siliq

Important safety information

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur. If a serious hypersensitivity reaction occurs, immediately discontinue SILIQ and initiate appropriate therapy. ( 5.3 ) • Infections: Serious infections have occurred. Consider the risks and benefits prior to initiating SILIQ in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue SILIQ until the infection resolves. ( 5.4 ) • Tuberculosis (TB): Evaluate patients for TB infection prior to initiating treatment with SILIQ. ( 5.5 ) • Eczematous Eruptions: The onset of eczematous eruptions was variable, ranging from days to months after the first dose of SILIQ. Some cases of severe eczematous eruptions resulted in hospitalization. Treatment may need to be discontinued to resolve the eczematous eruption. Some patients with limited psoriasis treatment options were successfully treated for eczema while continuing SILIQ. ( 5.6 ) • Crohn’s Disease: Crohn’s disease occurred during clinical trials. Discontinue SILIQ if patient develops Crohn’s disease while taking SILIQ. ( 5.7 ) • Immunizations: Avoid using live vaccines concurrently with SILIQ. ( 5.8 ) 5.1 Suicidal Ideation and Behavior Suicidal ideation and behavior, including four completed suicides, occurred in subjects treated with SILIQ in the psoriasis clinical trials. There were no completed suicides in the 12-week placebo-controlled portion of the trials. SILIQ users with a history of suicidality or depression had an increased incidence of suicidal ideation and behavior as compared to users without such a history [see Adverse Reactions ( 6.1 )] . A causal association between treatment with SILIQ and increased risk of suicidal ideation and behavior has not been established. Prescribers should weigh the potential risks and benefits before using SILIQ in patients with a history of depression or suicidality. Patients with new or worsening symptoms of depression or suicidality should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation and behavior, new onset or worsening depression, anxiety, or other mood changes. Prescribers should also re-evaluate the risks and benefits of continuing treatment with SILIQ if such events occur. Because of the observed suicidal ideation and behavior in subjects treated with SILIQ, if an adequate response to SILIQ has not been achieved within 12 to 16 weeks, consider discontinuing therapy. SILIQ is available only through a restricted program under a REMS [see Warnings and Precautions ( 5.2 )]. 5.2 SILIQ REMS Program SILIQ is available only through a restricted program under a REMS called the SILIQ REMS Program because of the observed suicidal ideation and behavior in subjects treated with SILIQ [see Warnings and Precautions ( 5.1 )]. Notable requirements of the SILIQ REMS Program include the following: • Prescribers must be certified with the program. • Patients must sign a Patient Enrollment Form. • Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive SILIQ. • Distributors must be authorized to distribute SILIQ and must only distribute to certified prescribers and pharmacies. Further information, including a list of qualified pharmacies, is available at www.SILIQREMS.com or by calling the SILIQ REMS Program Call Center at 855-511-6135. 5.3 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of SILIQ. Some cases required hospitalization. If a serious hypersensitivity reaction occurs, immediately discontinue SILIQ and initiate appropriate therapy. 5.4 Infections SILIQ may increase the risk of infections. In clinical trials, subjects treated with SILIQ had a higher rate of serious infections than subjects treated with placebo (0.5% versus 0.2%) and higher rates of fungal infections (2.4% versus 0.9%). One case of cryptococcal meningitis occurred in a subject treated with SILIQ during the 12-week randomized treatment period and led to discontinuation of therapy [see Adverse Reactions ( 6.1 )]. During the course of clinical trials for plaque psoriasis, the exposure-adjusted rates for infections and serious infections were similar in the subjects treated with SILIQ and those treated with ustekinumab. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SILIQ. Instruct patients to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy for the infection, monitor the patient closely and discontinue SILIQ therapy until the infection resolves. 5.5 Risk for Latent Tuberculosis Reactivation Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SILIQ. Do not administer SILIQ to patients with active TB infection. Initiate treatment for latent TB prior to administering SILIQ. Consider anti-TB therapy prior to initiation of SILIQ in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving SILIQ for signs and symptoms of active TB during and after treatment. 5.6 Eczematous Eruptions Postmarketing cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, were reported in patients receiving SILIQ. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of SILIQ. Some cases of severe eczematous eruptions resulted in hospitalization. Treatment may need to be discontinued to resolve the eczematous eruption. Some patients with limited psoriasis treatment options were successfully treated for eczema while continuing SILIQ. 5.7 Crohn’s Disease In psoriasis trials, which excluded subjects with active Crohn’s disease, Crohn’s disease occurred in one subject during treatment with SILIQ and led to discontinuation of therapy. In other trials, exacerbation of Crohn’s disease was observed with SILIQ use. SILIQ is contraindicated in patients with Crohn’s disease. Discontinue SILIQ if the patient develops Crohn’s disease while taking SILIQ. 5.8 Immunizations Avoid use of live vaccines in patients treated with SILIQ. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with SILIQ.