(Bimzelx) bimekizumab-bkzx – Guidelines+ Monograph

(Bimzelx) bimekizumab-bkzx is a humanized interleukin-17A and F antagonist indicated for the treatment of immune-mediated inflammatory diseases including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and more. Bimzelx was first approved in October 2023 for treating plaque psoriasis in adults, and most recently was approved to be used as treatment for adults with moderate to sever hidraenitis suppurative.

Read on to learn more about Bimzelx, including its warnings and precautions, adverse reactions, and more.

Medication Overview:

• Brand Name: Bimzelx
• Generic Name: bimekizumab-bkzx
• Treatment for: Plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, and hidradenitis suppurativa
• Company: UCB
• Initial FDA Approval: October 2023

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.

Dosage and Administration:

• Prior to treatment: Evaluate patients for tuberculosis infection. Test liver enzymes, alkaline phosphatase, and bilirubin. Complete all age-appropriate vaccinations as recommended by current immunization guidelines.
• Plaque Psoriasis: Administer 320 mg by subcutaneous injection at weeks zero, four, eight, 12, and 16, then every eight weeks thereafter. For patients weighing 120 kg or more, consider a dose of 320 mg every four weeks after week 16.
• Psoriatic Arthritis: Administer 160 mg by subcutaneous injection every four 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 four weeks.
• Ankylosing Spondylitis: Administer 160 mg by subcutaneous injection every four weeks.
• Hidradenitis Suppurativa: Administer 320 mg by subcutaneous injection at Week 0, 2, 4, 6, 8, 10, 12, 14 and 16, then every 4 weeks thereafter.
• See full prescribing information for recommendations regarding missed doses, preparation and administration instructions.

Contraindications:

None.

Drug Interactions:

CYP450 Substrates: The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Treatment with Bimzelx may modulate serum levels of some cytokines. Therefore, upon initiation or discontinuation of Bimzelx in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate. 

Population pharmacokinetic data analyses indicated that the clearance of Bimzelx was not impacted by concomitant administration of cDMARDs including methotrexate, or by prior exposure to biologics.

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.

Please note: This article is current as of June 29, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.

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