Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium
Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Bimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
Bimzelx is indicated for the treatment of adults 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).
Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.
Bimzelx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy (see section 5.1).
Bimzelx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Bimzelx is indicated.
The recommended dose for adult patients with plaque psoriasis is 320 mg (given as 2 subcutaneous injections of 160 mg each) at week 0, 4, 8, 12, 16 and every 8 weeks thereafter.
The recommended dose for adult patients with active psoriatic arthritis is 160 mg (given as 1 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 [320 mg (given as 2 subcutaneous injections of 160 mg each) at Week 0, 4, 8, 12, 16 and every 8 weeks thereafter]. After 16 weeks, regular assessment of efficacy is recommended and if a sufficient clinical response in joints cannot be maintained, a switch to 160 mg every 4 weeks can be considered.
The recommended dose for adult patients with axial spondyloarthritis is 160 mg (given as 1 subcutaneous injection) every 4 weeks.
The recommended dose for adult patients with hidradenitis suppurativa is 320 mg (given as 2 subcutaneous injections of 160mg each) every 2 weeks up to Week 16 and every 4 weeks thereafter.
For above indications, consideration should be given to discontinuing treatment in patients who have shown no improvement by 16 weeks of treatment.
For some patients with plaque psoriasis (including psoriatic arthritis with coexistent moderate to severe psoriasis) and a body weight ≥120 kg who did not achieve complete skin clearance at week 16, 320 mg every 4 weeks after week 16 may further improve treatment response (see section 5.1).
No dose adjustment is required (see section 5.2).
Bimekizumab has not been studied in these patient populations. Dose adjustments are not considered necessary based on pharmacokinetics (see section 5.2).
The safety and efficacy of bimekizumab in children and adolescents below the age of 18 years have not been established. No data are available.
This medicinal product 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.
The pre-filled syringe or pre-filled pen must not be shaken.
After proper training in subcutaneous injection technique, patients may self-inject Bimzelx with the pre-filled syringe or pre-filled pen 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 provided in the package leaflet.
Single doses of 640 mg intravenously or 640 mg subcutaneously, followed by 320 mg subcutaneously every two weeks for five doses have been administered in clinical studies without dose-limiting toxicity. In the event of overdose, it is recommended that the patient be monitored for any signs and symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
3 years.
Bimzelx 160 mg solution for injection in pre-filled syringe:
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light.
The pre-filled syringe may be stored at room temperature (up to 25°C) for a single period of maximum 25 days with protection from light. Once removed from the refrigerator and stored under these conditions, discard after 25 days or by the expiry date printed on the container, whichever occurs first. A field for the date is provided on the carton to record the date removed from the refrigerator.
Bimzelx 160 mg solution for injection in pre-filled pen:
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the pre-filled pen in the outer carton in order to protect from light.
The pre-filled pen may be stored at room temperature (up to 25°C) for a single period of maximum 25 days with protection from light. Once removed from the refrigerator and stored under these conditions, discard after 25 days or by the expiry date printed on the container, whichever occurs first. A field for the date is provided on the carton to record the date removed from the refrigerator.
Bimzelx 160 mg solution for injection in pre-filled syringe:
One mL pre-filled syringe (type I glass) with a fluoropolymer-laminated bromobutyl rubber stopper, staked 27G, ½" thin wall needle, and a polypropylene rigid needle shield assembled in a passive safety device.
Pack size of 1 pre-filled syringe.
Pack size of 2 pre-filled syringes.
Multipack containing 3 (3 packs of 1) pre-filled syringes.
Multipack containing 4 (2 packs of 2) pre-filled syringes.
Not all pack sizes may be marketed.
Bimzelx 160 mg solution for injection in pre-filled pen:
One mL pre-filled pen containing a pre-filled syringe (type I glass) with a fluoropolymer-laminated bromobutyl rubber stopper, staked 27G, ½" thin wall needle, and a polypropylene rigid needle shield.
Pack size of 1 pre-filled pen.
Pack size of 2 pre-filled pens.
Multipack containing 3 (3 packs of 1) pre-filled pens.
Multipack containing 4 (2 packs of 2) pre-filled pens.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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