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Drug Information: Enfuvirtide Injection

Why is this medication prescribed?

Enfuvirtide is used in combination with other medications to treat human immunodeficiency virus (HIV) infection in patients who have not responded well enough to other antiviral medications. Enfuvirtide is in a class of medications called HIV fusion inhibitors. It works by stopping HIV from entering healthy cells. Enfuvirtide does not cure HIV and may not prevent you from developing HIV related illnesses. Enfuvirtide does not prevent the spread of HIV to other people.

How should this medicine be used?

Enfuvirtide comes as a powder to be mixed with sterile water and injected subcutaneously (under the skin). It is usually injected twice a day. To help you remember to inject enfuvirtide, inject it at about the same times each day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use enfuvirtide exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Enfuvirtide controls HIV but does not cure it. Continue to use enfuvirtide even if you feel well. Do not stop using enfuvirtide without talking to your doctor. If you miss doses or stop using enfuvirtide, your condition may become more difficult to treat.

You will receive your first dose of enfuvirtide in your doctor's office. After that, you can inject enfuvirtide yourself or have a friend or relative perform the injections. Your doctor will train the person who will be injecting the medication, and will test him to be sure he can give the injection correctly. Be sure that you and the person who will be giving the injections read the manufacturer's information for the patient that comes with enfuvirtide before you use it for the first time at home.

You can inject enfuvirtide anywhere on your thighs, stomach, or upper arms except your navel (belly button) and any area directly under a belt or waistband. To reduce the chances of soreness or redness, choose a different area for each injection. Use your fingertips to check your chosen area for hard bumps under the skin. Never inject enfuvirtide into any skin that has a scar, bruise, mole, or reaction to a previous injection of enfuvirtide.

Never reuse needles, syringes, vials of enfuvirtide, or vials of sterile water. Dispose of used needles and syringes in a puncture-resistant container. You can dispose of used alcohol pads and vials in the trash, but if you see blood on an alcohol pad, put it in the puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Before preparing an enfuvirtide dose, wash your hands with soap and water. After you wash your hands, do not touch anything except the medication, supplies, and the area where you will inject the medication.

To prepare and inject enfuvirtide, follow these steps:

• Open the packages of one 3-mL (large) syringe and one 1-mL (small) syringe and remove the caps from one vial of enfuvirtide and one vial of sterile water. Throw away the packages and caps.
• Wipe each vial top with a new alcohol pad and allow to air dry. Be careful not to touch the tops of the vials after you clean them. If you do touch the tops, clean them again with a new alcohol pad.
• Gently tap the enfuvirtide vial to loosen the powder.
• Slowly pull back the plunger of the 3-mL syringe to the 1.1 mL mark. Be careful not to push the plunger past the 0.2 mL mark.
• Insert the needle into the sterile water vial and slowly inject the air into the vial. Do not remove the needle from the vial.
• Turn the vial upside down and check to be sure the needle tip is below the surface of the water. Slowly pull the plunger back to the 1.1 mL mark. The syringe should fill with 1.1 mL of water.
• Check the syringe for air bubbles. Gently tap the syringe and push and pull the plunger to remove air bubbles. You may need to pull the plunger back further to get the full amount of water.
• When you are certain that the syringe contains 1.1 mL of water and no air bubbles, carefully remove the needle from the vial.
• Insert the needle of the syringe you have just filled into the enfuvirtide vial at an angle.
• Push down the plunger slowly to inject the sterile water into the vial. The water should drip down the side of the vial onto the powder.
• Remove the needle from the vial and push the plunger all the way down with the tip of your thumb until you hear a snap. The needle will spring back into the syringe. Dispose of the syringe properly.
• Tap the enfuvirtide vial gently with your fingertip for 10 seconds. Then roll it between your hands for a short while, but do not shake it. Be sure there is no powder stuck to the walls of the vial.
• If you are not ready to inject the medication, you may write the date and time you mixed the medication on the vial and place the vial in the refrigerator at this point. You may store the mixed medication in the refrigerator for up to 24 hours. Allow the medication to warm to room temperature and be sure that it is clear before you use it.
• If you are ready to inject the medication, leave the vial upright on a flat surface and wait for the powder to dissolve. This may take up to 45 minutes. You will know the powder has dissolved when the vial is clear and not foamy. If there are small bubbles in the vial, tap the vial gently until they disappear. If there are particles in the vial, do not use the vial, and call the pharmacy that provided it.
• Rub a new alcohol pad over the place where you will inject enfuvirtide using pressure and a circular motion. Allow the area to air dry.
• Clean the vial top again with a new alcohol pad and allow it to air dry.
• Pull back the plunger on the 1-mL syringe to the 1-mL mark. Be careful not to push it past the 0.05 mL mark.
• Insert the needle into the enfuvirtide vial and slowly push down the plunger to inject air. Do not remove the needle from the vial.
• Turn the vial upside down and check to be sure the needle is below the surface of the liquid. Slowly pull back the plunger to the 1 mL mark. The syringe should fill with 1mL of liquid.
• Check the syringe for air bubbles. Gently tap the syringe and push and pull the plunger to remove air bubbles. You may need to pull the plunger back further to get the full amount of liquid.
• When you are certain that the syringe contains 1 mL of liquid and no air bubbles, carefully remove the needle and syringe from the vial.
• Pinch and hold a fold of skin around the cleaned area where you will inject enfuvirtide. With your other hand, hold the needle like a pencil at a 45 degree angle.
• Push the needle into your skin until 3/4 of the needle is under the skin.
• Use your thumb to push the plunger down as far as it will go. The needle should pull out of your skin and spring back into the syringe when you do this. If it does not, pull the needle out of your skin and push the plunger down until the needle goes into the syringe.
• Dispose of the needle properly and cover the spot where you injected enfuvirtide with a small bandage if you see any blood or medication on your skin.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before using enfuvirtide,

• tell your doctor and pharmacist if you are allergic to enfuvirtide or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking.
• tell your doctor if you smoke, if you use or have ever used intravenous (injected into the vein) street drugs and if you have or have ever had kidney or lung disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking enfuvirtide, call your doctor. You should not breastfeed if you are infected with HIVor if you are taking enfuvirtide.
• you should know that enfuvirtide may make you dizzy. Do not drive a car or operate machinery until you know how this medication affects you.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Inject the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

What side effects can this medication cause?

Enfuvirtide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• itching, swelling, pain, tenderness, redness, purple patches, hard skin, or bumps in the place where you injected enfuvirtide
• itching anywhere on the body
• difficulty falling or staying asleep
• depression
• nervousness
• weakness
• muscle pain
• loss of appetite
• changes in ability to taste food
• weight loss
• constipation
• flu-like symptoms
• warts or cold sores
• swollen glands

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• severe pain, oozing, swelling, heat, or increasing redness in the place you injected enfuvirtide
• cough
• fever
• fast breathing
• shortness of breath
• vomiting
• rash
• blood in urine
• swollen feet
• pale or fatty stools
• yellowing of skin or eyes
• dizziness
• fainting
• blurred vision
• pain or tingling in toes that spreads to legs
• numbness in any part of the body
• pain in hands or arms
• painful, red, or teary eyes

Enfuvirtide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication and the sterile water that comes with it in the containers they came in, tightly closed, and out of reach of children. Store them at room temperature and away from excess heat and moisture (not in the bathroom). If you mix the medication and sterile water in advance, store the mixture in the vial in the refrigerator for up to 24 hours. Never store mixed medication in the syringe. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to enfuvirtide.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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