EVENITY

What it is

EVENITY contains romosozumab , a humanised monoclonal antibody that binds and inhibits sclerostin, a negative regulator of bone formation . EVENITY is a sterile, preservative-free solution for injection containing 105 mg/1.17 mL of romosozumab in pre-filled syringe or pre-filled syringe with autoinjector . Romosozumab has a dual effect on bone, increasing bone formation and decreasing bone resorption .

Approved indications

— Treatment of osteoporosis in postmenopausal women at high risk of fracture . — Treatment to increase bone mass in men with osteoporosis at high risk of fracture .

Dosing overview

The recommended dose of EVENITY is 210 mg administered subcutaneously as 2 subcutaneous injections, once every month for 12 doses . After completing EVENITY therapy, transition to an antiresorptive osteoporosis therapy is required to preserve bone mass . To reduce the risk of hypocalcaemia, patients should be adequately supplemented with calcium and vitamin D .

Key safety warnings

In randomised controlled studies, an increase in serious cardiovascular events (myocardial infarction and stroke) has been observed in patients treated with EVENITY, compared to controls . EVENITY is contraindicated in patients with previous myocardial infarction or stroke . When determining whether to use EVENITY for an individual patient, consideration should be given to their fracture risk over the next year and their cardiovascular risk based on risk factors such as established cardiovascular disease, hypertension, hyperlipidaemia, diabetes mellitus, smoking, severe renal impairment, and age, and EVENITY should only be used if the prescriber and patient agree that the benefit outweighs the risk . Transient hypocalcaemia has been observed in patients receiving EVENITY, and hypocalcaemia must be corrected prior to initiating therapy . Monitor patients for signs and symptoms of hypocalcaemia . Clinically significant hypersensitivity reactions, including angioedema, erythema multiforme, and urticaria occurred in the EVENITY group in clinical trials . If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of EVENITY . Osteonecrosis of the jaw, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing and has occurred rarely in patients receiving EVENITY in the clinical trials . Atypical low-energy or low-trauma fracture of the femoral shaft, which can occur spontaneously, has occurred rarely in patients receiving EVENITY in the clinical trials .

Contraindications

Uncorrected hypocalcaemia . Known hypersensitivity to romosozumab, CHO-derived proteins or any of the excipients found in EVENITY . History of myocardial infarction or stroke .

PBS listing

EVENITY 105 mg in 1.17 mL single use pre-filled syringe is listed on the PBS as 2 items with authority required restriction, at an ex-manufacturer price of A$352.24 .

Regulatory history

EVENITY was first registered on the ARTG on 1 July 2019 as romosozumab 105 mg/1.17 mL injection solution, available in both syringe with pen injector and syringe presentations . This medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information . In March 2020, the PBAC recommended EVENITY for listing for severe osteoporosis in patients who have experienced a prior fracture while on anti-resorptive therapy . In March 2023, the PBAC recommended EVENITY for severe established osteoporosis in the first-line setting . In March 2024, the PBAC again recommended the medicine for osteoporosis in the severe, first-line setting, noting a TGA safety update regarding the risk of myocardial infarction and stroke, which led to a contraindication for patients with a history of these conditions .