Vedolizumab injection is used to treat:

• Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever).
• ulcerative colitis (condition that causes swelling and sores in the lining of the large intestine).

Vedolizumab injection is in a class of medications called integrin receptor antagonists. It works by blocking the action of certain cells in the body that cause inflammation.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Vedolizumab injection comes as a powder to be mixed with sterile water and injected intravenously (into a vein) over 30 minutes by a doctor or nurse and as a prefilled syringe and prefilled pen to be injected subcutaneously (under the skin). It is given once every 2 to 8 weeks. Your doctor may switch you from intravenous to subcutaneous injection at 6 weeks after 2 previous doses of intravenous vedolizumab given at weeks 0 and 2.

Vedolizumab injection (intravenous) may cause serious allergic reactions during an infusion and for several hours afterward. A doctor or nurse will monitor you during this time to be sure you are not having a serious reaction to the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms during or after your infusion: rash; itching; swelling of the face, eyes, mouth, throat, tongue, or lips; difficulty breathing or swallowing; wheezing, flushing; dizziness; feeling hot; or a fast or racing heartbeat.

Vedolizumab injection can be given subcutaneously at home by patients or caregivers. Always inspect vedolizumab prefilled syringe or pen before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless or slightly yellow. . Do not use a dosing pen or syringe if it is expired, appears damaged, or if the liquid is cloudy, discolored, or contains particles.

You can inject vedolizumab injection subcutaneously anywhere on front of your thighs (upper leg) or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. If a caregiver is giving you the injection, that person can also inject the medication into your upper, outer arms. Use a different site for each injection to reduce the chances of soreness or redness. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.

Store vedolizumab prefilled syringes or pens in the refrigerator. Remove the prefilled dosing pen or syringe from the refrigerator and allow it to warm to room temperature for 30 minutes before using it. Take it out of its carton, and allow it to rest on a flat surface so that it can warm to room temperature. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method. Vedolizumab prefilled syringes or pens can be left at room temperature for up to 7 days. Any used syringes need to be thrown away after 7 days at room temperature.

Do not remove the cap from the prefilled dosing pen while the medication is warming. You should remove the cap right before you inject the medication. Do not replace the cap after you remove it. Do not use the device if you drop it on the floor.

Never shake the prefilled dosing pen. This may damage the medication.

Vedolizumab injection may help control your symptoms, but it will not cure your condition. Your doctor will watch you carefully to see how well vedolizumab injection works for you. If your condition has not improved after 14 weeks, your doctor may stop treating you with vedolizumab injection. It is important to tell your doctor how you are feeling during your treatment.

You will be given the MedicationGuide. Readthe information carefully and ask your doctor or pharmacist if you have any questions.

Before taking vedolizumab,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving vedolizumab injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have liver problems, if you have tuberculosis or have been in close contact with someone with tuberculosis, or if you currently have or think you have an infection, or if you have infections that come and go or ongoing infections that do not go away.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking vedolizumab, call your doctor.

• ask your doctor whether you should receive any vaccinations before you begin your treatment with vedolizumab injection. If possible, all vaccinations should be brought up to date before beginning treatment. Do not have any vaccinations during your treatment without talking to your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive a vedolizumab infusion, call your doctor as soon as possible. If you miss a subcutaneous dose of vedolizumab injection, inject it as soon as you remember and then administer every 2 weeks thereafter.

Store prefilled syringes and pens in the refrigerator. Do not freeze or use any syringes or pens that have been frozen. Keep unused syringes and pens in original packaging until ready to use. Vedolizumab prefilled syringes and pens may be left at room temperature for up to 7 days. Discard unused pens or syringes left at room temperature after 7 days.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about vedolizumab.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.