Active Ingredient: Vedolizumab
Vedolizumab 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 tumour necrosis factor-alpha (TNFα) antagonist.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
300 - 300 mg
From 300 To 300 mg once every 14 day(s)
The recommended dose regimen of vedolizumab is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.
Therapy for patients with ulcerative colitis should be discontinued if no evidence of therapeutic benefit is observed by week 10.
Some patients who have experienced a decrease in their response may benefit from an increase in dosing frequency to vedolizumab 300 mg every four weeks.
In patients who have responded to treatment with vedolizumab, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
If therapy is interrupted and there is a need to restart treatment with vedolizumab, dosing at every four weeks may be considered. The treatment interruption period in clinical trials extended up to one year. Efficacy was regained with no evident increase in adverse reactions or infusion-related reactions during retreatment with vedolizumab.
Vedolizumab is administered as an intravenous infusion over 30 minutes. Patients should be monitored during and after infusion
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