Ilumetri 100mg solution for injection in pre-filled syringe
1. Name of the medicinal product
Ilumetri 100 mg solution for injection in pre-filled syringe.
2. Qualitative and quantitative composition
Each pre-filled syringe contains 100 mg of tildrakizumab in 1 mL.
Tildrakizumab is a humanised IgG1/k monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection (injection)
The solution is clear to slightly opalescent and colourless to slightly yellow. The solution pH is in the range of 5.7 - 6.3 and the osmolality is between 258 and 311 mOsm/kg.
4. Clinical particulars
4.1 Therapeutic indications
Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
4.2 Posology and method of administration
Ilumetri is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis.
Posology
The recommended dose of Ilumetri is 100 mg by subcutaneous injection at weeks 0, and 4 and every 12 weeks thereafter.
In patients with certain characteristics (e.g. high disease burden, body weight ≥ 90 kg) 200 mg may provide greater efficacy.
Consideration should be given to discontinuing treatment in patients who have shown no response after 28 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 28 weeks.
Special populations
Elderly
No dose adjustment is required (see section 5.2).
Renal or hepatic impairment
Ilumetri has not been studied in these patient populations. No dose recommendations can be made. For further information on elimination of tildrakizumab, see section 5.2.
Paediatric population
The safety and efficacy of Ilumetri in children and adolescents below the age of 18 years have not yet been established. No data are available.
Method of administration
Ilumetri is administered by subcutaneous injection. Injection sites should be alternated. Ilumetri should not be injected into areas where the skin is affected by plaque psoriasis or is tender, bruised, red, hard, thick, or scaly. The pre-filled syringe must not be shaken. Each pre-filled syringe is for single use only.
Inject the full amount of tildrakizumab according to the instructions for use are provided in the package leaflet.
After proper training in subcutaneous injection technique, patients may self-inject Ilumetri if a physician determines that it is appropriate. However, the physician should ensure appropriate follow-up of patients. Patients should be instructed to inject the full amount of Ilumetri 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.
Clinically important active infection, 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.
Infections
Ilumetri has the potential to increase the risk of infection (see section 4.8).
Caution should be exercised when considering the use of Ilum |
