Abstract
BackgroundZoledronic acid is a bisphosphonate that has been approved for the treatment and prevention of glucocorticoid-induced osteoporosis, post-menopausal and male osteoporosis. The infusion is given intravenous annually. It is an antiresorptive agent with high affinity for mineralized bone and particularly for areas of high bone turnover. ObjectiveComparison of acute side effects of innovator and generic zoledronic acid infusion. MethodRetrospective data of 222 patients who were prescribed zoledronic acid (innovator or generic) over a 3-year period were recorded for any adverse effect. A total of 154 (69.37%) patients received zoledronic acid (innovator) infusion and the 68 patients received generic zoledronic acid infusion. ResultsThe indications of using the infusion were rheumatoid arthritis (58%), lupus (24%), systemic sclerosis (5.4%) and others (12.6%). The commonest adverse effect in both groups was musculoskeletal. The 30% of patients with rheumatoid arthritis experienced worsening of joint pains after the infusion which lasted maximally 48h. Transient low grade fever was seen in 21% in the innovator group versus 56% in generic group (p=0.0001). High grade fever (38°C or more) was less common and was seen in 6.5% in innovator group and 20.6% in generic group (p=0.002). Reinfusion was associated with 30% lesser side effects as compared to first infusion. ConclusionThe frequency of side effects was more common in generic (55.88%) than the innovator group (35.06%). Musculoskeletal and gastrointestinal symptoms were common after infusion; therefore, we would recommend paracetamol and anti-emetic agents to be added empirically for 48h of therapy.
Published Version
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