BIMZELX 160MG/ML — DIN 02553627

What is BIMZELX?

BIMZELX 160MG/ML contains BIMEKIZUMAB : 320 MG / 2 ML. It is listed in the Health Canada Drug Product Database under DIN 02553627, held by UCB CANADA INC, supplied as SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 07-Apr-2025. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is BIMZELX used for?

Bimzelx (bimekizumab injection) is indicated for: • Psoriasis (PsO): The treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. • Psoriatic arthritis (PsA): The treatment of adult patients with active psoriatic arthritis. Bimzelx can be used alone or in combination with a conventional non-biologic disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate). • Axial Spondyloarthritis (axSpA): - Ankylosing Spondylitis (AS, radiographic spondyloarthritis): The treatment of adult patients with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy. - Non-radiographic axial spondyloarthritis (nr-axSpA): The treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). • Hidradenitis suppurativa (HS): The treatment of adult patients with moderate to severe hidradenitis suppurativa with an inadequate response to conventional systemic therapy.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

After proper training in subcutaneous injection technique, patients may self-inject if their physician determines that it is appropriate and with medical follow-up as necessary. Patients should be instructed to inject the full amount of Bimzelx according to the Instructions for Use. Each pre-filled syringe or autoinjector is for single-use only, and is available in the following presentations: • 160 mg bimekizumab for injection in a 1 mL pre-filled syringe or autoinjector • 320 mg bimekizumab for injection in a 2 mL pre-filled syringe or autoinjector PsO and HS patients should be instructed to inject either two separate 160 mg single-use pre-filled syringes or autoinjectors or one 320 mg single-use pre-filled syringe or autoinjector for the full 320 mg dose. Plaque Psoriasis (PsO): The recommended dose of Bimzelx (bimekizumab injection) for adult patients with plaque psoriasis is 320 mg (given as two subcutaneous injections of 160 mg or one subcutaneous injection of 320 mg) every 4 weeks for the first 16 weeks, and every 8 weeks thereafter. At the prescriber's discretion, discontinuation of treatment may be considered in patients who have shown no improvement after 16 weeks of treatment. For patients with a body weight ≥ 120 kg and who did not achieve a complete skin response, a dose of 320 mg every 4 weeks after Week 16 may be considered. Psoriatic Arthritis: The recommended dose for adult patients with active psoriatic arthritis is 160 mg (given as one subcutaneous injection of 160 mg) every 4 weeks. For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, the recommended dose is the same as for plaque psoriasis. After 16 weeks, regular assessment of efficacy is recommended and if a sufficient clinical response in joints cannot be maintained, a switch to the recommended dose for psoriatic arthritis can be considered. Axial spondyloarthritis (axSpA): The recommended dose of Bimzelx for adult patients with active axSpA (including ankylosing spondylitis and non-radiographic axial spondyloarthritis) is 160 mg (given as one subcutaneous injection of 160 mg) every 4 weeks. Hidradenitis suppurativa (HS): The recommended dose of Bimzelx for adult patients with hidradenitis suppurativa is 320 mg (given as two subcutaneous injections of 160 mg or one subcutaneous injection of 320 mg) every 2 weeks up to Week 16 and every 4 weeks thereafter. Administration: Bimzelx is administered by subcutaneous injection. Suitable areas for injection include thigh, abdomen and upper arm. Injection sites should be rotated, and injections should not be given into psoriasis plaques or areas where the skin is tender, bruised, erythematous, or indurated. Patients should self-administer in the thigh and abdomen only. Missed Dose: If a dose is missed, it should be administered as soon as possible. Thereafter, dosing should be resumed at the regular schedule (i.e. 2, 4 or 8 weeks later). Do not administer two doses at the same time to make up for a missed dose.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

Bimzelx (bimekizumab injection) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Warnings and precautions

As with all therapeutic proteins including Bimzelx, there is a potential for anaphylaxis. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue the administration of Bimzelx and initiate appropriate medical treatment. Inform patients/caregivers of the signs and symptoms of anaphylaxis and hypersensitivity reactions, and instruct them to seek immediate medical care if signs and symptoms occur. Vaccinations: Prior to initiating therapy with Bimzelx, consider completion of all age appropriate immunizations according to current immunization guidelines. Live vaccines should be avoided in patients treated with Bimzelx. Patients treated with Bimzelx may receive inactivated or non-live vaccinations. Infections: Bimzelx has the potential to increase the risk of infections. Higher rates of infections such as upper respiratory tract infections and oral candidiasis were observed in patients receiving Bimzelx compared with placebo. Caution should be exercised when considering the use of Bimzelx in patients with a chronic infection or a history of recurrent infection; patients with active infections, serious infections, or a history of opportunistic, recurrent or chronic infections were excluded from Bimzelx clinical trials. Treatment with Bimzelx should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients treated with Bimzelx should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important infection or is not responding to standard therapy, the patient should be closely monitored and Bimzelx should not be administered until the infection resolves. Pre-treatment evaluation for tuberculosis (TB): Prior to initiating treatment with Bimzelx, patients should be evaluated for TB infection. Bimzelx should not be given to patients with active TB. Patients receiving Bimzelx should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating Bimzelx in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.