Entyvio 108 mg vedolizumab pre‑filled pens × 2 (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 and Crohn’s disease.

• • This reduces 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

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.

How To Use:

• Always use this medicine exactly as your doctor or pharmacist has told you.
• Contact a doctor or pharmacist if you are unsure.
• You or your caregiver will be trained on how to inject Entyvio under the skin ( subcutaneously ).

How much Entyvio you should get

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

The recommended dose is 108 mg of Entyvio administered by subcutaneous injection every two weeks.

• • At the beginning of the treatment, the doctor will give you the first doses of Entyvio via a drip into a vein in your arm ( intravenous infusion) lasting approximately 30 minutes.

• • After at least 2 intravenous infusions, you can start receiving Entyvio as a subcutaneous injection.

• • The first subcutaneous injection is given at the time of the next scheduled intravenous infusion and every two weeks thereafter.

Injecting Entyvio:

• • The first injections can be given by yourself or a carer after you have received training on how to do it. There are instructions at the end of the package insert.

If you have forgotten to insert or miss an injection with Entyvio:

• • If you forget or miss a dose, the next dose should be injected as soon as possible and then every two weeks.

If you stop treatment with Entyvio:

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

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

Ingredients:

• VEDOLIZUMAB 180mg.