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About BONIVA Tablets

Protect Patients at Any Stage of Bone Loss*

Proven as clinically effective as Fosamax to increase BMD.^†1,2 Learn more >>
Delivers proven fracture protection Learn more >>
Reverses bone loss in 9 out of 10 women with osteoporosis^‡ Learn more >>

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

Once-Monthly Dosing Preferred by 2 out of 3 Patients§

Prescribe BONIVA 150-mg Tablet once a month
Instruct patients to take with water on an empty stomach upon rising in the morning, and to remain upright and in fasting state for at least 60 minutes … only once a month Learn more >>

*BONIVA is indicated for the management of postmenopausal osteoporosis.

^†Clinical effectiveness was defined by a noninferiority margin, which was predefined as 1.41% for lumbar spine and 0.87% for total hip.

^‡BMD increases from baseline in 9 out of 10 patients at lumbar spine, total hip, or trochanter, and in 3 out of 4 patients at the femoral neck.

^§BALTO dosing preference trials compared only once-monthly BONIVA with once-weekly Fosamax.³

Fosamax^® (alendronate sodium) is a registered trademark of Merck & Co., Inc.

Who Needs BONIVA?

Image: Ellen, Age 53, Wants to reverse bone loss

$Image: Marie, Age 64, Wants fracture protection$

Not actual patients.

References:
1. Miller PD, Epstein S, Sedariti F, et al. Once-monthly oral ibandronate compared with weekly oral alendronate in postmenopausal osteoporosis: results from the head-to-head MOTION study. Curr Med Res Opin. 2008;24(1):207-213.
2. Data on file (Ref. #161-206), Hoffmann-La Roche Inc., Nutley, NJ.
3. Emkey R, Koultun W, Beusterein K, et al. Patient preference for once-monthly ibandronate versus
once-weekly alendronate in a randomized, open-label, cross-over trial: the Boniva Alendronate Trial in Osteoporosis (BALTO). Curr Med Res Opin 2005;21:1895-1903.

BONIVA is indicated for the management of postmenopausal osteoporosis.

Important Safety Information for BONIVA Tablets
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. 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 ulcer. 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 medications containing multivalent cations (including antacids, supplements 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 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%).

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MyBONIVA is a registered trademark of Roche Therapeutics Inc.

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