Avoid areas of the skin that show psoriasis as inj sites. Discontinue administration if an anaphylactic or other serious hypersensitivity reaction occurs. Potential to increase risk of infections & reactivate latent infections. Caution in patients w/ chronic infection or history of recurrent infection. Evaluate for TB infection prior to treatment initiation. Consider anti-TB therapy prior to initiation of Wezlana in patients w/ history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor for signs & symptoms of active TB during & after treatment. Potential to increase risk of malignancy. Caution in patients w/ history of malignancy or patients who develop malignancy while receiving ustekinumab. Monitor for appearance of skin cancer, particularly in patients >60 yr, patients w/ medical history of prolonged immunosuppressant therapy or those w/ history of PUVA treatment; systemic & resp hypersensitivity reactions including anaphylaxis, angioedema, alveolitis, eosinophilic pneumonia, & non-infectious organising pneumonia. Regularly assess risk factors for CV disease during treatment. Monitor for symptoms of erythrodermic psoriasis or exfoliative dermatitis. Discontinue treatment if diagnosis of a lupus-related condition is confirmed. Before live viral or live bacterial vaccination, Wezlana treatment should be withheld for at least 15 wk after the last dose & can be resumed at least 2 wk after vaccination. Caution when considering concomitant use w/ other immunosuppressants or when transitioning from other immunosuppressive biologics. Has not been evaluated in patients who have undergone allergy immunotherapy. Has not been studied in patients w/ renal & hepatic impairment. Women of childbearing potential should use effective contraception during treatment & for at least 15 wk after treatment. Preferable to avoid use in pregnancy. Administration of live vaccines to infants exposed
in utero to ustekinumab is not recommended for 12 mth following birth or until ustekinumab infant serum levels are undetectable. Discontinue breast-feeding during treatment & up to 15 wk after treatment, or discontinue Wezlana therapy. Safety & efficacy of ustekinumab in childn w/ psoriasis <6 yr or in childn w/ psoriatic arthritis <18 yr have not yet been established.