ACTEMRA

What it is

Actemra is a medicine containing tocilizumab, available as a concentrate solution for intravenous infusion (80 mg, 200 mg or 400 mg per vial) or as a solution for subcutaneous injection (162 mg per pre-filled syringe or pre-filled pen).

Approved indications

— Moderate to severe active rheumatoid arthritis in adult patients in combination with methotrexate or other non-biological disease-modifying anti-rheumatic drugs, in case of either inadequate response or intolerance to previous therapy with one or more disease-modifying anti-rheumatic drugs. — Moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors in combination with methotrexate in those not previously treated with methotrexate. — Moderate to severe active rheumatoid arthritis in adult patients as monotherapy in case of intolerance to methotrexate or where continued treatment with methotrexate is inappropriate. — Giant cell arteritis in adult patients. — Moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate. — Active systemic juvenile idiopathic arthritis in patients 2 years of age and older (intravenous formulation). — Active systemic juvenile idiopathic arthritis in patients 1 year of age and older (subcutaneous formulation). — Chimeric antigen receptor T cell-induced severe or life-threatening cytokine release syndrome in adults and paediatric patients 2 years of age and older. — Coronavirus disease 2019 in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation (provisional approval).

Dosing overview

For rheumatoid arthritis in adults, the recommended intravenous dose is 8 mg per kilogram given once every 4 weeks as an infusion. For individuals weighing more than 100 kg, doses exceeding 800 mg per infusion are not recommended. <cite index index="1-48">The recommended subcutaneous dose is 162 mg given once every week as an injection.</cite>

Key safety warnings

During intravenous infusion and for 30 minutes after, patients must be closely monitored for signs or symptoms of hypersensitivity reaction. Necessary equipment, treatments and protocols to manage acute anaphylaxis must be in place with appropriately trained personnel available. For subcutaneous injection, at least the first injection must be performed under the supervision of a qualified healthcare professional in a healthcare facility with necessary medical treatment available, including resuscitation equipment. The patient must be closely monitored during and after the injection for signs and symptoms of hypersensitivity reaction.

Contraindications

The provided source documents do not contain information about contraindications for Actemra.

PBS listing

Actemra is listed on the PBS with authority required and streamlined restriction. The concentrate for intravenous injection is available in 80 mg (ex-manufacturer price A$80.97), 200 mg (A$200.71) and 400 mg (A$399.39) strengths. The solution for subcutaneous injection is available as 162 mg single-use pre-filled syringe (A$702.33) or pre-filled pen (A$702.33).

Regulatory history

Actemra intravenous concentrate formulations (80 mg, 200 mg and 400 mg) were first listed on the ARTG in May 2009. The subcutaneous pre-filled syringe formulation was registered in January 2016, and the pre-filled pen autoinjector formulation in February 2018. In November 2014, the PBAC recommended a change to the PBS listing for severe active rheumatoid arthritis to allow use in combination with methotrexate. In March 2016, the PBAC recommended authority required listing of subcutaneous tocilizumab for severe active rheumatoid arthritis on a cost-minimisation basis. In November 2017, the PBAC recommended amendment to allow tocilizumab to be used as a first-line biological disease-modifying anti-rheumatic drug for rheumatoid arthritis. In March 2019, the PBAC recommended authority required listing for giant cell arteritis and extended the PBS listing for polyarticular juvenile idiopathic arthritis. In March 2020, systemic juvenile idiopathic arthritis was added to the PBS listing. In December 2021, Actemra received provisional approval for the treatment of COVID-19 in hospitalised adults receiving systemic corticosteroids and requiring supplemental oxygen or mechanical ventilation, based on short-term efficacy and safety data with continued registration dependent on evidence from ongoing clinical trials and post-market assessment.