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:
For:
Regimen A: Subcutaneous, 108 milligrams vedolizumab, once every 2 weeks.
Regimen B: Intravenous, 300 milligrams vedolizumab, one dose, over the duration of 2 weeks. Afterwards, intravenous, 300 milligrams vedolizumab, one dose, over the duration of 4 weeks. Afterwards, intravenous, 300 milligrams vedolizumab, one dose, over the duration of 8 weeks. Afterwards, intravenous, 300 milligrams vedolizumab, once every 8 weeks.
The recommended dose regimen of subcutaneous vedolizumab as a maintenance treatment, following at least 2 intravenous infusions, is 108 mg administered by subcutaneous injection once every 2 weeks. The first subcutaneous dose should be administered in place of the next scheduled intravenous dose and every 2 weeks thereafter.
Insufficient data are available to determine if patients who experience a decrease in response on maintenance treatment with subcutaneous vedolizumab would benefit from an increase in dosing frequency.
There are no data on transition of patients from subcutaneous vedolizumab to intravenous vedolizumab during maintenance treatment.
In patients who have responded to treatment with vedolizumab, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
If treatment with subcutaneous vedolizumab is interrupted or if a patient misses a scheduled dose(s) of subcutaneous vedolizumab, patient should be advised to inject the next subcutaneous dose as soon as possible and then every 2 weeks thereafter. The treatment interruption period in clinical trials extended up to 46 weeks with no evident increase in adverse reactions or injection site reactions during re-initiation of treatment with subcutaneous vedolizumab.
The recommended dose regimen of intravenous vedolizumab is 300 mg administered by intravenous infusion at 0, 2 and 6 weeks and then every 8 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 intravenous vedolizumab 300 mg every 4 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 intravenous vedolizumab, dosing at every 4 weeks may be considered. The treatment interruption period in clinical trials extended up to 1 year. Efficacy was regained with no evident increase in adverse reactions or infusion-related reactions during retreatment with vedolizumab.
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