Vedolizumab

What is Vedolizumab?

• Vedolizumab (Entyvio) is an integrin α4β7 receptor antagonist used for the treatment of ulcerative colitis and Crohn's disease.

What are the uses of this medicine?

Vedolizumab (Entyvio) is a prescription medicine used in adults for the treatment of:

• moderately to severely active ulcerative colitis.
• moderately to severely active Crohn's disease.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have had an allergic reaction to Entyvio or any of the ingredients in Entyvio.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• adalimumab (Humira), certolizumab (Cimzia), golimumab (Simponi), infliximab (Remicade), or natalizumab (Tysabri).

Is this medicine FDA approved?

• 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.

How should this medicine be used?

• Prior to initiating treatment with Entyvio, all patients should be brought up to date with all immunizations according to current immunization guidelines.

Recommended dosage: Dosage in Adults with Ulcerative Colitis or Crohn's Disease:

• The recommended dosage of Entyvio in adults with ulcerative colitis or Crohn's disease is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.

Administration:

• Vedolizumab injection comes as a powder to be mixed with sterile water and injected intravenously (into a vein) over 30 minutes by a doctor or nurse.
• Entyvio is given through a needle placed in a vein (intravenous infusion) in your arm.
• Entyvio is given to you over a period of about 30 minutes.
• Your healthcare provider will monitor you during and after the Entyvio infusion for side effects to see if you have a reaction to the treatment.
• Vedolizumab injection may help control your symptoms, but it will not cure your condition.
• Your doctor will watch you carefully to see how well vedolizumab injection works for you.
• If your condition has not improved after 14 weeks, your doctor may stop treating you with vedolizumab injection.
• It is important to tell your doctor how you are feeling during your treatment.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 300 mg vedolizumab in a single-dose vial.

This medicine is available in fallowing brand namesː

• Entyvio

What side effects can this medication cause?

The most common side effects of this medicine include:

• common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities

Entyvio may cause serious side effects which may include:

• Infusion-related and serious allergic reactions
• Infections
• Progressive Multifocal Leukoencephalopathy (PML)
• Liver Problems

What special precautions should I follow?

• Infusion-related reactions and hypersensitivity reactions have been reported, including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of Entyvio immediately and initiate appropriate treatment.
• Patients treated with Entyvio are at increased risk for developing infections. Treatment with Entyvio is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding Entyvio in patients who develop a severe infection while on treatment with Entyvio.
• Inform patients that progressive multifocal leukoencephalopathy (PML) has occurred in patients who received some integrin receptor antagonist and systemic immunosuppressant products. Instruct patients to report if they experience any new onset or worsening of neurological signs and symptoms immediately, as these could be indicative of PML.
• There have been reports of elevations of transaminase and/or bilirubin in patients receiving Entyvio. Entyvio should be discontinued in patients with jaundice or other evidence of significant liver injury.
• Prior to initiating treatment with Entyvio, all patients should be brought up to date with all immunizations according to current immunization guidelines.
• 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.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• It is not known if Entyvio will harm your unborn baby.
• Tell your healthcare provider right away if you become pregnant while receiving Entyvio.
• Pregnancy Registry: There is a pregnancy registry for women who use Entyvio during pregnancy.
• The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry or you may contact the registry at 1-877-825-3327 to enroll.

Can this medicine be used in children?

• Safety and effectiveness of Entyvio in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: vedolizumab
• Inactive ingredients: arginine hydrochloride, histidine, histidine monohydrochloride, polysorbate 80 and sucrose

Who manufactures and distributes this medicine?

Manufactured by:

• Takeda Pharmaceuticals U.S.A., Inc.
• Lexington, MA
• Entyvio is a trademark of Millennium Pharmaceuticals Inc. and is used under license by Takeda Pharmaceuticals U.S.A., Inc.

What should I know about storage and disposal of this medication?

• Refrigerate unopened vials at 2ºC to 8ºC (36ºF to 46ºF).
• Retain in original package to protect from light.

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.

• Cholestyramine
• Colesevelam
• Colestipol
• Crofelemer
• Difenoxin
• Diphenoxylate
• Kaolin
• Loperamide
• Methylcellulose
• Octreotide
• Pectin
• Rifamycin
• Rifaximin
• Somatostatin
• Telotristat

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

• Hyoscyamine, Methscopolamine, Scopolamine

Antihistamines

• Cyclizine, Dimenhydrinate, Hydroxyzine, Meclizine, and Promethazine

Cannabinoid Receptor Agonists

• Dronabinol, Nabilone, Tetrahydrocannabinol
• Phenothiazines [See Antipsychotic Agents]
• Chlorpromazine, Prochlorperazine

Serotonin 5-HT3 Receptor Antagonists

• Alosetron, Dolasetron, Granisetron, Ondansetron, Palonosetron

Substance P/Neurokinin 1 Receptor Antagonists

• Aprepitant, Fosaprepitant, Rolapitant

Miscellaneous

• Dexamethasone, Metoclopramide, Trimethobenzamide

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

• Dexlansoprazole, Esomeprazole, Lansoprazole, Omeprazole, Pantoprazole, Rabeprazole

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.

• Bisacodyl
• Cascara Sagrada
• Castor Oil
• Docusate
• Fiber, Bran
• Lactulose
• Magnesium Sulfate
• Methylcellulose
• Naldemedine (Opioid Antagonist)
• Naloxegol (Opioid Antagonist)
• Plecanatide (for Chronic Idiopathic Constipation)
• Prucalopride (for Chronic Idiopathic Constipation)
• Senna

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

• Balsalazide, Mesalamine, Olsalazine, Sulfasalazine

Immunosuppressive Agents

• Azathioprine, Mercaptopurine, Methotrexate

Tumor Necrosis Factor Antagonists

• Adalimumab, Certolizumab, Golimumab, Infliximab

Miscellaneous

• Metronidazole, Natalizumab, Vedolizumab

Irritable Bowel Syndrome Agents Antimuscarinics/Antispasmodics [See Anticholinergic agents

• Dicyclomine, Glycopyrrolate, Hyoscyamine, Methscopolamine

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

Other

• Eluxadoline

• Dailymed label info on Vedolizumab
• FDA Vedolizumab

Vedolizumab Resources
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