From AIDSinfo
| February 2, 2007 |  View PDF |
Brand name: Fuzeon
Drug class: Entry and fusion inhibitors
Enfuvirtide, also known as Fuzeon or T-20, is a type of medicine called a fusion inhibitor. Fusion inhibitors work by blocking HIV from entering human cells.
HIV/AIDS-Related Uses
Enfuvirtide was approved by the FDA on March 13, 2003, for use with other anti-HIV drugs in the treatment of HIV infection. It is the first fusion inhibitor approved by the FDA. Enfuvirtide is approved for use in HIV infected adults and children 6 years of age or older whose HIV infection has not been controlled by other anti-HIV medications.
This medicine does not cure or prevent HIV infection or AIDS and does not reduce the risk of passing the virus to other people.
Dosage Form/Administration
Enfuvirtide comes in powder form that is mixed with sterile water and is injected under the skin using a needle-free injection device. Enfuvirtide should be injected in the skin of the abdomen, upper arm, or the front of the thigh. Patients should alternate enfuvirtide injections among these three places.
Enfuvirtide should not be injected in places where large nerves course close to the skin. Patients should consult their doctor and refer to the prescribing information provided by the manufacturer if they have questions about injection sites.
Recommended Daily Dose
The recommended dose of enfuvirtide is 90 mg (1 ml) twice a day. For children age 6 to 16 years, the recommended dose is 2 mg/kg twice a day (maximum dose 90 mg twice a day).
Some patients may benefit from different doses of enfuvirtide. Patients should always take enfuvirtide as prescribed by their doctors.
Contraindications
Individuals should tell a doctor about any medical problems before taking this medicine. Individuals taking medications that prevent blood clotting or who have hemophilia or other blood clotting disorders may have a higher risk of postinjection bleeding after enfuvirtide use.
Possible Side Effects
Along with its desired effects, enfuvirtide can cause some unwanted effects. The most common side effect is reaction in the skin where the shot was given that may cause bruising, cysts, itching, nodules, pain, and redness. Ninety-eight percent of patients will experience skin reactions.
Serious side effects of this medicine include severe allergic reactions with chills, fever, nausea and vomiting, kidney problems, low blood pressure, paralysis, severe rash, and trouble breathing. Severe infections at places where the injections were given have been reported. Use of the needle-free device to deliver enfuvirtide has been associated with nerve pain lasting up to 6 months near where large nerves course through the skin, bruising, and internal bleeding. Individuals should tell a doctor if they have any of these side effects.
In clinical trials, patients taking enfuvirtide were more likely to have bacterial pneumonia than patients taking a placebo. It is not known if enfuvirtide increases the risk of pneumonia, but patients taking enfuvirtide should report any symptoms of or concerns about pneumonia to their doctor.
Other side effects may not be serious and may lessen or disappear with continued use of the medicine. Less serious side effects of this medicine include bad taste in the mouth, constipation, cough, depression, diarrhea, eye infection, flu-like illness, fatigue, herpes simplex infection, itchy rash, loss of appetite, muscle pain and weakness, pain and tingling in the hands and feet, nausea, nervousness, sinus problems, skin warts, stomach pain, swollen glands, trouble sleeping; and weight loss. Individuals should tell a doctor if these side effects continue or are bothersome.
Drug and Food Interactions
A doctor should be notified of any other medications being taken, including prescription, nonprescription (over-the-counter), or herbal medications.
Clinical Trials
Click here to search ClinicalTrials.gov for trials that use enfuvirtide.
Manufacturer Information
Enfuvirtide
Roche Laboratories
340 Kingsland Street
Nutley, NJ 07110
(973) 235-5000
Enfuvirtide
Trimeris Inc
4727 Univ Dr
Durham, NC 27707
(919) 419-6050
Fuzeon
Roche Laboratories
340 Kingsland Street
Nutley, NJ 07110
(973) 235-5000