Entyvio Dosage/Direction for Use

Dosage: Ulcerative colitis: The recommended dose regimen of 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 14. 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
Crohn's disease: 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. Patients with Crohn's disease, who have not shown a response may benefit from a dose of Vedolizumab 300 mg at Week 10. Continue therapy every eight weeks from Week 14 in responding patients. Therapy for patients should be discontinued if no evidence of therapeutic benefit is observed by Week 14. 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.
Corticosteroids: 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 Vedolizumab, dosing at every 4 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 events or infusion-related reactions during retreatment with Vedolizumab.
Method of administration: Vedolizumab is for intravenous infusion only. It is to be reconstituted and further diluted prior to intravenous administration. Vedolizumab is administered as an intravenous infusion over 30 minutes. Do not administer as an intravenous push or bolus. Vedolizumab lyophilized powder must be reconstituted with sterile water for injection and diluted in 250 mL of sterile 0.9% sodium chloride injection solution or 250 mL of sterile Lactated Ringer's solution prior to administration. After the infusion is complete, flush with 30 mL of sterile 0.9% sodium chloride injection solution or 30 mL of sterile Lactated Ringer's solution. Observe patients during infusion and until the infusion is complete.
Special Patient Populations: Pediatric patients: The safety and efficacy of Vedolizumab in children aged 0 to 17 years old have not been established.
Elderly patients: No dose adjustment is required in elderly patients. Population pharmacokinetic analyses showed no effect on age.
Impaired renal or hepatic function: Vedolizumab has not been studied in patients with renal or hepatic impairment.