May increase risk of infections. Do not initiate treatment in patients w/ any clinically important active infection until infection resolves or is adequately treated. Evaluate patients for TB infection before initiating treatment. Consider anti-TB therapy prior to treatment initiation in patients w/ latent TB, history of TB or possible previous exposure to people w/ active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs & symptoms of active TB after spesolimab treatment. Risk of hypersensitivity & infusion-related reactions. Immediately discontinue & initiate appropriate treatment in case of signs of anaphylaxis or other serious hypersensitivity. For mild or moderate hypersensitivity during infusion, stop treatment & consider appropriate medical therapy. Upon resolution of the reaction, restart infusion at a slower infusion rate w/ gradual increase to complete the infusion. No experience in patients w/ immediate, life-threatening flare of generalised pustular psoriasis or a flare requiring intensive care treatment. No data available on the potential secondary transmission of infection by live vaccines in patients receiving spesolimab. Interval between live vaccinations & therapy initiation should be at least 4 wk. Do not administer live vaccines for at least 16 wk after treatment. Potential for peripheral neuropathy w/ spesolimab is unknown. Observe for symptoms potentially indicative of new-onset peripheral neuropathy. Pregnancy & lactation. Safety & efficacy in adolescents 12-18 yr have not yet been established. No relevant use in childn <12 yr.
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