Directions for the journey

SILIQ comes in ready-to-use, prefilled syringes

3 injections to start, followed by 1 injection every other week1

IMPORTANT ADMINISTRATION INFORMATION

  • Dosed as a single 210-mg injection weekly for the first 3 weeks and every 2 weeks thereafter1
  • SILIQ is supplied as a carton of two 1.5-mL (210-mg dose) prefilled syringes1
  • Do not inject SILIQ into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis
  • If an adequate response to SILIQ has not been achieved within 12 to 16 weeks, consider discontinuing therapy. Continued treatment beyond 12 weeks in patients who have not achieved an adequate response is not likely to result in greater success

SILIQ is a subcutaneous injection intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject SILIQ when deemed appropriate by a healthcare professional and after training in subcutaneous injection technique using the prefilled syringe. Patients should be instructed to review the Medication Guide and Instructions for Use before initiating treatment.

 

Each carton of SILIQ contains two 1.5 mL
(210 mg dose) prefilled syringes.1

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.