INDICATION

BIMZELX^® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Important Safety Information

Warnings and Precautions

Infections

BIMZELX^® (bimekizumab-bkzx) may increase the risk of infections. In clinical studies, infections occurred in 36% of the BIMZELX group compared to 23% of the placebo group through 16 weeks of treatment. Upper respiratory tract infections, oral candidiasis gastroenteritis, tinea pedis, and oral herpes occurred more frequently in the BIMZELX group than in the placebo group. Serious infections occurred in 0.3% of patients treated with BIMZELX and 0% treated with placebo. Treatment with BIMZELX should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves.

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid administration of BIMZELX to patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients closely for signs and symptoms of active TB during and after treatment.

Inflammatory Bowel Disease

In psoriasis trials, new onset of ulcerative colitis occurred in one subject out of a total of 1789 subjects treated with BIMZELX and led to discontinuation of therapy. New cases or exacerbation of Crohn’s disease and ulcerative colitis were observed in BIMZELX treated patients during clinical trials in other diseases. Caution should be used when prescribing BIMZELX to patients with active inflammatory bowel disease. During BIMZELX treatment, patients should be monitored closely.

Immunizations

Prior to initiating therapy with BIMZELX, consider completion of all age appropriate immunizations according to current immunization guidelines. Patients treated with BIMZELX should not receive live vaccines.

MOST COMMON ADVERSE REACTIONS

Most common adverse reactions (≥ 1%) are upper respiratory tract infections, oral candidiasis, headache, injection site reactions, acne, oropharyngeal candidiasis, folliculitis, gastroenteritis, tinea pedis, fatigue, and oral herpes.

Please see the full Prescribing Information, or visit BimzelxHCP.com.

REFERENCE: 1. Reich K, et al. N Engl J Med. 2021;385(2):142-152.

BIMZELX^® is a registered trademark of the UCB Group of Companies.
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©2021 UCB, Inc., Smyrna, GA 30080. All rights reserved.
October, 2021. US-P-BK-PSO-2100226.