Treating Rheumatoid Arthritis

Tuesday, March 1, 2016

Treating Rheumatoid Arthritis Pfizer KnowsJAKScience Pfizer is the leader in JAKscience with more than 20 yearde developmentof XELJANZ for the treatment of moderate to severe rheumat XELJANZ?(tofacitinib citrate) 5 mg tablets and XELJANZ? XR(tofacitinib citrate) extended-release 11 me tablets The Developmentof XELJANZ, the First and Only Approved Oral JAK Inhibitor for Moderate to Severe RA 2012 2014 2015 The discovery 1993 Tofacitinib XELJANZ XELJANZ US One of the process involved clinical trials t ng dail include data on hundreds of —to severe in the us a a and development advanced to screening thousands of compounds leading to the a 2016 a label updated to a . fastest growing RAtherapies XELJANZ XR approved by FDA as the first and in moderate leach aNV the reduction of in the Us’ only once-daily RA available for inwne the progression oralJAK inhibitor ofstructural joint damage patients with moderate to identification of severe RA tofacitinib SBTyacmantemani(esre rl sa MTcea of any JAKinhibitor in moderate to severe RA. XELJANZ has been studied in 6,194 FeTel Nie c-}e)cts-1a1 Mine)as -LOLO NY=r : : : " 47,000 patients IereVA Colcol A(R OTM AMONSeo Neri eKea Uc ePA 1) : : i prescribed aver 45 4 countries : : JAN XELJANZ XR 11 :fo. XELJANZ in the US JKI Ws wa i mg administered oncedaily ‘ orice is pharmacokinetically equivalent to XELJANZ (tofacitinib citrate) 5 mg : : : : : : administered twice daily. yA Mee aM LaRLe OM Ta)ar-ule gto ame =l Cec T NOM OTe ee gL MOLE ELJANZ/XELJANZ XR through a robustclinical development program WHATIS XELJANZ/XELJANZ XR? XELJANZ/XELJANZ XR is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ/XELJANZ XR is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well. It is not known if XELJANZ/XELJANZ XR is safe and effective in people with hepatitis B or C. XELJAN/XELJANZ XR is not for people with severeliver problems. It is not known if XELJANZ/XELJANZ XR is safe and effectivein children. IMPORTANT SAFETY INFORMATION Whatis the most important information | should know about XELJANZ/XELJANZ XR? XELJANZ/XELJANZ XR maycauseserioussideeffects, including: Seriousinfections. XELJANZ/XELJANZ XR can lower the ability of your immune system tofightinfections. Some people can haveserious infections while taking XELJANZ/XELJANZ XR, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting XELJANZ/XELJANZ XR, and monitoryou closely for signs and symptoms ofTBinfection during treatment. You should notstart taking XELJANZ/XELJANZ XRif you haveanykind ofinfection unless your healthcare provider tells youit is okay. You may be at a higher risk of developingshingles. Before starting XELJANZ/XELJANZ XR, tell your healthcare provider if you: think you have an infection or have symptoms of an infection, such as fever, sweating, or chills; cough; blood in phlegm; warm, red, or painful skin or sores on your body;burning whenyou urinate or urinating more often than normal; muscle aches; shortness of breath; weightloss; diarrhea or stomachpain; orfeeling very tired are being treated for an infection get a lotof infections or haveinfections that keep coming back have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections have TB, or have been in close contact with someone with TB live or havelived in, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) wherethereis an increased chancefor getting certain kinds of fungalinfections (histoplasmosis, coccidioidomycosis, or blastomy cosis). These infections may happen or become moresevereif you use XELJANZ/XELJANZ XR. Askyour healthcare providerif you do not knowif you have lived in an area where these infections are common + have or havehad hepatitis B or C After starting XELJANZ/XELJANZ XR, call your healthcare provider right away if you have any symptoms ofan infection. XELJANZ/XELJANZ XR can make you morelikely to get infections or make worse any infection that you have. Cancer and immunesystem problems. XELJANZ/XELJANZ XR mayincrease your riskof certain cancers by changing the wayyour immunesystem works, Lymphoma and other cancers, includingskin cancers, have happenedin patientstaking XELJANZ/XELJANZ XR. Tell your healthcare provider if you have ever had any type ofcancer. Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus-associated post-transplant lymphoproliferative disorder). Tears (perforation)in the stomachor intestines. Some people taking XELJANZ/XELJANZ XR can gettears in their stomachor intestine. This happens mostoften in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right awayif you have fever and stomach-area pain that does not go away anda changein your bowel habits. Changes in certain lab test results. Your healthcare provider should do blood tests before you start receiving XELJANZ/XELJANZ XR, and while you take XELJANZ/XELJANZ XR, to checkfor the following side effects: + changes in lymphocyte counts. Lymphocytesare white bloodcells that help the bodyfight off infections. + low neutrophil counts. Neutrophils are white bloodcells that help the bodyfight off infections. + low redbloodcell count. This may mean that you have anemia, which may makeyoufeel weak andtired. Your healthcare provider should routinely checkcertain liver tests. You should notreceive XELJANZ/XELJANZ XRif your lymphocyte count, neutrophil count, orred bloodcell countis too low or your liver tests aretoo high. Your healthcare provider maystop your XELJANZ/XELJANZ XR treatmentfor a periodoftime if needed becauseof changesin these blood testresults. Your healthcare provider should do blood tests to check your cholesterol levels 4-8 weeks after you start XELJANZ/XELJANZ XR, and as needed after that. Whatshould | tell my healthcare provider before taking XELJANZ/XELJANZ XR? XELJANZ/XELJANZ XR maynotberightfor you. Before taking XELJANZ/XELJANZ XR,tell your healthcare providerif you: have an infection have liver problems have kidney problems have any stomach area (abdominal) pain or been diagnosed with diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach orintestines or narrowing within your digestive tract have had a reaction to tofacitinib or any of the ingredients in XELJANZ/XELJANZ XR haverecentlyreceived or are scheduledto receive a vaccine. People taking XELJANZ/XELJANZ XR should notreceivelive vaccines but can receive non-live vaccines have any other medical conditions plan to become pregnant or are pregnant. It is not known if XELJANZ will harm an unborn baby Pregnancy Registry:Pfizer has a registry for pregnant women who take XELJANZ. The purpose ofthis registry is to check the health of the pregnant mother and her baby.If you are pregnant or become pregnant while taking XELJANZ, talk to your healthcare provider about how you can join this pregnancyregistry or you maycontactthe registry at 1-877-311-8972 to enroll + plan to breastfeedorare breastfeeding Tell your healthcare provider aboutall of the jicines you take, i any other icines to treat your id arthritis. You should not take tocilizumab (Actemra), etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), abatacept (Orencia), anakinra (Kineret), certolizumab pegol (Cimzia), golimumab (Simponi), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking XELJANZ/XELJANZ XR. Taking XELJANZ with these medicines mayincrease your risk of infection. + Tell your healthcare provider if you are taking medicinesthataffect the waycertain liver enzymeswork. Ask your healthcareprovider if you are not sure if your medicine is one of these. Taking XELJANZ XR Whenyou take XELJANZ XR, you may see something in your stool that lookslike a tablet. This is the emptyshell from thetablet after the medicine has been absorbed by your body. Whatare other possible side effects of XELJANZ/XELJANZ XR? XELJANZ/XELJANZ XR may cause serious side effects, including hepatitis B or C activation infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ/ XELJANZ XR. Tell your healthcare provider if you have the following symptoms of a possible hepatitis B or C infection: feel very tired, little or noappetite, clay-colored bowel movements,chills, muscle aches, skin rash, skin or eyes lookyellow, vomiting, fevers, stomach discomfort, or darkurine. Common side effects of XELJANZ/XELJANZ XR include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, and nasal congestion, sore throat, and runny nose (nasopharyngitis). Please see full Prescribing Information, including BOXED WARNING and Medication Guide, available at www.xeljanzpi.com. Ge 2016 Pfizer Al rights reserved, February 206 PP-XEL-USA-0823-01 XELJANZ’-2 (tofacitinib citrate) Sing XELJANZ'XR &Z (tofacitinib citrate) : (NAPSA)—The FDA has approveda pill that can help bring relief to people with rheumatoid arthritis (RA).

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