What is Fuzeon?
Fuzeon is available in a vial as a powder for solution for injection. 1 ml of the reconstituted solution contains 90 mg of the active substance enfuvirtide.
What is Fuzeon used for?
Fuzeon is an antiviral medicine used in combination with other antiviral medicines for the treatment of patients infected with HIV-1 (human immunodeficiency virus type 1), a virus that causes AIDS (acquired immunodeficiency syndrome). Fuzeon is used in patients who have not responded positively to other previous antiviral therapies or who are intolerant to these therapies. These therapies must contain at least one medicinal product from each of the following classes of drugs used for the treatment of HIV infection: protease inhibitors, non-nucleoside reverse transcriptase inhibitors, and nucleoside reverse transcriptase inhibitors.
Doctors should only prescribe Fuzeon after carefully considering the patient's previous antiviral treatments and the possibility that the virus will respond to the drug.
The medicine can only be obtained with a prescription.
How is Fuzeon used?
Fuzeon should be prescribed by physicians experienced in the treatment of HIV infection. In adults, the recommended dose is 90 mg twice a day injected under the skin in the upper arm, thigh or abdomen. The dose in children aged six to 16 years depends on their body weight. Fuzeon is not recommended for use in children under six years of age.
The patient can self-administer Fuzeon or ask another person to do so as long as the person giving the injection follows the instructions in the package leaflet. The injection should always be given at a different site than the previous injection.
How does Fuzeon work?
The active substance in Fuzeon, enfuvirtide, is a fusion inhibitor. Fuzeon binds to a protein found on the surface of the HIV virus. This prevents the virus from attaching itself to the surface of human cells and infecting them.Since HIV can only reproduce inside cells, Fuzeon, taken in combination with another antiviral medicine, reduces the amount of HIV in the blood, keeping it at a low level. Fuzeon does not cure HIV infection or AIDS, but it can delay damage to the immune system and the onset of AIDS-associated infections and diseases.
How has Fuzeon been studied?
The two main studies of Fuzeon involved 1,013 patients of at least 16 years of age who had contracted HIV infection and who had taken or did not respond to other antiviral medicines. On average, patients had received 12 antiviral medicines over a period of seven years. The two studies compared the effects of Fuzeon in combination with so-called "optimized background therapy" (a combination of other antiviral drugs selected for each patient because they offered the best chance of reducing HIV levels in the blood) versus background therapy. optimized without Fuzeon. The main measure of effectiveness was the changes in HIV levels in the blood (viral load) 48 weeks after treatment. Fuzeon was also studied in 39 children between the ages of three and 16. Studies were still ongoing. course at the time of the medicinal product evaluation.
What benefit has Fuzeon shown during the studies?
Treatment with Fuzeon in combination with optimized background therapy was more effective in reducing viral loads than optimized background therapy alone. In the first study, viral loads precipitated an average of 98% in patients treated with Fuzeon and 83% in subjects not treated with the drug. The values in the second study were 96% and 78%, respectively. of Fuzeon in children produces similar concentrations of the active substance in the blood to the approved dose in adults.
What is the risk associated with Fuzeon?
The most frequently reported adverse reactions with Fuzeon (seen in more than 1 in 10 patients) are injection site reactions (pain and inflammation), peripheral neuropathy (injury to the nerves in the extremities accompanied by tingling or numbness of hands and feet ) and weight loss In clinical studies, injection site reactions were reported by 98% of patients, mostly in the first week of treatment. These reactions were associated with mild to moderate pain or discomfort, the severity of which did not increase over the course of treatment. For the full list of side effects reported with Fuzeon, see the Package Leaflet.
Fuzeon must not be used in people who may be hypersensitive (allergic) to enfuvirtide or any of the other substances.
As with all other HIV medicines, patients receiving Fuzeon may be at risk for osteonecrosis (bone death) or immune reactivation syndrome (inflammatory signs and symptoms caused by reactivating the immune system). Patients with liver problems may be at an increased risk of developing liver damage if treated for HIV infection.
Why has Fuzeon been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Fuzeon's benefits are greater than its risks in combination with other antiretroviral medicines for the treatment of HIV-1 infected patients who have been treated and have not responded positively to regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or which are intolerant to previous antiretroviral therapy. The committee therefore recommended the granting of a marketing authorization for Fuzeon.
Fuzeon was originally authorized under 'Exceptional Circumstances' as, for scientific reasons, it had not been possible to obtain comprehensive information on the medicine. As the company provided the additional information requested, the condition referring to "exceptional circumstances" was removed on July 8, 2008. Fuzeon was authorized under "exceptional circumstances". This means that, for scientific reasons, it was not possible obtain complete information on the medicine. The European Medicines Agency (EMEA) reviews the new information available annually and updates this summary if necessary.
Other information about Fuzeon:
On 27 May 2003, the European Commission granted Roche Registration Limited a "Marketing Authorization" for Fuzeon, valid throughout the European Union. The "Marketing Authorization" was renewed on 27 May 2008.
For the full version of Fuzeon's EPAR click here.
Last update of this summary: 07-2008.
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