Important Safety Information
BONIVA is indicated for the treatment and prevention of osteoporosis in postmenopausal women.  BONIVA is contraindicated in patients unable to stand or sit upright for at least 60 minutes or with uncorrected hypocalcemia.  BONIVA is contraindicated in patients with known hypersensitivity to BONIVA or any of its components.  Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting therapy.  Adequate intake of calcium and vitamin D is important in all patients (see Information for Patients).  BONIVA is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min).  Rarely, patients have reported severe bone, joint and/or muscle pain after taking bisphosphonate therapy for osteoporosis.  Additionally, osteonecrosis of the jaw has rarely been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures.

BONIVA, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcer.  As aspirin, NSAIDs, and bisphosphonates are associated with GI irritation, caution should be exercised when used concomitantly.  The overall adverse events profile of BONIVA 2.5 mg daily was similar to that of placebo.  In a 1-year study comparing BONIVA 150 mg once-monthly and BONIVA 2.5 mg daily, the overall incidence of adverse events with the 2 dosing regimens was similar.  The most commonly reported adverse events (≥5%) regardless of causality were abdominal pain (BONIVA 150 mg 7.8% vs BONIVA 2.5 mg 5.3%), hypertension (6.3% vs 7.3%), dyspepsia (5.6% vs 7.1%), arthralgia (5.6% vs 3.5%), nausea (5.1% vs 4.8%) and diarrhea (5.1% vs 4.1%).

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