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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.
Posology: Plaque psoriasis: 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.
Psoriatic arthritis: 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.
Axial spondyloarthritis (nr-axSpA and AS): The recommended dose for adult patients with axial spondyloarthritis is 160 mg (given as 1 subcutaneous injection) every 4 weeks.
Hidradenitis suppurativa: 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 previously mentioned indications, consideration should be given to discontinuing treatment in patients who have shown no improvement by 16 weeks of treatment.
Special populations: Overweight patients with plaque psoriasis: 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 Pharmacology: Pharmacodynamics under Actions).
Elderly (≥65 years): No dose adjustment is required (see Pharmacology: Pharmacokinetics under Actions).
Renal or hepatic impairment: Bimekizumab has not been studied in these patient populations. Dose adjustments are not considered necessary based on pharmacokinetics (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of bimekizumab in children and adolescents below the age of 18 years have not been established. No data are available.
Method of administration: This medicinal product is administered by subcutaneous injection. A 320 mg dose can be given as 2 subcutaneous injections of 160 mg.
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. Administration in the upper arm may only be performed by a healthcare professional or cargiver.
The pre-filled pen must not be shaken.
After proper training in subcutaneous injection technique, patients may self-inject Bimzelx with the 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: Information for the user.
