brodalumab (Rx)

Brand and Other Names:Siliq
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for SC injection

  • 210mg/1.5mL (single-dose prefilled syringe)

Psoriasis

Indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies

210 mg SC at Weeks 0, 1, and 2, THEN

210 mg SC q2wk

If an adequate response has not been achieved after 12-16 weeks, 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

Dosing Considerations

Evaluate patients for tuberculosis (TB) prior to initiating (see Cautions)

Safety and efficacy not established

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Interactions

Interaction Checker

and brodalumab

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (1)

            • upadacitinib

              brodalumab, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.

            Serious - Use Alternative (20)

            • anthrax vaccine adsorbed

              brodalumab, anthrax vaccine adsorbed. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

            • axicabtagene ciloleucel

              brodalumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • BCG vaccine live

              brodalumab, BCG vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

            • brexucabtagene autoleucel

              brodalumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • cholera vaccine

              brodalumab, cholera vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

            • ciltacabtagene autoleucel

              brodalumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • idecabtagene vicleucel

              brodalumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • influenza virus vaccine quadrivalent, recombinant

              brodalumab, influenza virus vaccine quadrivalent, recombinant. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

              brodalumab, influenza virus vaccine quadrivalent, recombinant. Other (see comment). Avoid or Use Alternate Drug. Comment: Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

            • influenza virus vaccine trivalent, recombinant

              brodalumab, influenza virus vaccine trivalent, recombinant. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

              brodalumab, influenza virus vaccine trivalent, recombinant. Other (see comment). Avoid or Use Alternate Drug. Comment: Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

            • lisocabtagene maraleucel

              brodalumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • meningococcal A C Y and W-135 diphtheria conjugate vaccine

              brodalumab, meningococcal A C Y and W-135 diphtheria conjugate vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

            • meningococcal A C Y and W-135 polysaccharide vaccine combined

              brodalumab, meningococcal A C Y and W-135 polysaccharide vaccine combined. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

            • meningococcal group B vaccine

              brodalumab, meningococcal group B vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

            • pneumococcal vaccine 13-valent

              brodalumab, pneumococcal vaccine 13-valent. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

            • pneumococcal vaccine heptavalent

              brodalumab, pneumococcal vaccine heptavalent. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

            • pneumococcal vaccine polyvalent

              brodalumab, pneumococcal vaccine polyvalent. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

            • tetanus toxoid adsorbed or fluid

              brodalumab, tetanus toxoid adsorbed or fluid. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

            • tisagenlecleucel

              brodalumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • typhoid polysaccharide vaccine

              brodalumab, typhoid polysaccharide vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

            • typhoid vaccine live

              brodalumab, typhoid vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

            Monitor Closely (20)

            • carbamazepine

              brodalumab, carbamazepine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, brodalumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of brodalumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

            • clonidine

              brodalumab, clonidine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, brodalumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of brodalumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

            • cyclosporine

              brodalumab, cyclosporine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, brodalumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of brodalumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

            • dengue vaccine

              brodalumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

            • disopyramide

              brodalumab, disopyramide. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, brodalumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of brodalumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

            • efgartigimod alfa

              efgartigimod alfa will decrease the level or effect of brodalumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

            • fosphenytoin

              brodalumab, fosphenytoin. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, brodalumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of brodalumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

            • haemophilus influenzae type b vaccine

              brodalumab decreases effects of haemophilus influenzae type b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored.

            • isavuconazonium sulfate

              brodalumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

            • phenobarbital

              brodalumab, phenobarbital. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, brodalumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of brodalumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

            • phenytoin

              brodalumab, phenytoin. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, brodalumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of brodalumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

            • primidone

              brodalumab, primidone. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, brodalumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of brodalumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

            • quinidine

              brodalumab, quinidine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, brodalumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of brodalumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

            • quinine

              brodalumab, quinine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, brodalumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of brodalumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

            • sirolimus

              brodalumab, sirolimus. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, brodalumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of brodalumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

            • tacrolimus

              brodalumab, tacrolimus. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, brodalumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of brodalumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

            • theophylline

              brodalumab, theophylline. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, brodalumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of brodalumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

            • trastuzumab

              trastuzumab, brodalumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

            • trastuzumab deruxtecan

              trastuzumab deruxtecan, brodalumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

            • valproic acid

              brodalumab, valproic acid. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, brodalumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of brodalumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

            Minor (0)

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              Adverse Effects

              1-10%

              Headache (3.5%)

              Arthralgia (3.3%)

              Fungal infections (2.4%)

              Injection site reaction (1.3%)

              Fatigue (1.1%)

              Diarrhea (1.1%)

              Oropharyngeal pain (1.1%)

              Nausea (1.1%)

              <1%

              Serious infections (0.5%)

              Influenza (0.5%)

              Neutropenia (0.5%)

              Tinea infections (0.2%)

              Conjunctivitis

              Candida infections

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              Warnings

              Black Box Warnings

              Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with brodalumab

              Prior to prescribing, 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, brodalumab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program

              Patient wallet card

              • Give patients the Patient Wallet Card and instruct them to carry it with them at all times
              • Patients should seek medical evaluation and show the card, to the treating healthcare provider, if they experience symptoms of suicide or depression described on the card
              • They should also call the National Suicide Prevention Lifeline at 1-800-273-8255 if they experience suicidal thoughts

              Contraindications

              Crohn disease

              Cautions

              Suicidal ideation and behavior, including 4 completed suicides, occurred in subjects treated in the psoriasis clinical trials; there were no completed suicides in the 12-week placebo-controlled portion of the trials; brodalumab users with a history of suicidality or depression had an increased incidence of suicidal ideation and behavior as compared with users without such a history (see Black Box Warnings)

              Available only through a restricted access program (see Black Box Warnings)

              May increase risk of infections; in patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing; if a patient develops a serious infection or is not responding to standard therapy for the infection, monitor the patient closely and discontinue the drug until the infection resolves

              Evaluate patients for TB before initiating; do not administer to patients with active TB; initiate treatment for latent TB prior to administering brodalumab; closely monitor patients for signs and symptoms of active TB during and after treatment

              In psoriasis trials, which excluded subjects with active Crohn disease, Crohn disease occurred in 1 subject during treatment and led to brodalumab discontinuation; in other trials, exacerbation of Crohn disease was observed with brodalumab (see Contraindications)

              Drug interaction overview

              • Avoid use of live vaccines; no data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab
              • CYP450 substrates
                • The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, IL-1, IL-6, IL-10, TNF-alpha, IFN) during chronic inflammation
                • Brodalumab may modulate serum levels of some cytokines
                • Therefore, upon initiating or discontinuing brodalumab in patients who are receiving concomitant drugs that are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (eg, for warfarin) or drug concentration (eg, for cyclosporine) and consider dosage modification of the CYP450 substrate
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              Pregnancy

              Pregnancy

              There are no human data regarding use in pregnant women to inform a drug-associated risk

              Human IgG antibodies are known to cross the placental barrier; therefore, brodalumab may be transmitted from the mother to the developing fetus

              Animal studies

              • In a combined embryofetal development and prenatal and postnatal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after SC administration during organogenesis through parturition at doses up to 26 times the maximum recommended human dose

              Lactation

              Unknown if distributed in human breast milk

              Detected in the milk of lactating cynomolgus monkeys

              Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              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 used by multiple IL-17 family cytokines

              Blocking IL­17RA inhibits IL-17 cytokine-induced responses, including the release of proinflammatory cytokines and chemokines

              Absorption

              Bioavailability (SC): ~55%

              Peak plasma time: ~3 days

              Peak plasma concentration: 13.4 mcg/mL

              AUC: 111 mcg·day/mL

              Distribution

              Vd: 8.9 L

              Metabolism

              The metabolic pathway has not been characterized

              As a human monoclonal IgG2 antibody, brodalumab is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG

              Elimination

              Total clearance: 3 L/day

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              Administration

              SC Preparation

              Allow syringe to reach room temperature (~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 for particles and discoloration prior to administration; should appear as a clear to slightly opalescent, colorless to slightly yellow solution; a few translucent to white, amorphous proteinaceous particles may be present

              Do not use if solution 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, according to the directions provided

              SC Administration

              Administer SC

              Each prefilled syringe is for single dose only

              Instruct patients to review the Medication Guide before use

              Intended for use under the guidance and supervision of a healthcare professional

              Patients may self-inject when deemed appropriate by a healthcare professional and after proper training in SC injection technique using the prefilled syringe

              Advise patients who are self-administering to inject the full dose

              Do not inject into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis

              Storage

              Store refrigerated at 2-8°C (36-46°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

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              Images

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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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              Formulary

              FormularyPatient Discounts

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              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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              • View the formulary and any restrictions for each plan.
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              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.