Tolebrutinib

Chemical formula: C₂₆H₂₅N₅O₃  Molecular mass: 455.196 g/mol  PubChem compound: 124111565

Therapeutic indications

Tolebrutinib is indicated for:

Pregnancy

There are limited data available from the use of tolebrutinib in pregnant women. Tolebrutinib and/or its metabolites crossed the placenta in rabbits. Animal studies with tolebrutinib do not indicate reproductive toxicity. However, there is insufficient information on embryo-foetal development regarding the active metabolite M2, therefore, a risk to the unborn child cannot be excluded. Tolebrutinib is not recommended during pregnancy and in women of childbearing potential not using contraception.

Secondary progressive multiple sclerosis (SPMS)

Population group: only adults (18 years old or older)

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 (click for details):

Contraindications

Tolebrutinib is contraindicated in the following cases:

Lactation

Lactation

Moderate or severe hepatic impairment, ALT or AST >1.5 x ULN, ALP >2 x ULN, total bilirubin >1.5 x ULN

at least one of
Hepatic failure stage III
Hepatic failure stage IV
Elevated liver enzymes level
Serum alkaline phosphatase raised
Increased bilirubin level

Patients with severe immunodeficiency

Immunodeficiency disorder

Bone marrow disease

Bone marrow disorder

Severe, uncontrolled active infections

Infectious disease

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