What is Betaferon?
Betaferon is a powder and solvent for solution for injection. Contains 250 micrograms (8 million international units, MIU) per milliliter of active substance (interferon beta-1b).
What is Betaferon used for?
Betaferon is used to treat adult patients with multiple sclerosis (MS).
Betaferon is indicated for the treatment of:
• patients who have experienced signs of multiple sclerosis for the first time and whose signs are severe enough to warrant treatment with corticosteroids (anti-inflammatory medicines) given into a vein. The medicine is prescribed when the patient is considered to be at high risk of getting multiple sclerosis. Before prescribing it, the doctor must rule out other causes of the symptoms reported by the patient;
• patients with multiple sclerosis of the type known as "relapsing-remitting", characterized by attacks (relapses) alternating with symptom-free periods (remissions), in patients with at least two or more relapses in the last two years;
• patients with secondary progressive multiple sclerosis (the type of MS that occurs after relapsing-remitting multiple sclerosis), with active disease.
The medicine can only be obtained with a prescription.
How is Betaferon used?
Betaferon therapy should be started under the supervision of a physician experienced in the treatment of the disease. It is recommended to start with 62.5 micrograms (one quarter of the dose) every other day and slowly increase the amount over 2 1/2 weeks until the recommended dose of 250 micrograms (8 MIU) every other day is reached. Betaferon it is given by subcutaneous injection (under the skin). The patient can inject himself the medicine, after receiving the appropriate instructions. Treatment with Betaferon should be stopped if the patient does not respond to therapy.
How does Betaferon work?
Multiple sclerosis is an inflammatory disease that affects the central nervous system and occurs with the destruction of the protective sheath that covers the nerve cells (demyelination). The active ingredient in Betaferon, interferon beta-1b, belongs to the group of interferons. Interferons are natural substances produced by the body to help it cope with attacks such as
infections of a viral nature. The mechanism of action of Betaferon in multiple sclerosis is not yet fully understood, however it appears that beta interferon calms the immune system and prevents multiple sclerosis from recurring.
Interferon beta-1b is produced by a method known as the "recombinant DNA technique": it is made by a bacterium that has a gene (DNA) inserted into it, which makes it capable of producing interferon. Interferon beta-1b analog acts in the same way as natural interferon beta.
How has Betaferon been studied?
Betaferon was studied over a 2-year period on 338 patients with relapsing-remitting multiple sclerosis who were able to walk without assistance, comparing its effectiveness to that of a placebo (substances with no effect on the body). effectiveness in this study was the reduction in the number of relapses.
Betaferon was also tested in 1,657 patients over two studies in subjects with secondary progressive multiple sclerosis who were able to walk; in these studies the medicine was compared with placebo. The main measure of effectiveness was the delay in the progression of disability.
The study of Betaferon in patients with a single demyelinating event involved 487 patients, who were treated with Betaferon or placebo for two years.The study measured the time interval before the onset of the clinically defined form of multiple sclerosis.
What benefit has Betaferon shown during the studies?
In patients with relapsing-remitting multiple sclerosis, Betaferon was more effective than placebo in reducing the number of relapses: patients treated with the drug had an average of 0.84 relapses per year, those treated with placebo 1.27.
In one of the two studies carried out in patients with secondary progressive multiple sclerosis, a significant delay in the progression of disability was observed (31% risk reduction thanks to Betaferon) and an extension of the time prior to the time in which the patient is forced to "use of wheelchairs (39%). In the second study, no delay in the progression of disability was observed. In both studies, Betaferon found a reduction (30%) in the number of clinical relapses.
In the study in patients with a single demyelinating event, Betaferon was shown to reduce the risk of clinically defined multiple sclerosis: 28% of patients treated with Betaferon developed multiple sclerosis, compared with 45% of patients treated with placebo.
What is the risk associated with Betaferon?
Very common side effects are flu-like symptoms (fever, chills, arthralgia [joint pain], general malaise, headache or myalgia [muscle pain]) and injection site reactions. For the full list of side effects reported with Betaferon, see the package leaflet.
Betaferon 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 substances. Betaferon treatment should not be started during pregnancy. Patients who become pregnant during therapy should consult their physician. Also, Betaferon should not be taken by patients with severe depression and / or with suicidal thoughts. Betaferon is not indicated in patients with hepatic insufficiency (in whom the liver is unable to function normally).
Why has Betaferon been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Betaferon's benefits are greater than its risks in the treatment of patients with relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis and in patients with a single demyelinating episode severe enough to justify treatment with intravenous corticosteroids, and therefore recommended the granting of a marketing authorization.
Betaferon was initially authorized under "exceptional circumstances", because only limited information was available at the time the authorization was granted, for scientific reasons. As the company provided the additional information requested, the condition referring to "exceptional circumstances" was removed on April 3, 2001.
Other information about Betaferon:
On November 30, 1995, the European Commission granted the Schering Aktiengesellschaft a "Marketing Authorization" for Betaferon, valid throughout the European Union. The "Marketing Authorization" was renewed on November 30, 2000 and November 30. 2005.
For the full Betaferon evaluation (EPAR) version click here.
Last update of this summary: 09-2006.
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