Promptly discontinue use if serious hypersensitivity reaction occurs. Risk of serious & potentially fatal, or opportunistic infections. Possible progressive multifocal leukoencephalopathy in Xeljanz-treated RA patient w/ multiple contributory factors. Do not initiate in patients w/ an active infection including localized infections. Patients w/ chronic or recurrent infections, or those who have been exposed to TB, history of serious or opportunistic infection, resided or traveled in areas of endemic TB or mycoses; underlying conditions that may predispose to infection. Closely monitor for development of signs & symptoms of infection during & after treatment; TB including patients who tested -ve for latent TB prior to initiating therapy. Interrupt use if patient develops serious or opportunistic infection, or sepsis. Perform prompt & complete diagnostic testing & initiate appropriate antimicrobial therapy in patient who develops new infection during treatment. Patients w/ history of chronic lung disease. Possible events of ILD. Evaluate & test patients for latent or active infection prior to & during administration. Treat patients w/ latent TB w/ standard antimycobacterial therapy before Xeljanz administration. Perform viral hepatitis screening before starting therapy. Higher risk of herpes zoster in Japanese & Korean patients & those treated w/ 10 mg bd dose. Assess patients for risk factors & urgently evaluate patients w/ signs & symptoms of VTE; discontinue use while evaluating suspected VTE. Possible major adverse CV events including MI. Consider risks & benefits of treatment prior to therapy initiation in patients w/ current or history of malignancy other than successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Xeljanz in patients who develop malignancy. Patients ≥65 yr, who are current or past or long-time smokers & those w/ other CV or malignancy risk factors (eg, history of ASCVD; current or history of malignancy). Possible lymphoma; patients w/ highly active RA may be at higher risk. Possible lung cancer. Higher risk of NMSC in patients treated w/ 10 mg bd dose; perform periodic skin exam in patients at increased risk of skin cancer. Patients who may be at increased risk for GI perforation (eg, history of diverticulitis). Patients w/ known risk factors for fractures (eg, elderly, female & those w/ corticosteroid use). Not recommended to initiate in patients w/ lymphocyte count <500 cells/mm
3, or ANC <1,000 cells/mm
3, or Hb <9 g/dL. Monitor lymphocyte at baseline & every 3 mth thereafter; neutrophils & Hb at baseline & after 4-8 wk of treatment & every 3 mth thereafter. Routinely monitor liver enzymes. Interrupt administration if drug-induced liver injury is suspected. Assess lipid parameters approx 4-8 wk following therapy initiation. Do not concurrently give w/ live vaccines. Avoid use in combination w/ biological DMARDs (for RA & PsA); w/ biological agents (for UC); w/ TNF antagonists, IL-1R antagonists, IL-6R antagonists, anti-CD20 monoclonal Ab, IL-17 antagonists, IL-12/IL-23 antagonists, anti-integrins, selective co-stimulation modulators & potent immunosuppressants (eg, azathioprine, cyclosporine & tacrolimus). Not recommended to co-administer w/ potent CYP3A4 inducers. Patients w/ baseline CrCl <40 mL/min. Not to be used in patients w/ severe hepatic impairment. Advise women of reproductive potential to use effective contraception during treatment & for at least 4 wk after the last dose. Pregnancy. Do not breastfeed during treatment. Childn <18 yr.