Vedolizumab Intravenous

In the U.S.

• Entyvio

Available Dosage Forms:

• Powder for Solution

Pharmacologic Class: Monoclonal Antibody

A doctor or other trained health professional will give you vedolizumab. It is given through a needle that is placed in one of your veins.

vedolizumab should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Body aches or pain
• chills
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Back pain
• chest tightness
• flushing
• nausea and vomiting
• weakness

• Cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• tightness in the chest

• Abdominal or stomach pain
• blurred vision
• clay-colored stools
• confusion
• convulsions
• dark urine
• drowsiness
• headache
• loss of appetite
• lower back or side pain
• painful or difficult urination
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty with moving
• muscle pain or stiffness
• pain in the joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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 Vedolizumab Solution, Reconstituted (Recon Soln)

Read the Medication Guide provided by your pharmacist before you start using vedolizumab and each time you get a treatment. If you have any questions, ask your doctor or pharmacist. Discuss the risks and benefits of vedolizumab treatment.

Before starting treatment with vedolizumab, you should be up to date with all your vaccinations. Ask your doctor if you need to receive any vaccines before starting vedolizumab.

This medication is given by injection into a vein by a health care professional. It should be injected slowly over 30 minutes. After the first dose, you will usually receive the next two doses 2 weeks and 6 weeks later. After the third dose, this medication is given as directed by your doctor, usually every 8 weeks.

Serious allergic reactions can happen during or even several hours after your treatment. Careful monitoring by your doctor may decrease your risk. If you have a serious reaction, your treatment will be temporarily stopped. Get medical help right away if you have shortness of breath, fast heartbeat, flushing, or rash/itching.

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 improve or if it worsens.

See also How to Use section.

Nausea, headache, flu/common cold symptoms, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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: mouth/throat pain, pain in your arms/legs, symptoms of liver damage (such as persistent nausea/vomiting, 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 fever, chills, persistent sore throat, 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.