BONIVA Tolerability

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Prescribing Information

Information for Patients

BONIVA One tablet. Once a month.

Tolerability

The tolerability you want in a once-monthly, film-coated tablet

In the MOBILE trial, overall adverse events (AEs) for the 150 mg once-monthly dose were similar to the 2.5 mg daily dose

BONIVA 2.5 mg daily AEs similar to placebo

In the BONE trial, overall AEs for the 2.5 mg daily dose were similar to placebo
In patients taking aspirin, NSAIDs, PPIs and H² blockers, the incidence of upper gastrointestinal (GI) AEs was similar to placebo

^*For MOBILE study design, please visit the Efficacy page.

Withdrawal rate due to AEs was 8% for 150 mg once-monthly and 9% for 2.5 mg daily
Patients with a history of GI disease and/or patients taking aspirin, NSAIDs, PPIs and H² blockers were not excluded from the BONE and MOBILE trials

Contraindications

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.

Read full Prescribing Information.

Osteoporosis Treatment

Important Safety Information for BONIVA Tablets
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%).

GlaxoSmithKline