Active Ingredient: Tolebrutinib
Tolebrutinib is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) without relapses in the last 2 years.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 60 milligrams tolebrutinib, once daily to meals.
The recommended dose is 60 mg orally once daily with a meal. Liver monitoring should be performed before and during treatment.
The following table summarises recommendations for dose adjustment and monitoring for patients who develop elevated transaminases during therapy.
Therapy modifications and monitoring for elevated transaminases:
| Laboratory abnormalities | Therapy modifications |
| • ALT† or AST† > 3 x and ≤ 5 x ULN† with clinical symptoms‡ OR with concurrent total bilirubin > 2x ULN • ALT or AST > 5 x ULN | • Withhold treatment. • Repeat labs every 2-3 days until ALT or AST down-trending and monitor weekly until ALT or AST less than 1.5 x ULN. • Investigate to identify probable causes. If an alternative cause other than drug-induced liver injury (DILI) is identified, reinitiation of treatment can be considered when ALT or AST decreases to less than 1.5 x ULN. Upon reinitiation of treatment, if ALT or AST greater than 3 x ULN, permanently discontinue treatment. |
| If no alternative cause to DILI is identified: • Permanently discontinue treatment if any of the following occurred as the initial event: o ALT or AST greater than 8 x ULN o ALT or AST greater than 5 x ULN for greater than 2 weeks o ALT or AST greater than 3 x ULN and total bilirubin greater than 2 x ULN • If the above criteria are not met, continue treatment as clinically indicated. |
† ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal
‡ Fatigue, nausea, vomiting, abdominal pain or tenderness, fever, rash, anorexia, jaundice, and/or eosinophilia
If a dose is missed on the intended time of day, take the dose as soon as possible on the same day. Do not double the dose the next day to make up for a missed dose.
It must be taken with a meal preferably at the same time each day.
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