The Safety of SILIQ Was Studied in >4500 Patients5

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

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

*Subjects receiving 210mg of SILIQ at Weeks 0, 1, and 2, followed by treatment every 2 weeks during the 12-week period
SILIQ Full Prescribing Information.

Long-Term Safety4

  Year 1 Year 2
Adverse Reaction 4273 Patients
3955.3 Patient Years
#/100 Patient Years
3587 Patients
3107.9 Patient Years
#/100 Patient Years
Arthralgia 12.6 6.3
Headache 11.8 5.0
Fatigue 4.7 1.1
Diarrhea 5.0 2.3
Oropharyngeal pain 4.7 1.8
Nausea 3.5 1.0
Myalgia 2.9 0.7
Injection site reactions (AMQ) 4.8 0.8
Influenza 3.5 2.4
Neutropenia 4 (0.5) 15 (1.0)
Neutropenia (AMQ) 2.0 0.6
Tinea infections (tinea pedis, versicolor, cruris; HLT) 1.7 1.0
Conjunctivitis 1.9 1.0
Candida infections (HLT) 3.6 3.6
Serious Adverse Events 8.4 6.9
Death 0.2 0.0

Data from three phase 3 clinical trials and one phase 2 trial in plaque psoriasis were pooled to evaluate the safety of SILIQ in comparison to placebo up to 12 weeks after treatment initiation. These data included 4558 patients (3066 SILIQ, 613 ustekinumab, 879 placebo) in controlled clinical trials and open-label extension studies. Of these, 4464 patients received at least 1 dose of SILIQ; 3755 patients were exposed to SILIQ for at least 1 year.1

100% Real Stories

See how SILIQ changed the lives of patients who struggled to find lasting relief from their plaque psoriasis.

$5*

or

$25*

SILIQ Savings

Your eligible commercially insured patients can get SILIQ for as little as $5 a month, up to 12 months. Learn how we’re helping more patients go for total clearance.

*This offer is only valid for patients with commercial insurance. Patients whose commercial insurance does not cover SILIQ will pay more. These savings offers are not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B and D Plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. Click here for full eligibility terms and conditions.

Get SILIQ-certified

It’s simple. Enrolling in our REMS program takes just a few minutes.

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.

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

Indication

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.

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

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.

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