Fuzeon

Generic Name: enfuvirtide (en FYOO vir tide)
Brand Names: Fuzeon

What is Fuzeon?

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

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

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

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

Important information

You should not use Fuzeon if you are allergic to enfuvirtide.

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

Do not use Fuzeon as your only medication to treat HIV. Fuzeon must be used in combination with other HIV medications. Your disease may become resistant to Fuzeon 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.

Slideshow: Flashback: FDA Drug Approvals 2013

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 Fuzeon 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 Fuzeon have developed pneumonia. It is not clear whether Fuzeon 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.

Before using Fuzeon

You should not use Fuzeon if you are allergic to enfuvirtide.

To make sure you can safely use Fuzeon, tell your doctor if you have any of these other conditions:

  • a bleeding or blood clotting disorder such as hemophilia; or

  • a history of breathing problems.

Having HIV makes it easier for you to get other infections, and some people using Fuzeon have developed pneumonia. It is not clear whether Fuzeon 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.

FDA pregnancy category B. Fuzeon is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk. Do not give this medicine to a child younger than 6 years old without medical advice.

See also: Pregnancy and breastfeeding warnings (in more detail)

How should I use Fuzeon?

Use Fuzeon exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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

Fuzeon is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Fuzeon is usually injected twice a day. Follow your doctor's instructions.

Fuzeon is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

After mixing the powder and the liquid, gently tap the vial for 10 seconds and then slowly roll it between your hands. Let the vial stand until the powder completely dissolves (up to 45 minutes). If the mixture is foamy or gel-like, allow more time for it to dissolve.

Do not shake the mixed medicine or it may foam. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Do not mix Fuzeon with other medications in the same syringe.

Use a different place on your stomach, thigh, or upper arm each time you give the Fuzeon injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Carefully follow all instructions about giving yourself an Fuzeon injection. Most people using this medication have a skin reaction (itching, redness, swelling, pain, bruising, tenderness) where the medicine is injected. Your caregivers can tell you what type of skin reactions are serious and when to call your doctor.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

Use Fuzeon regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store unmixed Fuzeon powder and the liquid diluent separately at room temperature away from moisture and heat. You may also store unmixed Fuzeon powder in the refrigerator, do not freeze. After mixing Fuzeon with a diluent, store in the refrigerator and use it within 24 hours. Do not freeze.

You may take the mixed Fuzeon out of the refrigerator and allow it to reach room temperature before giving the injection. Do not heat the medicine before using.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Avoid injecting this medication near your elbow, knee, groin, navel, or buttocks. Do not inject into moles, scars, tattoos, burns, bruises, or skin that is not otherwise healthy.

Using Fuzeon will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Fuzeon can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Fuzeon side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Fuzeon: 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 Fuzeon 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 Fuzeon 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.

See also: Side effects (in more detail)

What other drugs will affect Fuzeon?

Tell your doctor about all other medicines you use, especially a blood thinner such as warfarin (Coumadin, Jantoven).

This list is not complete and other drugs may interact with Fuzeon. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Fuzeon.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Fuzeon only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 4.03. Revision Date: 2012-09-18, 11:07:59 AM.

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