Ustekinumab

Chemical formula: C₁₄H₁₈Cl₃N₅O₂

Therapeutic indications

Ustekinumab is indicated for:

Crohn's disease

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

Ustekinumab is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

260-520 mg initial intravenous dose once based on body weight, 90 mg subcutaneous dose at week 8 and thereafter every 8-12 weeks

Plaque psoriasis

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

Ustekinumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A).

For this indication, competent medicine agencies globally authorize below treatments (click for details):

45 or 90 mg once as initial dose, followed by 45 mg 4 weeks later, and thereafter 45 mg every 12 weeks

Paediatric plaque psoriasis

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old)

Ustekinumab is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

0.75 mg/kg for patients weighting <60 kg, 45 mg for patients weighting ≥60 - ≤100 kg and 90 mg for patients weighting >100 kg at Weeks 0 and 4, then every 12 weeks thereafter

Psoriatic arthritis

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

Ustekinumab, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifyin anti-rheumatic drug (DMARD) therapy has been inadequate.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

45 or 90 mg once for 4 weeks and thereafter 45 mg every 12 weeks

0.75 mg/kg for patients weighting <60 kg, 45 mg for patients weighting ≥60 and 90 mg for patients weighting >100 kg with co-existent plaque psoriasis, at Weeks 0 and 4, then every 12 weeks thereafter

Ulcerative colitis

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

Ustekinumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

260-520 mg initial intravenous dose once based on body weight, 90 mg subcutaneous dose at week 8 and thereafter every 8-12 weeks

Contraindications

Ustekinumab is contraindicated in the following cases:

Active infection

Lactation

Lactation

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