Not to be initiated in patients w/ active, serious infection [eg, appendicitis, COVID-19 infection (including pneumonia) & sepsis]; consider risks & benefits in patients w/ chronic or recurrent infection, who have been exposed to TB, history of serious or opportunistic infection, who have resided or traveled in areas of endemic TB or mycoses, or w/ underlying condition that may predispose them to infection. Closely monitor patients for signs & symptoms of infection during & after treatment. Interrupt treatment if patient develops serious or opportunistic infection. Perform prompt & complete diagnostic testing in patients who develop a new infection during treatment; initiate appropriate antimicrobial therapy & closely monitor immunocompromised patients. Possible higher incidence of infections in elderly & diabetic patients. Screen for TB before starting ritlecitinib. Start anti-TB therapy prior to ritlecitinib in patients w/ new diagnosis of latent TB or previously untreated latent TB. Consider anti-TB therapy in patients w/ -ve latent TB test before initiating ritlecitinib in those at high risk; screen patients at high TB risk during treatment. Possible viral reactivation including cases of herpes virus (eg, herpes zoster) reactivation; consider temporary treatment interruption if patient develops herpes zoster. Perform viral hepatitis screening before starting therapy. Monitor for viral hepatitis reactivation during treatment. Possible malignancies including non-melanoma skin cancer (NMSC); consider risks & benefits of ritlecitinib prior to initiating or continuing therapy particularly in patients w/ known malignancy other than a successfully treated NMSC or cervical cancer, who develop malignancy when on treatment & those who are long-term current or past smokers. Periodic skin exam in patients who are at increased risk of skin cancer. Possible venous & arterial thromboembolism including major adverse CV events; consider risks & benefits of ritlecitinib prior to initiating or continuing therapy particularly in patients who are long-term current or past smokers & those w/ known thromboembolic or other CV risk factors. Discontinue treatment & promptly re-evaluate patients w/ suspected thromboembolic event. Higher rate of all-cause mortality including sudden CV death in RA patients ≥50 yr w/ at least 1 additional CV risk factor. Discontinue treatment in case unexplained neurological symptoms occur. Perform absolute lymphocyte count (ALC) & platelet counts prior to treatment initiation; not to be initiated in patients w/ ALC <0.5 x 10
3/mm
3 or platelet count <100 x 10
3/mm
3. Perform ALC & platelet counts at 4 wk after therapy initiation & thereafter according to routine patient management. Avoid use of live attenuated vaccines during or immediately prior to treatment. Patient must be brought up to date w/ all immunisations including prophylactic herpes zoster vaccinations prior to initiating ritlecitinib. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Not recommended in patients w/ ESRD or renal transplants. Not recommended in women of childbearing potential not using contraception; women of childbearing potential have to use effective contraception during treatment & for 1 mth following final dose. Childn <12 yr. Elderly ≥65 yr.
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