Generic Name: vedolizumab
Date of Approval: May 19, 2014
Company: Takeda Pharmaceutical Company Limited

Treatment for: Ulcerative Colitis and Crohn’s Disease

FDA Approves Entyvio

The United States Food and Drug Administration (FDA) has approved Entyvio (vedolizumab), a new biologic therapy for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease, conditions marked by inflammation in the lining of the gastrointestinal tract.

Vedolizumab, an integrin receptor antagonist, is a humanized monoclonal antibody that works as a selective adhesion molecule blocker - blocking the interaction of a specific integrin receptor (α4β7 which is expressed on circulating inflammatory cells) with a specific protein (MAdCAM-1 which is expressed on cells in the interior wall of blood vessels), and thereby blocking the migration of those circulating inflammatory cells across those blood vessels and into areas of inflammation in the gastrointestinal tract. The interaction of the α4β7 integrin with MAdCAM-1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn’s disease.

Entyvio is used to treat adult patients with moderately to severely active ulcerative colitis, and Crohn‘s disease when one or more standard therapies (corticosteroids, immunomodulators, or tumor necrosis factor blocker medications) have not resulted in an adequate response.

Another less specific adhesion molecule blocker used to treat Crohn‘s disease is natalizumab (Tysabri) but is rarely prescribed because it increases the risk of progressive multifocal leukoencephalopathy (PML), a viral brain infection that usually results in death or severe disability. Although no cases of PML have been observed in vedolizumab clinical trials, the risk cannot be ruled out and patients must be monitored for any new or worsening neurological signs or symptoms. A similar drug called etrolizumab is undergoing clinical trials and being more specific to the gut, should help eliminate the risk of PML.

Entyvio is an intravenous infusion administered over approximately 30 minutes at zero, two and six weeks, then every eight weeks thereafter. Patients should be observed during infusion and until the infusion is complete as hypersensitivity reactions including anaphylaxis have occurred.

The most common adverse reactions reported with Entyvio were nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.

Entyvio is marketed by Takeda Pharmaceuticals North America, Inc.

Entyvio Medication Guide

Read this Medication Guide before you start using this medicine and each time you receive it. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Important information

Entyvio may cause serious side effects, including:

  • Infusion and serious allergic reactions. These reactions can happen while you are receiving the infusion 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 Entyvio: 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. Entyvio may increase your risk of getting a serious infection. Before receiving the infusion and anytime during treatment, 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 Entyvio. 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).

What is Entyvio?

Entyvio is a prescription medicine used in adults with moderate to severe active ulcerative colitis or Crohn’s disease when certain other medicines have not worked well enough or cannot be tolerated. It is not known if it is safe and effective in children under 18 years of age.

Who should not receive Entyvio?

Do not receive Entyvio if you have had an allergic reaction to vedolizumab or any of the other ingredients in the injection. See the end of this Medication Guide for a complete list of ingredients.

Before receiving the infusion, tell your health care provider about all of your medical conditions, including if you:

  • 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.
  • are pregnant or plan to become pregnant. Pregnancy category B. It is not known if Entyvio will harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment.
  • are breastfeeding or plan to breastfeed. It is not known if Entyvio passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you take or have recently taken Tysabri (natalizumab), a Tumor Necrosis Factor (TNF) blocker medicine, a medicine that weakens your immune system (immunosuppressant), or corticosteroid medicine.

How will I receive Entyvio?

  • Entyvio is given through a needle placed in a vein (intravenous infusion) in your arm. It is given to you over a period of about 30 minutes.
  • you will be monitored during and after the infusion for side effects to see if you have a reaction to the treatment.

Entyvio side effects

Entyvio may cause serious side effects, see Important information above.

The most common side effects include: 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, and pain in extremities.

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

General information about Entyvio

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about that is written for health professionals.

What are the ingredients?

Active ingredient: vedolizumab

Inactive ingredients: L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, sucrose and polysorbate 80