A serious adverse reaction of drug-induced liver injury was reported in a patient with Crohn’s disease (ALT: 54x ULN, AST: 30x ULN, and total bilirubin: 2.2x ULN) following two intravenous doses of SKYRIZI 600 mg in conjunction with a rash that required hospitalization. The liver test abnormalities resolved following administration of steroids. SKYRIZI was subsequently discontinued.

Infections: SKYRIZI may increase the risk of infections. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, monitor the patient closely and do not administer SKYRIZI until the infection resolves.

Tuberculosis (TB): Evaluate for TB infection prior to initiating treatment with SKYRIZI.

Vaccinations: Complete all age-appropriate vaccinations according to current immunization guidelines prior to initiating treatment with SKYRIZI.