When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to enfuvirtide.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This injection is usually given in the upper arm, upper leg, or stomach. Do not inject it near your elbow, knee, groin, lower or inner buttocks, or into your navel (belly button) or any skin where you have a mole, scar, bruise, tattoo, or burn.
• Use a new needle, syringe, and vial of medicine each time you inject your medicine.
• This medicine comes as a powder that must be mixed with sterile water. Use only the sterile water that came with your medicine to prepare the mixture.
• Do not shake the medicine after you add the water. Gently tap the vial for 10 seconds and then roll it between your hands to mix.
• Wait until the powder has completely dissolved before you inject it. The mixture should be clear and colorless and should not have any bubbles in it. This may take up to 45 minutes.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the powdered medicine at room temperature, away from heat, moisture, and direct light. After you mix the powder with the sterile water, you may use the mixture right away or store it in the refrigerator for up to 24 hours. Do not store the mixture in the syringe. If you use a mixture that has been in the refrigerator, let it slowly return to room temperature before you inject it.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how enfuvirtide works. Tell your doctor if you are using a blood thinner.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have bleeding problems (including hemophilia).
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may increase your risk of pneumonia. Tell your doctor if you smoke or have a history of lung disease.
• Almost everyone who uses this medicine has a reaction at the injection site, such as itching or swelling. Call your doctor if you have a severe reaction or a reaction that worries you. Call your doctor if the reaction does not get better within 7 days. Do not inject a new dose into a skin area that still has a reaction.
• Your immune system may get stronger when you start taking HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• This medicine will not keep you from giving HIV to others. Always practice safe sex, even if your partner also has HIV. Do not share needles or other items that may have blood or body fluids on them.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blood in your urine
• Chest pain, coughing, fever, trouble breathing
• Fever with vomiting and skin rash
• Pus or oozing where the shot was given, or skin swelling, redness, heat, or pain that gets worse
• Shooting nerve pain and tingling or severe bruises (when Biojector 2000 is used)

If you notice these less serious side effects, talk with your doctor:

• Mild itching, swelling, redness, or hardness where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088