DEZTRON

What it is

DEZTRON is a solution for intravenous infusion containing zoledronic acid. The 4 mg/5 mL concentrated solution formulation contains 4.264 mg zoledronic acid monohydrate, corresponding to 4 mg zoledronic acid. It is supplied as a solution for intravenous infusion.

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 treatment of postmenopausal osteoporosis, the recommended dose is a single intravenous infusion of 5 mg of zoledronic acid administered once a year. For prevention of clinical fractures after a low trauma hip fracture, the recommended dose is a single intravenous infusion of 5 mg zoledronic acid administered once a year. For treatment of osteoporosis in men, the recommended dose is a single intravenous infusion of 5 mg zoledronic acid administered once a year. For treatment and prevention of glucocorticoid-induced osteoporosis, the recommended dose is a single intravenous infusion of 5 mg zoledronic acid administered once a year. For treatment of Paget's disease, the recommended dose is a single intravenous infusion of 5 mg zoledronic acid. Patients must be appropriately hydrated prior to administration. Adequate hydration can be achieved by the patient drinking two glasses of fluid (such as water) before and after the infusion. Zoledronic acid is administered intravenously via a vented infusion line, given at a constant infusion rate. 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. The use of zoledronic acid in patients with severe renal impairment (creatinine clearance less than 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. If there are clinical reasons to suspect hypocalcaemia, vitamin D deficiency or other disturbances of mineral metabolism, the appropriate tests should be performed and, if abnormalities are discovered, these should be corrected before initiating therapy with zoledronic acid. Due to the rapid onset of effect on bone turnover, transient hypocalcaemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion. Adequate vitamin D intake is recommended in association with zoledronic acid administration. Adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured in patients with Paget's disease for at least 10 days following zoledronic acid administration. Atypical subtrochanteric and diaphyseal femoral fractures have been reported in association with bisphosphonate therapy. 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.

PBS listing

DEZTRON 4 mg in 5 mL as a concentrated solution for intravenous infusion is listed on the PBS. There are 2 PBS items. The restriction type is streamlined. The ex-manufacturer price is A$45.72.

Regulatory history

DEZTRON zoledronic acid 4 mg/5 mL concentrated solution for injection was first registered on the ARTG on 26 July 2012.