Uses
What is Entyvio used for?
Entyvio (vedolizumab) is used to treat ulcerative colitis (UC) and Crohn's disease.
Entyvio may also be used for other conditions as determined by your healthcare provider.
How does Entyvio work (mechanism of action)?
Your immune system uses white blood cells to fight infection. In people with ulcerative colitis or Crohn’s disease, the immune system mistakenly sees parts of the gut as harmful and sends too many white blood cells into the area. This causes inflammation in the gut. Entyvio stops these white blood cells from getting into your gut, helping to control inflammation and prevent damage.
How is Entyvio supplied (dosage forms)?
Entyvio is available as generic vedolizumab in the following dosage forms that are injected under the skin.
- 108 mg single dose prefilled syringe
- 108 mg single dose prefilled pen
Entyvio is also available in injectable forms that are given by a healthcare provider.
How should I store Entyvio?
Entyvio should be stored in a refrigerator between 36 F to 46 F (2 C to 8 C). Do not freeze. The prefilled syringe or pen can be exposed to room temperature up to 77 F (25 C) for up to 7 days, such as when transporting it. Do not use the medicine if left out of the refrigerator for more than 7 days or left in direct sunlight. Keep the medicine in its original package to protect it from light until you want to use it.
Side Effects
What are the most common side effects of Entyvio?
The most common side effects of Entyvio are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Cold symptoms such as fever, stuffy or runny nose, sore throat, and cough
- Headache
- Tiredness
- Nausea
- Joint pain, back pain, and pain in the arms and legs
- Rash and itching
- Pain, swelling, or redness at the injection site
There may be other side effects of Entyvio that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at https://www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at https://www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Entyvio?
The most serious side effects of Entyvio are described below, along with what to do if they happen.
Serious Allergic Reactions. Entyvio can cause allergic reactions, which can be serious. Stop using Entyvio and get help right away if you have any of the following symptoms of a serious allergic reaction during or after the use of Entyvio.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Infections. Entyvio may increase your risk of getting a serious infection. Tell your healthcare provider if you think you have an infection or have any of the following symptoms of an infection.
- Fever
- Chills
- Muscle pain
- Shortness of breath
- Runny nose, sore throat, or cough
- Red or painful skin sores on your body
- Tiredness
- Pain while you pee
Brain Infection. Entyvio may cause a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML) in people with a weak immune system. Call your healthcare provider right away if you experience any of the following symptoms of PML.
- 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 Damage. Liver damage, also called hepatotoxicity, can happen while using Entyvio. Call your healthcare provider right away if you have any of the following symptoms of liver damage.
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light colored poop
- Dark colored urine
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Warnings & Precautions
Who should not use Entyvio?
Allergies to Ingredients. People who are allergic to any of the following should not use Entyvio.
- Entyvio
- Vedolizumab
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Entyvio.
What should I know about Entyvio before using it?
Do not use Entyvio unless it has been prescribed to you by a healthcare provider. Use it as prescribed.
Do not share Entyvio with other people, even if they have the same condition as you. It may harm them.
Keep Entyvio out of the reach of children. Because this medicine must be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.
Do not shake Entyvio. Always check the label of your prefilled syringe or prefilled pen to make sure you have the correct medicine before each injection.
Use a different injection site each time you use Entyvio. Avoid administering the injection into moles, scars, bruises, or damaged skin.
What should I tell my healthcare provider before using Entyvio?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Entyvio is right for you.
In particular, make sure that you discuss any of the following.
Vaccines. Tell your healthcare provider if you have recently received a vaccine or plan to get a vaccine. Talk to your healthcare provider about bringing your vaccines up to date before starting Entyvio.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following health conditions.
- Liver problems
- Infection or an infection that keeps coming back
- Tuberculosis (TB) or close contact with someone with TB
- Cancer
Other Medicines and Supplements. Entyvio may interact with other medicines and supplements. Before using Entyvio, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section below for more details.
Pregnancy. It is not known if or how Entyvio could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.
Breastfeeding. Entyvio passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Entyvio while breastfeeding.
How can I get more information about Entyvio?
For more information about Entyvio, you can visit the manufacturer’s website at www.ENTYVIO.com or call them at 877-TAKEDA7 (877-825-3327).
Interactions
Does Entyvio interact with foods or drinks?
There are no known interactions between Entyvio and foods or drinks.
It is unknown if drinking alcohol will affect Entyvio.
Does Entyvio interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before using Entyvio.
- Natalizumab (Tysabri and Tyruko), which is used to treat multiple sclerosis and Crohn’s disease
- A tumor necrosis factor (TNF) blocker, such as infliximab, adalimumab, etanercept, golimumab, and certolizumab, which are medicines used to treat certain inflammatory conditions
- A medicine that weakens your immune system
- A corticosteroid, which is a medicine for certain inflammatory conditions
Entyvio may alter the blood levels of some other medicines. Tell your healthcare provider about all medicines that you take or have recently taken.
Overdose/Missed Dose
What should I do if I accidentally use too much Entyvio?
If you or someone else has used too much Entyvio, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Entyvio?
If you miss a scheduled dose, use it as soon as you remember and then every 2 weeks thereafter. Call your healthcare provider if you are not sure if you gave yourself the full dose.