ZOMETA

What it is

Osteovan (zoledronic acid) is supplied as a 5 mg/100 mL solution for infusion containing 5 mg zoledronic acid (anhydrous). The solution is sterile, clear and colourless. Zoledronic acid is a bisphosphonate that acts primarily on bone. It is an inhibitor of osteoclast-mediated bone resorption.

Approved indications

— Treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures. — Treatment of osteoporosis in patients over 50 years of age with a history of at least one low trauma hip fracture, to reduce the incidence of further fractures. — To increase bone mineral density in men with osteoporosis. — To increase bone mineral density in patients with osteoporosis associated with long term glucocorticoid use. — To prevent glucocorticoid-induced bone mineral density loss. — Treatment of Paget's disease of bone.

Dosing overview

For the treatment of postmenopausal osteoporosis, the recommended dose is a single intravenous infusion of 5 mg of Osteovan administered once a year. For the prevention of clinical fractures after a low trauma hip fracture, the recommended dose is a single intravenous infusion of 5 mg Osteovan administered once a year. For the treatment of osteoporosis in men, the recommended dose is a single intravenous infusion of 5 mg Osteovan administered once a year. For the treatment and prevention of glucocorticoid-induced osteoporosis, the recommended dose is a single intravenous infusion of 5 mg Osteovan administered once a year. For the treatment of Paget's disease, the recommended dose is a single intravenous infusion of 5 mg Osteovan. Osteovan is administered intravenously via a vented infusion line at a constant infusion rate, with the infusion time not less than 15 minutes.

Key safety warnings

Post-dose symptoms commonly occur within the first three days following Osteovan administration and may include fever, flu-like symptoms, myalgia, arthralgia and headache. The incidence of these symptoms can be reduced by approximately 50% with the administration of paracetamol shortly following Osteovan administration. The use of Osteovan in patients with severe renal impairment (creatinine clearance less than 35 mL/min) is contraindicated due to an increased risk of renal failure, especially in patients with pre-existing renal impairment or other risk factors including advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration. Patients must be appropriately hydrated prior to administration of Osteovan, especially the elderly and those receiving diuretic therapy; adequate hydration can be achieved by the patient drinking two glasses of fluid before and after the infusion. Severe and occasionally incapacitating bone, joint and/or muscle pain have been infrequently reported in patients taking bisphosphonates including Osteovan. Osteonecrosis of the jaw has been reported predominantly in cancer patients treated with bisphosphonates, with the majority of reported cases associated with dental procedures such as tooth extraction. Discuss with the patient the need to have dental work completed before commencing Osteovan treatment. Atypical subtrochanteric and diaphyseal femoral fractures have been reported in association with bisphosphonate therapy, occurring after minimal or no trauma with some patients experiencing thigh or groin pain weeks to months before presenting with a completed femoral fracture. Patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for possible femur fracture.

Contraindications

Osteovan is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates; hypocalcaemia; renal impairment with creatinine clearance less than 35 mL/min; current or recent uveitis, or a history of bisphosphonate-associated uveitis; pregnancy and lactation.

Regulatory history

Zoledronic acid 4 mg/5 mL concentrated injection was first registered on the ARTG on 26 March 2003, and zoledronic acid 4 mg/100 mL injection solution was first registered on 15 August 2012.