What is Betaferon?
Betaferon is a powder and solvent for solution for injection. Contains 250 micrograms (8 million international units, MUI) per milliliter of active ingredient (interferon beta-1b).
What is Betaferon used for?
Betaferon is used in the treatment of 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 in whom these signs are severe enough to justify 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 exclude 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 periods without symptoms (remissions), in patients with at least two or more relapses over the past two years;
• patients with secondary progressive multiple sclerosis (the type of MS that develops 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 doctor experienced in treating the disease. It is recommended to start with 62.5 micrograms (a quarter of the dose) every other day and slowly increase the quantity over 2 and a half weeks to reach the recommended dose of 250 micrograms (8 MIU) every other day. Betaferon is given by subcutaneous injection (under the skin). The patient can inject himself the medicine after receiving appropriate instructions. Treatment with Betaferon should be discontinued 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 manifests itself in the destruction of the protective sheath that covers nerve cells (demyelination). The active substance in Betaferon, interferon beta-1b, belongs to the group of interferons. Interferons are natural substances produced by the body to help it cope with such attacks
viral infections. The mechanism of action of Betaferon in multiple sclerosis is not yet fully known; however, interferon beta appears to calm the immune system and prevent relapses of multiple sclerosis.
Interferon beta-1b is produced by a method known as "recombinant DNA technique": that is, it is obtained from a bacterium in which a gene (DNA) has been inserted which makes it capable of producing interferon. Analogous interferon beta-1b acts in the same way as natural beta interferon.
How has Betaferon been studied?
Betaferon has been studied over 2 years on 338 patients with relapsing-remitting multiple sclerosis able to walk without assistance, comparing their efficacy to that of a placebo (substances without effects on the organism). The main measure of effectiveness in this study was the reduction in the number of relapses.
Betaferon was also analyzed in 1, 657 patients over two studies conducted on subjects with secondary progressive multiple sclerosis capable of walking; in these studies the medicine was compared with a 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 appearance 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 medicine had an average of 0.84 recurrences per year, those treated with placebo 1.27.
In one of the two studies carried out in patients with secondary progressive multiple sclerosis, there was a significant delay in the progression of disability (31% risk reduction thanks to Betaferon) and an extension of the time before the patient was forced to wheelchair use (39%). In the second study, no delay in disability progression was observed. In both studies, Betaferon reported a reduction (30%) in the number of clinical relapses.
In the study of patients with a single demyelinating event, Betaferon was shown to reduce the risk of clinically definite 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 frequent side effects are flu-like symptoms (fever, chills, arthralgia [joint pain], malaise, headache or myalgia [muscle pain]) and reactions at the injection point level. For the full list of all 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, to human albumin or to any of the other substances. Betaferon treatment should not be started during pregnancy. Patients who begin pregnancy during therapy should consult their doctor. Furthermore, Betaferon should not be taken by patients with severe depression and / or suicidal thoughts. Betaferon is not indicated in patients with hepatic insufficiency (in which the liver is not able 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 for the treatment of patients with relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis and patients with a single sufficiently severe demyelinating episode from justify treatment with intravenous corticosteroids, and therefore recommended that it be given marketing authorization.
Betaferon was initially authorized in "exceptional circumstances" because only limited information was available for scientific reasons at the time the authorization was granted. As the company provided the additional information requested, the condition referring to "exceptional circumstances" was removed on 3 April 2001.
Other information on Betaferon:
On 30 November 1995, the European Commission granted Betaferon a marketing authorization valid throughout the European Union to Schering Aktiengesellschaft. The marketing authorization was renewed on 30 November 2000 and 30 November 2005.
For the full version of the evaluation (EPAR) of Betaferon click here.
Last update of this summary: 09-2006.
