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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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (14)

              • 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.

              • 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.

              • 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.

              • 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.

              • 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.

              • 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.

              • 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.

              • warfarin

                brodalumab, warfarin. 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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                • 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
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