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General Information about BONIVA and Postmenopausal Osteoporosis





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Indication

BONIVA is a prescription medicine used to treat or prevent osteoporosis in women after menopause. BONIVA helps increase bone mass and helps reduce the chance of having a spinal fracture (break).

It is not known how long BONIVA works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if BONIVA is still right for you.

Important Safety Information

You should not take BONIVA if you have certain problems with your esophagus (the tube that connects your mouth and stomach), low blood calcium, cannot sit or stand for at least 60 minutes, or are allergic to BONIVA or any of its ingredients.

BONIVA can cause serious side effects including problems with the esophagus, low blood calcium, bone, joint or muscle pain, severe jaw bone problems, and unusual thigh bone fractures.

Before starting BONIVA, tell your doctor if you have problems with swallowing, stomach or digestive problems, have low blood calcium, plan to have dental surgery or teeth removed or have kidney problems.

Stop taking BONIVA and tell your doctor right away if you have pain or trouble swallowing, chest pain, or severe or continuing heartburn, as these may be signs of serious upper digestive problems. Call your doctor immediately if jaw problems, hip, groin, or thigh pain develop, or if you have symptoms of low blood calcium such as spasms, twitching, cramps in your muscles, or numbness or tingling in your fingers, toes, or around your mouth.

Follow the dosing instructions for once-monthly BONIVA carefully.

The most common side effects are back pain, heartburn, stomach area pain, pain in your arms and legs, diarrhea, headache, muscle pain, and flu-like symptoms.

You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch, or by calling
1-800-FDA-1088.

Talk to your doctor for more information or if you have questions about your treatment.

Please see full
Prescribing Information and Medication Guide for additional important safety information.