New Drug Approval: Vedolizumab Approved for Ulcerative Colitis and Crohn’s Disease
On May 20, 2014, Takeda Pharmaceutical Company Limited and the FDA announced vedolizumab as a treatment option for moderate to severe ulcerative colitis (UC) and Crohn’s disease (CD) for adults whose illness did not respond to or tolerate other treatment options.
Specifically, the labeling for this monoclonal antibody therapy indicates it is for use with UC or CD patients who did not adequately respond to tumor necrosis factor (TNF) blocker or immunomodulator or to corticosteroid therapy treatments.
Clinical Trials
Placebo controlled clinical trials were used with patients who had UC, and with patients who had CD. The UC trial showed patients who received this type of therapy were more likely to achieve clinical remission. They were also more likely to achieve a corticosteroid-free clinical remission, and had improved endoscopic findings. The CD trial showed similar results.
In clinical trials, the most common side effects were: nasopharyngitis, fever, nausea, headache, and joint pain.
Vedolizumab will be supplied in sterile 20-mL single-use vials containing 300 mg of the medicine. The vials should be refrigerated at 35°-46°F/2°-8°C until use.
Product Name, Release, and Recommended Dosage
Takeda will market the drug as Entyvio, but a U.S. launch date has yet to be announced.
For most patients, the recommended dose is 300 mg, administered by IV infusion. A second dose should be administered two weeks later. A third dose should be administered four weeks after the second, with any subsequent doses given every eight weeks. Treatment should be discontinued in patients who do not see a response by week 14 of treatment.
Instructions for Use
The labeling provides detailed information about how to reconstitute the medication with sterile water to prepare it for injection, and how to add it to an infusion bag containing 250 mL of 0.9% sodium chloride. During reconstitution, up to half an hour may be required to ensure the vedolizumab fully dissolves. After dilution, it is best to use the medication as soon as possible, but it may be refrigerated at 35°-46°F/2°-8°C, for up to two hours, if necessary.
There is an FDA-required medication guide included on the labeling to alert doctors, pharmacists, and patients of the most serious risks associated with the use of this therapy: serious allergic reaction, infusion reaction, liver injury, and a theoretical risk for progressive multifocal leukoencephalopathy.
Who Should Not Receive Vedolizumab Treatment
Vedolizumab should not be given to any patients who have an active, severe, infection. If a severe infection develops over the course of treatment, consider withholding treatment.
Patients should be up-to-date with their immunizations, and if they are not, should receive recommended vaccinations before starting treatment. Vaccines may be given during therapy, so long as the benefits outweigh the risks.