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Serious infections have been reported in patients receiving ritlecitinib. The most frequent serious infections have been appendicitis, COVID-19 infection (including pneumonia), and sepsis [see Adverse Reactions (6.1)]. Among opportunistic infections, multi-dermatomal herpes zoster was reported with ritlecitinib.
In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including suddencardiovascular death, was observed in patients treated with the JAK inhibitor compared with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with ritlecitinib.
Malignancies, including non-melanoma skin cancer (NMSC), were observed in clinical trials of ritlecitinib.
In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE) defined as cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke was observed with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk.
An event of pulmonary embolism (PE) was reported in a patient receiving ritlecitinib. In a ritlecitinib higher dosing group, 1 patient reported an event of retinal artery occlusion.
Serious reactions including anaphylactic reactions, urticaria and rash have been observed in patients receiving ritlecitinib in clinical trials. If a clinically significant hypersensitivity reaction occurs, discontinue ritlecitinib and institute appropriate therapy.
Treatment with ritlecitinib was associated with decreases in lymphocytes and platelets.
No data are available on the response to vaccination in patients receiving ritlecitinib. Use of live attenuated vaccines should be avoided during or shortly prior to initiating treatment. Prior to initiating ritlecitinib, it is recommended that patients be brought up to date with all immunizations, including prophylactic herpes zoster vaccinations, in agreement with current immunization guidelines.
from FDA，2023.06
