Entyvio 300 mg vedolizumab concentrate for infusion – single vial (refrigerated)

Entyvio contains the active substance VEDOLIZUMAB.

• • VEDOLIZUMAB belongs to a group of biological medicines called monoclonal antibodies (mabs).

How Entyvio works:

• • Entyvio works by blocking a protein on the surface of white blood cells that causes inflammation in ulcerative colitis , Crohn’s disease and pouchitis.

• • This reduces the inflammation.

What Entyvio Is Used For:

Entyvio is used to treat signs and symptoms in adults with:

• • Moderately to severely active ulcerative colitis

• • Moderately to severely active Crohn’s disease

• • Moderate to severe active chronic pouchitis

• • Ulcerative colitis:
    Ulcerative colitis is a disease that causes inflammation of the colon. If you have ulcerative colitis , you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, your doctor may give you Entyvio to reduce the signs and symptoms of your disease.

Crohn’s disease:

• • Crohn’s disease is a disease that causes inflammation in the digestive system.

• • If you have Crohn’s disease , you will first be given other medicines.

• • If you do not respond well enough or cannot tolerate these medicines, your doctor may give you Entyvio to reduce the signs and symptoms of your disease.

Pouchitt:

• • Pouchitt is a disease that causes inflammation of the lining of the pouch that was created during surgery to treat ulcerative colitis.

• • If you have pouchitis, you may first be given antibiotics.

• • If you do not respond well enough to antibiotics, your doctor may give you Entyvio to reduce the signs and symptoms of your disease.

How To Use:

• • Treatment with Entyvio is similar for ulcerative colitis , Crohn’s disease and pouchitis.

The recommended dose is 300 mg of Entyvio given as follows:

• • Your doctor may consider changing this treatment regimen depending on how well Entyvio works for you.

• • The infusion will be given to you by a doctor or nurse via a drip in a vein in your arm ( intravenous infusion) over approximately 30 minutes.

• • For the first two infusions, a doctor or nurse will closely monitor you during the infusion and for approximately 2 hours after the infusion has ended.

• • For all subsequent infusions (after the first 2), you will be monitored during the infusion and for approximately 1 hour after the end of the infusion.

If you have forgotten or miss an infusion with Entyvio:

• • If you forget or miss an appointment to receive an infusion, get a new appointment as soon as possible.

If you stop treatment with Entyvio:

• • You should not stop treatment with Entyvio without talking to your doctor first.

• Ask your doctor or nurse if you have any questions about the use of this medicine.

Ingredients:

• • The active substance is VEDOLIZUMAB.

• • Each vial contains 300 mg of VEDOLIZUMAB.

What Entyvio looks like and the contents of the pack:

• • Entyvio is a white to off-white powder to concentrate for infusion solution that comes in a vial with a rubber stopper and a plastic cap.

• Each box of Entyvio contains one vial.