Precautions of Tofacitinib

1 Serious Infections

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.

2 Mortality

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.

3 Malignancy and Lymphoproliferative Disorders

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