Bimekizumab

Plaque Psoriasis, Psoriatic Arthritis, Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis

Subcutaneous Injection 160mg/mL (single-dose prefilled syringe or prefilled autoinjector) Plaque Psoriasis Administer 320 mg (two 160 mg injections) by subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing > 120 kg, consider a dose of 320 mg every 4 weeks after Week 16. Psoriatic Arthritis Administer 160 mg by subcutaneous injection every 4 weeks. For patients with coexisting moderate to severe plaque psoriasis, use the dosage and administration for plaque psoriasis Non-Radiographic Axial Spondyloarthritis Administer 160 mg by subcutaneous injection every 4 weeks. Ankylosing Spondylitis Administer 160 mg by subcutaneous injection every 4 weeks.

SC Preparation Before injecting, remove carton from refrigerator and allow vial to reach room temperature (30-45 minutes) without removing prefilled syringes or autoinjectors from carton to protect from light Inspect visually for particulate matter and discoloration before administering, whenever solution and container permit; solution is clear to slightly opalescent, and colorless to pale brownish- yellow Discard if solution contains visible particles, is discolored, or cloudy SC Administration Use under guidance and supervision of a healthcare professional May self-inject after training in SC injection technique Provide proper training to patients and/or caregivers on SC injection technique Each prefilled syringe or autoinjector contains 160 mg of bimekizumab For each dose, inject 2 separate 160 mg single-dose prefilled syringes or autoinjectors SC at different anatomic locations (eg, thighs, abdomen, or back of upper arm) Discard the syringes or autoinjectors after use; do not reuse Do not inject within 2 inches (5 cm) of navel or into areas where skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis Administration in the upper, outer arm may only be performed by a healthcare professional or caregiver

Suicidal ideation and behavior (SI/B) May increase risk of SI/B. Weigh potential risks and benefits before use in patients with a history of severe depression or suicidal ideation or behavior Advise monitoring for emerging or worsening of depression, suicidal ideation, or other mood changes If such changes occur, advise them to promptly seek medical attention Refer treated patients with new or worsening symptoms of depression or suicidal ideation and/or behavior to a mental health professional, as appropriate Re-evaluate the risks and benefits of continuing treatment if such events occur Infections May increase risk of infections Do not initiate treatment in patients with any clinically important active infection until the infection resolves or is adequately treated In patients with a chronic infection or a history of recurrent infection, consider risks and benefits before prescribing Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur If an infection develops or patient is not responding to standard therapy, closely monitor the patient and discontinue therapy until the infection resolves Tuberculosis Evaluate for tuberculosis (TB) infection before initiating treatment Avoid use in patients with active TB infection Initiate treatment of latent TB before administering Consider anti-TB therapy before initiating in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed Closely monitor for signs and symptoms of active TB during and after treatment Liver abnormalities May increase liver enzymes Liver serum transaminase elevations >3x the upper limit of normal (ULN) were reported Elevated liver serum transaminases resolved after discontinuation Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment, and according to routine patient management If treatment-related increases in liver enzymes occur and drug-induced liver injury

Not Classi Pregnancy Available data on use in pregnant females are insufficient to evaluate for drug-associated risks of major birth defects, miscarriages, or other adverse maternal or fetal outcomes Transport of human IgG antibody across the placenta increases as pregnancy progresses and peaks during the third trimester; therefore, bimekizumab may be transmitted from the mother to the developing fetus Since bimekizumab may interfere with immune response to infections, consider risks and benefits before administering live vaccines to infants exposed in utero There are no data regarding infant serum levels of bimekizumab at birth and duration of persistence of bimekizumab in infant serum after birth Although a specific timeframe to delay live virus immunizations in infants exposed in utero is unknown, may consider a minimum of 4 months after birth because of the half-life of bimekizumab Pregnancy exposure registry Monitors pregnancy outcome in females exposed to bimekizumab during pregnancy Animal data No adverse developmental effects were observed in infants born to pregnant monkeys after SC administration of bimekizumab during organogenesis through parturition at doses up to 38 times the maximum recommended human dose (MRHD) Lactation There are no data on presence of bimekizumab in human or animal milk, effects on breastfed infants, or effects on milk production Endogenous IgG and monoclonal antibodies are transferred in human milk Effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to bimekizumab are unknown

Immunizations Before initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines Avoid the use of live vaccines in treated patients Limited data are available regarding coadministration with non-live vaccines CYP450 substrates Upon initiation or discontinuation of bimekizumab in patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index, consider monitoring for effect (eg, for warfarin) or drug concentration (eg, cyclosporine) and consider dosage modification of the CYP450 substrate 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 Bimekizumab may modulate serum levels of some cytokines Contraindicated (0) Serious (6) axicabtagene ciloleucel brexucabtagene autoleucel ciltacabtagene autoleucel idecabtagene vicleucel lisocabtagene maraleucel tisagenlecleucel

>10% Upper respiratory tract infections (15%) 1-10% Oral candidiasis (9%) Headache (3%) Injection site reactions (3%) Tinea infections (3%) Gastroenteritis (2%) Passive suicidal ideation (1.8%) Herpes simplex infection (1%) Acne (1%) Folliculitis (1%) Other Candida infections (1%) Fatigue (1%)

Bimekizumab-bkzx is a humanized immunoglobulin IgG1/ κ monoclonal antibody with two identical antigen binding regions that selectively bind to human interleukin 17A (IL-17A), interleukin 17F (IL17F), and interleukin 17-AF cytokines, and inhibits their interaction with the IL-17receptor complex. IL17A and IL-17F are naturally occurring cytokines that are involved in normal inflammatory and immune responses. Bimekizumab-bkzx inhibits the release of proinflammatory cytokines and chemokines.