SOTYKTU Rx

Discontinue and treat if clinically significant hypersensitivity reactions (eg, angioedema) occur. Increased risk of infections (eg, pneumonia, COVID-19). Avoid in active or serious infection. Consider the risks/benefits in chronic, recurrent, history of serious or opportunistic infections, or underlying conditions that may predispose to infection. Monitor closely for signs/symptoms of infection during and after treatment. Interrupt therapy if a serious infection occurs; do not resume until infection resolves or is adequately treated. Consider viral hepatitis screening and monitoring for reactivation prior to and during therapy; evaluate if occurs. Active hepatitis B or C: not recommended. Test/treat latent and active tuberculosis (TB) infection prior to initiation. Monitor for active TB during therapy. Increased malignancies (including lymphomas). Consider benefits/risks prior to or continuing therapy esp. in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and those who develop a malignancy during therapy. Increased risk of rhabdomyolysis and creatine phosphokinase (CPK) elevation; discontinue if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Periodically evaluate serum triglycerides during therapy. Evaluate liver enzymes at baseline and thereafter in those with known or suspected liver disease; interrupt therapy if treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected. Consider completion of all age-appropriate immunizations according to current guidelines prior to initiation. Potential risks related to JAK inhibition: higher rates of all-cause mortality including sudden CV death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer). Severe hepatic impairment (Child-Pugh C): not recommended. Pregnancy. Nursing mothers.