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What is Entyvio and how is it used?
Entyvio is a prescription medicine used in adults for the treatment of:
- moderately to severely active ulcerative colitis.
- moderately to severely active Crohn’s disease.
Entyvio (vedolizumab), an integrin receptor antagonist, is a humanized IgG1 monoclonal antibody produced in Chinese hamster ovary cells.
It is not known if Entyvio is safe and effective in children under 18 years of age.
What are the most important side effects and other facts about Entyvio?
Entyvio may cause serious side effects, including:
- Infusion-related and serious allergic reactions. These reactions can happen while you are receiving Entyvio 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 Entyvio and during treatment with Entyvio, 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). People with weakened immune systems can get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). Although unlikely while receiving Entyvio, a risk of PML cannot be ruled out. 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).
Other side effects of Entyvio
The most common side effects of Entyvio include:
- common cold,
- joint pain,
- infections of the nose and throat,
- back pain,
- sinus infection,
- throat pain, and
- pain in extremities.
These are not all of the possible side effects of Entyvio.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Entyvio?
- Entyvio is given through a needle placed in a vein (intravenous infusion) in your arm.
- Entyvio is given to you over a period of about 30 minutes.
- Your healthcare provider will monitor you during and after the Entyvio infusion for side effects to see if you have a reaction to the treatment.
Entyvio Contraindications, Pregnancy Safety and Drug Interactions
Do not receive Entyvio if you have had an allergic reaction to Entyvio or any of the ingredients in Entyvio. See the end of this Medication Guide for a complete list of ingredients in Entyvio.
Before receiving Entyvio, tell your healthcare 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 (see “What is the most important information I should know about Entyvio?”).
- 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 Entyvio.
- are pregnant or plan to become pregnant. It is not known if
Entyvio will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving
- Pregnancy Registry: There is a pregnancy registry for women who use Entyvio during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry or you may contact the registry at 1-877-825-3327 to enroll.
- are breastfeeding or plan to breastfeed. Entyvio can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Entyvio.
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.
Entyvio is a prescription medicine used in adults for the treatment of ulcerative colitis and Crohn’s disease. This drug may cause serious allergic reactions and increase your infection risk.
Multimedia: Slideshows, Images & Quizzes
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Related Disease Conditions
Ulcerative Colitis Diet Plan
An ulcerative colitis diet plan can help a person with the disease avoid foods and drinks that trigger flares. There also are foods that can soothe ulcerative colitis symptoms during a flare. Types of ulcerative colitis plans include a high-calorie diet, a lactose-free diet, a low-fat diet, a low-fiber diet (low-residue diet), or a low-salt diet. Self-management of ulcerative colitis using healthy lifestyle habits and a nutrient rich diet can be effective in management of the disease. Learn what foods to avoid that aggravate, and what foods help symptoms of the disease and increase bowel inflammation.
Second Source WebMD Medical Reference
Second Source article from Government
Ulcerative colitis is a chronic inflammation of the colon. Symptoms and signs include abdominal pain, diarrhea, and rectal bleeding. Ulcerative colitis is closely related to Crohn's disease, and together they are referred to as inflammatory bowel disease. Treatment depends upon the type of ulcerative colitis diagnosed.
Crohn's Disease vs. Ulcerative Colitis
Crohn's disease and ulcerative colitis are diseases that cause inflammation of part of or the entire digestive tract (GI). Crohn's affects the entire GI tract (from the mouth to the anus), while ulcerative colitis or ulcerative colitis only affects the large and small intestine and ilium. Researchers do not know the exact cause of either disease. About 20% of people with Crohn's disease also have a family member with the disease. Researchers believe that certain factors may play a role in causing UC. Both Crohn's disease and ulcerative colitis are a type of inflammatory bowel disease or IBD. Crohn's disease and ulcerative colitis both have similar symptoms and signs, for example, nausea, loss of appetite, fatigue, weight loss, episodic and/or persistent diarrhea, fever, abdominal pain and cramping, rectal bleeding, bloody stools, joint pain and soreness, eye redness, or pain. Symptoms unique to Crohn’s disease include anemia and skin changes. Symptoms of unique to ulcerative colitis include certain rashes, and an urgency to defecate (have a bowel movement). Doctors diagnose both diseases with similar tests and procedures. While there is no cure for either disease, doctors and other health care professionals can help you treat disease flares, and manage your Crohn's or ulcerative colitis with medication, diet, nutritional supplements, and/or surgery.
Crohn's disease is a chronic inflammatory disease, primarily involving the small and large intestine, but which can affect other parts of the digestive system as well. Abdominal pain, diarrhea, vomiting, fever, and weight loss are common symptoms and signs.
Is Crohn's Disease Contagious?
Crohn's disease, a form of inflammatory bowel disease (IBD), and is characterized by symptoms and signs that include diarrhea, fever, weight loss, vomiting, and abdominal pain. Though Crohn's disease is not contagious it can spread throughout a person's gastrointestinal tract. An increase in the above symptoms and signs warrants a visit to a doctor's office.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.