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BONSITY is a prescription medicine used in both men and postmenopausal women with osteoporosis who are at high risk for having bone fractures—defined as those who have had a fracture related to osteoporosis, who are at high risk for fracture, or who cannot use other osteoporosis treatments. It is also used for treating osteoporosis associated with glucocorticoid medicines, such as prednisone, in patients who are at high risk for fracture.

Important Safety Information

Do not use BONSITY if you are allergic to any of its ingredients. Serious allergic reactions may occur.

Before taking BONSITY, inform your healthcare provider if you have a bone disease other than osteoporosis; have bone cancer or a history of bone cancer, have trouble injecting yourself, are a child or young adult whose bones are still growing, have had radiation therapy, have a greater risk of getting bone cancer, have been diagnosed with too much calcium in your blood, have or have had a skin condition with wounds caused by too much calcium, have or have had kidney stones, take medicines that contain digoxin, are pregnant or thinking about becoming pregnant, are breastfeeding or plan to breastfeed, or have any other medical conditions. Tell your healthcare provider about all the medicines you take.

BONSITY can cause serious side effects, including bone cancer, increased calcium in your blood, worsening of your kidney stones, and a decrease in blood pressure upon changing positions. Dizziness, accelerated heartbeat, or a feeling of faintness may occur, usually within four hours of taking BONSITY, and typically go away within a few hours. You should not use BONSITY for more than two years during your lifetime unless your healthcare provider finds that you need longer treatment.

Other side effects include pain, nausea, and joint aches.

Injection site reactions can include pain, swelling and bruising.

If symptoms persist, stop taking BONSITY and call your healthcare provider.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088 to report any additional negative side effects to the FDA.

For additional safety information, please see the Medication Guide and Prescribing Information, including the full User Manual which accompanies the delivery device.