ACLASTA

What it is

ACLASTA contains zoledronic acid 5 mg per 100 mL 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 of ACLASTA 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 ACLASTA administered once a year. For the treatment of osteoporosis in men, the recommended dose is a single intravenous infusion of 5 mg ACLASTA administered once a year. For the treatment and prevention of glucocorticoid-induced osteoporosis, the recommended dose is a single intravenous infusion of 5 mg ACLASTA administered once a year. For the treatment of Paget's disease, the recommended dose is a single intravenous infusion of 5 mg ACLASTA. The infusion time must not be 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 zoledronic acid administration. Patients must be appropriately hydrated prior to administration of zoledronic acid, which is especially important in the elderly and for patients receiving diuretic therapy. Adequate hydration can be achieved by the patient drinking two glasses of fluid before and two glasses of fluid after the infusion. The use of zoledronic acid in patients with severe renal impairment (creatinine clearance <35 mL/min) is contraindicated due to an increased risk of renal failure. Renal impairment has been observed following the 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 occurring after zoledronic acid administration. Severe and occasionally incapacitating bone, joint and/or muscle pain have been infrequently reported in patients taking bisphosphonates including zoledronic acid. Atypical subtrochanteric and diaphyseal femoral fractures have been reported in association with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. 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. Cases of iritis/uveitis/episcleritis/conjunctivitis have been reported in patients treated with bisphosphonates. In the treatment of postmenopausal osteoporosis trial, 9 (0.2%) patients treated with zoledronic acid and 1 (<0.1%) patient treated with placebo developed iritis/uveitis/episcleritis.

Contraindications

ACLASTA 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 < 35 mL/min; current or recent uveitis, or a history of bisphosphonate-associated uveitis; pregnancy and lactation.

PBS listing

Information regarding PBS listing, item count, restriction type and ex-manufacturer price is not available in the provided source documents.

Regulatory history

ACLASTA (zoledronic acid 5 mg/100 mL injection solution) was first registered on the ARTG on 23 June 2008.