Aclasta

Osteoporosis in men & postmenopausal women at increased risk of fracture, including those w/ recent low-trauma hip fracture. Paget's disease of bone. Treatment & prevention of glucocorticoid-induced osteoporosis. Prevention of postmenopausal osteoporosis.

IV Adequate supplemental intake of Ca & vit D is recommended. Treatment of postmenopausal osteoporosis/treatment & prevention of glucocorticoid-induced osteoporosis/osteoporosis in men/prevention of postmenopausal osteoporosis & fractures after a hip fracture 5 mg as single 15-min infusion once a yr. Patient w/ recent low-trauma hip fracture Loading dose: Vit D 50,000-125,000 IU PO or IM prior to 1st infusion. Paget's disease 5 mg as single 15-min infusion. Supplement w/ Ca 500 mg bid for at least 10 days following administration. Retreatment Additional 5 mg IV infusion after interval of ≥1 yr from initial treatment.

Hypersensitivity to zoledronic acid or any bisphosphonates. Hypocalcaemia. Severe renal impairment w/ CrCl <35 mL/min. Pregnancy & lactation.

Discontinue in patients w/ suspected atypical femur fracture. Not to be used in patient treated w/ Zometa. Severe & occasionally incapacitating bone, joint, &/or muscle pain; osteonecrosis of jaw predominantly in cancer patients; osteonecrosis of other bones including femur, hip, knee & humerus; atypical subtrochanteric & diaphyseal femoral fractures in long-term treatment. Periodically assess serum alkaline phosphatase levels eg, every 6-12 mth. Monitor serum creatinine in at-risk patients. Ensure appropriate hydration prior to administration. Adequate supplemental Ca & vit D intake prior to therapy in patients w/ preexisting hypocalcemia, & for 10 days following therapy in patients w/ Paget's disease of bone. Consider dental exam w/ appropriate preventive dentistry prior to treatment in patients w/ concomitant risk factors eg, cancer, chemotherapy, anti-angiogenic drugs, corticosteroids & poor oral hygiene. Maintain good oral hygiene, undergo routine dental check-ups & avoid invasive procedures during treatment. Examine contralateral femur in bisphosphonate-treated patients who sustained femoral shaft fracture. Concomitant use w/ nephrotoxic medicinal products, diuretics, & other drugs affecting renal function. Transient increase in serum creatinine in patients w/ underlying impaired renal function. Women of childbearing potential should avoid becoming pregnant while on treatment. Childn & adolescent <18 yr. Elderly.

Pyrexia; headache; nausea; myalgia; pain, chills. Decreased appetite; dizziness, tremor, lethargy; vomiting, diarrhoea, abdominal & upper abdominal pain, constipation; arthralgia, bone, back, musculoskeletal chest, jaw & neck pain, pain in extremity, muscle spasms; flu-like illness, fatigue, asthenia, malaise, peripheral oedema, infusion-related reaction, non-cardiac chest pain.

Concomitant use w/ medicinal products that can significantly impact renal function (eg, aminoglycosides or diuretics causing dehydration). Increased systemic exposure to medicinal products primarily excreted via kidneys.

Agents Affecting Bone Metabolism

M05BA08 - zoledronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.

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