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:
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.
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
Call your doctor for medical advice about side effects. 1-800-FDA-1088 or www.fda.gov/medwatch or to Genentech at 1-888-835-2555.
Please see accompanying FUZEON full Prescribing Information, including Patient Information and, FUZEON Instructions for Use, for additional Important Safety Information.
Department of Health and Human Services. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf Accessed July 8, 2022.
Department of Health and Human Services. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf Accessed July 8, 2022.
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