BONIVA Tolerability

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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

Chart: GI adverse events with an incidence >=5%*

*The Monthly Oral IBandronate In LadiEs (MOBILE) trial was a 2-year, randomized, double-blind, phase III, noninferiority trial designed to confirm that once-monthly dosing was as effective as daily dosing in increasing lumbar spine BMD at year 1. Women with postmenopausal osteoporosis (N=1609) were assigned to one of four oral ibandronate regimens including 2.5 mg daily (n=395) and 150 mg once-monthly (n=396). All patients took 400 IU vitamin D and 500 mg calcium supplementation each day.

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 tablets are 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.

Osteoporosis Treatment

BONIVA is indicated for the management of postmenopausal osteoporosis.

Important Safety Information for BONIVA Tablets
BONIVA Tablets are contraindicated in patients with known hypersensitivity to any component of this product, with hypocalcemia, or the inability to stand or sit upright for at least 60 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be treated before starting therapy. Adequate intake of calcium and vitamin D is important in all patients.

BONIVA, like other bisphosphonates administered orally, may cause upper gastrointestinal (GI) disorders such as dysphagia, esophagitis, and esophageal or gastric ulcers. Discontinue use if new or worsening symptoms occur. 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. Patients have reported severe bone, joint, and/or muscle pain after taking BONIVA and other bisphosphonate therapy for osteoporosis. Consider discontinuation of use if severe symptoms develop. Osteonecrosis of the jaw has been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures. BONIVA is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min). The overall adverse event 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 in patients with postmenopausal osteoporosis, 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%). In a study of postmenopausal women with osteopenia the overall pattern of adverse events for BONIVA 150 mg once monthly was similar to that previously observed.

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