The safety of SILIQ was studied in >4500 patients7

Events occurring in ≥1% of subjects and more frequently than placebo

Placebo SILIQ 210 mg Q2W* Stelara Adverse Reaction N=879 n (%) N=1496 n (%) N=613 n (%) Arthralgia Headache Fatigue Diarrhea Oropharyngeal pain Nausea Myalgia Injection site reactions (pain, erythema, bruising, hemorrhage, pruritus) Influenza Neutropenia Tinea infections (tinea pedis, versicolor, cruris) 29 (3.3) 71 (4.7) 15 (2.4) 31 (3.5) 64 (4.3) 23 (3.8) 10 (1.1) 39 (2.6) 16 (2.6) 10 (1.1) 33 (2.2) 5 (0.8) 10 (1.1) 31 (2.1) 8 (1.3) 10 (1.1) 28 (1.9) 6 (1.0) 3 (0.3) 26 (1.7) 4 (0.7) 11 (1.3) 23 (1.5) 12 (2.0) 4 (0.5) 19 (1.3) 7 (1.1) 4 (0.5) 15 (1.0) 5 (0.8) 2 (0.2) 15 (1.0) 3 (0.5) *Subjects receiving 210 mg of SILIQ at Weeks 0, 1, and 2, followed by treatment every 2 weeks during the 12-week period Q2W = once every 2 weeks.
Q2W = once every 2 weeks.*Subjects receiving 210 mg of SILIQ at Weeks 0, 1, and 2, followed by treatment every 2 weeks during the 12-week period. Placebo SILIQ 210 mg Q2W* Stelara Adverse Reaction N=879 n (%) N=1496 n (%) N=613 n (%) Arthralgia Headache Fatigue Diarrhea Oropharyngeal pain Nausea Myalgia Injection site reactions (pain, erythema, bruising, hemorrhage, pruritus) Influenza Neutropenia Tinea infections (tinea pedis, versicolor, cruris) 29 (3.3) 71 (4.7) 15 (2.4) 31 (3.5) 64 (4.3) 23 (3.8) 10 (1.1) 39 (2.6) 16 (2.6) 10 (1.1) 33 (2.2) 5 (0.8) 10 (1.1) 31 (2.1) 8 (1.3) 10 (1.1) 28 (1.9) 6 (1.0) 3 (0.3) 26 (1.7) 4 (0.7) 11 (1.3) 23 (1.5) 12 (2.0) 4 (0.5) 19 (1.3) 7 (1.1) 4 (0.5) 15 (1.0) 5 (0.8) 2 (0.2) 15 (1.0) 3 (0.5)

Long-term safety4

Exposure-adjusted treatment-emergent adverse events

Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Total patient-years of exposure Number of TEAEs (Exposure-adjusted event rate per 100 patient-years)a TEAEs of interest (Exposure-adjusted event rate per 100 patient-years)a 172.9 N=181 N=181 N=181 N=181 N=181 N=181 330.1 475.2 725.7 731.7 611.0 All TEAEs 748 (432.6) 1154 (349.6) 1373 (288.9) 1750 (241.1) 1770 (241.9) 1565 (256.1) Grade >2 380 (219.8) 593 (179.6) 733 (154.3) 997 (137.4) 1014 (138.6) 863 (141.2) Grade >3 18 (10.4) 29 (8.8) 37 (7.8) 59 (8.1) 62 (8.5) 49 (8.0) Serious TEAEs 13 (7.5) 18 (5.5) 22 (4.6) 40 (5.5) 41 (5.6) 31 (5.1) Nervous system disorder 29 (16.8) 51 (15.4) 62 (13.0) 78 (12.8) 90 (12.4) 91 (12.4) 28 (16.2) 38 (11.5) 40 (8.4) 40 (6.5) 41 (5.6) 41 (5.6) Injection-site reaction 17 (9.8) 23 (7.0) 28 (5.9) 34 (5.6) 41 (5.6) 41 (5.6) Oropharyngeal candidiasis 4 (2.3) 6 (1.8) 7 (1.1) 6 (1.3) 8 (1.1) 8 (1.1) Serious infectious episode 8 (4.6) 12 (3.6) 12 (2.0) 12 (2.5) 12 (1.7) 12 (1.6) Hypersensitivity event 0 0 4 (0.7) 1 (0.2) 7 (1.0) 7 (1.0) Ischemic heart disease 4 (2.3) 4 (1.2) 7 (1.1) 6 (1.3) 9 (1.2) 9 (1.2) Depression 1 (0.6) 1 (0.3) 1 (0.2) 1 (0.2) 1 (0.1) 1 (0.1) Neutropenia 0 0 0 0 1 (0.1) 1 (0.1) Suicide/self-injuryb 0 0 0 0 0 0 Ischemic cerebrovascular event 0 0 0 0 0 0 Crohn’s disease The total patient-years of exposure and number of TEAEs of interest are cumulative TEAE=treatment-emergent adverse event. aMultiple occurrences of the same event for a patient are counted as multiple events. Exposure-adjusted event rate per 100 patient-years calculated as number of events/total patient-years of exposure x 100 bIndicates a TEAE of suicidal ideation 19 (11.0) 27 (7.0) 32 (6.7) 44 (7.2) 49 (6.8) Psychiatric disorder 49 (6.7)

The total patient-years of exposure and number of TEAEs of interest are cumulative

TEAE=treatment-emergent adverse event.

aMultiple occurrences of the same event for a patient are counted as multiple events. Exposure-adjusted event rate per 100 patient-years calculated as number of events/total patient-years of exposure x 100

bIndicates a TEAE of suicidal ideation

Psoriasis patient shares SILIQ treatment story

SILIQ success stories

See how SILIQ could save their day — even if the day is just spent relaxing at the pool with their kids.

Savings offer for SILIQ: $25/month

SILIQ Savings

We're helping more patients go for total clearance with Siliq Solutions™.

SILIQ certified dermatologist

Get SILIQ certified

It’s simple. Enrolling through the REMS portal takes just a few minutes.

SILIQ certified dermatologist

Important Safety Information for SILIQ (brodalumab) Injection

INDICATION

SILIQ® injection is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL IDEATION AND BEHAVIOR
Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes [see Warnings and Precautions (5.1) in the full Prescribing Information].

Because of the observed suicidal behavior in subjects treated with SILIQ, SILIQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program [see Warnings and Precautions (5.2) in the full Prescribing Information].

Crohn’s Disease

SILIQ is contraindicated in patients with Crohn’s disease. In clinical trials, which excluded Crohn’s patients, one SILIQ patient was withdrawn after developing Crohn’s disease.

SILIQ Risk Evaluation and Mitigation Strategy (REMS) Program

SILIQ is available only through a restricted program called the SILIQ REMS because of observed suicidal ideation and behavior in patients treated with SILIQ. Before prescribing SILIQ, prescribers must be certified with the program, have each patient sign a Patient-Prescriber Agreement Form, and provide the patient a Wallet Card describing symptoms requiring immediate medical evaluation. Pharmacies must be certified and only dispense to patients authorized to receive SILIQ. More information is available at SILIQREMS.com

Infections

SILIQ may increase the risk of infections. Serious infections and fungal infections were observed at a higher rate in patients treated with SILIQ than placebo-treated patients in clinical trials, including one case of cryptococcal meningitis that led to discontinuation of therapy.

  • Consider risks and benefits prior to prescribing SILIQ in patients with a chronic infection or history of recurrent infection
  • Instruct patients to seek treatment if signs or symptoms of a chronic or acute infection occur

Risk for Latent Tuberculosis (TB) Reactivation

Evaluate patients for TB prior to initiating treatment with SILIQ and do not treat patients with active TB. Initiate treatment for latent TB prior to starting SILIQ and consider anti-TB therapy prior to initiation in patients with history of latent TB if adequate treatment cannot be confirmed. Monitor closely for symptoms of active TB during and after treatment.

Immunizations

Avoid use of live vaccines in patients treated with SILIQ.

Adverse Reactions

The most commonly reported adverse reactions in clinical trials were arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinea infections.

To report SUSPECTED ADVERSE REACTIONS, contact Customer Service at 1-800-321-4576 or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.

Please click here for full Prescribing Information, including Boxed Warning about suicidal ideation and behavior.

Indication
Indication and Important Safety Information

SILIQ® injection is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.

WARNING: SUICIDAL IDEATION AND BEHAVIOR

Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health

Important Safety Information for SILIQ (brodalumab) Injection

INDICATION

SILIQ® injection is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL IDEATION AND BEHAVIOR
Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes [see Warnings and Precautions (5.1) in the full Prescribing Information].

Because of the observed suicidal behavior in subjects treated with SILIQ, SILIQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program [see Warnings and Precautions (5.2) in the full Prescribing Information].

Crohn’s Disease

SILIQ is contraindicated in patients with Crohn’s disease. In clinical trials, which excluded Crohn’s patients, one SILIQ patient was withdrawn after developing Crohn’s disease.

SILIQ Risk Evaluation and Mitigation Strategy (REMS) Program

SILIQ is available only through a restricted program called the SILIQ REMS because of observed suicidal ideation and behavior in patients treated with SILIQ. Before prescribing SILIQ, prescribers must be certified with the program, have each patient sign a Patient-Prescriber Agreement Form, and provide the patient a Wallet Card describing symptoms requiring immediate medical evaluation. Pharmacies must be certified and only dispense to patients authorized to receive SILIQ. More information is available at SILIQREMS.com

Infections

SILIQ may increase the risk of infections. Serious infections and fungal infections were observed at a higher rate in patients treated with SILIQ than placebo-treated patients in clinical trials, including one case of cryptococcal meningitis that led to discontinuation of therapy.

  • Consider risks and benefits prior to prescribing SILIQ in patients with a chronic infection or history of recurrent infection
  • Instruct patients to seek treatment if signs or symptoms of a chronic or acute infection occur

Risk for Latent Tuberculosis (TB) Reactivation

Evaluate patients for TB prior to initiating treatment with SILIQ and do not treat patients with active TB. Initiate treatment for latent TB prior to starting SILIQ and consider anti-TB therapy prior to initiation in patients with history of latent TB if adequate treatment cannot be confirmed. Monitor closely for symptoms of active TB during and after treatment.

Immunizations

Avoid use of live vaccines in patients treated with SILIQ.

Adverse Reactions

The most commonly reported adverse reactions in clinical trials were arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinea infections.

To report SUSPECTED ADVERSE REACTIONS, contact Customer Service at 1-800-321-4576 or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.

Please click here for full Prescribing Information, including Boxed Warning about suicidal ideation and behavior.