Do your mod­er­ate to se­vere ul­cer­a­tive col­i­tis or Crohn’s symp­toms leave you sec­ond guess­ing?

If your cur­rent treat­ments haven’t worked well enough, ask your gas­troen­terol­o­gist about ENTYVIO.

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• De­vel­oped only for UC and Crohn’s

• Works at the site of in­flam­ma­tion in the GI tract

• Proven to pro­vide symp­tom re­lief and re­mis­sion

In­di­vid­ual re­sults may vary.

Uses of ENTYVIO (vedolizumab):

ENTYVIO is a pre­scrip­tion medicine used in adults:

with mod­er­ate to se­vere ul­cer­a­tive col­i­tis (UC) when cer­tain other UC medicines have not worked well enough or can­not be tol­er­ated. ENTYVIO may help to: be­gin re­duc­ing some symp­toms, in­duce and main­tain re­mis­sion, re­duce or stop the use of cor­ti­cos­teroids, and im­prove the way the lin­ing of your large in­tes­tine looks to your health­care provider.

with mod­er­ate to se­vere Crohn’s dis­ease (CD) when cer­tain other CD medicines have not worked well enough or can­not be tol­er­ated. ENTYVIO may help to: be­gin re­duc­ing some symp­toms, achieve re­mis­sion, and re­duce or stop the use of cor­ti­cos­teroids.

Im­por­tant Safety In­for­ma­tion about ENTYVIO

• Do not re­ceive ENTYVIO if you have had an al­ler­gic

re­ac­tion to ENTYVIO or any of its ingredients.

• ENTYVIO may cause se­ri­ous side ef­fects, in­clud­ing:

• In­fu­sion and se­ri­ous al­ler­gic re­ac­tions can hap­pen while you are re­ceiv­ing ENTYVIO or sev­eral hours af­ter treat­ment. You may need treat­ment if you have an al­ler­gic re­ac­tion. Tell your health­care provider or get im­me­di­ate med­i­cal help if you get any of th­ese symp­toms dur­ing or af­ter an in­fu­sion of ENTYVIO: rash, itch­ing, swelling of your lips, tongue, throat or face, short­ness of breath or trouble breath­ing, wheez­ing, dizzi­ness, feel­ing hot, or pal­pi­ta­tions (feel like your heart is rac­ing).

• ENTYVIO may in­crease your risk of get­ting a se­ri­ous in­fec­tion. Be­fore re­ceiv­ing and dur­ing treat­ment with ENTYVIO, tell your health­care provider if you think you have an in­fec­tion or symp­toms of an in­fec­tion, such as fever, chills, mus­cle aches, cough, short­ness of breath, runny nose, sore throat, red or painful skin or sores on your body, tired­ness, or pain dur­ing uri­na­tion.

• It may be pos­si­ble for a per­son to get pro­gres­sive mul­ti­fo­cal leukoen­cephalopa­thy (PML) (a rare, se­ri­ous brain in­fec­tion caused by a virus). Peo­ple with weak­ened im­mune sys­tems can get PML, which can re­sult in death or se­vere dis­abil­ity. There is no known treat­ment, pre­ven­tion, or cure for PML. Tell your health­care provider right away if you have any of the fol­low­ing symp­toms:

con­fu­sion or prob­lems think­ing, loss of bal­ance, change in the way you walk or talk, de­creased strength or weak­ness on one side of the body, blurred vi­sion, or loss of vi­sion.

• Liver prob­lems can hap­pen in peo­ple who re­ceive ENTYVIO. Tell your health­care provider right away if you have any of the fol­low­ing symp­toms: tired­ness, loss of ap­petite, pain on the right side of your ab­domen, dark urine, or yel­low­ing of the skin and eyes (jaun­dice).

• The most com­mon side ef­fects of ENTYVIO 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. Th­ese are not all the pos­si­ble side ef­fects of ENTYVIO. Call your health­care provider for med­i­cal ad­vice about side ef­fects.

• Be­fore re­ceiv­ing ENTYVIO, tell your health­care provider about all of your med­i­cal con­di­tions, in­clud­ing if you: have or think you may have an in­fec­tion or have in­fec­tions that keep com­ing back; have liver prob­lems; have tu­ber­cu­lo­sis (TB) or have been in close con­tact with some­one with TB; have re­cently re­ceived or are sched­uled to re­ceive a vac­cine; or if you are preg­nant, breast­feed­ing, plan to be­come preg­nant, or plan to breastfeed.

Please see the Im­por­tant Facts for ENTYVIO on the ad­ja­cent page and talk with your health­care provider.

You are en­cour­aged to re­port neg­a­tive side ef­fects of pre­scrip­tion drugs to the FDA.

Visit www.fda.gov/med­watch or call 1-800-FDA-1088.

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