Aclasta Indications
Aclasta® is indicated for treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures and to increase bone mineral density.
Aclasta is indicated for prevention of clinical fractures after hip fracture in men and women.
Aclasta is indicated for treatment of osteoporosis in men.
Aclasta is indicated for treatment and prevention of glucocorticoid-induced osteoporosis.
Aclasta is indicated for the prevention of postmenopausal osteoporosis.
Aclasta is indicated for the treatment of Paget's disease of the bone.
As is the case with all medicines, the national regulatory status and approved product labelling for Aclasta may vary from country to country. Please consult the prescribing information in your country for detailed approved indications and appropriate use.
Important Safety Information
Aclasta is contraindicated in patients with hypocalcaemia, severe renal impairment with creatinine clearance <35 mL/min, hypersensivity to any component of this product, or in pregnant or breast feeding women. Aclasta contains the same active ingredient found in Zometa (zoledronic acid) injection. 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.
The use of Aclasta in patients with severe renal impairment (creatinine clearance <35 mL/min) is contraindicated due to an increased risk of renal failure in this population. Cases of acute renal failure requiring hospitalization and/or dialysis or with a fatal outcome have been reported. Monitor serum creatinine before each dose and consider interim monitoring for at-risk patients.
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. Other clinically important adverse reactions were flu-like illness, nausea, vomiting, diarrhea, and eye inflammation. Paracetamol or ibuprofen taken shortly following Aclasta administration may reduce these symptoms.
Please see full prescribing information in the country where you practice medicine.