Vedolizumab

Vedolizumab is a prescription medication used to treat patients with ulcerative colitis and Crohn’s disease.

Vedolizumab belongs to a group of drugs called integrin receptor antagonist. These work by blocking the migration of inflammatory cells into areas of inflammation in the gastrointestinal tract.

Vedolizumab is available in an injectable form to be given directly into a vein (IV) by a healthcare professional at zero, two and six weeks and then every eight weeks thereafter.

Common side effects of vedolizumab include common cold, headache, joint pain, nausea, and fever.

Vedolizumab is a prescription medication used to in patients with moderate to severe active ulcerative colitis when certain other ulcerative colitis medicines have not worked well enough or cannot be tolerated.

Vedolizumab is also used in patients with moderate to severe active Crohn’s disease when certain other Crohn’s disease medicines have not worked well enough or cannot be tolerated.

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

Vedolizumab may be found in some form under the following brand names:

• Entyvio

Serious side effects have been reported with vedolizumab. See the “Vedolizumab Precautions” section.

Common side effects of vedolizumab include the following:

• common cold
• headache
• joint pain
• nausea
• fever
• infections of the nose and throat
• tiredness
• cough
• bronchitis
• flu
• back pain
• rash
• itching
• sinus infection
• throat pain
• pain in extremities

This is not a complete list of vedolizumab side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Tysabri (natalizumab)
• Tumor Necrosis Factor (TNF) blocker medicine such as Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab)
• A medicine that weakens your immune system (immunosuppressant)
• Corticosteroid medicines
• Live vaccines

This is not a complete list of vedolizumab drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with vedolizumab including the following:

• Infusion and serious allergic reactions. These reactions can happen while you are receiving vedolizumab or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of vedolizumab: rash, itching, swelling of your lips, tongue throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing).

• Infections. Vedolizumab may increase your risk of getting a serious infection. Before receiving vedolizumab and during treatment with vedolizumab, tell your healthcare provider if you think you have an infection or have symptoms of an infection such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination.
• Progressive Multifocal Leukoencephalopathy (PML). Although it has not been reported with vedolizumab, it may be possible for a person to get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision.
• Liver Problems. Liver problems can happen in people who receive vedolizumab. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your stomach (abdomen), dark urine, or yellowing of the skin and eyes (jaundice).

Do not take vedolizumab if you:

• are allergic to vedolizumab or to any of its ingredients
• have had an allergic reaction to vedolizumab or any of the ingredients in vedolizumab

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of vedolizumab, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking vedolizumab, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to vedolizumab or to any of its ingredients
• have an infection, think you may have an infection or have infections that keep coming back
• have liver problems
• have tuberculosis (TB) or have been in close contact with someone with TB
• have recently received or are scheduled to receive a vaccine. Talk to your healthcare provider about bringing your vaccines up-to-date before starting treatment with vedolizumab.
• are pregnant or plan to become pregnant. It is not known if vedolizumab. will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving vedolizumab.
• are breastfeeding or plan to breastfeed. It is not known if vedolizumab passes into your breast milk.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Vedolizumab falls into category B. There are no well-done studies that have been done in humans with vedolizumab. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if vedolizumab crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using vedolizumab.

Vedolizumab is available in an injectable form to be given directly into a vein (IV) or muscle (IM) by a healthcare professional.

If you miss a dose, be sure to make a follow-up appointment.

The recommended dosage of Entyvio (vedolizumab) in adults with ulcerative colitis or Crohn's disease is 300 mg administered into a vein (IV) at zero, two and six weeks and then every eight weeks thereafter.

If vedolizumab is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention

Keep all of your doctors and laboratory appointments.