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Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Tofacitinib Oral Solution. Tofacitinib Oral Solution should be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with Tofacitinib Oral Solution should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored.
A Tofacitinib Oral Solution 10 mg twice daily (or a Tofacitinib 22 mg once daily) dosage is not recommended for the treatment of RA , PsA, or AS.
For the treatment of UC, use XELJANZ/Tofacitinib at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Tofacitinib Oral Solution, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy while on treatment, and patients who are current or past smokers. A Tofacitinib Oral Solution 10 mg twice daily (or a Tofacitinib 22 mg once daily) dosage is not recommended for the treatment of RA or PsA.
from FDA，2024.09
