Aclasta® is indicated for treatment of osteoporosis in postmenopausal women. In patients with a recent low-trauma hip fracture, Aclasta reduces the incidence of new clinical fractures.
Aclasta is indicated for treatment of osteoporosis in men at increased risk of fracture, including those with a recent low-trauma hip fracture.
Aclasta is indicated for treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in postmenopausal women and in men with increased risk of fracture.
Aclasta is indicated for the treatment of Paget's disease of the bone.
Important Safety Information
Aclasta is contraindicated in patients with hypocalcaemia or hypersensivity to any component of this product. Aclasta contains the same active ingredient found in Zometa (zoledronic acid) injection and patients receiving Zometa should not receive Aclasta.
Disturbances of mineral metabolism must be treated before starting therapy. Patients must be adequately supplemented with calcium and vitamin D. A single dose of Aclasta should not exceed 5 mg and infusion time should be no less than 15 minutes. Aclasta is not recommended for use in patients with severer renal impairment (creatinine clearance <35 mL/min). Monitor serum creatinine before each dose.
Osteonecrosis of the jaw has been reported rarely in postmenopausal osteoporosis patients treated with bisphosphonates. A routine oral exam should be performed by the prescriber prior to treatment.
Aclasta should not be used during pregnancy and women should be advised to avoid becoming pregnant because of potential harm to the foetus.
Among patients treated with bisphosphonates, there have been infrequent reports of severe and occasionally incapacitating bone, joint, and/or muscle pain. The most common side effects (>10%) were pyrexia, myalgia, headache, arthralgia and pain in extremity.
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