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Bimzelx

Bimzelx

Manufacturer:

UCB

Distributor:

Zuellig
Concise Prescribing Info
Contents
Bimekizumab
Indications/Uses
Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Alone or in combination w/ MTX for active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to ≥1 DMARDs. Active non-radiographic axial spondyloarthritis w/ objective signs of inflammation as indicated by elevated C-reactive protein &/or MRI in adults who have responded inadequately or are intolerant to NSAIDs. Active ankylosing spondylitis in adults who have responded inadequately or are intolerant to conventional therapy. Active moderate to severe hidradenitis suppurativa (acne inversa) in adults who have an inadequate response to conventional systemic therapy.
Dosage/Direction for Use
Adult Plaque psoriasis 320 mg (given as 2 SC inj of 160 mg each) at wk 0, 4, 8, 12, 16 & every 8 wk thereafter. Psoriatic arthritis 160 mg (given as 1 SC inj of 160 mg) every 4 wk. Axial spondyloarthritis 160 mg every 4 wk. Hidradenitis suppurativa 320 mg every 2 wk up to wk 16 & every 4 wk thereafter. Psoriatic arthritis patient w/ coexistent moderate to severe plaque psoriasis 320 mg at wk 0, 4, 8, 12, 16 & every 8 wk thereafter. If sufficient clinical response in joints cannot be maintained after 16 wk, consider switching to 160 mg every 4 wk. Overwt patient w/ plaque psoriasis (including psoriatic arthritis w/ coexistent moderate to severe psoriasis) & weighing ≥120 kg If complete skin clearance was not achieved at wk 16, treatment response may be further improved on 320 mg every 4 wk after wk 16.
Contraindications
Hypersensitivity. Clinically important active infections (eg, active TB).
Special Precautions
Immediately discontinue administration in case of serious hypersensitivity reactions. Rotate inj sites. Do not inj into psoriasis plaques or areas where skin is tender, bruised, erythematous, or indurated. Increased risk of infections eg, URTI & oral candidiasis. Exercise caution when considering use in patients w/ chronic infection or history of recurrent infection. Do not initiate treatment in patients w/ any clinically important active infection until infection resolves or is adequately treated. Evaluate patients for TB infection prior to initiating treatment. Monitor for signs & symptoms of active TB. Consider anti-TB therapy prior to initiating bimekizumab in patients w/ past history of latent or active TB. Not recommended in patients w/ inflammatory bowel disease. Discontinue treatment in case of signs & symptoms of inflammatory bowel disease or exacerbation of pre-existing inflammatory bowel disease. Has not been studied in patients w/ renal or hepatic impairment. Women of childbearing potential should use effective contraception during treatment & for at least 17 wk after treatment. Avoid use during pregnancy. Discontinue breast-feeding or discontinue/abstain from Bimzelx therapy. Safety & efficacy in childn & adolescents <18 yr have not been established.
Adverse Reactions
URTI. Oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, vulvovaginal mycotic infection (including vulvovaginal candidiasis); headache; rash, dermatitis, eczema, acne; inj site reactions, fatigue.
Drug Interactions
May result in normalisation of CYP450 levels w/ accompanying lower exposure of CYP450-metabolised medicinal products. Should not be concurrently given w/ live vaccines.
MIMS Class
Immunosuppressants
ATC Classification
L04AC21 - bimekizumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Bimzelx soln for inj 160 mg/mL
Packing/Price
1's
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