Fuzeon

DRUG DESCRIPTION

FUZEON (enfuvirtide) is an inhibitor of the fusion of HIV-1 with CD4 cells. Enfuvirtide is a linear 36-amino acid synthetic peptide with the N-terminus acetylated and the C-terminus is a carboxamide. It is composed of naturally occurring L-amino acid residues.

Enfuvirtide is a white to off-white amorphous solid. It has negligible solubility in pure water and the solubility increases in aqueous buffers (pH 7.5) to 85-142 g/100 mL. The empirical formula of enfuvirtide is C204H301N51O64, and the molecular weight is 4492. It has the following primary amino acid sequence:

CH3CO-Tyr-Thr-Ser-Leu-Ile-His-Ser-Leu-Ile-Glu-Glu-Ser-Gln-Asn-Gln-Gln-Glu-Lys-Asn-Glu-Gln-Glu-LeuLeu-Glu-Leu-Asp-Lys-Trp-Ala-Ser-Leu-Trp-Asn-Trp-Phe-NH2 and the following structural formula:

FUZEON® (enfuvirtide) Structural Formula Illustration

The drug product, FUZEON (enfuvirtide) for Injection, is a white to off-white, sterile, lyophilized powder. Each single-use vial contains 108 mg of enfuvirtide for the delivery of 90 mg. Prior to subcutaneous administration, the contents of the vial are reconstituted with 1.1 mL of Sterile Water for Injection giving a volume of approximately 1.2 mL to provide the delivery of 1 mL of the solution. Each 1 mL of the reconstituted solution contains approximately 90 mg of enfuvirtide with approximate amounts of the following excipients: 22.55 mg of mannitol, 2.39 mg of sodium carbonate (anhydrous), and sodium hydroxide and hydrochloric acid for pH adjustment as needed. The reconstituted solution has an approximate pH of 9.0.

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, chills; nausea, vomiting; difficulty breathing; feeling light-headed or fainting; swelling of your face, lips, tongue, or throat.

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

  • cough with fever, chest congestion, and shortness of breath;
  • signs of a new infection, such as fever or chills, cough, or flu symptoms.
  • nerve pain lasting for several...

Read All Potential Side Effects and See Pictures of Fuzeon »

What are the precautions when taking enfuvirtide (Fuzeon)?

Before using enfuvirtide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (e.g., hemophilia, coagulopathy), smoking, IV drug abuse, lung disease.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Because breast milk can transmit HIV, do not...

Read All Potential Precautions of Fuzeon »


Fuzeon Consumer (continued)

SIDE EFFECTS: Pain, redness, itching, bruising, hardened skin, or bumps at the injection site may occur. These types of reactions are common and may last up to 7 days. Runny nose may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: anxiety, muscle pain, numbness/tingling/shooting nerve pain near injection site, signs of injection site infection (such as oozing, warmth, persistent pain and redness), abdominal pain, loss of appetite, cough with fever, rapid breathing, shortness of breath, night sweats, vision/eye changes.

An allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing, fever, chills, nausea/vomiting.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using enfuvirtide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (e.g., hemophilia, coagulopathy), smoking, IV drug abuse, lung disease.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.


Fuzeon Patient Information Including Side Effects

Brand Names: Fuzeon

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

  • What is enfuvirtide (Fuzeon)?
  • What are the possible side effects of enfuvirtide (Fuzeon)?
  • What is the most important information I should know about enfuvirtide (Fuzeon)?
  • What should I discuss with my healthcare provider before using enfuvirtide (Fuzeon)?
  • How should I use enfuvirtide (Fuzeon)?
  • What happens if I miss a dose (Fuzeon)?
  • What happens if I overdose (Fuzeon)?
  • What should I avoid while using enfuvirtide (Fuzeon)?
  • What other drugs will affect enfuvirtide (Fuzeon)?
  • Where can I get more information?

What is enfuvirtide (Fuzeon)?

Enfuvirtide is an antiviral medication in a group of HIV medicines called fusion inhibitors. Enfuvirtide prevents human immunodeficiency virus (HIV) from entering and taking over the 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 other 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, chills; nausea, vomiting; difficulty breathing; feeling light-headed or fainting; swelling of your face, lips, tongue, or throat.

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

  • cough with fever, chest congestion, and shortness of breath;
  • signs of a new infection, such as fever or chills, cough, or flu symptoms.
  • nerve pain lasting for several weeks or months; or
  • severe or prolonged (more than 7 days) injection site reaction.

Less serious side effects may include:

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

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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

Before using enfuvirtide, tell your doctor if you are allergic to any drugs, if you take a blood thinner such as Coumadin, or if you have a bleeding or blood clotting disorder, such as hemophilia. You may not be able to use enfuvirtide, or you may need dosage adjustments or special tests during treatment.

Enfuvirtide may increase your risk of developing pneumonia, especially if you have a high viral load, a history of lung disease, or if you smoke. Call your doctor at once if you have symptoms of pneumonia, such as cough, fever, rapid breathing, or shortness of breath.

Do not use enfuvirtide as your only HIV medication. HIV/AIDS is usually treated with a combination of different drugs. Your disease may become resistant to enfuvirtide if you do not use it in combination with other HIV medicines your doctor has prescribed.

To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Stop using enfuvirtide and call your doctor at once if you have serious side effects such as a signs of a new infection, such as fever or chills, cough, or flu symptoms; or severe pain, irritation, or skin changes where you injected the medicine.

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