Brodalumab

Moderate to severe plaque psoriasis

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 Administer 210 mg of SILIQ by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks. ( If an adequate response has not been achieved after 12-16 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

Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 years and older was not sufficient to determine whether they responded differently from younger subjects.

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

Hypersensitivity. Patients w/ serious infection & active TB.

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 Infections: Serious infections have occurred. Consider the risks and benefits prior to initiating SILIQ in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue SILIQ until the infection resolves. Tuberculosis (TB): Evaluate patients for TB infection prior to initiating treatment with SILIQ. Crohn’s Disease: Crohn’s disease occurred during clinical trials. Discontinue SILIQ if patient develops Crohn’s disease while taking SILIQ. Immunizations: Avoid using live vaccines concurrently with SILIQ

Not Classi 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 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

Live vaccines. Contraindicated (1) upadacitinib Serious (19) anthrax vaccine adsorbed axicabtagene ciloleucel BCG vaccine live brexucabtagene autoleucel cholera vaccine ciltacabtagene autoleucel idecabtagene vicleucel influenza virus vaccine quadrivalent, recombinant influenza virus vaccine trivalent, recombinant lisocabtagene maraleucel meningococcal A C Y and W-135 diphtheria conjugate vaccine meningococcal A C Y and W-135 polysaccharide vaccine combined meningococcal group B vaccine pneumococcal vaccine 13-valent pneumococcal vaccine polyvalent tetanus toxoid adsorbed or fluid tisagenlecleucel typhoid polysaccharide vaccine typhoid vaccine live

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

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