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Brodalumab: Drug information

Brodalumab: Drug information
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For additional information see "Brodalumab: Patient drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US Boxed Warning
Suicidal ideation and behavior:

Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with brodalumab. Prior to prescribing brodalumab, 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.

Because of the observed suicidal behavior in subjects treated with brodalumab, brodalumab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program.

Brand Names: US
  • Siliq
Brand Names: Canada
  • Siliq
Pharmacologic Category
  • Anti-interleukin 17-Receptor Antibody;
  • Antipsoriatic Agent;
  • Monoclonal Antibody
Dosing: Adult

Dosage guidance:

Safety: Prior to initiation, certain assessments (clinical and laboratory) are required with documentation and age-appropriate vaccinations should be up to date. In general, live vaccines should not be administered within 4 weeks prior to starting therapy (Ref). Refer to institutional protocols for vaccination and monitoring requirements prior to initiating therapy.

Plaque psoriasis

Plaque psoriasis: SubQ: 210 mg at weeks 0, 1, and 2, followed by 210 mg once every 2 weeks. Consider discontinuing if an adequate response is not achieved after 12 to 16 weeks (continuing treatment beyond 16 weeks in patients without an adequate response is not likely to result in greater success).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%: Infection: Infection (25%; including bronchitis, fungal infection [2%], influenza [1%], nasopharyngitis, pharyngitis, upper respiratory tract infection, urinary tract infection)

1% to 10%:

Dermatologic: Tinea (1%; including tinea cruris, tinea pedis, tinea versicolor)

Gastrointestinal: Diarrhea (2%), nausea (2%)

Hematologic & oncologic: Neutropenia (≤1%)

Immunologic: Antibody development (3%)

Local: Injection-site reaction (2%; including bleeding at injection site, bruising at injection site, erythema at injection site, injection-site pruritus, pain at injection site)

Nervous system: Fatigue (3%)

Neuromuscular & skeletal: Arthralgia (5%), myalgia (2%)

Respiratory: Oropharyngeal pain (2%)

<1%:

Gastrointestinal: Crohn disease (including exacerbation of Crohn disease)

Infection: Candidiasis (including esophageal, genital, oral)

Nervous system: Suicidal ideation

Ophthalmic: Conjunctivitis

Postmarketing: Dermatologic: Eczematous rash (including atopic dermatitis-like eruptions)

Contraindications

Crohn disease

Canadian labeling: Additional contraindications (not in US labeling): Clinically significant hypersensitivity to brodalumab or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Eczematous eruptions: Severe eczematous eruptions, including atopic dermatitis-like eruptions, have been reported; some cases required hospitalization and/or discontinuation of therapy. The onset ranged from days to months after initiation of therapy.

• Infections: Brodalumab may increase the risk of infections. In clinical trials, serious infections and fungal infections occurred at a higher rate in patients who received brodalumab, compared to those who received placebo. Cryptococcal meningitis has been reported (case report). Consider the risks versus benefits prior to treatment initiation in patients with a history of chronic or recurrent infection. Monitor for infections; patients should seek medical attention for signs/symptoms of a clinically important infection (acute or chronic). If a serious infection develops or is unresponsive to appropriate therapy for the infection, monitor closely and discontinue brodalumab until the infection resolves.

• Suicidal thinking/behavior: Risks and benefits of continuing treatment should be evaluated in the event of suicidal behavior. Patients with a history of depression or suicidality had an increased incidence of suicidal ideation/behavior compared to those without a history. Consider discontinuing treatment if an adequate response to brodalumab therapy is not achieved within 12 to 16 weeks (due to the risk of suicidal ideation/behavior).

• Tuberculosis: Patients should be evaluated for tuberculosis (TB) infection (latent TB) prior to initiating therapy. Do not administer brodalumab to patients with TB disease (active TB). Treatment for TB infection should be administered prior to administering brodalumab. Consider anti-TB therapy prior to treatment initiation in patients with a history of TB infection or disease in whom an adequate course of TB treatment cannot be confirmed. Monitor closely for signs/symptoms of TB disease during and after brodalumab treatment.

Disease-related concerns:

• Inflammatory bowel disease: Treatment with brodalumab in patients with a history of or active inflammatory bowel disease (IBD) may cause reactivation or worsening of Crohn disease and ulcerative colitis. Monitor patients for onset or exacerbation of IBD; discontinue use and initiate appropriate treatment if IBD occurs. Use is contraindicated in patients with Crohn disease.

Other warnings/precautions:

• Immunizations: Avoid the use of live vaccines in patients treated with brodalumab; there is no data on the ability to elicit an immune response with live or inactive vaccines in patients receiving brodalumab.

• REMS program: Prescribers and pharmacies must be certified with the program and patients must sign a patient-prescriber agreement; pharmacies can only dispense to patients who are authorized to receive brodalumab. Further information is available at http://www.SILIQREMS.com or at 855-511-6135.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Siliq: 210 mg/1.5 mL (1.5 mL)

Generic Equivalent Available: US

No

Pricing: US

Solution Prefilled Syringe (Siliq Subcutaneous)

210 mg/1.5 mL (per mL): $2,294.72

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Subcutaneous:

Siliq: 210 mg/1.5 mL (1.5 mL)

Administration: Adult

SubQ: Administer subcutaneously into the thigh, abdomen (except the 2 inch area around the navel), or outer upper arm. Do not inject into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis. Allow prefilled syringe to reach room temperature for ~30 minutes prior to use (do not warm in any other way). Do not shake the syringe. The prefilled syringe may be self-injected in appropriate patients following proper training in subcutaneous injection technique.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Siliq: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761032s014lbl.pdf#page=14

Use: Labeled Indications

Plaque psoriasis: 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.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Anifrolumab: Biologic Anti-Psoriasis Agents may increase immunosuppressive effects of Anifrolumab. Risk X: Avoid

Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Belimumab: May increase immunosuppressive effects of Biologic Anti-Psoriasis Agents. Management: Consider alternatives to the use of belimumab with other biologic therapies. Monitor closely for increased toxicities related to additive immunosuppression (ie, infection, malignancy) if combined. Risk D: Consider Therapy Modification

Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

InFLIXimab: May increase immunosuppressive effects of Biologic Anti-Psoriasis Agents. Risk X: Avoid

Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

The American Academy of Dermatology considers brodalumab for the treatment of psoriasis to be likely acceptable for use in male patients planning to father a child (AAD-NPF [Menter 2019]).

Pregnancy Considerations

Brodalumab is a humanized monoclonal antibody (IgG2). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).

Breastfeeding Considerations

It is not known if brodalumab is present in breast milk.

According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

Prior to therapy start:

• Evaluate for malignancy (especially skin cancer), current or latent infection, lymphadenopathy, inflammatory bowel disease; ensure age-appropriate vaccinations are up to date and, in general, no live vaccines are administered within 4 weeks of starting therapy (AAD-NPF [Menter 2019]). Refer to institutional protocols for vaccination and monitoring requirements prior to initiating therapy. Evaluate for suicidal ideation/depression prior to initiating therapy (AAD-NPF [Menter 2019]; EuroGuiDerm [Nast 2024]).

Labs: CBC with differential; complete metabolic panel; testing for tuberculosis (TB) infection (latent TB) (eg, Quantiferon Gold) or interferon gamma release assay for TB in patients who have had Bacillus Calmette-Guerin (BCG) vaccine; chest radiograph if testing for TB infection is positive; serologic testing for hepatitis B virus (HBV) (HBsAg, HBVsAb, HBVAbcore), hepatitis C virus antibody, HIV, pregnancy test, C-reactive protein (AAD-NPF [Menter 2019]; EuroGuiDerm [Nast 2024]).

During therapy:

• Evaluate for infection, suicidal ideation/depression, malignancy (specifically skin cancer screening, especially for patients who have a history of skin cancer or UV phototherapy), infusion/injection site reactions, and exacerbation or development of inflammatory bowel disease (AAD-NPF [Menter 2019]; EuroGuiDerm [Nast 2024]).

• Labs: CBC and LFTs after 3 to 6 months or as clinically indicated, pregnancy test as needed; annual testing/chest radiograph for TB in patients at high risk (eg, contact with individuals with TB disease [active TB]) (AAD-NPF [Menter 2019]; EuroGuiDerm [Nast 2024]); periodically evaluate patients who are hepatitis B carriers for signs/symptoms of active hepatitis B infection (AAD-NPF [Menter 2019]).

After therapy:

Periodically evaluate patients who are hepatitis B carriers for signs/symptoms of active hepatitis B infection (AAD-NPF [Menter 2019]).

Mechanism of Action

Brodalumab is a human monoclonal IgG2 antibody that antagonizes the interleukin-17 receptor A (IL-17RA) pathway. Brodalumab selectively binds with high affinity to IL-17RA and blocks the activity with cytokines IL-17A, IL-17C, IL-17F, IL-17A/F heterodimer, and IL-17E (IL-25) (Papp 2012). IL-17A, IL-17C, and IL-17F are elevated in psoriatic plaques. Inhibiting IL-17RA blocks cytokine-induced responses, including release of pro-inflammatory cytokines and chemokines.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Psoriasis: Response best determined after 12 weeks (AAD-NPF [Menter 2019]).

Distribution: Vd: 8.9 ± 9.4 L.

Metabolism: Degraded into small peptides in a manner similar to endogenous IgG.

Bioavailability: SubQ: ~55%.

Time to peak: ~3 days.

Excretion: Clearance: Mean (±SD) apparent total clearance (CL/F) of a 210 mg subcutaneous dose was 3.0 ± 3.5 L/day.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Weight: Trough concentrations were lower in subjects with higher body weight.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Kyntheum;
  • (BE) Belgium: Kyntheum;
  • (CZ) Czech Republic: Kyntheum;
  • (DE) Germany: Kyntheum;
  • (DK) Denmark: Kyntheum;
  • (ES) Spain: Kyntheum;
  • (FI) Finland: Kyntheum;
  • (FR) France: Kyntheum;
  • (GB) United Kingdom: Kyntheum;
  • (GR) Greece: Kyntheum;
  • (IE) Ireland: Kyntheum;
  • (IT) Italy: Kyntheum;
  • (JP) Japan: Lumicef;
  • (LU) Luxembourg: Kyntheum;
  • (MY) Malaysia: Lumicef;
  • (NL) Netherlands: Kyntheum;
  • (NO) Norway: Kyntheum;
  • (PR) Puerto Rico: Siliq;
  • (PT) Portugal: Kyntheum;
  • (SE) Sweden: Kyntheum;
  • (SK) Slovakia: Kyntheum;
  • (TH) Thailand: Lumicef;
  • (TW) Taiwan: Lumicef
  1. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072. doi:10.1016/j.jaad.2018.11.057 [PubMed 30772098]
  2. Nast A, Spuls PI, Dressler C, et al; European Dermatology Forum, European Centre for Guidelines Development. EuroGuiDerm guideline for the systemic treatment of psoriasis vulgaris. https://www.guidelines.edf.one/guidelines/psoriasis-guideline. Updated March 2024. Accessed October 24, 2024.
  3. Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. [PubMed 22235228]
  4. Papp KA, Leonardi C, Menter A, et al. Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. N Engl J Med. 2012;366(13):1181-1189. [PubMed 22455412]
  5. Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol. 2009;86(4):328-344. [PubMed 19626656]
  6. Siliq (brodalumab) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America, LLC; July 2024.
  7. Siliq (brodalumab) [product monograph]. Laval, Quebec, Canada: Bausch Health, Canada Inc; April 2024.
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