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A New Monoclonal Antibody for Ulcerative Colitis and Crohn's Disease

Aschenbrenner, Diane S. MS, RN

AJN, American Journal of Nursing: September 2014 - Volume 114 - Issue 9 - p 25
doi: 10.1097/01.NAJ.0000453754.39012.e7
Drug Watch

* Vedolizumab (Entyvio) is a newly approved treatment for adults with moderate-to-severe ulcerative colitis or moderate-to-severe Crohn's disease when standard therapies haven't been successful.

* The most common adverse effects are nasopharyngitis, headache, joint pain, nausea, and fever. Vedolizumab can also produce hypersensitivity (anaphylactic) and infusion-related reactions, hepatotoxicity, and progressive multifocal leukoencephalopathy.

Vedolizumab (Entyvio) is a newly approved treatment for adults with moderate-to-severe ulcerative colitis or moderate-to-severe Crohn's disease when standard therapies haven't been successful. Vedolizumab is an integrin-receptor antagonist and is considered an immunomodulator. It's part of a larger class known as humanized immunoglobulin G1 monoclonal antibodies. Integrin receptors are proteins on the surface of some cells that function as a link for cell-to-cell interactions. Vedolizumab blocks the integrin receptors on circulating inflammatory cells from interacting with a specific protein in the interior wall of blood vessels. This prevents the inflammatory cells from migrating across the blood vessel into the gastrointestinal tract.

The most common adverse effects, occurring in at least 3% of patients, are pain (headache, joint pain, back pain, pain in the extremities, or oropharyngeal pain), respiratory effects (nasopharyngitis, sinusitis, upper respiratory tract infection, cough, bronchitis, or influenza), fatigue, rash, pruritus, nausea, and fever. In studies, the adverse effects occurring at the highest rates were nasopharyngitis (13% of patients), headache (12%), joint pain (12%), nausea (9%), and fever (9%).

The labeling of vedolizumab carries warnings regarding the most serious possible adverse effects: serious infections (such as anal abscess, sepsis, tuberculosis, salmonella sepsis, listeria meningitis, giardiasis, and cytomegalovirus colitis); hypersensitivity and infusion-related reactions; hepatotoxicity (hepatitis, elevations of liver enzyme and bilirubin levels); and progressive multifocal leukoencephalopathy (PML), which is a rare and often fatal opportunistic infection of the central nervous system. Although there were no cases of PML in clinical trials of vedolizumab, the warning exists because it has occurred in patients who have received another integrin receptor antagonist, natalizumab (Tysabri), used in the treatment of multiple sclerosis and Crohn's disease.

Vedolizumab is administered intravenously. Nurses should read the drug's labeling carefully for complete information regarding reconstitution, dilution, and administration of the drug. Vedolizumab is administered as an IV infusion over 30 minutes; it should never be administered as a push or a bolus. It should be reconstituted in sterile water and then fully diluted in normal saline.

To minimize the risk of infection, the nurse should confirm that the patient's immunizations are current before first administering vedolizumab. Nonlive vaccines such as influenza vaccine may still be administered after vedolizumab is started, but live vaccines are generally to be avoided. The nurse should assess the patient carefully for infections prior to the start of vedolizumab therapy. A thorough drug history is important; vedolizumab and tumor necrosis factor blockers (which disrupt the normal inflammatory response) should not be given concomitantly because of the risk of infections. The nurse should provide patient education related to the importance of handwashing and other methods of decreasing infection risk.

Because of the risk of anaphylaxis, the nurse should closely monitor the patient during vedolizumab infusion and keep emergency medical supplies close at hand. Nurses should assess patients receiving vedolizumab for evidence of any new onset or worsening of a neurologic problem such as progressive weakness on one side of the body; clumsiness of limbs; disturbance of vision; or changes in thinking, memory, or orientation leading to confusion and personality changes. Such changes may indicate PML. If PML is suspected, vedolizumab shouldn't be administered again until the patient has been assessed by a neurologist and PML is determined not to be present. Because of the potential for PML, vedolizumab and natalizumab (known to have produced PML, although rarely) shouldn't be given concomitantly.

Nurses should assess liver enzyme and bilirubin levels in patients receiving vedolizumab. Patient education should also include the importance of reporting any symptoms of liver injury, including fatigue, anorexia, right upper abdominal pain, dark urine, and jaundice, to the prescriber.

For complete prescribing information for vedolizumab, see

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