Entyvio vedolizumab

Get an overview of ENTYVIO (vedolizumab injection, powder, lyophilized, for solution), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Entyvio can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Entyvio.

Drug Basics

Brand Name: Entyvio

Generic Name: VEDOLIZUMAB

Drug Type: HUMAN PRESCRIPTION DRUG

Route: INTRAVENOUS

Dosage Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Data Current As Of: 2020-04-13

Warnings and Precautions
  Infusion-Related Reactions and Hypersensitivity Reactions (5.1)
03/2020
  Progressive Multifocal Leukoencephalopathy (5.3) 03/2020

indications & usage

ENTYVIO is indicated in adults for the treatment of:

  • moderately to severely active ulcerative colitis.
  • moderately to severely active Crohn's disease.

ENTYVIO is an integrin receptor antagonist indicated in adults for the treatment of:

  • moderately to severely active ulcerative colitis. (1)
  • moderately to severely active Crohn's disease. (1)

drug interactions

natalizumab

Because of the potential for increased risk of PML and other infections, avoid the concomitant use of ENTYVIO with natalizumab.

tnf blockers

Because of the potential for increased risk of infections, avoid the concomitant use of ENTYVIO with TNF blockers.

live vaccines

Live vaccines may be administered concurrently with ENTYVIO only if the benefits outweigh the risks [see Warnings and Precautions (5.5)].

patient counseling information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Infusion-Related and Hypersensitivity Reactions

Instruct patients to report immediately if they experience symptoms consistent with a hypersensitivity reaction during or following an infusion of ENTYVIO [see Warnings and Precautions (5.1)].

Infections

Inform patients that they may be more likely to develop infections when taking ENTYVIO. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of an infection [see Warnings and Precautions (5.2)].

Progressive Multifocal Leukoencephalopathy

Inform patients that progressive multifocal leukoencephalopathy (PML) has occurred in patients who received some integrin receptor antagonist and systemic immunosuppressant products. Instruct patients to report if they experience any new onset or worsening of neurological signs and symptoms immediately, as these could be indicative of PML [see Warnings and Precautions (5.3)].

Liver Injury

Inform patients that elevated transaminase levels with or without elevated bilirubin has occurred in patients who received ENTYVIO. Instruct patients to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions (5.4)].

Pregnancy

Inform patients that there is a pregnancy registry to monitor pregnancy outcomes of women who are pregnant or become pregnant while exposed to ENTYVIO [see Use in Specific Populations (8.1)].

Manufactured by:
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015

U.S. License No. 1898

VMB245 R4

This Medication Guide has been approved by the U.S. Food and Drug Administration VMB245 R4 Revised: March 2020
MEDICATION GUIDE
ENTYVIO (en ti' vee oh)
(vedolizumab)
for injection, for intravenous use
What is the most important information I should know 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).

See "What are the possible side effects of ENTYVIO?" for more information about side effects.

What is ENTYVIO?
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.

It is not known if ENTYVIO 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 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 ENTYVIO.
    • 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.

How will I receive 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.
What are the possible side effects of ENTYVIO?
ENTYVIO may cause serious side effects,
see "What is the most important information I should know about ENTYVIO?".
The most common side effects of ENTYVIO 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 of ENTYVIO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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 ENTYVIO that is written for health professionals.
What are the ingredients in ENTYVIO?
Active ingredient: vedolizumab
Inactive ingredients: L-arginine hydrochloride, L-histidine, L-histidine monohydrochloride, polysorbate 80 and sucrose
Manufactured by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015
U.S. License No. 1898
ENTYVIO is a trademark of Millennium Pharmaceuticals Inc. and is used under license by Takeda Pharmaceuticals America, Inc.
All other trademark names are the property of their respective owners.
©2014 – 2020 Takeda Pharmaceuticals America, Inc.
For more information, go to www.ENTYVIO.com or call 1-877-TAKEDA-7 (1-877-825-3327).
This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. 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.
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