ENFUVIRTIDE (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Fuzeon

Another commonly used name is T-20.

? Not commercially available in Canada.

Category

• Antiviral

Description

Enfuvirtide (en-FYOO-vir-tide) is used, in combination with other medicines,in the treatment of the infection caused by the human immunodeficiency virus(HIV). HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).

Enfuvirtide will not cure or prevent HIV infection or AIDS; however, ithelps keep HIV from reproducing and appears to slow down the destruction ofthe immune system. This may help delay the development of problems usuallyrelated to AIDS or HIV disease. Enfuvirtide will not keep you from spreadingHIV to other people. People who receive this medicine may continue to haveother problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Parenteral
• Injection (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must beweighed against the good it will do. This is a decision you and your doctorwill make. For enfuvirtide the following should be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to enfuvirtide. Also tell your doctor and pharmacistif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Enfuvirtide has not been studied in pregnant women.Enfuvirtide has not been shown to cause birth defects or other problems inanimal studies. Enfuvirtide should be used with caution in pregnant womenand should be used only if clearly needed. Discuss this with your doctor.Tell your doctor right away if you become pregnant while taking this medicine.

Breast-feeding?It is not known whether enfuvirtide passes intobreast milk. Mothers who are taking this medicine and wishto breast-feed should discuss this with their doctor.Youshould not breast-feed if you are HIV-positive because of the chance of passingthe HIV virus to your baby.

Children?This medicine has been studied in children ages6 to 16 years old and it is not expected to cause different effects than itdoes in adult patients.

Older adults?Many medicines have not been studied specificallyin older people and it may not be known if they work the same way they doin younger adults.

Other medical problems?The presence of other medical problems mayaffect the use of enfuvirtide. Make sure you tell your doctor if you haveany other medical problems, especially:

• Pneumonia risk factors, such as
• Immune system blood tests (abnormal) or
• Cigarette smoking
• Intravenous drug use or
• Lung disease (history of)?Patients with these conditions mayhave an increased chance of getting bacterial pneumonia

Proper Use of This Medicine

It is veryimportant that you read the information for patients and the injection instructionsvery carefully. Ask your healthcare professional if you have any questions.

Enfuvirtide can be given by a health care professional. However, medicinesgiven by injection are sometimes used at home. If you will be using enfuvirtideat home, your health care professional will teach you how get the medicineready for injection and how the injections are to be given. Be certain that you understand exactly how to get the medicine ready for injectionand how the medicine is to be injected. Do not reuse needles and syringes.

Put used needles and syringes in a puncture-resistantdisposable container, or dispose of them as directed by your healthcare professional.

It is important to take enfuvirtide as part of a combination treatment.Be sure to take all the medicines your doctor has prescribed for you, includingenfuvirtide.

Do not stop taking this medicine without checking with your doctor first.

This medicine may cause a severe allergic reaction in some patients. Stop taking this medicine and check with your doctor immediatelyif you notice cough; difficulty breathing; fever; skin rash; unusual tirednessor weakness.

This medicine may increase the chance of bacterial pneumonia in some patients. Stop taking this medicine and check with your doctorimmediately if you notice cough with fever; difficulty breathing; fast breathing;shortness of breath.

This medicine can cause reactions at the place on your body where it wasinjected. Almost all people get injection site reactions with enfuvirtide.These reactions hurt and itch, and they are usually mild to moderate but canoccasionally be severe. These reactions generally happen within the firstweek of treatment and usually happen again as you keep using enfuvirtide. If the injection site nodules drain pus or cause redness thatspreads or streaks from the sites, or you are worried about the reaction youare having, call your healthcare provider right away.

Dosing?The dose of enfuvirtide can be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of enfuvirtide. If your dose is different,do not change it unless your doctor tells you to do so.

Take this medicine only as directed by your doctor. Do not take more ofit and do not take it more often than your doctor ordered.

• For parenteral dosage form (injection):
  • For treatment of HIV infection:
    • Adults?90 milligrams (mg) twice a day given by injection
    • Children?Dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine, take itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store reconstituted solution (mixed with water) in the refrigeratorand use within 24 hours.
• Store medicine at room temperature
• Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check you at regularvisits.

Enfuvirtide does not reduce the risk of giving HIV to other people. Cautionshould be taken to avoid spreading HIV.

This medicine may make you dizzy. Avoid driving, using machines,or doing anything else that could be dangerous if you are not alert.

Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Check with your doctorimmediately if any of the following side effects occur:

More common

Awkwardness; burning, numbness, tingling,or painful sensations or weakness in arms, hands, legs, or feet; cough; headache; pain or tenderness around eyes and cheekbones; shortness of breath or troubled breathing; stuffyor runny nose; tightness of chest; unsteadiness; wheezing

Less common

Bloating; chills; constipation; darkened urine; dry or itching eyes; excessive tearing; eye discharge; fast heartbeat; fever; indigestion; itching, pain, redness, swelling, tenderness, or warmth on skin at injectionsite; loss of appetite; lump or growth on skin; nausea; pains in stomach, side, or abdomen, possibly radiating to the back; redness, pain, swelling of eye, eyelid, or inner lining of eyelidburning; vomiting; yelloweyes or skin

Rare

Difficulty in breathing or swallowing; fast heartbeat; skin itching, rash, or redness; swelling of face, throat, or tongue

Incidence not known

Black, tarry stools; bleeding gums; blood in urine or stools; bloody urine; chest pain; decreasedfrequency or amount of urine; inability to move armsand legs; increased blood pressure; increased thirst; lower back or sidepain; painful or difficult urination; pale skin; pinpoint red spots on skin; sneezing; sore throat; sudden numbness and weakness in the arms and legs; swelling of face, fingers, lower legs; weight gain; ulcers, sores, or white spots in mouth; unusual bleeding or bruising; unusualtiredness or weakness

Other side effects may occur that usuallydo not need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome.

More common

Abnormal growth filled with fluid or semisolid material; bruising; burning or stinging of skin; decreased appetite; diarrhea; discouragement; dry mouth; fear; feeling sad or empty; flushing; hard lump; itchingskin; irritability; lackof appetite; lack or loss of strength; large, flat, blue or purplish patches in the skin; muscle pain; nervousness; painful cold sores or blisters on lips, nose, eyes, or genitals; redness of skin; smalllumps under the skin; tiredness; trouble concentrating; trouble sleeping; unusually warm skin; weight loss

Less common

Bad, unusual or unpleasant (after) taste; burning, itching, and pain in hairy areas; change in taste; diarrhea; general feeling of discomfort or illness; joint pain; pus at root of hair; stomach pain; swollen, painful, or tenderlymph glands in neck, armpit, or groin

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.