What this product is and what it is used for Entyvio contains the active substance vedolizumab. Vedolizumab belongs to a group of biological medicines called monoclonal antibodies (MAbs). Vedolizumab blocks a protein on the surface of white blood cells that cause the inflammation in ulcerative colitis and Crohn’s disease, and so the amount of inflammation is reduced. Entyvio is used to treat the signs and symptoms in adults of: · moderately to severely active ulcerative colitis · moderately to severely active Crohn’s disease. Warnings and precautions: When you first receive this medicine and during the course of the treatment, also between doses, tell your doctor or nurse immediately if you: · have an infection, or think you have an infection, if you develop chills, shivering, persistent cough or a high fever. Some infections may become serious and possibly even life-threatening if left untreated. · experience signs of an allergic reaction or other reaction to the infusion such as wheezing, difficulty breathing, hives, itching, swelling or dizziness. These could occur during or after the infusion. For more detailed information, see infusion and allergic reactions in section 4. · Have a tiredness, loss of appetite, pain on the right side of your stomach (abdomen), dark urine or yellowing of the skin and eyes (jaundice). · are going to receive any vaccination or have recently had a vaccination. Entyvio may affect the way you respond to a vaccination. · have cancer, tell your doctor. Your doctor will have to decide if you can still be given Entyvio. · are not feeling any better as vedolizumab may take up to 14 weeks to work in some patients with very active Crohn’s disease. How to use this product. · The infusion will be given to you, by your doctor or nurse, through a drip in one of the veins in your arm (intravenous infusion) over about 30 minutes. · For your first 2 infusions, your doctor or nurse will monitor you closely during the infusion and for approximately 2 hours after you have completed the infusion. For all subsequent infusions (after the first two), you will be monitored during the infusion and for approximately 1 hour after you have completed the infusion. Dose and frequency Treatment with Entyvio is the same for ulcerative colitis and Crohn’s disease. The recommended dose is 300 mg of Entyvio given as follows (see table below): Treatment (infusion) number Timing of treatment (infusion) Treatment 1 0 weeks Treatment 2 2 weeks after Treatment 1 Treatment 3 6 weeks after Treatment 1 Further treatments Every 8 weeks Possible side effects: · common cold · joint pain · headache · cough · itching / itchiness · rash and redness How to store this product: Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month. Entyvio is given by a doctor or nurse and patients should not need to store or handle Entyvio. Entyvio is for single-use only. Unopened vial: Store in a refrigerator (2°C‑8°C). Keep the vial in the original carton in order to protect from light.