What is Avonex?
Avonex is a powder and solvent in a vial, to make up a solution for injection, and a solution for injection in a pre-filled syringe. Each vial and each syringe contain 30 micrograms (6 million international units or MIU) of the active substance, interferon beta-1a.
What is Avonex used for?
Avonex is used in the treatment of the following patient groups:
- patients with relapsing multiple sclerosis (MS); it is a type of multiple sclerosis that causes recurring seizures (relapses) that occur during periods when the patient has no symptoms. Avonex slows the progression of disability and decreases the number of relapses;
- patients who experience symptoms of the disease for the first time if they are severe enough to warrant treatment by injection of corticosteroids (anti-inflammatory), i.e. when it is believed that the patient has a high risk of getting multiple sclerosis. Before using Avonex, doctors should rule out that symptoms are due to other causes.
Avonex is used in patients 12 years of age and older.
The medicine can only be obtained with a prescription.
How is Avonex used?
Avonex treatment should be started by a doctor who has experience in the management of multiple sclerosis. The recommended dose of Avonex is 30 micrograms, administered by intramuscular injection once a week. To help patients adjust their treatment, the doctor may recommend the patient to start with about half of this dose once a week and then increase to the full dose. This is only possible with the pre-filled syringe, if it is equipped with a special device that attaches to the syringe itself, which allows you to inject only about half the dose of Avonex.
The point at which the injection is given should vary each week. The patient can administer the injection himself, provided that he has been properly trained. Before each injection and for the next 24 hours, the patient can take a pain reliever with antipyretic action (against fever) to relieve flu symptoms that may occur in the first few months of treatment. Avonex treatment should be discontinued in patients who develop progressive multiple sclerosis, which means their disease is getting worse.
How does Avonex work?
Multiple sclerosis is a nerve disease in which inflammation destroys the protective covering around the nerves. This is called "demyelination." The active ingredient in Avonex, interferon beta-1a, belongs to the class of interferons, natural substances produced by "organism to fight, for example, infections caused by viruses. The mechanism of action of Avonex in the treatment of multiple sclerosis is not yet fully known, but it seems that interferon beta is able to regulate the immune system and prevent hence the relapses of the disease.
"Interferon beta-1a is produced by a method known as" recombinant DNA technology ": it is made by a cell that has received a gene (DNA), which makes it capable of producing interferon beta-1a. L" Replacement interferon beta-1a behaves like naturally produced interferon beta.
How has Avonex been studied?
Avonex has been the subject of three main studies.
The first, conducted on 301 patients with relapsing multiple sclerosis, compared it with a placebo (a dummy treatment). Patients had had at least two relapses in the past three years or at least one relapse per year if they had had the disease for less than three years. Treatment continued for up to two years. The main measure of effectiveness was the number of patients whose disability had worsened.
The second study, involving 802 patients, compared the effectiveness of the 60 microgram dose with that of the 30 microgram dose.
The third study, involving 383 patients who had had a "single demyelination crisis, compared the effectiveness of Avonex with that of placebo in reducing the risk of a second seizure."
The company did not carry out formal studies in patients under the age of 16, but presented information from published studies on the use of Avonex in young people aged 12 to 18 years.
What benefit has Avonex shown during the studies?
In the first study, 22% of patients with relapsing multiple sclerosis treated with Avonex and 35% of patients treated with placebo experienced worsening of disability by the end of two years. The second study found no difference in efficacy between the two dosages. The third study showed that, among patients who had had a demyelination crisis, those treated with Avonex had a lower estimated risk of a second seizure than those treated with placebo: for patients treated with Avonex the risk of a second seizure it was 21% over two years and 35% over three years, while the risk for patients treated with placebo was 39% over two years and 50% over three years, respectively.
In patients aged 12 to 18 years, published studies show that these patients experienced a lower relapse rate. This may be due to treatment with Avonex.
What is the risk associated with Avonex?
The most frequent side effects reported with Avonex (seen in more than 1 in 10 patients) are headache, symptoms normally associated with flu, pyrexia (fever), chills and sweating. These side effects diminish over time with continued treatment. side effects in younger people are similar. For a full list of side effects reported with Avonex, see the package leaflet.
Avonex should not be used in patients with a history of hypersensitivity (allergy) to natural or recombinant interferon beta, human albumin or any of the other ingredients. The medicine sold in pre-filled syringe does not contain human albumin. Avonex treatment should not be started during pregnancy; if pregnancy begins during treatment with Avonex, the patient should consult her doctor. Avonex should not be used in patients who have severe depression or have suicidal thoughts.
Why has Avonex been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Avonex's benefits are greater than its risks for the treatment of patients diagnosed with relapsing multiple sclerosis as well as patients who have had a "single process demyelination crisis. active inflammatory, if severe enough to warrant treatment with intravenous corticosteroid injection. The Committee recommended the granting of a marketing authorization.
Avonex was originally authorized "in exceptional circumstances" because, for scientific reasons, the data available at the time of approval was limited. As the company has meanwhile provided the additional data requested, the "in exceptional circumstances" restriction has dropped. on March 22, 2006.
Learn more about Avonex
On March 13, 1997, the European Commission issued a "marketing authorization" for Avonex, valid throughout the European Union. The authorization was renewed on March 13, 2002 and March 13, 2007. The holder of the marketing authorization. "placing on the market is Biogen Idec Limited.
For the full version of Avonex's EPAR, click here.
Last update of this summary: 12-2008
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