ENTYVIO® (Non-English)

Treatment with Entyvio is the same for ulcerative colitis, Crohn’s disease, and pouchitis. The recommended dose is 300 mg of Entyvio. Entyvio 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. Your healthcare provider will monitor you during and after the Entyvio infusion for side effects to see if you have a reaction to the treatment.

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
• Moderately to severely active chronic pouchitis

Entyvio contains the active substance vedolizumab. Vedolizumab belongs to a group of biological medicines called monoclonal antibodies (MAbs). Entyvio works by blocking a protein on the surface of white blood cells that cause inflammation in ulcerative colitis, Crohn’s disease, and pouchitis. This reduces the amount of inflammation.

Instructions for administration:

• After removing the pre-filled syringe or pre-filled pen from the refrigerator, wait 30 minutes before injecting to allow the solution to reach room temperature.
• Do not leave the pre-filled syringe or pre-filled pen in direct sunlight.
• Do not freeze. Do not use if it has been frozen.
• Inspect the solution visually for particulate matter and discoloration prior to administration. The solution should be colorless to yellow. Do not use pre-filled syringe or pre-filled pen with visible particulate matter or discoloration.
• Each pre-filled syringe or pre-filled pen is for single use only.
• Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Contraindications

• Hypersensitivity to the active substance.
• Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML).

After-care

The most common side effects of ENTYVIO include common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all the possible side effects of ENTYVIO. Call your healthcare provider for medical advice about side effects.