OSTEOVAN

What it is

Zoledronate-RDY 5 is a solution for injection containing 5 mg/100 mL zoledronic acid monohydrate, corresponding to 5 mg zoledronic acid. It is presented as a solution for intravenous infusion. Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone as 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 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 administered once a year. For the treatment of osteoporosis in men, the recommended dose is a single intravenous infusion of 5 mg administered once a year. For the treatment and prevention of glucocorticoid-induced osteoporosis, the recommended dose is a single intravenous infusion of 5 mg administered once a year. For the treatment of Paget's disease, the recommended dose is a single intravenous infusion of 5 mg. The medicine is administered intravenously via a vented infusion line at a constant infusion rate, with an infusion time of not less than 15 minutes.

Key safety warnings

Post-dose symptoms commonly occur within the first three days following zoledronic acid 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 administration. Renal impairment has been observed following administration of zoledronic acid, especially in patients with pre-existing renal impairment or other risk factors including advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration. Renal impairment has been observed in patients after a single administration. Renal failure requiring dialysis or with fatal outcome has rarely occurred in patients with underlying renal impairment or with risk factors described above. Severe and occasionally incapacitating bone, joint and/or muscle pain have been infrequently reported in patients taking bisphosphonates including zoledronic acid. Osteonecrosis of the jaw has been reported predominantly in cancer patients treated with bisphosphonates including zoledronic acid. The majority of reported cases have been associated with dental procedures such as tooth extraction. Symptoms include persistent pain and/or non-healing sores of the mouth or jaw. Many had signs of local infection including osteomyelitis. Atypical subtrochanteric and diaphyseal femoral fractures have been reported in association with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare. These fractures occur after minimal or no trauma and some patients experience thigh or groin pain weeks to months before presenting with a completed femoral fracture.

Contraindications

Zoledronic acid 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 5 mg/100 mL injection solution was first listed on the ARTG on 23 June 2008. An Australian Public Assessment Report was issued on 29 July 2011 for the approved indications of treatment of osteoporosis in postmenopausal women, osteoporosis in patients over 50 years with prior hip fracture, osteoporosis in men, glucocorticoid-induced osteoporosis treatment and prevention, and Paget's disease of bone.