Brodalumab

Brodalumab is a human monoclonal IgG2 antibody that selectively binds to human IL-17RA and inhibits its interactions with cytokines IL-17A, IL-17F, IL-17C, IL-17A/F heterodimer, and IL-25. IL-17RA is a protein expressed on the cell surface and is a required component of receptor complexes utilized by multiple IL-17 family cytokines.

• SILIQ ® (brodalumab) 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. SILIQ is a human interleukin-17 receptor A (IL-17RA) antagonist 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.ICD-10: L40.9

• SILIQ is contraindicated in patients with: • Crohn’s disease because SILIQ may cause worsening of disease [see Warnings and Precautions ( 5.7 )] . • Clinically significant hypersensitivity to brodalumab or to any of the excipients in SILIQ or component of the container.contraindicated

Administer 210 mg of SILIQ by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks. ( 2.2 ) 2.1 Tuberculosis Assessment Prior to Initiation of SILIQ Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SILIQ [see Warnings and Precautions ( 5.4 )]. 2.2 Dosage The recommended SILIQ dose is 210 mg administered by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks. If an adequate response has not been achieved after 12 to 16 weeks of treatment with SILIQ, consider discontinuing therapy. Continued treatment beyond 16 weeks in patients who have not achieved an adequate response is not likely to result in greater success. 2.3 Important Administration Instructions Administer SILIQ subcutaneously. Each prefilled syringe is for single dose only. Instruct patients to review the Medication Guide before use [see Medication Guide] . SILIQ is 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 proper training in subcutaneous injection technique using the prefilled syringe. Advise patients who are self-administering to inject the full dose and to read the Instructions for Use before administration [see Instructions for Use] . Do not inject SILIQ into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis. 2.4 Preparation of SILIQ Prefilled Syringe • Allow SILIQ prefilled syringe to reach room temperature (approximately 30 minutes) before injecting.

• 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.

The following serious adverse reactions are discussed in greater detail in other sections of labeling: • Suicidal Ideation and Behavior [see Warnings and Precautions ( 5.1 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] • Infections [see Warnings and Precautions ( 5.4 )] • Crohn’s Disease [see Contraindications ( 4 ), Warnings and Precautions ( 5.7 )] Most common adverse reactions (incidence ≥1%) were arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinea infections. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The overall safety population included 4,558 subjects (3,066 SILIQ, 613 ustekinumab, 879 placebo) in controlled clinical trials and open-label extension studies. The majority of subjects were male (69%), white (91%), and aged 40-64 years old (58%). One third of subjects reported previous biologic use prior to enrollment. Across the clinical development program, 4,464 subjects received at least one dose of SILIQ; 3,755 subjects were exposed to SILIQ for at least 1 year.

8.1 Pregnancy Risk Summary There are no human data on SILIQ use in pregnant women to inform a drug-associated risk. Human IgG antibodies are known to cross the placental barrier; therefore, SILIQ may be transmitted from the mother to the developing fetus. In a combined embryofetal development and pre- and postnatal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of brodalumab during organogenesis through parturition at doses up to 26 times the maximum recommended human dose (MRHD) [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data A combined embryofetal development and pre- and postnatal development study was conducted in cynomolgus monkeys administered brodalumab. No brodalumab-related effects on embryofetal toxicity or malformations, or on morphological, functional, or immunological development were observed in infants from pregnant monkeys administered weekly subcutaneous doses of brodalumab up to 26 times the MRHD from the beginning of organogenesis to parturition (on a mg/kg basis of 90 mg/kg/week).

Metabolism

Absorption Following a single subcutaneous dose of 210 mg in subjects with plaque psoriasis, brodalumab reached peak mean (±SD) serum concentration (C max ) of 13.4±7.3 mcg/mL by approximately 3 days post-dose. The mean (±SD) area-under-the-concentration-time curve (AUC) of brodalumab was 111±64 mcg•day/mL.

• Feb 15, 2017BLABLA761032Valeant Luxembourg

1. 1Psoriasis48325%
2. 2Drug Ineffective23512%
3. 3Arthralgia1889.7%
4. 4Fatigue1688.7%
5. 5Psoriatic Arthropathy1598.2%
6. 6Intentional Product Use Issue1547.9%
7. 7Product Dose Omission Issue1387.1%
8. 8Disease Recurrence1316.8%
9. 9Headache1286.6%
10. 10Therapy Interrupted1286.6%
11. 11Off Label Use1216.2%
12. 12Inappropriate Schedule Of Product Administration1176.0%
13. 13Diarrhoea934.8%
14. 14Pain In Extremity894.6%
15. 15Covid-19874.5%

The 10 most recently updated of 59 ClinicalTrials.gov registrations naming Brodalumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Psoriasis Longitudinal Assessment and Registry
  Active not recruiting · Observational · 15,849 enrolled · Janssen Scientific Affairs, LLC
  NCT00508547updated 2026-06-05
• Mediterranean Diet vs no Dietary Intervention for Improving Signs and Symptoms of Psoriasis in Patients Treated With Anti-IL-17 or Anti-IL-23 Inhibitors
  Recruiting · Interventional · 36 enrolled · University Hospitals Cleveland Medical Center
  NCT06399432updated 2026-06-03
• Brodalumab in the Treatment of Immune-Related Adverse Events
  Recruiting · Phase 1 · Interventional · 11 enrolled · Brian Henick, MD
  NCT06673329updated 2026-05-13
• Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight
  Completed · Phase 4 · Interventional · 385 enrolled · LEO Pharma
  NCT04306315updated 2026-04-24
• Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis
  Completed · Phase 4 · Interventional · 244 enrolled · Radboud University Medical Center
  NCT04340076updated 2026-03-17
• Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Work Productivity
  Active not recruiting · Observational · 394 enrolled · Bausch Health Americas, Inc.
  NCT05132231updated 2025-09-26
• LTS of Siliq vs. Other Therapies Treating of Adults With Moderate-to-Severe Psoriasis
  Enrolling by invitation · Observational · 3,500 enrolled · Bausch Health Americas, Inc.
  NCT03254667updated 2025-09-16
• An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects
  Active not recruiting · Phase 4 · Interventional · 2 enrolled · Bausch Health Americas, Inc.
  NCT03240809updated 2025-09-16
• A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers
  Recruiting · Phase 4 · Interventional · 50 enrolled · Taichung Veterans General Hospital
  NCT07149792updated 2025-09-02
• SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
  Recruiting · Observational · 840 enrolled · Leiden University Medical Center
  NCT07021495updated 2025-08-19

Frequently asked questions

How does Brodalumab work?

Brodalumab is a human monoclonal IgG2 antibody that selectively binds to human IL-17RA and inhibits its interactions with cytokines IL-17A, IL-17F, IL-17C, IL-17A/F heterodimer, and IL-25. IL-17RA is a protein expressed on the cell surface and is a required component of receptor complexes utilized by multiple IL-17 family cytokines.

What is Brodalumab used for?

According to FDA labeling, Brodalumab carries indications including: SILIQ ® (brodalumab) 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. SILIQ is a human interleukin-17 receptor A (IL-17RA) antagonist 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Brodalumab?

Brodalumab is classified as Interleukin inhibitors, Interleukin-17 Receptor A Antagonist, Interleukin 17 Receptor A Antagonists, Interleukin 17 Receptor A Interactions.

What are the brand names for Brodalumab?

Brodalumab is marketed under brand names including Siliq.

What are the contraindications for Brodalumab?

Brodalumab labeling lists contraindications including: SILIQ is contraindicated in patients with: • Crohn’s disease because SILIQ may cause worsening of disease [see Warnings and Precautions ( 5.7 )] . • Clinically significant hypersensitivity to brodalumab or to any of the excipients in SILIQ or component of the container.. Always consult the full prescribing information and a clinician.