Active Ingredient: Interferon beta-1b
Interferon beta-1b is indicated for the treatment of:
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
62.5 - 250 ug
From 62.5 To 250 ug once every 2 day(s)
The recommended dose of interferon beta 1b is 250 microgram, to be injected subcutaneously every other day.
Generally, dose titration is recommended at the start of treatment.
Patients should be started at 62.5 microgram subcutaneously every other day, and increased slowly to a dose of 250 microgram every other day (see Table A). The titration period may be adjusted, if any significant adverse reaction occurs. In order to obtain adequate efficacy, a dose of 250 microgram every other day should be reached.
Table A. Schedule for dose titration*:
| Treatment day | Dose |
|---|---|
| 1, 3, 5 | 62.5 microgram |
| 7, 9, 11 | 125 microgram |
| 13, 15, 17 | 187.5 microgram |
| ≥19 | 250 microgram |
* The titration period may be adjusted if any significant adverse reaction occurs.
The optimal dose has not been fully clarified.
At the present time, it is not known for how long the patient should be treated. There are follow-up data under controlled clinical conditions for patients with relapsing-remitting multiple sclerosis for up to 5 years and for patients with secondary progressive multiple sclerosis for up to 3 years. For relapsing-remitting multiple sclerosis, efficacy has been demonstrated for therapy for the first two years. The available data for the additional three years are consistent with sustained treatment efficacy of interferon beta 1b over the whole time period.
In patients with a single clinical event suggestive of multiple sclerosis, efficacy has been demonstrated over a period of three years.
Treatment is not recommended in patients with relapsing-remitting multiple sclerosis who have experienced less than 2 relapses in the previous 2 years or in patients with secondary-progressive multiple sclerosis who have had no active disease in the previous 2 years.
If the patient fails to respond, for example a steady progression in Expanded Disability Status Scale (EDSS) for 6 months occurs or treatment with at least 3 courses of adrenocorticotropic hormone (ACTH) or corticosteroids during a one-year period is required despite interferon beta 1b therapy, treatment with interferon beta 1b should be stopped.
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