bimzelx

Important safety information

Suicidal Ideation and Behavior (SI/B) : May increase risk of SI/B. Advise patients, their caregivers, and families to monitor for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct patients to promptly seek medical attention or call the National Suicide and Crisis Lifeline at 988. Carefully weigh risks and benefits of treatment with BIMZELX in patients with a history of severe depression and/or suicidal ideation or behavior. ( 5.1 ) Infections : May increase risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, do not administer BIMZELX until the infection resolves. ( 5.2 ) Tuberculosis (TB) : Avoid use in patients with active TB. Initiate treatment of latent TB prior to BIMZELX treatment. ( 5.3 ) Liver Biochemical Abnormalities : Elevated serum transaminases were reported in clinical trials. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline and according to routine patient management. Permanently discontinue use of BIMZELX in patients with causally - associated combined elevations of transaminases and bilirubin. ( 5.4 ) Inflammatory Bowel Disease (IBD) : Cases of IBD were reported in clinical trials with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. Monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs. ( 5.5 ) Immunizations : Avoid the use of live vaccines in patients treated with BIMZELX. ( 5.6 ) 5.1 Suicidal Ideation and Behavior An increased incidence of new onset or worsening suicidal ideation and behavior was observed in subjects treated with BIMZELX. A causal association between treatment with BIMZELX and increased risk of suicidal ideation and behavior has not been definitively established. Suicidal ideation and behavior were prospectively monitored using the Columbia Suicide Severity Rating Scale (C-SSRS) in clinical trials. The C-SSRS is an interview-based instrument used to monitor for the presence and severity of suicidal ideation (ranging from "none" to "active suicidal ideation with specific plan and intent") and behaviors (rating the injury and potential lethality of self-injury, if present). Plaque Psoriasis During the two 16-week, placebo-controlled periods of Trials Ps-1 and Ps-2, higher rates of suicidal ideation as assessed by C-SSRS were reported in BIMZELX-treated subjects than in subjects receiving placebo. Pooled analysis of C-SSRS data indicated that 12/670 (1.8%) BIMZELX-treated subjects and 1/169 (0.6%) subjects receiving placebo reported passive suicidal ideation with an estimated relative risk of 3.0 (95% confidence interval: 0.39, 22.74). Subjects without a prior history of SI/B treated with BIMZELX also reported a higher rate of new onset suicidal ideation on the C-SSRS than subjects receiving placebo (1.3% vs 0.6%). During the open-label extension trial, one completed suicide was reported in a BIMZELX-treated subject [see Adverse Reactions (6.1) ]. Psoriatic Arthritis Pooled analysis of C-SSRS data from the two 16-week, placebo-controlled periods of Trials PsA-1 and PsA-2 indicated that 2/698 (0.3%) BIMZELX-treated subjects and 3/413 (0.7%) subjects receiving placebo reported passive suicidal ideation with an estimated relative risk of 0.35 (95% confidence interval: 0.05, 2.29) [see Adverse Reactions (6.1) ] . Non-Radiographic Axial Spondyloarthritis Analysis of C-SSRS data from a 16-week, placebo-controlled period of Trial nr-axSpA-1 indicated that no subjects, being treated either with BIMZELX or placebo, reported suicidal ideation [see Adverse Reactions (6.1) ] . Ankylosing Spondylitis Analysis of C-SSRS data from a 16-week, placebo-controlled period of Trial AS-1 indicated that no subjects, being treated either with BIMZELX or placebo, reported suicidal ideation [see Adverse Reactions (6.1) ] . Hidradenitis Suppurativa During the two 16-week, placebo-controlled periods of Trials HS-1 and HS-2, higher rates of suicidal ideation as assessed by C-SSRS were reported in BIMZELX-treated subjects than in subjects receiving placebo. Based on a pooled analysis of the first 16 weeks of the placebo controlled clinical trials, 16/861 subjects in the BIMZELX group (1.9 %) reported suicidal ideation on the C-SSRS compared to 1/146 subjects in the placebo group (0.7%) with an estimated relative risk of 2.70 (95% confidence interval: 0.36, 20.12). Subjects without a prior history of SI/B treated with BIMZELX also reported a higher rate of new-onset suicidal ideation on the C-SSRS than subjects treated with placebo (0.9% vs. 0%). [see Adverse Reactions 6.1 ]. Consider the potential risks and benefits before prescribing BIMZELX to patients with a history of severe depression or suicidal ideation or behavior. Advise patients, their caregivers, and families to monitor for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct patients to promptly seek medical attention or call the National Suicide and Crisis Lifeline at 988 [see Patient Counseling Information (17) ] . Refer BIMZELX-treated patients with new or worsening symptoms of depression or suicidal ideation and/or behavior to a mental health professional, as appropriate. Re-evaluate the risks and benefits of continuing treatment with BIMZELX if such events occur. 5.2 Infections BIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and discontinue BIMZELX until the infection resolves. 5.3 Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients treated with BIMZELX for signs and symptoms of active TB during and after treatment. 5.4 Liver Biochemical Abnormalities Treatment with BIMZELX was associated with increased incidence of liver enzyme elevations compared to treatment with placebo in randomized clinical trials. Liver serum transaminase elevations > 3 times the upper limit of normal were reported in subjects treated with BIMZELX [see Adverse Reactions (6.1) ] . Elevated liver serum transaminases resolved after discontinuation of BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Patients with acute liver disease or cirrhosis may be at increased risk for severe hepatic injury; avoid use of BIMZELX in these patients. 5.5 Inflammatory Bowel Disease Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX [see Adverse Reactions (6.1) ]. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new…