Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (23)
- 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.
- efgartigimod/hyaluronidase SC
efgartigimod/hyaluronidase SC 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.
- rozanolixizumab
rozanolixizumab will decrease the level or effect of brodalumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.
- 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. .
- ublituximab
ublituximab and brodalumab both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
- 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)
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
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
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.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
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
Images
Formulary
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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.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
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