TREMFYA

What it is

TREMFYA contains guselkumab, a fully human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody that binds selectively to the extracellular human interleukin 23 (IL-23) protein with high specificity and affinity. Guselkumab is produced in a mammalian cell line using recombinant DNA technology. TREMFYA is available in presentations for subcutaneous injection (pre-filled syringe at 100 mg / 1 mL and 200 mg / 2 mL, and pre-filled pen at 45 mg / 0.45 mL, 100 mg / 1 mL and 200 mg / 2 mL) and for intravenous infusion (single-dose vial at 200 mg / 20 mL).

Approved indications

— Moderate to severe plaque psoriasis in adult patients (18 years of age or older) who are candidates for systemic therapy or phototherapy. — Moderate to severe plaque psoriasis in paediatric patients (6 years of age or older) who are candidates for systemic therapy or phototherapy. — Active psoriatic arthritis in adult patients who have had an inadequate response to, or are intolerant to prior DMARD therapy. — Moderately to severely active ulcerative colitis in adult patients who have had an inadequate response, lost response, or were intolerant to either conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor. — Moderately to severely active Crohn's disease in adult patients who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

Dosing overview

Key safety warnings

TREMFYA may increase the risk of infection. Treatment with TREMFYA should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Infections were observed in clinical trials in plaque psoriasis (23% vs 21% placebo; ≤0.2% serious infections in both groups) and psoriatic arthritis (21% in both TREMFYA and placebo groups; ≤0.8% serious infections in both groups), with a similar risk of infection seen in ulcerative colitis and Crohn's disease trials. Patients should be evaluated for tuberculosis infection prior to initiating treatment with TREMFYA, and treatment of latent TB should be initiated prior to administering TREMFYA. Patients receiving TREMFYA should be monitored for signs and symptoms of active TB during and after treatment. TREMFYA should not be administered to patients with active TB infection. All appropriate immunisations according to current immunisation guidelines should be completed prior to initiating therapy with TREMFYA. Live vaccines should not be used concurrently in patients treated with TREMFYA. Serious hypersensitivity reactions, including anaphylaxis, have been reported in the postmarketing setting, with some occurring several days after treatment and including cases with urticaria and dyspnea. If a serious hypersensitivity reaction occurs, appropriate therapy should be instituted and administration of TREMFYA should be discontinued.

Contraindications

Serious hypersensitivity to guselkumab or any of the excipients.

PBS listing

TREMFYA 100 mg in 1 mL single-use pre-filled syringe is listed on the PBS with 2 items under authority required restriction at an ex-manufacturer price of A$3452.89. TREMFYA 100 mg in 1 mL single-use pre-filled pen is listed on the PBS with 1 item under authority required restriction at the same ex-manufacturer price of A$3452.89.

Regulatory history

TREMFYA guselkumab 100 mg solution for injection pre-filled syringe (ARTG 286020) was first registered on 2018-03-15. In July 2018, PBAC recommended TREMFYA for severe chronic plaque psoriasis on a cost-minimisation basis against the lowest cost biological agent available. In July 2020, PBAC recommended a new pre-filled pen presentation for severe chronic plaque psoriasis. In November 2020, PBAC recommended TREMFYA for psoriatic arthritis. On 2021-01-21, the TGA approved the extension of indication for TREMFYA for active psoriatic arthritis in patients who have had an inadequate response to, or are intolerant to prior DMARD therapy. In July 2025, PBAC recommended TREMFYA for severe Crohn's disease to be cost-minimised to ustekinumab over 2 years. In July 2025, TREMFYA guselkumab 200 mg / 2 mL pre-filled syringe (ARTG 460498), 200 mg / 2 mL pre-filled pen (ARTG 460499), and 200 mg / 20 mL intravenous infusion vial (ARTG 460503) were registered.