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Bimekizumab

Brand and Other Names: BIMZELX
Mechanism of Action:

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 (IL-17F), and interleukin 17-AF cytokines, and inhibits their interaction with the IL-17 receptor complex. IL-17A 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.

Indications:

BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of:

  • Moderate to severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy or phototherapy.
  • Adults with active psoriatic arthritis (PsA).
  • Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
  • Adults with active ankylosing spondylitis (AS).
  • Adults with moderate to severe hidradenitis suppurativa (HS).
Route: Subcutaneous
Dose:
  • Injection: 160 mg/mL in a single-dose prefilled syringe or single-dose prefilled autoinjector.

  • Injection: 320 mg/2 mL (160 mg/mL) in a single-dose prefilled syringe or single-dose prefilled autoinjector.

Adverse Reactions:

Most common adverse reactions are:

  • Psoriasis and Hidradenitis Suppurativa (incidence ≥ 1%): upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes simplex infections, acne, folliculitis, other candida infections, and fatigue.

  • Psoriatic Arthritis (incidence ≥ 2%): upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infection.

  • Non-Radiographic Axial Spondyloarthritis (incidence ≥ 2%): upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsilitis, transaminase increase, and urinary tract infection.

  • Ankylosing Spondylitis (incidence ≥ 2%): upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash and vulvovaginal mycotic infection. 

Contraindication:

None

Warnings and Precautions:
  • Suicidal Ideation and Behavior (SI/B): May increase risk of SI/B. Advise patients, their caregivers, and families to monitor for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct patients to promptly seek medical attention or call the National Suicide and Crisis Lifeline at 988. Carefully weigh risks and benefits of treatment with BIMZELX in patients with a history of severe depression and/or suicidal ideation or behavior.
  • Infections: May increase risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, do not administer BIMZELX until the infection resolves. 
  • Tuberculosis (TB): Avoid use in patients with active TB. Initiate treatment of latent TB prior to BIMZELX treatment. 
  • Liver Biochemical Abnormalities: Elevated serum transaminases were reported in clinical trials. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline and according to routine patient management. Permanently discontinue use of BIMZELX in patients with causally-associated combined elevations of transaminases and bilirubin. 
  • Inflammatory Bowel Disease (IBD): Cases of IBD were reported in clinical trials with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. Monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.
  • Immunizations: Avoid the use of live vaccines in patients treated with BIMZELX.
See package insert for full prescribing information.