ENTYVIO® (Vedolizumab) Infusion

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What Is Entyvio?

Entyvio, also known by its generic name Vedolizumab, is a medical drug used to treat moderate to severe ulcerative colitis and Crohn’s disease in patients who don’t show improvement while on other medications. It’s usually given as an intravenous infusion received at a healthcare provider’s office or infusion center.

Entyvio belongs to a class of advanced drugs known as monoclonal antibodies. Monoclonal antibodies are molecules created in a lab which are specifically designed to target a particular protein or substance that’s contributing to illness, damage or disease in the body.

In the case of Entyvio, the drug is engineered to block the action of a certain type of natural substance called integrin, which can contribute to inflammation in the gut. In doing so, Entyvio can help decrease inflammation in the GI tract, alleviating symptoms of moderately- to severely-active Crohn’s disease and ulcerative colitis by potentially slowing or stopping damage to the colon and other parts of the digestive system.

Unlike some other treatments for autoimmune disorders, Entyvio acts primarily on the gastrointestinal tract, which means it has less of an effect on a patient’s systemic — or whole-body — immune response. This can help patients avoid infections while still seeing improvement in their gastrointestinal symptoms.

What Conditions Is Entyvio Used To Treat?

Entyvio is primarily prescribed for the treatment of:

  • Ulcerative colitis: A condition characterized by severe inflammation and the formation of ulcers in the lining of the large intestine.
  • Crohn’s disease: A type of inflammatory bowel disease can impact any part of the gastrointestinal tract, from the mouth to the rectum.

Both of these conditions are considered inflammatory bowel diseases (IBD), a type of autoimmune disorder where the body’s immune system mistakenly attacks healthy tissues in the gastrointestinal tract.

Both Crohn’s disease and ulcerative colitis can cause widespread inflammation in the digestive system, which can lead to symptoms like severe abdominal pain, cramping, blood in the stool and chronic diarrhea.

How Does Entyvio Work Inside The Body?

Entyvio works by blocking a specific, naturally-occurring substance called integrin. The therapeutic benefit of Entyvio is that it can help reduce the movement of white blood cells into inflamed tissues in the gut. That can decrease autoimmune-related inflammation of the digestive tract and the symptoms and conditions it can cause, including Crohn’s disease and ulcerative colitis.

By targeting the gut specifically, Entyvio treatment offers a more targeted and localized approach compared to other prescription drugs and therapies, with less reduction of the body’s overall disease fighting defense mechanisms while still achieving a therapeutic benefit for many patients with moderately to severely-active ulcerative colitis and Crohn’s disease.

What Is A “Monoclonal Antibody”?

Monoclonal antibodies are specialized, lab-made molecules that are engineered to replicate and support the body’s ability to fight off harmful pathogens, such as viruses. They are specifically created to block a particular protein or substance in the body, offering a very targeted and precise approach to treatment.

In the case of Entyvio, the drug targets a natural substance called integrin, which helps cause inflammation in the gut.

How Is Entyvio Administered?

Entyvio is delivered through an intravenous (IV) infusion directly to the bloodstream, usually at an infusion center or the office of a healthcare provider.

The Entyvio infusion is delivered slowly over a period of about a half hour, and should be administered by a healthcare professional prepared to observe patients who receive Entryvio closely and deal with and manage hypersensitivity reactions during treatment.

Hypersensitivity reactions can include allergic reaction, chest pain, shortness of breath, hives and increased blood pressure and heart rate. These complications aren’t usually life threatening, and can be managed by the healthcare professional handling the infusion.

After the initial dose, subsequent Entyvio infusions are usually given 2 weeks and 6 weeks later as part of what’s called the induction phase. By week 6, patients who respond to Entyvio should see some symptom improvement.

Following these initial doses, patients enter what’s called the maintenance phase. The third dose and subsequent doses are usually administered at 8 week intervals, depending on the doctor’s recommendation.

Will My Doctor Have To Perform Any Tests Before I Can Take Entyvio?

Because Entyvio suppresses the immune response in the gut, patients taking Entyvio are at increased risk of contracting certain serious infections. Before starting treatment, patients should be up to date with all their vaccinations. It’s important to discuss with your doctor any vaccines you might need before beginning the treatment, along with all the medicines you are taking. You may need to be tested for tuberculosis every year while taking Entyvio.

Additionally, certain lab tests, including endoscopy, blood tests and liver function tests, might be required to evaluate your overall condition, and ensure it’s safe for you to be treated with Entyvio.

How Long Does It Take For Entyvio To Have An Effect On Symptoms?

The time it takes for treatment with Entyvio to show a positive effect on symptoms can vary from person to person. Some patients might notice improvements within weeks, while for others, it might take longer.

Regular consultation with your healthcare provider is important to monitor the drug’s effectiveness, watch for allergic reactions and drug interactions, make any necessary adjustments to your treatment plan and provide any needed medical support measures.

Consult your healthcare provider, but patients whose symptoms show no improvement after taking Entyvio infusions for 14 weeks are generally advised to discontinue therapy with the drug.

Are There Any Potential Side Effects Of Entyvio?

Like most medications, Entyvio can have side effects. The side effects of Entyvio can impact both the GI tract and the body outside the digestive system.

The most common side effects of Entyvio, occurring in about 1-3% of patients, include:

  • Inflammation of the nose, sinuses or throat
  • Headache
  • Joint pain and pain in the extremities
  • Nausea
  • Fever
  • Upper respiratory tract infection and bronchitis
  • Fatigue/Tiredness
  • Recurring cough
  • Back pain
  • Itchy skin or developing a rash
  • Sore throat

Serious Possible Side Effects Of Entyvio

In rare cases, some people taking Entyvio may experience more serious and potentially life-threatening side effects and complications, and should be taken with caution by patients with a history of severe infections. Serious complications may include:

  • Increased risk of serious infections, due to the way Entyvio suppresses the immune response in the gut. These may include: tuberculosis, abscess, salmonella, sepsis, Listeria meningitis, cytomegaloviral colitis and giardiasis.
  • Severe allergic reaction, including anaphylactic shock. Mild to moderate allergic reaction — an example of what are known as hypersensitivity reactions to Entyvio — can be managed with Benadryl and steroids.
  • A serious and sometimes fatal brain infection known as progressive multifocal leukoencephalopathy (PML), which can rarely be contracted by people with weakened immune systems who take Entyvio. While taking Entyvio, tell your doctor immediately if you experience issues with confusion or your balance, changes in the way you speak or walk, weakness on one side of the body, blurry vision or loss of vision. These symptoms may indicate PML

It’s essential to consult a doctor immediately if you experience any unusual or severe symptoms while taking Entyvio.

Entyvio And Alcohol Use

For patients taking Entyvio who drink alcohol, it’s important to note that drinking alcohol may worsen some of the common side effects of Entyvio, including sinus issues, headaches and nausea.

Will Entyvio Cause Any Dangerous Interactions With Other Drugs I May Be Taking?

Entyvio can interact with certain other medications, especially those that weaken the immune system. Because of that, it’s important to provide your doctor with a list of all medications, vitamins and herbal supplements you’re taking to ensure there are no harmful or dangerous interactions from any drug combination you may be taking.

Is Entyvio (Vedolizumab) Safe For Every Patient?

While Entyvio can be beneficial for many patients with moderate to severe Crohn’s disease or ulcerative colitis, it’s not suitable for everyone.

Patients with have a serious infection, a history of certain infections, cancer, liver injury, liver disease or other medical issues should discuss the potential risks with their doctor.

Additionally, the drug might not be recommended for those with a weakened immune system or certain other medical conditions like HIV.

Should I Take Entyvio If I’m Pregnant Or Breastfeeding?

The use of Entyvio hasn’t been been linked to fertility issues, miscarriages, birth defects, preterm birth or other pregnancy and fetal issues. However, if you are on Entyvio during pregnancy, it’s recommended that your infant not receive what are called live virus vaccines, such as the rotavirus vaccine, within the first six months of life.

Entyvio has not been shown to pass from mother to child through breast milk, but not enough studies have been done to definitively say breastfeeding while on Entyvio is completely safe. If you have concerns about the drug being passed to your infant through breast milk, be sure to consult a licensed healthcare professional.

Should I Take Entyvio If I Have A Weakened Immune System?

Entyvio can lower the body’s ability to fight infections, potentially making existing infections worse or increasing the risk of new ones, including serious and life-threatening infections.

For this reason, Entyvio may not be right for patients with a weakened immune system. Those who are immunocompromised should discuss the potential risks of the medication with their healthcare provider before starting treatment.