Generic name |
siponimod |
|
---|---|---|
Strength |
0.25 mg |
|
Form |
tablet |
Special Authority criteria |
Approval period |
---|---|
Treatment of patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features characteristic of multiple sclerosis inflammatory activity, to delay the progression of physical disability, only if ALL of the following conditions1 are met.
|
1 year Patients should be assessed for a response to siponimod every six months. |
Renewal criteria Siponimod may be renewed for patients who do not exhibit evidence of disease progression since the previous assessment. Disease progression is defined as an increase in the EDSS score of ≥ 1 point if the EDSS score was 3.0 to 5.0 at siponimod initiations, or an increase of ≥ 0.5 points if the EDSS score was 5.5 to 6.5 at siponimod initiation. |
1 year Patients should be assessed for a response to siponimod every six months. |
Discontinuation criteria In patients who exhibit either of the following:
|
|
1 Siponimod should NOT be used in combination with other disease-modifying treatments used to treat multiple sclerosis.