IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ENFUVIRTIDE - INJECTION

(en-FEW-ver-tide)

COMMON BRAND NAME(S): Fuzeon

USES: This medication is used in combination with other anti-HIV drugs to treat HIV (Human Immunodeficiency Virus) infection. It works by blocking the HIV virus' ability to infect healthy immune cells (CD4 cells). This medication does not cure HIV. Patients treated with this medication may continue to acquire "opportunistic" infections associated with HIV. This product also does not prevent the spread of HIV to others through sexual contact, blood, or sharing of needles.

HOW TO USE: Learn how to prepare and inject this drug and review the patient information leaflet and the injection instructions leaflet. If any of the information is unclear, consult your doctor or pharmacist. Inject this medication under the skin (subcutaneously) usually twice daily into the upper arm, thigh, or abdomen. Rotate injection sites with each shot. Do not inject in or near bumps from past injections. Also, do not inject into moles, scars, bruises, or your belly button. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist. It is very important to continue using this medication (and other anti-HIV medications) exactly as prescribed by your doctor. Do not skip any doses. If you have a very serious allergic reaction to enfuvirtide, do not use it again (see Side Effects section).

SIDE EFFECTS: Pain, redness, itching, bruising, hardened skin, or bumps at the injection site may occur. These types of reactions are common and may last up to 7 days. Runny nose may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these serious side effects occur: anxiety, muscle pain, signs of injection site infection (such as oozing, warmth, persistent pain and redness). Tell your doctor immediately if any of these unlikely but serious side effects occur: abdominal pain, loss of appetite, cough with fever, rapid breathing, shortness of breath. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing, fever, chills, nausea/vomiting. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist your medical history, especially of: smoking, IV drug abuse, lung disease, any allergies. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

DRUG INTERACTIONS: Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., blood test, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is within 2 hours of the next dose, skip the missed dose and resume your usual dosing schedule. It is important not to miss doses of this drug.

STORAGE: Store unmixed drug at room temperature at 77 degrees F (25 degrees C). Brief storage between 59 and 86 degrees F (15-30 degrees C) is permitted. Inject the mixed drug immediately. If you are unable to use it right away, the mixed drug should be refrigerated between 36 and 46 degrees F (2-8 degrees C) and used within 24 hours. Discard any unused medication after the expiration date. Do not store in the bathroom. Keep all medicines away from children and pets.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854- 1166 (USA) or 1-800-668-1507 (Canada).

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Copyright 2004 by First DataBank, Inc.