ACLASTA
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Package:
BOTTLES (solution for infusion): 1 x 100 ml.
Dosage:
The recommended dose is a single I.V. infusion of 5 mg administered once a year.
Prescribing Restrictions:
Indications:
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture, including those with recent low-trauma hip fracture. Treatment and prevention of glucocorticoid-induced osteoporosis. Prevention of postmenopausal osteoporosis in women for whom bisphosphonate theray is indicated. Treatment of Paget's disease of the bone.
Contra-Indications:
Hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates. Patients with hypocalcemia. Pregnancy and lactation.
Special Precautions:
Severe renal impairment (creatinine clearance <30 ml/min). Patients must be appropriately hydrated prior to administration, especially for patients receiving diuretic therapy. In conjunction with medicinal products that can significantly impact renal function. Pre-existing hypocalcemia must be treated by adequate intake of calcium and vitamin D before initiating therapy. Other disturbances of mineral metabolism must also be effectively treated. Transient hypocalcemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion. Adequate vitamin D intake is recommended. Adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily should be ensured in patients with Paget's disease for at least 10 days following administration. A dental examination with appropriate preventive dentistry should be considered prior to treatment in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor oral hygiene). While on treatment, these patients should avoid invasive dental procedures if possible.
Side Effects:
Hypocalcemia, headache, lethargy, dyspnea. Diarrhea, nausea, dyspepsia, bone pain, arthralgia, myalgia, flu-like symptoms. Pyrexia, rigors, fatigue, pain, asthenia. Local reactions at the infusion site.
Drug Interactions:
Medicinal products that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration).
