Vedolizumab Injection

Vedolizumab injection is used to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) of the gastrointestinal tract including:

• Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) that has not improved when treated with other medications.
• ulcerative colitis (condition that causes swelling and sores in the lining of the large intestine) that has not improved when treated with other medications.

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.

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. It is usually given in a doctor's office once every 2 to 8 weeks, more often in the beginning of your treatment and less often as your treatment continues. Vedolizumab injection also comes as a prefilled syringe and prefilled pen to be given subcutaneously (under the skin). 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. It is usually given every 2 weeks when given subcutaneously.

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. You may be given other medications to treat reactions to vedolizumab injection. 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 trained on subcutaneous technique. Always look at 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. The liquid should not contain visible particles. 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 anywhere on front of your thighs (upper leg) or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. If someone else 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.

Vedolizumab prefilled syringes or pens should be stored 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.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with vedolizumab injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

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

Before taking vedolizumab,

• tell your doctor and pharmacist if you are allergic to vedolizumab, any other medications, or any of the ingredients in vedolizumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• 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.

Vedolizumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nausea
• joint or back pain
• pain in your arms and legs

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• fever, cough, runny nose, sore throat, chills, aches and other signs of infection
• red or painful skin or sores on your body
• pain during urination
• confusion or memory problems
• loss of balance
• changes in walking or speech
• decreased strength or weakness on one side of your body
• blurred vision or loss of vision
• extreme tiredness
• loss of appetite
• pain in the upper right part of the stomach
• unusual bruising or bleeding
• dark urine
• yellowing of the skin or eyes

Vedolizumab may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Entyvio^®