Ilumetri

This medicinal product 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 is 100 mg by subcutaneous injection at weeks 0, and 4 and every 12 weeks thereafter.

At the physician’s discretion, in patients with high disease burden or in patients above 90 kg of body weight a dose of 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. Missed dose If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.

2). Renal or hepatic impairment Ilumetri has not been studied in these patient populations. No dose recommendations can be made. 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 This medicinal product 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 syringe or the pen must not be shaken. Each syringe or pen is for single use only. 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 tildrakizumab according to the instructions provided in the package leaflet. Comprehensive instructions for administration are given in the package leaflet.

3%). Tabulated list of adverse reactions Adverse reactions from clinical studies (Table 1) are listed by MedDRA system organ class (SOC) and frequency, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000); and not known (cannot be estimated from available data).

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 6 Table 1. List of adverse reactions MedDRA System organ class Preferred term Frequency category Infections and infestations Upper respiratory tract infectionsa Very common Nervous system disorders Headache Common Gastrointestinal disorders Gastroenteritis Common Diarrhoea Common Nausea Common General disorders and administration site conditions Back pain Common Injection site pain Common aIncluding nasopharyngitis.

Long-term Safety The safety profile of tildrakizumab observed during the long-term extensions periods of reSURFACE 1 and reSURFACE 2 was consistent with that of the double-blind periods. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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. 8). Caution should be exercised when considering the use of tildrakizumab in patients with a chronic infection or a history of recurrent or recent serious infection.

Patients should be instructed to seek medical advice if signs or symptoms suggestive of a clinically relevant chronic or acute infection occur. 3). Pre-treatment evaluation for tuberculosis Prior to initiating treatment, patients should be evaluated for tuberculosis (TB) infection.

Patients receiving tildrakizumab should be closely monitored for signs and symptoms of active TB during and after treatment. Anti-TB therapy should be considered prior to initiating treatment in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

3). Vaccinations Prior to initiating treatment with tildrakizumab, consider completion of all appropriate immunisations according to current immunisation guidelines. If a patient has received live viral or bacterial vaccination it is recommended to wait at least 4 weeks prior to starting treatment with tildrakizumab.

5). 5 mg/mL. Polysorbates may cause allergic reactions.

1. g. 4). 4