History of multiple allergies. Promptly discontinue if serious hypersensitivity reaction occurs. Do not initiate in patients w/ active infection, including localized infections. Consider patients w/ chronic or recurrent infections or exposed to TB; history of serious or opportunistic infection, or have resided or travelled in areas of endemic TB or endemic mycoses; or have underlying conditions that may predispose to infection prior to initiating treatment. Closely monitor patients for development of signs & symptoms of infection during & after treatment; signs & symptoms of TB, including patients who tested -ve for latent TB infection prior to initiating therapy. Interrupt therapy if serious & opportunistic infection, or sepsis develop. Patients who develop new infection during treatment should undergo prompt & complete diagnostic testing, initiate antimicrobial therapy & close monitoring. Diabetic patients. History of chronic lung disease. Consider lymphocyte counts due to higher risk of infection w/ increasing degrees of lymphopenia. Evaluate & perform test for latent or active infection prior to & during administration. Treat patients w/ latent TB w/ standard antimycobacterial therapy before administration. Perform screening test for viral hepatitis before starting therapy. Higher risk of herpes zoster in Japanese & Korean patients. Assess patients for VTE risk factors before starting & periodically during treatment; discontinue for suspected VTE, regardless of dose or indication. Consider risks & benefits of treatment prior to initiating therapy in patients w/ current or history of malignancy other than successfully treated non-melanoma skin cancer (NMSC) or when considering continuing therapy in patients who develop malignancy. Higher risk for the development of lymphoma in patients w/ RA, particularly those w/ highly active disease. Periodic skin exam is recommended for patients who are at increased risk for skin cancer. Patients who may be at increased risk for GI perforation (eg, patients w/ history of diverticulitis). Promptly evaluate patients w/ new onset abdominal symptoms for early identification of GI perforation. Not recommended for patients w/ low lymphocyte count (ie, <500 cells/mm
3), low neutrophil count [ie, ANC <1,000 cells/mm
3], confirmed ANC <500 cells/mm
3 & low Hb values (ie, <9 g/dL). Monitor lymphocytes at baseline & every 3 mth thereafter; neutrophil & Hb at baseline & after 4-8 wk of treatment & every 3 mth thereafter. Reduce or interrupt dosing until ANC is >1,000 cells/mm
3 for patients who develop persistent ANC 500-1,000 cells/mm
3. Interrupt treatment in patients who develop Hb levels <8 g/dL or Hb level drops >2 g/dL on treatment. Perform assessment of lipid parameters approx 4-8 wk following initiation of therapy. Avoid concomitant use w/ live vaccines. Vaccination should occur at least 2 wk but preferably 4 wk before initiating immunomodulatory agents eg, tofacitinib. Dose reduction in patients w/ moderate or severe renal impairment; moderate hepatic impairment. Do not administer in patients w/ severe hepatic impairment. Avoid in RA patients in concomitant use w/ biological DMARDs, eg, TNF antagonists, IL-1R antagonists, IL-6R antagonists, anti-CD20 monoclonal Abs & selective co-stimulation modulators & potent immunosuppressants, (eg, azathioprine & cyclosporine). Women of reproductive potential should use effective contraception during treatment & for at least 4 wk after the last dose. Pregnancy. Avoid during breastfeeding. Childn <18 yr. Neonates. Higher incidence of infections in the elderly.
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