vedolizumab

What is the most important information I should know about vedolizumab?

Tell your caregivers if you have any reactions during the injection, such as dizziness, nausea, itching, headache, chest tightness, trouble breathing, or swelling in your face.

What is vedolizumab?

Vedolizumab is used in adults with moderate to severe ulcerative colitis (UC), or moderate to severe Crohn's disease.

Vedolizumab treats active disease and may help keep UC or Crohn's symptoms under control long term. Vedolizumab may also reduce the need for steroid medicines in helping to control symptoms long term.

Vedolizumab is usually given after other treatments have failed.

Vedolizumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving vedolizumab?

Tell your doctor if you have ever had:

• an active or recent infection;
• liver disease;
• signs of infection such as fever, cough, or flu symptoms;
• if you are scheduled to receive any vaccines.

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

You should be up to date with all needed vaccinations before receiving vedolizumab.

Tell your doctor if you are pregnant or plan to become pregnant. Having active UC or Crohn's disease during pregnancy may increase the risk of premature birth or low birth weight. The benefit of treating these conditions may outweigh any risks to the baby.

If you use vedolizumab while you are pregnant, make sure any doctor caring for your new baby knows that you used the medicine during pregnancy. Being exposed to vedolizumab in the womb could affect your baby's vaccination schedule during the first few months of life.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of vedolizumab on the baby.

Tell your doctor if you are breastfeeding.

How is vedolizumab given?

Before you start treatment with vedolizumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Vedolizumab is given as an infusion into a vein, usually once every 2 to 8 weeks. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 30 minutes to complete.

You will be watched closely for a short time after receiving vedolizumab, to make sure you do not have an allergic reaction.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 14 weeks of treatment.

What happens if I miss a dose?

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving vedolizumab?

Do not receive a "live" vaccine while using vedolizumab, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

You may receive "killed-virus" vaccines such as a flu shot, polio vaccine, rabies vaccine, or hepatitis A vaccine. Ask your doctor before receiving any vaccine while you are being treated with vedolizumab.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

What are the possible side effects of vedolizumab?

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

• fever, chills, body aches, cold or flu symptoms, mouth and throat ulcers, skin sores;
• pain, warmth, swelling, or oozing around your anal area;
• nausea, vomiting, severe diarrhea, diarrhea that is watery or bloody, stomach cramps, weight loss;
• cough, pain when swallowing; or
• liver problems --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• fever, sore throat, flu symptoms;
• cold symptoms such as stuffy nose, sinus pain, sneezing;
• cough with mucus, shortness of breath, chest discomfort;
• pain in your arms or legs;
• tiredness;
• headache, joint pain, back pain;
• rash, itching; or
• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect vedolizumab?

Tell your doctor about all your other medicines, especially:

• natalizumab;
• medicines to treat psoriasis or rheumatoid arthritis, such as etanercept or golimumab;
• other medicines to treat Crohn's disease or ulcerative colitis, such as adalimumab, certolizumab, infliximab; or
• other drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may affect vedolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about vedolizumab.