BRENZYS

What it is

BRENZYS is etanercept, supplied as a powder for injection containing 25 mg of the active ingredient in each vial. BRENZYS is also available as a 50 mg solution for injection in single-use auto-injector and pre-filled syringe presentations. Etanercept is the active ingredient in BRENZYS.

Approved indications

— Active, adult rheumatoid arthritis in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). — Severe, active rheumatoid arthritis in adults to slow progression of disease-associated structural damage in patients at high risk of erosive disease. — Signs and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate. — Moderate to severe chronic plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy. — Signs and symptoms of active ankylosing spondylitis in adults. — Active non-radiographic axial spondyloarthritis in adults with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or MRI change who have had an inadequate response to NSAIDs.

Dosing overview

The recommended dose of BRENZYS for rheumatoid arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis is 50 mg per week, given as a subcutaneous injection, either once weekly as a single 50 mg injection or twice weekly as two separate 25 mg injections given 3–4 days apart. For plaque psoriasis, the recommended dose is 50 mg per week, given once weekly or twice weekly as a subcutaneous injection; higher responses may be achieved from initial treatment for up to 12 weeks with a dose of 50 mg given twice weekly, after which the dose should be reduced to the standard dose of 50 mg per week.

Key safety warnings

Serious infections including sepsis and tuberculosis have been reported with the use of BRENZYS, and some of these infections have been fatal. Opportunistic infections have also been reported, including listeriosis, legionellosis and invasive fungal infections. Administration of BRENZYS should be discontinued if a patient develops a serious infection such as tuberculosis or an atypical mycobacterial infection, or sepsis. Tuberculosis, including disseminated or extrapulmonary presentation, has been observed in patients receiving BRENZYS, and may be due to reactivation of latent TB infection or to new infection. Before initiating therapy with BRENZYS, any patient at increased risk for TB should be evaluated for active or latent infection; if active TB is diagnosed, BRENZYS therapy must not be initiated, and prophylaxis of latent TB infection should be initiated prior to therapy. Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus and had received BRENZYS has been reported, and in some instances has been fatal. Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with BRENZYS. Post-marketing reports of worsening of congestive heart failure have been received, and there have also been rare reports of new onset congestive heart failure.

Contraindications

Known hypersensitivity to etanercept or to any of its excipients is a contraindication. BRENZYS is contraindicated in patients with, or at risk of, sepsis, and treatment should not be initiated in patients with serious, active infection including chronic or localised infections. Concurrent treatment with Interleukin-1 antagonists is contraindicated.

PBS listing

BRENZYS 50 mg solution for injection is listed on the PBS in both auto-injector and pre-filled syringe presentations with 15 items in each formulation. Both presentations are restricted, requiring authority approval and streamlined authority processes. The ex-manufacturer price is A$743.60.

Regulatory history

BRENZYS was first listed on the ARTG on 22 July 2016 with two entries: a 50 mg solution for injection auto-injector (ARTG 245253) and a 50 mg solution for injection pre-filled syringe (ARTG 245252). The AusPAR approval date was 15 July 2016, covering indications in adults aged 18 years and over for rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.