Ulcerative colitis

Active Ingredient: Adalimumab

Indication for Adalimumab

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

Adalimumab is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

For this indication, competent medicine agencies globally authorize below treatments:

160 mg at Week 0 and 80 mg at Week 2, 40 - 80 mg every other week

Route of admnistration

Subcutaneous

Defined daily dose

40 - 160 mg

Dosage regimen

From 40 To 160 mg once every 14 day(s)

Loading dose

160 mg

Maintenance dose

40 mg

Detailed description

The recommended adalimumab induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at Week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at Week 2 (given as two 40 mg injections in one day). After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.

During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.

Some patients who experience decrease in their response to adalimumab 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.

Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment. adalimumab therapy should not be continued in patients failing to respond within this time period.

Adalimumab may be available in other strengths and/or presentations depending on the individual treatment needs.

Active ingredient

Adalimumab

Adalimumab binds specifically to TNF and neutralizes the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM).

Read more about Adalimumab

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