Enfuvirtide (Systemic)
   
Enfuvirtide (Systemic)
US Brand Names
• Fuzeon
Another commonly used name is T-20.
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, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Enfuvirtide will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.
This medicine is available only with your doctor's prescription, in the following dosage form:
Parenteral
• Injection (U.S.)
Special Considerations
In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For enfuvirtide the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to enfuvirtide. Also tell your doctor and pharmacist if 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 in animal studies. Enfuvirtide should be used with caution in pregnant women and should be used only if clearly needed. Discuss this with your doctor.
Breast-feeding
It is not known whether enfuvirtide passes into breast milk. Mothers who are taking this medicine and wish to breast-feed should discuss this with their doctor.
Children
This medicine has been studied in children ages 6 to 16 years old and it is not expected to cause different effects than it does in adult patients.
Older adults
Many medicines have not been studied specifically in older people and it may not be known if they work the same way they do in younger adults.
Other medical problems
The presence of other medical problems may affect the use of enfuvirtide. Make sure you tell your doctor if you have any 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 may have an increased chance of getting bacterial pneumonia
Administration
It is very important that you read the information for patients and the injection instructions very carefully. Ask your healthcare professional if you have any questions.
Enfuvirtide can be given by a health care professional. However, medicines given by injection are sometimes used at home. If you will be using enfuvirtide at home, your health care professional will teach you how get the medicine ready for injection and how the injections are to be given. Be certain that you understand exactly how to get the medicine ready for injection and how the medicine is to be injected. Do not reuse needles and syringes.
Put used needles and syringes in a puncture-resistant disposable container, or dispose of them as directed by your health care 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, including enfuvirtide.
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 immediately if you notice cough; difficulty breathing; fever; skin rash; unusual tiredness or weakness.
This medicine may increase the chance of bacterial pneumonia in some patients. Stop taking this medicine and check with your doctor immediately 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 was injected. Almost all people get injection site reactions with enfuvirtide. These reactions hurt and itch, and they are usually mild to moderate but can occasionally be severe. These reactions generally happen within the first week of treatment and usually happen again as you keep using enfuvirtide. If the injection site nodules drain pus or cause redness that spreads or streaks from the sites, or you are worried about the reaction you are having, call your healthcare provider right away .
Dosing
The dose of enfuvirtide can be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the 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 of it and do not take it more often than your doctor ordered.
• For parenteral dosage form (injection):
o 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 it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
To store this medicine:
• Keep out of the reach of children.
• Store reconstituted solution (mixed with water) in the refrigerator and use within 24 hours.
• Store medicine at room temperature
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.
Precautions
It is very important that your doctor check you at regular visits.
Enfuvirtide does not reduce the risk of giving HIV to other people. Caution should be taken to avoid spreading HIV.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately 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; stuffy or 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; 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 eyelid burning; vomiting; yellow eyes or skin.
Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of 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; discouragement; fear; feeling sad or empty; flushing; hard lump; itching skin; irritability; lack of 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; small lumps under the skin; tiredness; trouble concentrating; trouble sleeping; unusually warm skin; weight loss.
Less common
Bad, unusual or unpleasant (after) taste; change in taste; diarrhea; general feeling of discomfort or illness; joint pain; stomach pain; swollen, painful, or tender lymph glands in neck, armpit, or groin.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
March 22, 2004 
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