Vedolizumab

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Information about Vedolizumab

Vedolizumab is a humanized monoclonal antibody to integrin α4β7 which is used in the treatment of inflammatory bowel disease.

Liver safety of Vedolizumab

Vedolizumab has been linked to a low rate of serum enzyme elevations during therapy, but has not been linked to cases of idiosyncratic, clinically apparent liver injury with jaundice. Because vedolizumab is a potent inhibitor of lymphocyte function, it may cause reactivation of chronic hepatitis B in susceptible patients.

Mechanism of action of Vedolizumab

Vedolizumab (ve” doe liz’ ue mab) is a humanized monoclonal immunoglobulin G1 antibody to integrin α4β7 (also known as lymphocyte Peyer’s patch adhesion molecule 1: LPAM-1), a cell surface molecule that plays a role trafficking inflammatory cells to sites of injury in the gastrointestinal mucosa. Vedolizumab is one of several inhibitors of integrin α4β7 that have been evaluated in autoimmune conditions. In controlled clinical trials, vedolizumab has been shown to decrease inflammation and improve symptoms in patients with refractory or relapsing inflammatory bowel disease.

FDA approval information for Vedolizumab

Vedolizumab was approved for use in the United States for both ulcerative colitis and Crohn colitis in 2014 and is recommended only for patients with moderate-to-severe inflammatory bowel disease who have not responded to corticosteroids, immunosuppressants or TNF antagonists.

Dosage and administration for Vedolizumab

Vedolizumab is available as a lyophilized power in single use vials of 300 mg under the brand name Entyvio. Vedolizumab is given intravenously in a dose of 300 mg over approximately 30 minutes at 0 and 2 weeks, followed by every 4 weeks thereafter.

Side effects of Vedolizumab

Common side effects include injection site reactions, chills, fever, skin rash and fatigue. Less common, but potentially severe side effects include hypersensitivity reactions and anaphylaxis, opportunistic infections, reactivation of tuberculosis or hepatitis B, congestive heart failure, lymphoma and other malignancies and demyelinating diseases.

Antidiarrheal agents

Antidiarrheal agents include bulk forming agents, hydroscopic agents, bile acid resins, bismuth, inhibitors of intestinal motility, non-absorbed antibiotics and hormones. Bulk forming agents include methylcellulose; hydroscopic agents include pectin and kaolin; bile acid resins are cholestyramine, colestipol and colesevalam; inhibitors of intestinal motility include opioids such as diphenoxylate and loperamide. Antibiotics include rifamycin and rifaximin which are non-absorbed and are used for travelers' diarrhea. Hormones with antidiarrheal activity include octretide and somatostatin. Most antidiarrheal agents are active locally in the small intestine and colon and are largely not absorbed. Some, however, have been implicated in rare causes of liver injury (senna, cascara, cholestyramine). Telotristat is a relatively new agent that inhibits the synthesis of serotonin and is used specifically for the diarrhea of carcinoid syndrome.

Antiemetics are a diverse group of medications that act at different points in the pathways that regulate nausea and vomiting. These include antihistamines, anticholinergic agents, phenothiazines, serotonin type 3 receptor blockers, centrally acting benzamides, cannabinoid receptor agonists, substance P antagonists and miscellaneous.

Anticholinergic Agents

Antihistamines

Cannabinoid Receptor Agonists

Serotonin 5-HT3 Receptor Antagonists

Substance P/Neurokinin 1 Receptor Antagonists

Miscellaneous

Acid peptic disease/antiulcer agents that include antacids, the histamine type 2 receptor blockers (H2 blockers), and the proton pump inhibitors (PPIs). These agents are some of the most commonly taken medications and are very well tolerated, most being available both by prescription and over-the-counter. While many of these drugs are approved for use in duodenal and gastric ulcer disease, their major use is for acid reflux and indigestion.

Histamine H2 Receptor Antagonists (H2 Blockers) Cimetidine, Famotidine, Nizatidine, Ranitidine

Proton Pump Inhibitors

Cathartics, laxatives or agents for constipation include bulk forming agents, osmotic agents, stool wetting agents, nonspecific stimulants, prokinetic agents and agents that increase fluid secretion. Many of these therapies are not systemically absorbed and none are considered particularly hepatotoxic. Naldemedine and naloxegol are opioid antagonists and are used to treat the constipation associated with opioid use.

Inflammatory bowel disease encompasses several disorders, most commonly ulcerative colitis and Crohn colitis. Agents can be classified as 5-aminosalicyclic acid (5-ASA) based agents, immunosuppressive drugs, antitumor necrosis factor agents, corticosteroids, antibiotics and miscellaneous.

5-Aminosalicyclic Acid (5-ASA) Derivatives

Immunosuppressive Agents

Tumor Necrosis Factor Antagonists

Miscellaneous

Irritable Bowel Syndrome Agents Antimuscarinics/Antispasmodics [See Anticholinergic agents

Prokinetic Agents - See Serotonin 5-ht4 receptor agonists Alosetron, Cisapride, Domperidone, Linaclotide, Lubiprostone, Metoclopramide, Plecanatide, Prucalopride, Tegaserod

Other

Cost and Coupons - Vedolizumab

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