Vedolizumab (ve-doe-LIZ-ue-mab)

Treats Crohn disease and ulcerative colitis.

Brand Name(s):

Entyvio, Entyvio Pen

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed into a vein or as a shot under your skin of your stomach, thigh, or upper arm.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are red, bruised, tender, damaged, hard, or areas with scars or moles.
• This medicine is available in 3 forms: vial, prefilled syringe, and prefilled pen.
• To use the prefilled pen:
  • Wash your hands with soap and water before and after using this medicine.
  • Allow 30 minutes for the pen to warm up to room temperature.
  • Peel off the paper on the tray and lift the pen straight out. Do not shake. Do not remove the purple cap.
  • Check the liquid in the pen. It should be colorless to pale yellow. Do not use it if it is cloudy, discolored, or has particles in it. Do not use the pen if it is damaged.
  • Pull off the purple cap. Do not put or press your thumb, fingers, or hands over the yellow needle shield. Do not put the purple cap back on.
  • Push the pen straight down and hold for 10 seconds. You may hear a first click when the injection starts. A second click, the injection is still ongoing. Continue holding the pen with pressure and watch the window turn purple to make sure you have received your full dose.
• To use the prefilled syringe:
  • Wash your hands with soap and water before and after using this medicine.
  • Allow 30 minutes for the pen to warm up to room temperature.
  • Do not lift from the purple plunger. Do not shake. Do not remove the needle cap.
  • Check the liquid in the syringe. It should be colorless to pale yellow. Do not use it if it is cloudy, discolored, or has particles in it. Do not use the syringe if it is damaged.
  • Pull the needle cap straight off. Do not touch or pull back the plunger.
  • Hold the syringe in one hand and pinch the skin around the injection site with the other hand.
  • Insert the needle at a 45 degree angle. Avoid touching the plunger until the needle is inserted.
  • Push the plunger all the way down. Keep pressure on the plunger and take the needle out of the skin.
  • Remove your thumb from the plunger to allow the needle guard to cover the needle.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose or if you are not able to inject this medicine at your regular scheduled time, inject it as soon as possible and then every 2 weeks thereafter. Call your doctor or pharmacist for instructions.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. If needed, the prefilled syringe or prefilled pen can be stored at room temperature for up to 7 days (including traveling).
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how vedolizumab works. Tell your doctor if you are using natalizumab or a tumor necrosis factor (TNF) blocker including adalimumab, certolizumab, etanercept, or infliximab.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease or an infection.
• This medicine may cause the following problems:
  • Higher risk of infection (including bacteria, virus, or fungus infection)
  • Risk of progressive multifocal leukoencephalopathy (brain disease)
  • Liver problems
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, confusion, dizziness, drowsiness, or unusual tiredness or weakness
• Change in how much or how often you urinate, bloody or cloudy urine, painful urination
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast, pounding, or uneven heartbeat
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches

If you notice these less serious side effects, talk with your doctor:

• Headache
• Joint pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088