Kyntheum 210 mg Solution for Injection
1. Name of the medicinal product
Kyntheum 210 mg solution for injection in pre-filled syringe
2. Qualitative and quantitative composition
Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution.
1 ml solution contains 140 mg brodalumab.
Brodalumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection (injection)
The solution is clear to slightly opalescent, colourless to slightly yellow and free from particles.
4. Clinical particulars
4.1 Therapeutic indications
Kyntheum is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
4.2 Posology and method of administration
Kyntheum is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Posology
The recommended dose is 210 mg administered by subcutaneous injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks.
Consideration should be given to discontinuing treatment in patients who have shown no response after 12-16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Special populations
Elderly (aged 65 years and over)
No dose adjustment is recommended in elderly patients (see section 5.2).
Real and hepatic impairment
Kyntheum has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population
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.
Method of administration
Kyntheum is administered by subcutaneous injection. Each pre-filled syringe is for single use only. Kyntheum should not be injected into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis. The pre-filled syringe must not be shaken.
After proper training in subcutaneous injection technique, patients may self-inject Kyntheum when deemed appropriate by a physician. Patients should be instructed to inject the full amount of Kyntheum according to the instructions provided in the package leaflet. Comprehensive instructions for administration are given in the package leaflet.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Active Crohn's disease.
Clinically important active infections (e.g. active tuberculosis, see section 4.4).
4.4 Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Crohn's disease
There is limited data in patients with a history of Crohn's disease. Exercise caution when prescribing Kyntheum to patients with a history of Crohn's disease. Patients with a history of Crohn's disease should be followed for signs and symptoms of active Crohn's disease. If patients develop active Crohn's disease, treatment should be discontinued permanently.
Suicidal ideation and behaviour
Suicidal ideation and behaviour, including completed suicide, have been reported in patients treated with Kyntheum. The majority of patients with sui |
