Uses

This medication is used to treat certain bowel disorders (ulcerative colitis, Crohn's disease). In these conditions, the body's defense system (immune system) attacks healthy tissues in the gut, causing symptoms such as abdominal pain, blood in the stool, and diarrhea. Vedolizumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking the actions of a certain natural substance (integrin) in the body. This helps to decrease swelling (inflammation) in the gut, which lessens symptoms and may slow or stop damage from these bowel disorders.

How To Use

Read the Patient Information leaflet if available from your pharmacist before you start using vedolizumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Take the medication out of the refrigerator at least 30 minutes before you inject it to allow it to reach room temperature. Protect the product from direct sunlight. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Inject this medication under the skin in the thigh, abdomen, or upper arm as directed by your doctor, usually once every 2 weeks.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is damaged, bruised, tender, hardened, or red, or into scars or moles. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder.

Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

Swelling or mild rash/itching at injection site, nausea, headache, flu/common cold symptoms, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• pain/numbness in your arms/legs
• symptoms of liver damage (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects:

• clumsiness
• loss of coordination/balance
• weakness
• sudden change in your thinking (such as confusion, difficulty concentrating, memory loss)
• difficulty talking/walking
• seizure
• vision changes

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using vedolizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• symptoms of infection (such as fever, chills, sore throat, cough, runny nose)
• current/past/returning infections (such as tuberculosis)

Vedolizumab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Tell your health care professional that you are using vedolizumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab, TNF blockers such as adalimumab/infliximab)

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. Use your next dose at the regular time from when you remembered to use your missed dose. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store in the refrigerator. Do not freeze. Do not use this medication if it has been frozen. Keep product in original carton to protect from light. Product may be kept at room temperature for up to 7 days. If kept at room temperature, product should be discarded if not used in 7 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).