Entyvio Dosage/Direction for Use

Posology: Infusion concentrate: 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.
Solution for injection: Entyvio treatment should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of ulcerative colitis or Crohn's disease (see Precautions).
Ulcerative colitis and Crohn's disease: 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 maintenance dose should be administered in place of the next scheduled intravenous dose and every 2 weeks thereafter.
For the intravenous dose regimen, see previously mentioned Dosage & Administration of the Entyvio 300 mg powder for concentrate for solution for infusion.
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.
Retreatment and missed dose(s): 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 studies extended up to 46 weeks with no evident increase in adverse reactions or injection site reactions during re-initiation of treatment with subcutaneous vedolizumab (see Adverse Reactions).
Method of administration: Infusion concentrate: 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.
Solution for injection: Entyvio solution for injection (in a pre-filled pen) is for subcutaneous injection only.
After proper training on correct subcutaneous injection technique, a patient or caregiver may inject with subcutaneous vedolizumab if their physician determines it is appropriate. Comprehensive instructions for administration using the pre-filled pen are given in the respective package leaflet.
For further instructions on preparation and special precautions for handling, see Special precautions for disposal and other handling under Cautions for Usage.
Special Patient Populations: Pediatric patients: The safety and efficacy of Vedolizumab in children aged 0 to 17 years old have not been established.
Solution for injection: No data are available.
Elderly patients: No dose adjustment is required in elderly patients. Population pharmacokinetic analyses showed no effect on age (see Pharmacology: Pharmacokinetics under Actions).
Impaired renal or hepatic function: Vedolizumab has not been studied in patients with renal or hepatic impairment. No dose recommendations can be made.