Entyvio

Conditions Treated

Entyvio is used to treat adults with moderate to severe cases of the following inflammatory bowel diseases:

• Ulcerative Colitis: A chronic condition that causes inflammation and sores (ulcers) in the lining of the large intestine and rectum.
• Crohn's Disease: A chronic condition that causes inflammation in the digestive tract, which can lead to abdominal pain, severe diarrhea, and weight loss.

When It Is Prescribed

Healthcare providers typically prescribe Entyvio when standard therapies have not provided adequate relief or have caused intolerable side effects. It is often used for patients who have had an inadequate response to, lost response to, or were unable to tolerate one or more of the following:

• Corticosteroids (such as prednisone).
• Immunomodulators (such as azathioprine or 6-mercaptopurine).
• Tumor necrosis factor (TNF) blockers (such as adalimumab or infliximab).

Treatment Goals

The primary goals of using Entyvio are to reduce the active signs and symptoms of the disease and to achieve clinical remission, which is a period where symptoms are significantly reduced or absent. It is also used as a long-term maintenance therapy to help keep the disease in remission and to reduce or eliminate the need for ongoing corticosteroid use.

Targeting Gut Inflammation

Entyvio (vedolizumab) belongs to a class of medications called integrin receptor antagonists. It is a monoclonal antibody designed to target the specific cause of inflammation in the digestive system for people with ulcerative colitis or Crohn's disease.

In these conditions, the immune system mistakenly sends too many white blood cells to the lining of the gastrointestinal (GI) tract. This influx of cells causes the chronic inflammation and damage associated with the disease. Entyvio works by:

• Binding to specific proteins: The medication attaches to a protein called alpha4beta7 integrin, which is found on the surface of certain white blood cells.
• Blocking entry: By binding to these proteins, Entyvio prevents the white blood cells from interacting with the blood vessels in the gut. This stops the cells from moving out of the bloodstream and into the GI tissue.
• Reducing inflammation: Because fewer inflammatory cells reach the gut, the swelling and irritation in the digestive tract are reduced over time.

Unlike some other treatments that suppress the immune system throughout the entire body, Entyvio is gut-selective. This means its primary action is focused on the digestive tract, which may help limit its impact on the rest of the immune system.

Common Side Effects

Some people may experience mild side effects while taking Entyvio. Common symptoms include:

• Nausea
• Fever, cough, or sore throat
• Headache
• Joint or back pain
• Tiredness
• Sinus infections
• Pain in the arms or legs
• Redness, itching, or swelling at the site of injection

Serious Side Effects

Serious side effects are less common but require immediate medical attention. These may include:

• Infusion or Injection Reactions: Symptoms such as dizziness, flushing, rash, shortness of breath, or a fast heartbeat can occur during or shortly after receiving a dose.
• Infections: Entyvio can affect the immune system, potentially increasing the risk of serious infections. Symptoms may include persistent fever, chills, or muscle aches.
• Liver Problems: Signs of liver injury include yellowing of the skin or eyes, dark urine, unusual fatigue, or pain in the upper right stomach area.
• Allergic Reactions: Severe reactions can cause hives, swelling of the face, tongue, or throat, and difficulty breathing.

Although rare, medications that affect the immune system have been associated with a serious brain infection called progressive multifocal leukoencephalopathy (PML). Seek medical help for new or worsening symptoms such as confusion, changes in vision, or difficulty with speech or walking.

Serious Allergic Reactions

Some people may experience serious allergic reactions during or after receiving Entyvio. Symptoms can include hives, itching, swelling of the lips or tongue, shortness of breath, or feeling faint. Medical help is typically required immediately if these symptoms occur.

Risk of Infections

Because Entyvio affects the immune system, it can increase the risk of developing infections or worsening existing ones. It is generally recommended that the medication not be started while a person has a serious active infection. Healthcare providers usually screen for tuberculosis (TB) before beginning treatment.

Neurological Concerns

While rare, there is a potential risk for a serious brain infection called progressive multifocal leukoencephalopathy (PML). This condition is caused by a virus and can lead to severe disability or death. Monitoring for new or worsening symptoms such as confusion, vision changes, or difficulty moving is important.

Liver Problems

Entyvio can cause liver injury in some patients. Signs of liver issues may include yellowing of the skin or eyes (jaundice), dark urine, pain on the right side of the abdomen, or unusual tiredness.

Vaccinations

Live vaccines should not be administered while using Entyvio. It is often recommended that all necessary vaccinations be brought up to date before starting the medication.

Pregnancy

There is limited information regarding the safety of Entyvio use during pregnancy. While animal studies have not shown evidence of direct harm to the developing fetus, human data is insufficient to rule out all risks. As a monoclonal antibody, Entyvio is known to cross the placenta, particularly during the second and third trimesters.

If you are pregnant or planning to become pregnant, you should discuss the risks and benefits of continuing treatment with your healthcare provider. They may recommend monitoring through a pregnancy registry, which tracks health outcomes for both the mother and the baby during and after pregnancy.

Breastfeeding

It is currently unknown whether Entyvio passes into human breast milk or if it could cause side effects in a nursing infant. Although many monoclonal antibodies are excreted in small amounts in breast milk, the specific impact of vedolizumab on a breastfeeding child has not been established. You should consult your doctor to determine if the benefits of breastfeeding outweigh the potential risks while you are receiving this medication.

Administration Forms

Entyvio is supplied in two primary formats for administration:

• Powder for Intravenous Infusion: This form is a sterile powder provided in a single-dose vial. A healthcare professional must reconstitute and dilute the powder into a liquid solution before it is administered through a needle into a vein (IV infusion).
• Solution for Subcutaneous Injection: This form is a liquid solution provided in single-dose prefilled syringes or single-dose prefilled pens. This version is designed to be injected into the fatty tissue just under the skin (subcutaneously).

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) has approved Entyvio for use in adults with the following conditions:

• Moderate to severe ulcerative colitis: For patients who have had an inadequate response to, lost response to, or were intolerant to other treatments such as corticosteroids, immunomodulators, or tumor necrosis factor (TNF) blockers.
• Moderate to severe Crohn's disease: For patients who have not responded well to or cannot tolerate standard therapies.

Administration Status

Entyvio is available in two FDA-approved forms for adult patients. It was initially approved as an intravenous (IV) infusion administered by a healthcare professional. The FDA later approved a subcutaneous (SC) injection for maintenance treatment in adults with either ulcerative colitis or Crohn's disease after they have received initial induction therapy via IV infusion.

Safety and Regulatory Monitoring

Entyvio does not currently carry a Boxed Warning, which is the FDA's most serious type of warning. However, regulatory information emphasizes the need for monitoring during and after treatment due to the following risks:

• Infections: Because Entyvio affects the immune system, it may increase the risk of serious infections.
• Liver Injury: Healthcare providers may monitor liver function, as liver injury has been reported in some patients.
• Hypersensitivity: Regulatory labeling includes warnings about potential allergic reactions, including anaphylaxis, which can occur during or after administration.

Factors Affecting Cost

The price of Entyvio depends on several variables, including whether the medication is administered as an intravenous (IV) infusion or a subcutaneous injection. Infusion costs often include additional fees for the healthcare facility and the medical staff performing the procedure.

Insurance coverage is a primary factor in determining out-of-pocket expenses. Most commercial insurance plans, Medicare, and Medicaid cover Entyvio, but the specific copayments, coinsurance, and deductibles will differ by plan.

Financial Assistance Programs

There are options available to help reduce the cost of treatment:

• Copay Savings Cards: Patients with commercial insurance may be eligible for programs that lower out-of-pocket costs for the medication.
• Patient Assistance: For those without insurance or with limited coverage, the manufacturer may provide the drug at a reduced cost or for free based on financial need.

Because Entyvio is a biologic medication, it is generally more expensive than traditional therapies. Patients are encouraged to speak with their insurance provider and healthcare team to understand the total cost of treatment.