Vedolizumab

Vedolizumab, also known by the brand name Entyvio in the US, is an IV infusion that is prescribed to treat ulcerative colitis and Crohn’s disease by directly affecting the white blood cells overproduced in the gut and causing symptoms.

Overview

What is Vedolizumab?

Vedolizumab is a drug containing a monoclonal antibody, which means that it is a clone of an immune cell or white blood cell. The drug directly targets the white blood cells found in the colon and gut, bonds with them and works to decrease them, therefore easing or preventing them from causing more symptoms. Vedolizumab is a biological drug, made from natural substances, and specifically engineered to attack the white blood cells that are overproduced in the lining of the gut, causing inflammation and other issues in patients who have been diagnosed with Ulcerative Colitis or Crohn’s Disease.

Vedolizumab has proven effective in adult patients who suffer from ulcerative colitis. Ulcerative colitis is a condition that affects the inner lining of the rectum and colon. This disease has been known to cause inflammation and ulcers on the surface of the lining, which may bleed or produce pus. This is a life-long condition during which periods of remission can be experienced, as well as flare-ups.

Crohn’s Disease, like ulcerative colitis, causes inflammation in the digestive system, but it affects any part of the gut. Typically, though, Crohn’s Disease affects the end portion of the small intestine known as the colon. Crohn’s Disease, like Ulcerative Colitis, is also a life-long condition with periods of remission and flare-ups.

Both ulcerative colitis and Crohn’s Disease patients commonly demonstrate the following symptoms:

  • Diarrhea
  • Abdominal cramping
  • Fatigue
  • Fever
  • Appetite loss
  • Weight loss
  • Anemia

Crohn’s Disease sufferers often show signs of mouth ulcers as well as the symptoms above. Only a doctor can, after extensive testing, determine whether a patient has Ulcerative Colitis or Crohn’s Disease. Neither condition has a cure, but with use of drug therapies such as Vedolizumab, symptoms can be made easier to live with.

Patients have reported easing of symptoms in as little as six weeks, though some patients take longer to respond to the drug. It has been reported that some Crohn’s Disease patients took 14 weeks of treatment to respond to Vedolizumab. Some patients experienced severe reactions to Vedolizumab, which forced them to seek other remedies for their symptoms.

Conditions Treated

  • Ulcerative Colitis, Crohn’s Disease

Type of Medicine

  • Anti-integrin (integrin receptor antagonist)

How is Vedolizumab administered?

Vedolizumab is typically administered in an intravenous (IV) infusion by a doctor or nurse during a short hospital day visit. There is no need to get into a bed, undress or plan an overnight visit, though you will be monitored for a few hours after the infusion, which takes 30 minutes in a typical hospital setting. Monitoring during and after the infusion is to prevent allergic reactions to Vedolizumab that the patient may experience.

Side Effects

Vedolizumab has a low rate of reported complications, but some patients may experience side effects. Some side effects are almost immediate and some don’t appear for weeks after the infusion. A diary should be kept during the first treatment and thereafter to report any side effects. This diary should also be kept as a record of symptoms to determine if Vedolizumab has had any effect on the severity.

An immediate reaction during infusion means that you may have an allergy to Vedolizumab, and any side effects should be reported to the medical staff right immediately to determine the best course of action.

The most common side effects of Vedolizumab include the following:

  • Cold or flu symptoms such as fever, sore throat, aches, pains or chills
  • Difficulty breathing
  • Congested nasal passages or ears
  • Sneezing, coughing, loss of voice
  • Weakness or fatigue

The following side effects, while less common, can also be experienced by those under treatment of Vedolizumab:

  • Nausea, vomiting
  • Flushed skin
  • Tight chest
  • Joint or back pain

Very rarely, patients on Vedolizumab may experience symptoms such as:

  • Erratic heartbeat
  • Hives, itching or rashes
  • Swollen eyelids, lips or tongue
  • Difficulty when swallowing
  • Yellowing of skin or eyes
  • Dark urine

Pediatric side effects

No studies have been carried out to determine the safety or effectiveness of Vedolizumab on pediatric patients.

Geriatric side effects

To date, no appropriate study has demonstrated any issues with usefulness or elevated risk with use of Vedolizumab in the elderly.

Pregnancy or breastfeeding side effects

Adequate studies have not been performed to determine if there is any evidence of harm to the fetus or infant due to treatment with Vedolizumab during pregnancy or while breastfeeding.

Dosage

Vedolizumab IV infusions are typically 300 milligrams per dose administered over a 30 minute period. The following treatment schedule is usually prescribed:

  • First dose of 300 milligrams
  • Two weeks later another 300 milligram dose
  • Six weeks after the first dose, another 300 milligrams

Patients with Crohn’s Disease that don’t experience relief in their symptoms after the three starter treatments of Vedolizumab may have another dose during week 10 of treatment. If there is a positive response to the treatment, a series of maintenance infusions are given every eight weeks; if no symptom improvement is experienced, a more intense schedule of infusions every four weeks may be prescribed.

Interactions

Other types of biologic drugs shouldn’t generally be taken along with Vedolizumab. These drugs include:

  • Natalizumab (for treatment of multiple sclerosis)
  • Rituximab (for treatment of certain cancers or rheumatoid arthritis)
  • Adalimumab (Humira)
  • Certolizumab (Cimzia)
  • Infliximab (Remicade)
  • Golimumab (Simponi)
  • Natalizumab (Tysabri)

Provide a list to your doctor of any prescription or non-prescription medicines you are taking, as well as any herbal or holistic remedies you use on a regular basis.

Check with your doctor before having any immunizations such as flu shots or pneumonia shots and others. Ideally, you will be current on all vaccinations before beginning your Vedolizumab treatment schedule.

If you have tuberculosis or in close contact with someone who does or if you have liver problems, infections, are pregnant or planning to become pregnant or are breastfeeding, make sure you inform your doctor.

Warnings

Experiencing side effects during or immediately after an injection of Vedolizumab can be an indication of an allergic reaction to the drug. It is imperative that you report any side effects to a physician immediately. These symptoms include flu-like symptoms such as a fever, chills, aches and pains but also may include chest pain, rashes, dizziness, fainting and lightheadedness or headache. Swelling of the face, tongue and throat should be reported right away, as it could be an indication of anaphylaxis, a life-threatening condition requiring immediate medical care.

The body’s ability to fight infection may be affected by Vedolizumab. Report any infections that don’t clear up or recur to your physician. Vedolizumab may also increase your risk for developing multifocal leukoencephalopathy (PML), a deadly brain infection, which has symptoms that include back pain, blurry vision, dizziness, fever, headache or confusion. In general, keep away from people with cold or flu symptoms and void public places and wash hands frequently.

Tenderness in the upper stomach area, pale stools and dark urine along with appetite loss and other stomach symptoms or yellow eyes and skin could be indicating a severe problem with the liver caused by Vedolizumab. Immediate reporting of these symptoms to your doctor is recommended.

Storage

As this drug is kept and maintained in a hospital setting, there is no recommendation for personal storage, other than, if you must store this drug in your home, follow your doctor’s instructions.

Summary

Vedolizumab is a biological drug that is prescribed to relieve autoimmune disorders in the gut such as Ulcerative Colitis and Crohn’s Disease. Vedolizumab works by bonding with the over-produced white blood cells that are causing inflammation, ulcers and symptoms in the gut and blocking them. Symptoms experienced by sufferers of these diseases are similar and include diarrhea, vomiting, fatigue and loss of appetite.

Administered by IV infusion, 300 milligrams is the typical dose injected during a hospital visit that lasts 30 minutes for the injection and two hours for monitoring. A controlled schedule is used for the first three dose injections, with maintenance doses thereafter. Side effects during and immediately after the injection may indicate an allergic reaction to Vedolizumab must be reported to the physician immediately.

While Vedolizumab may help control symptoms of Ulcerative Colitis and Crohn’s Disease, it will not cure either condition. Regular monitoring for improvement should be done over 14 weeks, at which time your doctor will help you decide whether to continue treatment or try another therapy.

Keeping to the treatment schedule is imperative and reporting any effects on your symptoms or side effects from Vedolizumab are imperative during the course of treatment. For this reason, regular monitoring via office visit or phone call is recommended. It is also recommended that you read all information materials provided to you.

Resources
Last Reviewed:
December 24, 2017
Last Updated:
December 22, 2017