Enfuvirtide, Injection

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KEY POINTS

• This medicine is given by injection to treat HIV infection. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antiretroviral (anti-HIV)

Generic and brand names: enfuvirtide, injection; Fuzeon; 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.

This medicine may be used to treat other conditions as determined by your healthcare provider.

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 healthcare provider if you take any medicine to treat or prevent blood clots, such as warfarin (Coumadin).

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?

Check the label on the medicine for directions about your specific dose. Be sure you know when to take the medicine and how much medicine you should take. Carefully follow the instructions that come in the medicine package for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children under age 6.

You can give yourself these shots or have someone at home give them to you. Your healthcare provider will teach you how to use this medicine at home. 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. Use a different area each time you give yourself a shot.

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.

Before using the medicine, make sure the solution is clear, colorless, and without bubbles

Discard the needles as instructed by your healthcare provider. Use each needle only once. Throw them away after use in rigid puncture-resistant containers with lids or caps, such as heavy plastic bleach bottles with screw caps. Do not throw them directly into garbage cans or dumpsters.

What if I miss a dose?

Try not to miss a shot. 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?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222

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. These reactions are usually mild to moderate, but occasionally may be severe. Talk with your healthcare provider about this and ways to lessen your discomfort.

When you start taking this medicine, your immune system may get stronger and could begin to fight infections that have been hidden in your body, such as pneumonia or tuberculosis. If you have new symptoms after starting your medicine, contact your healthcare provider right away.

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, fast breathing 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, lab tests, 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 cannot 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, fast or trouble breathing (possible signs of bacterial pneumonia); blood in urine; chest pain; swelling of your feet; depression; sudden or severe stomach pain; severe nausea or vomiting; numbness or tingling that won't go away; oozing, swelling, redness, heat, and pain at the injection site.

Other: Diarrhea, mild nausea, tiredness, trouble sleeping, weakness, loss of appetite, weight loss, 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) and sterile water at room temperature. If the powdered medicine cannot be kept at room temperature, it may be kept in the refrigerator. Protect it from heat and bright light.

After mixing the medicine with sterile water, use the medicine right away or store it in the refrigerator for up to 24 hours. Discard any unused mixed medicine after 24 hours. Do not store mixed solutions in syringes.

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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.