Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Almirall, S.A., Ronda General Mitre, 151, 08022, Barcelona, Spain
Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Ilumetri is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis.
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.
No dose adjustment is required (see section 5.2).
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.
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.
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 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.
Doses up to 10 mg/kg intravenously have been safely administered in clinical trials. In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and that appropriate symptomatic treatment be instituted immediately.
3 years.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Unopened pre-filled syringe of Ilumetri may be removed from the refrigeration and stored up to 25°C for a single period of up to 30 days. Once removed from the refrigerator and stored under these conditions, discard after 30 days or by the expiry date printed on the container, whichever occurs first. A field for the date is provided on the carton to record the removal from refrigerator date.
Keep the pre-filled syringes in the outer carton in order to protect from light until the time of use.
Do not shake.
1 mL solution in a type I glass pre-filled syringe with stainless steel 29G x 1⁄2" needle, covered with a needle shield and rigid needle shield of polypropylene with a fluropolymer lamination, plunger stopper assembled in a passive safety device.
Pack size of 1 pre-filled syringe or 2 pre-filled syringes.
Not all pack sizes may be marketed.
Ilumetri is a sterile solution for injection in pre-filled syringe. The pre-filled syringes are for single use only.
Do not shake or freeze the pre-filled syringe. The pre-filled syringe should be taken out of the refrigerator 30 minutes before injecting to allow it to reach room temperature (up to 25°C).
Prior to use, a visual inspection of the pre-filled syringe is recommended. The liquid should be clear. Its colour may vary from colourless to slightly yellow. A small air bubble may be apparent: this is normal.
Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown.
The instructions for using the pre-filled syringes, included with the package leaflet, must be followed carefully.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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