BONIVA SUMMARY
BONIVA®
(ibandronate sodium)
TABLETS
BONIVA (ibandronate sodium) is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption.
BONIVA is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Treatment of Postmenopausal Osteoporosis
In postmenopausal women with osteoporosis, BONIVA increases BMD and reduces the incidence of vertebral fractures (see CLINICAL STUDIES). Osteoporosis may be confirmed by the presence or history of osteoporotic fracture or by a finding of low bone mass (BMD more than 2 standard deviations below the premenopausal mean [ie, T-score]).
Prevention of Postmenopausal Osteoporosis
BONIVA may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of fracture.
Factors such as family history of osteoporosis, early menopause, previous fracture, high bone turnover, reduced BMD (at least 1.0 SD below the premenopausal mean), thin body frame, Caucasian or Asian race, and smoking, are associated with an increased risk of developing osteoporosis and fractures. The presence of these risk factors may be important when considering the use of BONIVA for preventing osteoporosis.
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