THE SAFETY OF SILIQ WAS STUDIED IN >4500 PATIENTS1

Safety data from 4 clinical trials1

Suicidal ideation and behavior
  • Incidence of suicidal ideation or behavior through Week 52 was 7 of 4019 patients (0.2 per 100 patient-years) treated with SILIQ vs 2 of 613 (0.4 per 100 patient-years) treated with ustekinumab1
  • In plaque psoriasis clinical trials, suicidal ideation or behavior occurred in 34 of 4464 patients using SILIQ (0.37 per 100 patient-years). Among patients who attempted or completed suicide, 8 of 10 had a history of depression and/or suicidal ideation or behavior1
Healthcare providers who prescribe SILIQ must be certified under the SILIQ REMS Program and enroll their patients
  • SILIQ is available only through a restricted REMS program because of observed suicidal ideation and behavior in patients being treated with SILIQ
  • Under the program only certified prescribers and pharmacies are allowed to prescribe and distribute SILIQ
  • To become certified to prescribe SILIQ, prescribers must review the Prescribing Information for SILIQ and enroll in the SILIQ REMS Program by completing the SILIQ REMS Program Prescriber Enrollment Form
  • As a condition of certification, prescribers must enroll each patient in the SILIQ REMS Program by performing the following:
    • Prior to providing the first prescription, counsel the patient that suicidal ideation and behavior (SIB), including completed suicides, have occurred in patients treated with SILIQ by informing the patient of the following key safety information
      • SIB events and symptoms may occur at any time during treatment with SILIQ
      • Be aware of symptoms of SIB events and steps to take if SIB symptoms occur
    • Complete the SILIQ REMS Program Patient-Prescriber Agreement Form for each patient. Submit the completed form to the SILIQ REMS Program and store a copy in the patient's records
    • Provide the patient with the SILIQ REMS Program Patient Wallet Card
      • Understand that patients with new or worsening symptoms of depression or suicidality should be referred to a mental health professional, as appropriate
      • Inform SILIQ REMS Program if an enrolled patient has discontinued therapy or is no longer under your care

Visit SILIQ REMS for more information or to get certified.

Infections
  • During the 12-week randomized treatment period, infections occurred in 25.4% of the SILIQ group compared to 23.4% of the placebo group1
  • 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 therapy1
    • 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
Serious adverse events
  • Incidence of serious adverse events through Week 52 was 8.3 per 100 patient-years for SILIQ vs 8.5 per 100 patient-years for ustekinumab5

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-treated 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 Valeant Pharmaceuticals at 1-800-321-4576 or 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.

*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.

  • Data from Study 2, a study of 1831 adults with a diagnosis of plaque psoriasis for ≥6 months involving ≥10% body surface area (BSA), PASI score ≥12, and sPGA score ≥3.1,3

  • Study evaluating 1881 patients, eligibility criteria similar to study 2.1,3

  • §Study evaluating 661 patients, eligibility criteria similar to study 2.1,4

  • ||PASI 90 at Week 12 was specified as an "other" endpoint that was not included in the multiplicity testing strategy. Because there was no statistical procedure for controlling inflation of the false-positive rate, it would not be possible to determine whether findings are statistically significant for this endpoint.

  • Studies 2 and 3 included a phase during which patients originally randomized to receive SILIQ during the first 12 weeks were rerandomized to one of 4 SILIQ regimens at the Week 12 visit. Data include only patients who were rerandomized to continue using the recommended dose of SILIQ.1

  • 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

References: 1. SILIQ [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2017. 2. Blauvelt A, Papp KA, Lebwohl MG, et al. Rapid onset of action in patients with moderate-to-sever psoriasis treated with brodalumab: A pooled analysis of data from two phase 3 randomized clinical trials (AMAGINE-2 and AMAGINE-3). J AM Acad Dermatol. 2017;77(2):374. 3. Lebwohl M, Strober B, Menter A, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373(14):1318-1328. 4. Papp KA, Reich K, Paul C, et al. A prospective phase III, randomized, double-blind, placebo-controlled study of brodalumab in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2016;175(2):273-286. 5. Data on file. Valeant Pharmaceuticals International, Inc.; Bridgewater, NJ.

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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-treated 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 Valeant Pharmaceuticals at 1-800-321-4576 or 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.

*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.

References: 1. SILIQ [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2017. 2. Blauvelt A, Papp KA, Lebwohl MG, et al. Rapid onset of action in patients with moderate-to-sever psoriasis treated with brodalumab: A pooled analysis of data from two phase 3 randomized clinical trials (AMAGINE-2 and AMAGINE-3). J AM Acad Dermatol. 2017;77(2):374. 3. Lebwohl M, Strober B, Menter A, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373(14):1318-1328. 4. Papp KA, Reich K, Paul C, et al. A prospective phase III, randomized, double-blind, placebo-controlled study of brodalumab in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2016;175(2):273-286. 5. Data on file. Valeant Pharmaceuticals International, Inc.; Bridgewater, NJ.