▼ THIS MEDICINAL PRODUCT IS SUBJECT TO ADDITIONAL MONITORING
Kyntheum® is a fully human monoclonal antibody and the only biologic treatment
for moderate to severe plaque psoriasis that selectively targets the IL-17 receptor subunit A.2,3
This means that it blocks multiple IL-17 cytokines with an active role in the pathogenesis of plaque psoriasis.2,3
Kyntheum® is delivered in pre-filled syringes each containing 210 mg of brodalumab in 1.5 ml solution.
1 ml of solution contains 140 mg of brodalumab.3
Solution for injection.
The solution is clear to slightly opalescent, colourless to slightly yellow and free of particles.3
Kyntheum® blocks the biological activity of the proinflammatory cytokines IL-17A, IL-17F, heterodimer IL-17A/F and IL-17E,
and inhibits inflammation and the clinical symptoms associated with psoriasis.1
Special Precautions for Storage
Store in the refrigerator (2° to 8° C).
Do not freeze.
Keep the pre-filled syringe in the outer box to protect it from light.3
Kyntheum® may be stored at room temperature (up to 25°C) once, in the outer carton, for a maximum single period of 14 days.
Once Kyntheum® has been removed from the refrigerator and has reached room temperature (up to 25°C)
it must either be used within 14 days or discarded.3
POSOLOGY AND FORM
The recommended dose is 210 mg administered by subcutaneous injection at weeks 0, 1 and 2, followed by 210 mg every 2 weeks.3
Treatment interruption should be considered for patients who have not responded after 12-16 weeks of treatment3. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.3
No dose adjustment is recommended in elderly patients (aged 65 years and over).3
Kyntheum® has not been studied in patient populations with renal and hepatic impairment. Therefore, no dose recommendations can be made.3
The safety and efficacy of Kyntheum® in children and adolescents below the age of 18 years have not yet been established. No data are available.3
Each pre-filled syringe is for single use only. Kyntheum® should not be injected into areas where the skin is sensitive, bruised, red, hard, thick, scaly or affected by psoriasis.3
The pre-filled syringe must not be shaken.3
After proper training in subcutaneous injection technique, patients may self-inject Kyntheum® when deemed appropriate by a physician.3
Link to patient support service to patients on brodalumab treatment with information on psoriasis and how patient can take control of the disease
View Kyntheum® instruction for use video that also patients can access in Medicininstruktioner.se
- Campa M, Mansouri B, Warren Ret al. A Review of Biologic Therapies Targeting IL-23 and IL-17 for Usein Moderate-to-Severe Plaque Psoriasis. DermatolTher2016;6:1-12.
- Lebwohl M, Strober B, Menter A, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med 2015; 373:1318-28.
- Kyntheum® SPC (12.09.2017)
MAT-24966 May 2019