ILUMYA

What it is

ILUMYA is a 100 mg/1 mL solution for injection containing tildrakizumab. Tildrakizumab is a humanised IgG1/κ monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary cells. The medicine is supplied as a solution for injection in a single-use pre-filled syringe.

Approved indications

— Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

Dosing overview

The recommended dose of ILUMYA is 100 mg by subcutaneous injection at weeks 0, 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 who had unsatisfactory response at 100 mg, a dose of 200 mg may be considered. After proper training in subcutaneous injection technique, patients may self-inject ILUMYA if a healthcare professional determines that it is appropriate.

Key safety warnings

**Infections.** ILUMYA must not be given to patients with active tuberculosis. Prior to initiating treatment with ILUMYA, patients should be evaluated for tuberculosis infection, and patients receiving ILUMYA should be monitored for signs and symptoms of active TB during and after treatment. Caution should be exercised when considering the use of ILUMYA in patients with a chronic infection or a history of recurrent infection. **Immunisations.** Prior to initiating treatment with ILUMYA, completion of all appropriate immunisations should be considered, and if a patient has received live viral or bacterial vaccination it is recommended to wait at least 4 weeks prior to starting treatment. Patients treated with ILUMYA should not receive live vaccines during treatment and for at least 17 weeks after treatment. **Hypersensitivity.** Non-serious cases of urticaria occurred in ILUMYA-treated subjects in clinical trials. If a serious hypersensitivity reaction occurs, administration of ILUMYA should be discontinued immediately and appropriate therapy initiated. **Adverse reactions.** The most common adverse reactions observed with ILUMYA in clinical trials were nasopharyngitis, headache, and injection site pain. Most adverse reactions were considered mild and no adverse reaction led to discontinuation of treatment in greater than 1% of patients.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Clinically important active infection (for example, active tuberculosis).

PBS listing

ILUMYA 100 mg in 1 mL single dose pre-filled syringe is listed on the PBS with 2 items under authority required restriction, with an ex-manufacturer price of A$2954.55.

Regulatory history

ILUMYA tildrakizumab 100 mg/1 mL solution for injection pre-filled syringe was first listed on the ARTG on 10 September 2018. In July 2018, the PBAC recommended ILUMYA for listing on the basis that cost-effectiveness would be accepted if cost-minimised against the lowest cost biologic DMARD for severe chronic plaque psoriasis. In March 2023, the PBAC did not recommend an extension adding a grandfathering restriction for patients enrolled in two clinical trials.