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Medications and Drugs

Brand Names: Fuzeon

Generic Name: enfuvirtide (Pronunciation: en FYOO vir tide)

What is enfuvirtide (Fuzeon)?

Enfuvirtide is an antiviral medication that prevents human immunodeficiency virus (HIV) from infecting healthy cells in your body.

Enfuvirtide is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Enfuvirtide is not a cure for HIV or AIDS.

Enfuvirtide is usually given after other medications have been tried without successful treatment of HIV.

Enfuvirtide may also be used for purposes not listed in this medication guide.

What are the possible side effects of enfuvirtide (Fuzeon)?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; fever with vomiting; blood in your urine; difficulty breathing; fainting; swelling of your feet, face, lips, tongue, or throat.

Stop using enfuvirtide and call your doctor at once if you have any of these serious side effects:

  • fever, chills, chest congestion, cough with yellow or green mucus, stabbing chest pain, wheezing, feeling short of breath;
  • signs of a new infection such as sore throat, flu symptoms, swollen glands, easy bruising or bleeding (bleeding from your nose or gums), loss of appetite, mouth sores;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting;
  • rapid heart rate, increased sweating, tremors, feeling anxious or irritable;
  • diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;
  • swelling in your neck or throat (enlarged thyroid);
  • problems with balance or eye movement, trouble speaking or swallowing;
  • severe lower back pain, loss of bladder or bowel control;
  • weakness or prickly feeling in your fingers or toes, tingling or nerve pain lasting for several weeks or months; or
  • pain, warmth, swelling, oozing, or redness where an injection was given, especially if these symptoms get worse or last longer than 7 days.

Less serious side effects may include:

  • constipation;
  • itching, irritation, mild redness, mild swelling, or raised bumps under your skin where the medicine was injected;
  • pain or numbness in your feet or legs;
  • tired feeling, muscle weakness or loss of strength;
  • muscle pain;
  • runny or stuffy nose;
  • sleep problems (insomnia); or
  • depression.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about enfuvirtide (Fuzeon)?

You should not use this medication if you are allergic to enfuvirtide.

Before using enfuvirtide, tell your doctor if you have a bleeding or blood clotting disorder (such as hemophilia), or a history of breathing problems.

Do not use enfuvirtide as your only medication to treat HIV. Enfuvirtide must be used in combination with other HIV medications. Your disease may become resistant to enfuvirtide if you do not use it in combination with other medicines your doctor has prescribed.

Most people using this medication have a skin reaction (itching, redness, swelling, pain, bruising, tenderness) where the medicine is injected. Call your doctor if these symptoms get worse or last longer than 7 days.

To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor. Your blood will need to be tested often. Visit your doctor regularly.

Stop using enfuvirtide and call your doctor at once if you have a serious side effect such as fever, cough with yellow or green mucus, stabbing chest pain, wheezing, trouble breathing, sore throat, flu symptoms, swollen glands, easy bruising or bleeding, mouth sores, severe pain in your upper stomach, ongoing nerve pain or tingly feeling, signs of infection such as swelling or oozing where an injection was given.

Having HIV makes it easier for you to get other infections, and some people using enfuvirtide have developed pneumonia. It is not clear whether enfuvirtide is the actual cause of pneumonia but it may increase your risk. You may also be more likely to have pneumonia if you smoke, if you have ever had lung disease, or if you have a history of intravenous (IV) drug use.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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