Entyvio: A Targeted Treatment for Ulcerative Colitis and Crohn’s Disease

Entyvio (vedolizumab) is a medication developed by Takeda Pharmaceuticals. The FDA first approved it on May 20, 2014 [1]. It is used to treat ulcerative colitis (UC) and Crohn’s disease. 

Entyvio is a type of medication called a monoclonal antibody that works by targeting specific parts of the immune system. Doing this helps lessen inflammation in the gut, which causes serious symptoms of UC and Crohn’s disease. This medication can be especially helpful if other medications don’t give you enough relief. 

Entyvio is a more focused treatment option that makes managing your condition easier. But, like any other medication, it also has some side effects, some of which can be severe. 

What Is Entyvio Used To Treat?

Entyvio is FDA-approved  to treat the following inflammatory bowel diseases [2]:

Ulcerative Colitis (UC): UC is a long-term bowel disease in which your colon and rectum are inflamed. It leads to symptoms like stomach pain, diarrhea, and bleeding from your rectum. Entyvio is used to treat moderate to severe ulcerative colitis.

Crohn’s Disease: This is another type of bowel disease that can cause inflammation anywhere in the digestive tract (from the mouth to the anus). It leads to symptoms like belly pain, severe diarrhea, weight loss, fatigue, and malnutrition. Entyvio can treat moderate to severe Crohn’s disease.

It is usually reserved for people who haven’t had success treating their symptoms with other treatments.

How It Works

Your immune system becomes overactive in both ulcerative colitis and Crohn’s disease. Your white blood cells mistakenly identify the cells in your gut lining as threats and attack them. As a result, inflammation occurs in your gut, and you experience symptoms associated with UC and Crohn’s Disease, such as pain and diarrhea. 

Entyvio is a monoclonal antibody. It works by stopping white blood cells from entering your gut [2]. This action lessens inflammation and damage that these cells would typically cause. Unlike some other medications that affect the entire immune system, Entyvio specifically targets the gut. So, it can help reduce inflammation while minimizing side effects that would typically be seen with other medications.

Side Effects

Like all medications, Entyvio can also cause side effects. These can range from common, mild reactions to more serious side effects. Here are some of the side effects of Entyvio [3, 4]:

Common Side Effects

The most common side effects are:

• Headaches
• Nausea
• Fever
• Joint pain
• Upper respiratory tract infections (e.g., colds, sinus infections)
• Pain, swelling, hives, or redness at the injection site

These common side effects usually go away on their own after a short time. However, consult your healthcare provider if they worsen or do not go away.

Serious Side Effects

Serious side effects for Entyvio are generally rare. Most people do not experience them, but they can still potentially occur. So, it’s important to seek medical attention if you experience any of the following serious side effects of Entyvio: 

Infusion-Related Reactions: You can experience infusion-related reactions during or shortly after the infusion. The symptoms include rash, itching, difficulty breathing, or chest pain. It’s possible your healthcare provider might monitor you for these reactions for a bit of time after you receive your dose.

Infections: Entyvio can raise your risk of getting serious infections like sepsis or tuberculosis. Symptoms of an infection can include fever, chills, difficulty breathing, cough, and nasal congestion. Get medical attention if you experience any of these symptoms.

Progressive Multifocal Leukoencephalopathy (PML): PML is a serious brain infection caused by a virus that has no cure. People who have a weakened immune system can get it. Although unlikely, Entyvio can increase your chance of getting PML, as it weakens your immune system.

Liver Problems: Entyvio can cause serious liver problems. Symptoms of liver problems include dark urine, yellowing of the skin or eyes, or severe fatigue.

Dosage and Treatment

Entyvio is available as a 300 mg lyophilized powder for injection. This medication is administered via intravenous (IV) infusion over about 30 minutes. Before starting treatment, make sure you are up-to-date with all necessary vaccinations. This is to ensure that your immune system is prepared to fight an infection because Entyvio lowers the activity of your immune system, which raises the risk of infections. The dosing schedule of Entyvio treatment is [2]:

• Initial Dose: The typical dose is 300 mg at week 0, week 2, and week 6.
• Maintenance Dose: After the initial doses, you should receive an infusion every 8 weeks.

Note: If you don’t see signs of improvement by the 14th week of treatment, you should talk to your prescriber about whether or not you should discontinue treatment with Entyvio. 

Cost

The cash price for Entyvio is $9,135 for a 300 mg powder for intravenous (IV) injection [5]. However, the real cost will depend on your insurance plan and location. You may also apply for Takeda Pharmaceutical’s financial assistant program. If qualified, you could pay as low as $5 for each Entyvio dosage, up to a total benefit of $20,000 per year [6].

Entyvio FAQs

Here are some answers to frequently asked questions about Entyvio:

1. How long does it take for Entyvio to work?

The time it takes for this medication to work varies from person to person. In clinical trials, some patients saw improvements in ulcerative colitis and Crohn’s disease symptoms within 6 weeks of starting treatment [7]. But it can take up to 14 weeks to get the full effects of the medication. If there is no evidence of improvement by week 14, your healthcare provider may decide to stop the treatment.

2. Is Entyvio safe to use during pregnancy or breastfeeding?

The safety of Entyvio usage during pregnancy and breastfeeding is still unknown [2]. So, if you are pregnant, planning to become pregnant, or breastfeeding, consult with your healthcare provider first.

3. Can I receive live vaccinations while on Entyvio?

No, you can not. Entyvio usually weakens your immune system and increases your risk of getting an infection. Therefore, you should avoid live vaccines while receiving this medication. It’s recommended that all necessary vaccinations be received before starting treatment.