BONIVA Tablets are indicated for the treatment and prevention of postmenopausal osteoporosis. 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. 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 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 (GI) 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 using them concomitantly. The overall adverse events profile of BONIVA 2.5 mg 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 a prescription medicine used to treat postmenopausal osteoporosis. 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 only be administered intravenously 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 (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 2.5 mg daily, the overall safety and tolerability profiles with the two dosing regimens were similar. The most commonly reported adverse events (≥5%) regardless of causality were arthralgia (9.6% BONIVA Injection vs 8.6% BONIVA Tablet 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 Tablet) 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 in 24-48 hours.