Fuzeon^®

enfuvirtide

Indications & Important Safety Information

Indication
What is FUZEON?

FUZEON is a prescription medicine used in combination with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in people who have taken other antiretroviral medicines and whose HIV-1 levels have continued to increase while on treatment.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

It is not known if FUZEON is safe and effective for use in children under 6 years of age.

Do not use FUZEON if you are allergic to enfuvirtide or any of the ingredients in FUZEON.

Before using FUZEON, tell your healthcare provider about all your medical conditions, including if you:

• have bleeding problems
• have or had lung problems
• have a low CD4 count
• smoke or use intravenous (IV) street drugs
• are pregnant or plan to become pregnant. It is not known if FUZEON can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with FUZEON.
  • Pregnancy Registry: There is a pregnancy registry for women who use antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
• are breastfeeding or plan to breastfeed. Do not breastfeed if you use FUZEON.
  • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
  • It is not known if FUZEON passes into your breast milk. 
  • Talk to your healthcare provider about the best way to feed your baby during treatment with FUZEON.
• are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take medicines that affect blood clotting. Some medicines interact with FUZEON. Keep a list of your medicines to show to your healthcare provider and pharmacist when you get a new medicine.
Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to use FUZEON with other medicines.

What are the possible side effects of FUZEON?
FUZEON may cause serious side effects, including:

• Injection site reactions. Injection site reactions including pain and discomfort, redness, rash, itching and bruising have happened in people who use FUZEON. Call your healthcare provider right away if you have pain, redness, or swelling around the injection site that does not go away within a few days or gets worse.
• Nerve pain (neuralgia) or numbness, burning, or prickling feeling of your skin (paresthesia) have happened in people who use the Biojector 2000 needle-free device to give their FUZEON dose. These symptoms can last up to 6 months.
• Bleeding after your injection. People who take medicines that affect blood clotting (anticoagulants) or people with hemophilia or other blood clotting problems may have a higher risk.
• Allergic reactions. Stop using FUZEON and call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of these signs and symptoms of an allergic reaction:
  • rash
  • fever
  • chills
  • trouble breathing
  • hives
  • nausea and vomiting
  • swelling of your face, eyes, lips or mouth
  • low blood pressure
• Pneumonia. Pneumonia which can be serious and cause hospitalization and death has happened in people who use FUZEON. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of these signs or symptoms of pneumonia:
  • cough with fever
  • fast breathing
  • shortness of breath
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when an HIV-1 infected person starts taking antiretroviral medicines including FUZEON. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting FUZEON.

The most common side effects of FUZEON include local injection site reactions, diarrhea, nausea, tiredness, weight loss, sinus problems, stomach pain, cough, herpes simplex, decreased appetite, pancreas problems, pain in arms and legs, pneumonia, pain and numbness in feet or legs, flu-like symptoms, infected hair follicle, dry mouth, and eye infection.
These are not all the possible side effects of FUZEON.

What should I avoid while using FUZEON?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how FUZEON affects you.

Call your doctor for medical advice about side effects.  You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or to Genentech at 1-888-835-2555.

Please see full Prescribing Information, including Patient Information and Instructions for Use, for additional Important Safety Information.