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Treatment should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of ulcerative colitis, Crohn's disease or pouchitis (see Precautions). Patients should be given the package leaflet and the Patient Alert Card.
Posology: Ulcerative colitis: 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 (see Pharmacology: Pharmacodynamics under Actions).
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.
Retreatment: If therapy is interrupted and there is a need to restart treatment with intravenous vedolizumab, dosing at every 4 weeks may be considered (see Pharmacology: Pharmacodynamics under Actions). 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 (see Adverse Reactions).
Crohn's disease: 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.
Patients with Crohn's disease, who have not shown a response may benefit from a dose of intravenous vedolizumab at Week 10 (see Precautions). Therapy should be continued every 8 weeks from Week 14 in responding patients. Therapy for patients with Crohn's disease should be discontinued if no evidence of therapeutic benefit is observed by Week 14 (see Pharmacology: Pharmacodynamics under Actions).
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.
Retreatment: If therapy is interrupted and there is a need to restart treatment with intravenous vedolizumab, dosing at every 4 weeks may be considered (see Pharmacology: Pharmacodynamics under Actions). 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 (see Adverse Reactions).
Pouchitis: 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.
Treatment with vedolizumab should be initiated in parallel with standard of care antibiotic (e.g., four-week of ciprofloxacin) (see Pharmacology: Pharmacodynamics under Actions).
Discontinuation of treatment should be considered if no evidence of therapeutic benefit is observed by 14 weeks of treatment with vedolizumab.
Retreatment: There are no retreatment data available in patients with pouchitis.
Special populations: Elderly patients: No dose adjustment is required in elderly patients. Population pharmacokinetic analyses showed no effect of age (see Pharmacology: Pharmacokinetics under Actions).
Patients with renal or hepatic impairment: Vedolizumab has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population: The safety and efficacy of vedolizumab in children aged 0 to 17 years old have not been established. No data are available.
Method of administration: Entyvio 300 mg powder for concentrate for solution for infusion is for intravenous use only. It is to be reconstituted and further diluted prior to intravenous administration.
Entyvio 300 mg powder for concentrate for solution for infusion is administered as an intravenous infusion over 30 minutes. Patients should be monitored during and after infusion (see Precautions).
For instructions on reconstitution and dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.
