Tremfya Special Precautions

Infections: Guselkumab (Tremfya) may increase the risk of infection. Treatment with Guselkumab (Tremfya) should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Infections have been observed in clinical trials in plaque psoriasis (23% vs 21% for placebo; ≤ 0.2% serious infections in both groups) and psoriatic arthritis (21% in both Guselkumab (Tremfya) and placebo groups; ≤ 0.8% serious infections in both groups).
Instruct patients treated with Guselkumab (Tremfya) to seek medical advice 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, monitor the patient closely and discontinue Guselkumab (Tremfya) until the infection resolves.
Pre-treatment evaluation for tuberculosis: In clinical studies, subjects with latent tuberculosis (TB) who were concurrently treated with Guselkumab (Tremfya) and appropriate TB prophylaxis did not develop TB. Evaluate patients for TB infection prior to initiating treatment with Guselkumab (Tremfya). Initiate treatment of latent TB prior to administering Guselkumab (Tremfya). Patients receiving Guselkumab (Tremfya) should be monitored for signs and symptoms of active TB during and after treatment. Do not administer Guselkumab (Tremfya) to patients with active TB infection. Consider anti-TB therapy prior to initiating Guselkumab (Tremfya) in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Immunizations: Prior to initiating therapy with Guselkumab (Tremfya), consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Guselkumab (Tremfya). No data are available on the response to live or inactive vaccines.
Hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylaxis have been reported in the postmarketing setting. Some cases occurred several days after treatment with guselkumab, including cases with urticaria and dyspnea. If a serious hypersensitivity reaction occurs, appropriate therapy should be instituted and administration of Guselkumab (Tremfya) should be discontinued.
Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use machines have been performed with Guselkumab (Tremfya).