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Enfuvirtide

Generic Name: enfuvirtide (en-FUE-vir-tide)
Brand Name: Fuzeon

Enfuvirtide is used for:

Treating HIV infection in combination with other anti-HIV medicines.

Enfuvirtide is an HIV fusion inhibitor. It works by blocking HIV from infecting healthy immune cells (CD4 cells).

Do NOT use enfuvirtide if:

  • you are allergic to any ingredient in enfuvirtide

Contact your doctor or health care provider right away if any of these apply to you.

Before using enfuvirtide:

Some medical conditions may interact with enfuvirtide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of lung problems or intravenous (IV) drug use, or if you smoke

Some MEDICINES MAY INTERACT with enfuvirtide. However, no specific interactions with enfuvirtide are known at this time.

Ask your health care provider if enfuvirtide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use enfuvirtide:

Use enfuvirtide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with enfuvirtide. Talk to your pharmacist if you have questions about this information.
  • Food does not affect enfuvirtide. You may use enfuvirtide whether you have eaten or not. You must keep taking your other medicines the way you did before you started taking enfuvirtide.
  • Enfuvirtide is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using enfuvirtide at home, a health care provider will teach you how to use it. Be sure you understand how to use enfuvirtide. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use enfuvirtide if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. If the solution is foamy or jelled, allow more time for it to dissolve.
  • Enfuvirtide is injected under the skin into the upper arm, thigh, or stomach. Rotate injection sites with each shot. Do not inject near the elbow, knee, groin area, or the lower or inner buttocks. Do not inject in or near injection site reactions from past injections or directly over a blood vessel. Also, do not inject into abnormal skin, such as moles, scars, bruises, tattoos, burn sites, or your belly button.
  • When drawing a dose into a syringe, be sure to follow the procedure demonstrated to you to prevent contamination of the vial, syringe, or medicine. Never touch the rubber stopper of the vial or the needle of the syringe with your fingers.
  • Do not mix your other medicines in the same syringe with enfuvirtide.
  • Use enfuvirtide within 24 hours after mixing it. Throw away any unused medicine left in the vial after your dose. If you do not use enfuvirtide within 24 hours after mixing it, throw it away.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • You may use enfuvirtide with a needle-free injection device (eg, Biojector 2000). Avoid injecting into areas close to joints or large nerves. Certain nerve problems (eg, pain, numbness or tingling) may occur if the medicine is injected near these areas. Bruising or bleeding under the skin may also occur with the use of this device. The risk may be greater if you take anticoagulants (eg, warfarin) or have bleeding problems (eg, hemophilia). Check with your health care provider if you have questions about using this type of injection device.
  • If you miss a dose of enfuvirtide, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. It is important not to miss doses of enfuvirtide.

Ask your health care provider any questions you may have about how to use enfuvirtide.

Important safety information:

  • Enfuvirtide may cause dizziness. These effects may be worse if you take it with alcohol or certain medications. Use enfuvirtide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Enfuvirtide is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
  • Enfuvirtide may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start enfuvirtide.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking enfuvirtide, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Do not change your dose or stop taking this or any other HIV medicine without checking with your doctor. Contact your doctor immediately if you stop taking this or any other HIV medicine.
  • Enfuvirtide does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
  • Lab tests, including blood counts, CD4 counts, liver function tests, and physical exams, may be performed while you use enfuvirtide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Enfuvirtide should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
  • The dose of enfuvirtide in CHILDREN is determined based on body weight; they will need to have regular weight checks while they take enfuvirtide.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using enfuvirtide while you are pregnant. It is not known if this medicine is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or enfuvirtide to the baby.

Possible side effects of enfuvirtide:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; injection site reactions (eg, mild redness, pain, or swelling; itching; bleeding; bruising; hardened skin; bumps; tenderness); loss of appetite; muscle pain; nausea; sinus pain; stuffy nose; tiredness; trouble sleeping; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; blood in the urine; burning, numbness, or tingling; change in the amount of urine produced; chest pain; decreased movement of the face muscles; depression; fainting; fever, chills, or persistent sore throat; flu-like symptoms; muscle weakness or loss of muscle function; severe nausea; severe or unusual dizziness; shortness of breath; signs of infection at the injection site (eg, oozing, swelling, increasing heat, redness or pain); signs of pneumonia (eg, cough with fever, rapid breathing, shortness of breath); stomach or back pain (with or without nausea or vomiting); suicidal thoughts or attempts; swelling of the feet; swollen lymph nodes; unusual bruising or bleeding; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of enfuvirtide:

Store enfuvirtide at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). If enfuvirtide cannot be stored at room temperature, store in the refrigerator. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom.

After mixing with sterile water, enfuvirtide may be stored in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C) for up to 24 hours. Do not freeze. Do not use after the expiration date on the vial. Keep enfuvirtide out of the reach of children and away from pets.

General information:

  • If you have any questions about enfuvirtide, please talk with your doctor, pharmacist, or other health care provider.
  • Enfuvirtide is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take enfuvirtide or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about enfuvirtide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to enfuvirtide. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using enfuvirtide.

Review Date: November 3, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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