Entyvio 300 mg powder for concentrate for solution for infusion
Each vial contains 300 mg of vedolizumab.
After reconstitution, each ml contains 60 mg of vedolizumab.
Vedolizumab is a humanised IgG1 monoclonal antibody that binds to the human α4β7 integrin and is produced in Chinese hamster ovary (CHO) cells.
For the full list of excipients, see section 6.1.
Powder for concentrate for solution for infusion.
White to off-white lyophilised cake or powder.
Ulcerative Colitis
Entyvio 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.
Crohn's Disease
Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn's disease 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.
Entyvio treatment should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of ulcerative colitis or Crohn's disease. Patients should be given the package leaflet and the Patient Alert Card.
Posology
Ulcerative Colitis
The recommended dose regimen of Entyvio is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.
Continued therapy for patients with ulcerative colitis should be carefully reconsidered if no evidence of therapeutic benefit is observed by Week 10 (see section 5.1).
Some patients who have experienced a decrease in their response may benefit from an increase in dosing frequency to Entyvio 300 mg every four weeks.
In patients who have responded to treatment with Entyvio, 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 Entyvio, dosing at every four weeks may be considered (see section 5.1). 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 (see section 4.8).
Crohn's disease
The recommended dose regimen of Entyvio is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.
Patients with Crohn's disease,
