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Entyvio Now Approved for Ulcerative Colitis and Crohn’s

by Roni Shye on May 28, 2014 at 9:57 am

Entyvio (vendolizumab) was approved by the FDA on May 20, 2014 for the treatment of ulcerative colitis and Crohn’s disease in patients where other treatments have not worked or cannot be tolerated.

What are ulcerative colitis and Crohn’s disease, and how do they differ?

Ulcerative colitis and Crohn’s are branches of a larger umbrella term known as inflammatory bowel disease (IBD). Ulcerative colitis is the inflammation of the lining of the large intestine (colon) and rectum. Crohn’s disease is inflammation that can occur anywhere in the digestive tract with the ability to spread affected tissues.

The signs and symptoms for ulcerative colitis and Crohn’s disease are very similar and can often be confusing. Your doctor may perform a test called a colonoscopy to determine where the inflammation is occurring within your body.

Can Entyvio or other medications cure ulcerative colitis or Crohn’s disease?

No. Currently, there is a not a cure for any type of IBD. However, there are treatments which can reduce the signs and symptoms of these diseases and even lead to long-term remission.

What are some of the other treatment options for ulcerative colitis and Crohn’s disease?

Yes. There are various treatment options available to help with ulcerative colitis and/or Crohn’s disease.

Some of the various types of medications available to help manage ulcerative colitis and/or Crohn’s disease include aminosalicylates, corticosteroids, immunomodulators, or biologic therapies.

  • Aminosalicylates are derivatives of aspirin that help treat inflammation associated with mild-to-moderate ulcerative colitis and Crohn’s disease. These are typically used first-line. Examples of aminosalicylates include sulfasalazine (Azulfidine) and mesalamine (Asacol HD, Delzicol).
  • Immunomodulators are used to suppress the immune system which in turn decreases inflammation. These medications can take between 3 to 6 months to take their full effect. They are sometimes used in patients who do not respond to aminosalicylates. Immunomodulators include azathioprine, mercaptopurine, or cyclosporine.
  • Biologic therapies, like immunomodulators, are used when aminosalicylates or other treatments can’t be used or aren’t effective. These medications are the most popular and widely used treatments today. Examples of biologic therapy include Remicade, Enbrel, Humira, Cimzia, or Simponi.

Biologic treatment with Humira or Enbrel is typically preferred by insurance companies and provides convenient patient-administered dosing with prefilled syringes or injectable pens.

So when should Entyvio be used?
Entyvio is going to be considered a second- or third-line treatment option. Entyvio also works by decreasing inflammation and treats moderate-to-severe ulcerative colitis or Crohn’s disease, but it will be used after other options have been tried and exhausted (when previous medications didn’t work, didn’t work well enough, or when someone has shown dependence on corticosteroids).

Entyvio, unlike most of the biologic options, will require visits to the doctor’s office for 30 minute infusions. However, after the initial infusions, Entyvio will only be used once every 8 weeks, where most biologic treatment options are more frequent with once-weekly, every other week, or once-monthly dosing.

Some important information about Entyvio:
Entyvio is a specialty medication, and must be infused over a period of 30 minutes at your doctor’s office.

See this article for more information on specialty medications.

How is Entyvio used?
Entyvio is infused over 30 minutes initially, then at 2 weeks and 6 weeks, then every 8 weeks thereafter.

In what strength and dosage form is Entyvio available?
Entyvio is available for injection as a 300 mg single-use 20 mL vial.

What are the common side effects of Entyvio?

The common side effects of Entyvio include common cold, headache, joint pain, nausea, fever, infections of the nose/throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities.

Where can I find more information on Entyvio?

For now, you can find more information on the official Entyvio page, and watch for prices, images and more info coming soon here.

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