the risk of infecting others.
6. After you have given yourself the shot, withdraw the needle and syringe and press an alcohol swab on the spot where the shot was given. Cover the injection site with a small strip bandage.
7. Discard the syringe, needle, and drug vial. Use the syringes and needles ONLY ONCE. Throw them away after use. Put used needles in rigid puncture-resistant containers with lids or caps (sharps container). DO NOT throw needles directly into garbage cans or dumpsters.

If you are not sure of how to give yourself the shots, ask your healthcare provider or pharmacist for help.

Do not stop these injections or change the dosage unless your healthcare provider approves. You must have regular injections (twice a day) every day in order for this medicine to be effective. The amount of virus in your blood may increase if this medicine is stopped for even a short time.

What if I miss a dose?

If you miss a shot, give it as soon as you remember unless it is almost time for the next scheduled shot. In that case, skip the missed shot and give the next one as directed. Do not use a double dose. If you are not sure of what to do if you miss a shot, or if you miss more than one shot, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This treatment does not lower the risk of spreading the infection to others by unprotected sex, sharing needles, or exposure to HIV infected blood.

This medicine is likely to cause redness, swelling, pain, itching, or other reactions at the injection site that lasts for up to 7 days. Talk with your healthcare provider about ways to lessen your discomfort.

You may need to have lab tests to determine how the medicine is affecting you. Keep all appointments for these tests.

Contact your healthcare provider right away if you develop a cough, fever, or trouble breathing. These may be symptoms of bacterial pneumonia.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert and clearheaded.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you are unable to reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives, itching, rash, tightness in your chest, swelling of your lips, tongue or throat, trouble breathing)

Serious (report these to your healthcare provider right away: Cough, fever, or fever with vomiting and skin rash, trouble breathing (possible signs of bacterial pneumonia); blood in urine; swelling of your feet; depression; oozing, swelling, redness, heat, and pain at the injection site.

Other: Diarrhea, nausea, tiredness, trouble sleeping, weakness, loss of appetite, constipation, muscle pain, tingling or numbness in feet or hands, bumps or hardened skin at injection site, stuffy nose.

What products might interact with this medicine?

No significant interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store vials of the powdered medicine (before mixing) at room temperature or in the refrigerator. Protect it from heat and bright light.

After mixing the medicine with sterile water, it must be used within 24 hours. Do not store mixed solutions in syringes.

Dispose of used syringes in a sharps container.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.