Tremfya Special Precautions

Infections: TREMFYA may increase the risk of infection. Treatment with 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 TREMFYA and placebo groups; ≤ 0.8% serious infections in both groups).
Instruct patients treated with 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 TREMFYA until the infection resolves.
Pre-treatment evaluation for tuberculosis: In clinical studies, subjects with latent tuberculosis (TB) who were concurrently treated with TREMFYA and appropriate TB prophylaxis did not develop TB. Evaluate patients for TB infection prior to initiating treatment with TREMFYA. Initiate treatment of latent TB prior to administering TREMFYA. Patients receiving TREMFYA should be monitored for signs and symptoms of active TB during and after treatment. Do not administer TREMFYA to patients with active TB infection. Consider anti-TB therapy prior to initiating 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 TREMFYA, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with TREMFYA. No data are available on the response to live or inactive vaccines.
Hypersensitivity reactions: Serious hypersensitivity reactions 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 TREMFYA should be discontinued.
Hepatic transaminase elevations: In psoriatic arthritis clinical studies, an increased incidence of liver enzyme elevations was observed in patients treated with TREMFYA q4w compared to patients treated with TREMFYA q8w or placebo (see section Adverse reactions, Table 3).
When prescribing TREMFYA q4w in psoriatic arthritis, it is recommended to evaluate liver enzymes at baseline and thereafter according to routine patient management. If increases in alanine aminotransferase [ALT] or aspartate aminotransferase [AST] are observed and drug-induced liver injury is suspected, TREMFYA should be temporarily interrupted until this diagnosis is excluded.
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 TREMFYA.