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Entyvio Infusion for Crohn's Disease: Side Effects & Interactions

If you've been diagnosed with inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis (UC), your doctor might suggest Entyvio as part of your treatment plan. Entyvio is the brand name for vedolizumab, a biologic that is intended for adults with IBD, specifically those dealing with severely active Crohn's disease or severely active ulcerative colitis. Entyvio is a brand-name-only prescription medication. Entyvio is available for intravenous use (an infusion into the vein) for the treatment of ulcerative colitis and Crohn’s disease. 

Entyvio is also available as a prefilled pen, given as a subcutaneous (under the skin) injection for the maintenance of UC. Continue reading to learn more about Entyvio infusion, including what patients receiving Entyvio can expect, the uses, side effects, and dosage information of this medication.

What is Entyvio Infusion used for?

Entyvio (vedolizumab) belongs to a drug class called integrin receptor antagonist. Entyvio is a single-dose vial of solution given by intravenous infusion, meant to manage chronic inflammation caused by inflammatory bowel disease. Entyvio is used to treat ulcerative colitis, Crohn’s disease, and other inflammatory bowel diseases. 

Side effects

Similar to most medications, Entyvio can potentially lead to mild or moderate to severe side effects. These effects vary based on your age, medical history, immune system health, and other medications you are currently taking. Below are some of the more common side effects of Entyvio.

Mild side effects of Entyvio

  • Common cold and flu symptoms, such as fever, nausea, runny nose, sinus pain, sore throat, and headache

  • Fatigue

  • Back and joint pain

  • Mouth and throat ulcers

  • Rash, itching

  • Pain in arms and legs  

  • Bronchitis and upper respiratory infection

Weight gain is not a side effect reported in clinical trials of Entyvio. However, there have been reports of weight gain since Entyvio is available. This is probably the result of being able to eat more food than before treatment with Entyvio. 

For more information on other mild side effects, talk with your doctor or pharmacist. Mild side effects of Entyvio tend to resolve within a few days to a few weeks. However, if these side effects persist or become bothersome, you should call your doctor to discuss lower Entyvio doses.

Moderate to severe side effects of Entyvio 

Entyvio can potentially lead to moderate to severe side effects, although they are rare. Call your doctor immediately if you experience any of the following side effects. Call 911 and seek emergency medical care at the nearest emergency department if the side effects are life-threatening:

  • Infusion reactions (similar to an allergic reaction) with symptoms including:

    • Chills, fever, dyspnea, hypotension, wheezing, bronchospasm, tachycardia, decreased oxygen saturation, respiratory distress, rash, nausea, vomiting and headache

  • Anaphylactic allergic reactions with symptoms including:

    • Skin rash and itchiness, hives, trouble breathing, or swelling of the face, tongue, or throat

  • Symptoms of liver damage, such as nausea, vomiting, loss of appetite, upper stomach pain, dark urine, yellowing of skin and eyes

  • Increased risk of serious infection

    • Tuberculosis

    • Giardiasis (small intestine infection)

    • Cytomegaloviral colitis (colon inflammation)

    • Listeria meningitis (serious brain infection and spinal cord lining inflammation)

  • Sepsis

  • Immunogenicity (an immune response to Intravenous-use drug)

  • Progressive multifocal leukoencephalopathy (PML)

  • Severe allergic reaction

  • Trouble breathing

If you encounter severe side effects of Entyvio, call your doctor immediately. In the event of a medical emergency, dial 911 or your local emergency number.

Drug interactions

Entyvio has the potential to interact with various classes of medications. It's important to be aware of these interactions and discuss possible interactions from a drug combination with your healthcare provider.

The following are tumor necrosis factor (TNF) inhibitors, which are used for autoimmune diseases and should not be combined with Entyvio:

For a comprehensive list of potential interactions with other medications and their implications, talk with your doctor or pharmacist. 

Other interactions

Avoid receiving any live vaccines while receiving Entyvio treatment. Live vaccines contain weakened pathogens and are designed to provide immunity by simulating an infection. However, since Entyvio reduces the effectiveness of your immune system, getting a live vaccine while on this medication can heighten the risk of contracting the disease the vaccine is meant to prevent. 

Examples of live vaccines include: 

  • Flu vaccine (FluMist)

  • Measles, mumps, and rubella vaccine (MMR)

  • Chickenpox vaccine (Varivax)

  • Smallpox vaccine

  • Yellow fever vaccine

  • Rotavirus vaccine

  • Hepatitis A vaccine

Before beginning treatment with Entyvio:

  1. Discuss your immunizations with your doctor.

  2. Ensure that you are fully immunized before starting Entyvio doses.

  3. Ask your physician if it is safe for others in your household to receive live 

Talk with your doctor about vaccinations and timing in relation to receiving Entyvio treatment.

Entyvio and COVID-19 vaccines

Note that the COVID-19 vaccines approved for use in the United States are not live vaccines. Entyvio may potentially increase your susceptibility to certain infections. Therefore, it's essential to consult with your physician to determine the safety and timing of receiving a COVID-19 vaccine while taking Entyvio. 

Your healthcare provider can offer personalized guidance based on your medical situation and needs.

Entyvio infusion warnings

If you have certain medical conditions or other factors that could impact your health, Entyvio may not be suitable for you. It is crucial to have a detailed discussion about your health history with your doctor before initiating Entyvio treatment. Here are some considerations that should be taken into account:

Infusion reaction

In rare cases, individuals receiving Entyvio infusions may experience an infusion reaction. This can include flu symptoms like chills, fever, dyspnea, wheezing, nausea, vomiting, and headache, as well as hypotension, bronchospasm, tachycardia, decreased oxygen saturation, respiratory distress, and rash. 

Your doctor will closely monitor you for signs of infusion reactions each time you are receiving Entyvio treatment. If you happen to have a severe reaction to Entyvio, the infusion will be promptly halted to ensure your safety, and appropriate medical attention can be provided.

Allergic reaction

Avoid receiving Entyvio intravenous infusion if you have ever had an allergic reaction to the medication or any of its ingredients. In such cases, you should talk with your doctor to explore alternative medications that may be more suitable for your treatment. Your healthcare provider can help you make an informed decision about the most appropriate treatment options based on your medical history and needs.


If you have an existing, active, or recent infection, it's important to address and eliminate the infection before starting Entyvio treatment. If you happen to develop a severe infection while taking Entyvio, your doctor will advise you to discontinue the medication. Entyvio should only be resumed once the infection has been successfully treated and resolved. This approach helps ensure your safety and overall health during the course of treatment.

Joint pain

Entyvio may potentially lead to joint pain and discomfort. It's worth noting that joint pain is a common symptom of inflammatory bowel disease (IBD) or severe Crohn’s disease, which Entyvio is designed to treat effectively. Among individuals with IBD or Crohn’s disease, the most frequently reported types of joint pain are located in the ankle, wrist, and knee areas. If you experience joint pain while receiving Entyvio intravenous infusion, it could be related to your IBD symptoms, and it's important to discuss this with your healthcare provider for proper evaluation and management.

Progressive multifocal leukoencephalopathy (PML)

PML (progressive multifocal leukoencephalopathy) is a rare and serious brain infection. Individuals with conditions that compromise the immune system, such as HIV, cancer, or organ transplant recipients, may face an increased risk of developing PML. 

Before starting Entyvio, consult your physician to evaluate whether Entyvio is a safe treatment option for you, especially if you have any conditions that weaken your immune system. 

Liver problems

If you have a history of liver disease, it's vital to inform your doctor before starting Entyvio treatment. Entyvio can cause liver damage and potentially worsen existing liver problems. Discuss your specific risk for liver problems with your physician. Your healthcare provider may want to monitor your liver function while you are on the medication if you are at a higher risk for liver injury or liver disease. 

Before starting Entyvio, it's important to tell your doctor if you have a history of hepatitis or any other significant liver issues.

Entyvio and alcohol

Alcohol is not known to have direct interactions with Entyvio. However, drinking alcohol may worsen the symptoms of inflammatory bowel disease (IBD), ulcerative colitis, and Crohn’s disease, which are the conditions Entyvio is prescribed to treat. It can lead to increased inflammation and digestive discomfort.

Note that some of the side effects of Entyvio, such as nausea and headache, can be exacerbated when you drink alcohol.

Excessive alcohol intake while taking Entyvio can also elevate the risk of liver injury, especially if you have pre-existing liver conditions.

It's advisable to consult your doctor regarding alcohol consumption while on Entyvio. Your healthcare provider can provide personalized guidance on whether it's safe for you to drink alcohol and recommend safe limits based on your specific medical condition and treatment plan.

Entyvio Infusion during pregnancy and breastfeeding

The risks of receiving treatment with Entyvio during pregnancy are not well understood. If you are pregnant or planning to become pregnant, talk with a licensed healthcare professional about the potential benefits and risks associated with this medication.

Pregnant women who are taking Entyvio to treat Crohn's disease have the option to participate in the drug's pregnancy registry, which can provide valuable data on the effects of the medication during pregnancy. Enrolling in the registry can help researchers and healthcare professionals better understand the risks associated with Entyvio use during pregnancy. You can contact 1-877-TAKEDA7 (1-877-825-3327) for more information on this registry.

It's also worth noting that Entyvio can pass into breast milk, although the risks to breastfed infants are not fully understood. If you are breastfeeding and considering Entyvio treatment, it's crucial to talk with your doctor to assess the safety of breastfeeding while taking the medication. 

Your healthcare provider can offer guidance and may recommend alternative feeding methods for your child during the time you are receiving Entyvio to ensure the best possible care for both you and your baby.



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