TALTZ

What it is

TALTZ (ixekizumab) is a humanised immunoglobulin G subclass 4 (IgG4) monoclonal antibody with neutralising activity against interleukin-17A (IL-17A). TALTZ is supplied as a solution for injection and is administered as a subcutaneous injection. Each prefilled pen or prefilled syringe contains ixekizumab 80 mg/mL.

Approved indications

— Treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. — Treatment of active psoriatic arthritis in adult patients who have responded inadequately, or who are intolerant, to previous DMARD therapy. — Treatment of active ankylosing spondylitis in adult patients. — Treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or MRI evidence, who have responded inadequately to, or are intolerant to, nonsteroidal anti-inflammatory drugs (NSAIDs).

Dosing overview

No dose adjustment is required for elderly patients.

Key safety warnings

TALTZ may increase the risk of infections. In clinical trials, a higher rate of infection such as upper respiratory tract infection, oral candidiasis, conjunctivitis and tinea infections were observed in TALTZ treated patients compared to placebo. Patients should be evaluated for tuberculosis (TB) infection prior to initiating treatment with TALTZ. TALTZ should not be administered to patients with active TB infection. Treatment of latent TB should be initiated prior to administering TALTZ. Serious hypersensitivity reactions, including some cases of anaphylaxis, angioedema and urticaria, have been reported. If a serious hypersensitivity reaction occurs, administration of TALTZ should be discontinued immediately and appropriate therapy initiated. Exercise caution when prescribing TALTZ to patients with inflammatory bowel disease, including Crohn's disease and ulcerative colitis, as new cases or exacerbations have been reported. Patients treated with TALTZ and who have inflammatory bowel disease should be monitored closely.

Contraindications

TALTZ is contraindicated in patients with known serious hypersensitivity to ixekizumab or any of the excipients.

PBS listing

TALTZ 80 mg in 1 mL single dose pre-filled pen is listed on the PBS with authority required restriction at an ex-manufacturer price of A$3097.00.

Regulatory history

TALTZ was approved by the TGA on 1 September 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The product received initial registration on the Australian Register of Therapeutic Goods (ARTG) on 6 September 2016. In July 2016, PBAC recommended TALTZ as a new authority required listing for the treatment of severe chronic plaque psoriasis refractory to treatment with non-biological DMARDs. In November 2017, PBAC recommended extension to authority required streamlined listing for treatment of severe chronic plaque psoriasis and severe active psoriatic arthritis. In July 2020, PBAC recommended extension to ankylosing spondylitis, and in November 2021, PBAC recommended listing for non-radiographic axial spondyloarthritis, though this recommendation was subsequently withdrawn.