Home › Drugs › Brodalumab

Brodalumab

FDA Drug Information • Also known as: Siliq

Brand Names
Siliq
Dosage Form
INJECTION
Product Type
DRUG FOR FURTHER PROCESSING

⚠ Boxed Warning (Black Box)

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 )]. 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 )]. WARNING: SUICIDAL IDEATION AND BEHAVIOR See full prescribing information for complete boxed warning.

  • Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. ( 5.1 , 6.1 )
  • Prior to prescribing, weigh potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. ( 5.1 )
  • Patients with new or worsening suicidal thoughts and behavior should be referred to a mental health professional, as appropriate. ( 5.1 )
  • 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. ( 5.1 )
  • SILIQ is available only through a restricted program called the SILIQ REMS Program. ( 5.2 )

    • Description

    11 DESCRIPTION Brodalumab is a human monoclonal IgG2κ antibody directed against human interleukin-17 receptor A (IL-17RA). It is expressed in a Chinese Hamster Ovary (CHO) cell line. Brodalumab is comprised of 1312 amino acids and has an estimated molecular mass of 144,000 Daltons. SILIQ (brodalumab) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution delivered via subcutaneous injection. SILIQ is supplied in a single-dose syringe made from type 1 glass with stainless steel 27G x ½” needle. Each SILIQ single-dose prefilled syringe delivers 1.5 mL of solution containing 210 mg of brodalumab formulated in glutamate (6.5 mg), polysorbate 20 (0.15 mg), proline (36 mg), and Water for Injection, USP at pH 4.8.

    What Is Brodalumab Used For?

    1 INDICATIONS AND USAGE 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. ( 1 )

    Dosage and Administration

    2 DOSAGE AND ADMINISTRATION 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. Do not warm in any other way. Do not remove the gray needle cap on the prefilled syringe while allowing it to reach room temperature.
  • Visually inspect SILIQ for particles and discoloration prior to administration. SILIQ is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use SILIQ if it is cloudy or discolored or if foreign matter is present.
  • Instruct patients to use the prefilled syringe and to inject the full amount (1.5 mL), which provides 210 mg of SILIQ, according to the directions provided in the Instructions for Use [see Instructions for Use].

    • Side Effects (Adverse Reactions)

    6 ADVERSE REACTIONS 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. Weeks 0 to 12: Data from one multicenter, randomized, placebo-controlled trial (Trial 1), two multicenter, randomized, placebo- and active-controlled trials (Trials 2 and 3), and one dose-finding trial (Trial 4) in plaque psoriasis were pooled to evaluate the safety of SILIQ (210 mg weekly at Weeks 0, 1, and 2, followed by treatments every 2 weeks [Q2W]) compared to placebo for up to 12 weeks after treatment initiation. During the 12-week, randomized treatment period, about 1% of the subjects in the treatment groups (SILIQ, ustekinumab, and placebo) discontinued treatment because of adverse events. Adverse events leading to discontinuation of SILIQ included neutropenia, arthralgia, and urticaria. The proportion of subjects who developed serious adverse events was similar among the SILIQ, ustekinumab, and placebo groups. Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the SILIQ 210 mg Q2W group than in the placebo group during the 12-week randomized treatment period of the pooled trials. Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects in the SILIQ Group and More Frequently than in the Placebo Group in Plaque Psoriasis Trials through Week 12 Adverse Reactions Placebo (N=879) n (%) SILIQ 210 mg 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. (N=1,496) n (%) Ustekinumab (N=613) Trials 2 and 3 included the active comparator, ustekinumab. 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) Adverse reactions that occurred in less than 1% of subjects in the SILIQ group through Week 12 were conjunctivitis and candida infections (including oral [0.2%], genital [0.1%], and esophageal [0.1%] versus none in the placebo group). Week 0 to End of Trial: Through Week 52, exposure-adjusted rates of serious adverse events were similar between subjects treated with SILIQ and those treated with ustekinumab. Through the end of the trial, the exposure-adjusted rates of...

    • Drug Interactions

    7 DRUG INTERACTIONS CYP450 Substrates The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Treatment with SILIQ may modulate serum levels of some cytokines. Therefore, upon initiation or discontinuation of SILIQ in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate [see Clinical Pharmacology ( 12.3 )].

    Contraindications

    4 CONTRAINDICATIONS 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. Hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of SILIQ [see Warnings and Precautions ( 5.3 )] .
  • Crohn’s disease ( 4 )
  • Clinically significant hypersensitivity to brodalumab or to any of the excipients in SILIQ or component of the container ( 4 )

    • Pregnancy and Breastfeeding

    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).

    How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied SILIQ ® (brodalumab) injection is available in a single-dose prefilled syringe containing a sterile, preservative-free clear to slightly opalescent, colorless to slightly yellow solution.

  • NDC 0187-0004-02: Carton of two 210 mg/1.5 mL single-dose prefilled syringes Storage and Handling
  • Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light and physical damage during storage.
  • When necessary, prefilled syringes can be stored at room temperature up to a maximum of 77°F (25°C) in the original carton for a maximum single period of 14 days with protection from light and sources of heat. Once the prefilled syringe has reached room temperature, do not place back into the refrigerator. Discard after 14 days at room temperature.
  • Do not freeze.
  • Do not shake.

    • About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.