Zoledronic Acid

Source: UK SPC (eMC) for Aclasta 5 mg solution for infusion, §4.2 (https://www.medicines.org.uk/emc/product/210/smpc). PREPARATION FOR THE PATIENT: patients must be appropriately hydrated prior to administration, especially the elderly (>= 65 years) and patients receiving diuretic therapy; adequate calcium and vitamin D intake are recommended in association with administration. DURATION: the optimal duration of bisphosphonate treatment for osteoporosis has not been established — re-evaluate the need for continued treatment periodically on an individual basis, particularly after 5 or more years of use. RECENT LOW-TRAUMA HIP FRACTURE: give the infusion at least two weeks after hip fracture repair, and a loading dose of 50,000 to 125,000 IU of vitamin D orally or intramuscularly is recommended before the first infusion. PAGET'S DISEASE OF BONE: should be prescribed only by physicians experienced in treating Paget's disease; the recommended dose is a single intravenous infusion of 5 mg. In Paget's disease it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following administration, and measurement of serum calcium before infusion is recommended. RE-TREATMENT OF PAGET'S DISEASE: after initial treatment an extended remission is observed in responders; re-treatment consists of an additional intravenous infusion of 5 mg after an interval of one year or longer from initial treatment in patients who have relapsed (limited data available). HEPATIC IMPAIRMENT: no dose adjustment required. ELDERLY (>= 65 years): no dose adjustment necessary, as bioavailability, distribution and elimination were similar to younger subjects. PAEDIATRIC: the SPC states Aclasta should NOT be used in children and adolescents below 18 years of age; there are no data for children under 5 years, and data for children aged 5 to 17 years are described in §5.1 only — no paediatric dose is given here. Verify any under-18 use against a children's formulary. HYPOCALCAEMIA: pre-existing hypocalcaemia must be treated with adequate calcium and vitamin D intake before starting therapy, and other disturbances of mineral metabolism (e.g. diminished parathyroid reserve, intestinal calcium malabsorption) must also be effectively treated; because of the rapid onset of effect on bone turnover in Paget's disease, transient and sometimes symptomatic hypocalcaemia may develop, usually maximal within the first 10 days after infusion. Patients should be informed about symptoms of hypocalcaemia and receive adequate clinical monitoring. Patients should be given the package leaflet and the patient reminder card. DIFFERENT PRESENTATION AND INDICATIONS — CROSS-REFERENCE ONLY: this page carries the 5 mg Aclasta bone-density/Paget's licence. The US label in this bundle is a DIFFERENT product (zoledronic acid injection 4 mg/5 mL, Avet Pharmaceuticals) for ONCOLOGY indications, with a different dose: hypercalcaemia of malignancy (albumin-corrected serum calcium >= 12 mg/dL [3.0 mmol/L]) 4 mg as a single intravenous infusion over no less than 15 minutes, with re-treatment at 4 mg after a minimum of 7 days if serum calcium does not return to or remain normal; and multiple myeloma or bone metastases from solid tumours 4 mg as a single intravenous infusion over no less than 15 minutes every 3 to 4 weeks for patients with creatinine clearance greater than 60 mL/min (reduce the dose in renal impairment), with oral calcium 500 mg and a multivitamin containing 400 international units of vitamin D daily. Do NOT mix the 5 mg annual osteoporosis regimen with the 4 mg oncology regimen — if this page is meant to cover oncology use, the corresponding UK SPC (Zometa or equivalent) must be sourced separately. Note: eMC §4.5 was not retrieved in this bundle, and §4.4 and §4.8 were truncated at the source-fetch limit.