What is Rebif?
Rebif is a solution for injection in pre-filled syringes and cartridges. The syringes contain 8.8, 22 or 44 micrograms of the active substance interferon beta-1a. The cartridges contain a total of 66 or 132 micrograms of interferon beta-1a and are designed for multiple dosing via an electronic injector delivering 8.8, 22 or 44 micrograms per dose.
What is Rebif used for?
Rebif is indicated for the treatment of relapsing multiple sclerosis (MS). It is a type of multiple sclerosis in which the patient suffers from attacks (relapses), followed by symptom-free periods. The medicine has not been demonstrated to be effective in patients with secondary progressive MS (MS that occurs after MS with relapses) in the absence of exacerbations. Rebif should not be used in children under 12 years of age due to lack of information on the use of the medicine in this population.
The medicine can only be obtained with a prescription.
How is Rebif used?
Rebif treatment should be started under the supervision of a physician experienced in the treatment of MS. The recommended dose of Rebif is 44 micrograms three times a week by subcutaneous (under the skin) injection. The 22 microgram dose is recommended for patients who cannot tolerate the higher dose and for adolescents aged 12 to 16 years.
When starting treatment with Rebif for the first time, the dosage should be gradually increased to avoid adverse reactions, starting with 8.8 micrograms three times a week for the first two weeks, then continuing with 22 micrograms three times a week for the next two weeks. weeks. Special packs with the correct number of syringes or cartridges are available to start treatment. The electronic injector used with the cartridges is programmed to deliver the correct doses of Rebif at the start of treatment and during the standard dose phase.
The patient can inject Rebif himself if he has been instructed appropriately. The doctor may advise the patient to take an antipyretic analgesic before each injection and 24 hours after the injection in order to alleviate flu-like symptoms that may occur as an adverse reaction to treatment. All patients should be monitored at least once. every two years.
How does Rebif work?
MS is a nerve disease in which inflammation destroys the protective sheath that covers the nerves. This is called "demyelination." The active substance in Rebif, interferon beta-1a, belongs to the group of interferons. Interferons are substances. natural products produced by the body to help it cope with attacks such as viral infections. The mechanism of action of Rebif in MS is not yet fully understood, but interferon beta appears to calm the immune system and prevent MS recurrence.
Interferon beta-1a is produced by a method known as the "recombinant DNA technique": it is made from a cell that has been inserted into a gene (DNA) that allows it to produce interferon beta-1a. Interferon beta-1a analog acts in the same way as natural interferon beta.
How has Rebif been studied?
Rebif has been studied in 560 patients with relapsed MS. Patients had experienced at least two relapses in the previous 2 years. Patients were treated with Rebif (22 or 44 micrograms) or placebo (a dummy treatment) for two years. The study was subsequently extended to four years.
The number of patient relapses was considered as the main measure of effectiveness.
Rebif has also been studied in patients with secondary progressive MS. This study evaluated the drug's effectiveness in preventing the progression of disability over three years.
The company has not conducted formal studies in patients under the age of 16. However, it presented information from published studies on the use of Rebif in adolescents aged 12 to 18 years.
What benefit has Rebif shown during the studies?
Rebif was more effective than placebo in reducing the number of relapsing-remitting MS relapses. Relapse decreased by approximately 30% over two years with both Rebif 22 micrograms and Rebif 44 micrograms compared to placebo, and by 22% (Rebif 22 micrograms) and 29% (Rebif 44 micrograms) over four years.
In the study in patients with progressive MS, no significant effect on the progression of disability was observed, but the relapse rate decreased by approximately 30%. Some effects on disability progression were seen only in patients who had reported relapses in the two years prior to the start of the study.
Published studies have shown a decline in the relapse rate for patients aged 12 to 18 years. This decline may be related to Rebif treatment.
What is the risk associated with Rebif?
The most common side effects (seen in more than 1 in 10 patients) with Rebif are flu-like symptoms, neutropenia, lymphopenia and leukopenia (reduced number of white blood cells), thrombocytopenia (reduced number of platelets), anemia (reduced number of blood cells) reds), headache, inflammation and other reactions at the injection site, as well as increased transaminases (liver enzymes). Similar side effects have been observed in minors. For the full list of side effects reported with Rebif, see brochure.
Rebif must not be used in patients with a history of hypersensitivity (allergy) to natural or recombinant interferon beta or any of the other ingredients. Treatment with Rebif should not be started during pregnancy. Patients who become pregnant during therapy They should consult their doctor Furthermore, Rebif should not be taken by patients with severe depression or who are suicidal.
Why has Rebif been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Rebif's benefits are greater than its risks in the treatment of relapsing MS patients and therefore recommended that it be given marketing authorization.
Other information about Rebif:
On May 4, 1998, the European Commission granted Serono Europe Limited a "marketing authorization" for Rebif, valid throughout the European Union. The "marketing authorization" was renewed on May 4, 2003 and on 4 May 2008.
For the full version of Rebif's EPAR, click here.
Last update of this summary: 01-2009
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