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INDICATION AND IMPORTANT SAFETY INFORMATION
ILUMYA™ (tildrakizumab-asmn) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
ILUMYA™ is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Cases of angioedema and urticaria occurred in ILUMYA™-treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA™ immediately and initiate appropriate therapy.
ILUMYA™ may increase the risk of infection. Treatment with ILUMYA™ should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated.
Consider the risks and benefits of treatment prior to prescribing ILUMYA™ in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA™ to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and consider discontinuation of ILUMYA™ until the infection resolves.
Pretreatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA™. Do not administer ILUMYA™ to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA™. Consider anti-TB therapy prior to initiation of ILUMYA™ in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA™ should be monitored closely for signs and symptoms of active TB during and after treatment.
Prior to initiating therapy with ILUMYA™, consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA™ should not receive live vaccines.
The most common (≥1%) adverse reactions associated with ILUMYA™ treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea.
Please see full Prescribing Information.