BONIVA is indicated for the management of postmenopausal osteoporosis.

BONIVA Tablets are contraindicated in patients with uncorrected hypocalcemia, known hypersensitivity to any component of this product, or the inability to stand or sit upright for at least 60 minutes. 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. BONIVA is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min).

BONIVA, like other bisphosphonates administered orally, may cause upper gastrointestinal (GI) disorders such as dysphagia, esophagitis, and esophageal or gastric ulcers. As aspirin, NSAIDs, and bisphosphonates are associated with GI irritation, caution should be exercised when using them concomitantly. BONIVA Tablets should be taken at least 60 minutes before any oral medication or supplementation including calcium, antacids, or vitamins. Rarely, patients have reported severe bone, joint, and/or muscle pain after taking bisphosphonate therapy for osteoporosis. Osteonecrosis of the jaw has been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures. The overall adverse events profile of BONIVA 2.5 mg once daily was similar to that of placebo. In a one-year study comparing BONIVA 150 mg once-monthly and BONIVA 2.5 mg daily, the overall incidence of adverse events with the two 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%).

BONIVA Injection is indicated for the treatment of osteoporosis in postmenopausal women.

BONIVA Injection is contraindicated in patients with uncorrected hypocalcemia or known hypersensitivity to BONIVA Injection or any of its excipients. BONIVA Injection, like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values. Hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism must be effectively treated before starting therapy. Patients must receive supplemental calcium and vitamin D. BONIVA Injection must be administered intravenously only by a healthcare professional. Patients who receive BONIVA Injection should have serum creatinine measured prior to each dose. BONIVA Injection should not be administered to patients with severe renal impairment (serum creatinine >2.3mg/dL or creatinine clearance <30 mL/min). Rarely, patients have reported severe bone, joint, and/or muscle pain after taking bisphosphonate therapy for osteoporosis. Osteonecrosis of the jaw has been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures who received intravenous bisphosphonates.

In a one-year study comparing BONIVA Injection 3 mg quarterly and BONIVA Tablets 2.5mg daily, the overall safety and tolerability profiles of the two dosing regimens were similar. The most commonly reported adverse events (>5.0%), regardless of causality, were arthralgia (9.6% BONIVA Injection vs 8.6% BONIVA Tablets 2.5 mg), back pain (7.0% vs 7.5%), hypertension (5.3% vs 7.1%), abdominal pain (5.1% vs 5.6%), influenza (4.7% vs 8.0%) and nasopharyngitis (3.4% vs 6.0%). In some patients acute phase reaction-like events (10% BONIVA Injection vs 4% BONIVA Tablets) have been reported within 3 days of an IV dose and lasting for 7 days or less, most commonly after the first injection. In most cases, no specific treatment was required and symptoms subsided within 24-48 hours.