BONIVA Tolerability

Tolerability of BONIVA—1-year results from DIVA Trial

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*Combination of abdominal pain and abdominal pain upper.

The overall AE profile for the quarterly injection was similar to the once-daily tablets
The overall AE profile for the 2.5 mg once daily tablets was similar to placebo
Overall incidence of acute phase reaction-like (APR) events was 4% in the BONIVA Tablets group vs 10% in the BONIVA Injection group
- In most cases, no specific treatment was required and symptoms subsided in 24-48 hours
- For patients experiencing APR events, 80% of them occurred only with the first dose⁵
Overall, BONIVA side effects were mild or moderate, transient and resolved without treatment⁶

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References:
1. Chesnut CH, Ettinger MP, Miller PD, et al. Ibandronate produces significant, similar antifracture efficacy in North American and European women: new clinical findings from BONE. Curr Med Opin. 2005;21:391-401.
2. Chesnut CH III, Skag A, Christiansen C, et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res. 2004;19:1241-1249.
3. Data on file (Ref. #161-013), Hoffmann-La Roche Inc., Nutley, NJ.
4. Data on file (Ref. #161-014), Hoffmann-La Roche Inc., Nutley, NJ.
5. Data on file (Ref. #161-DIVA 2 yr # to come), Hoffmann-La Roche Inc., Nutley, NJ.
6. Data on file (Ref. #161-DIVA 1 yr # to come), Hoffmann-La Roche Inc., Nutley, NJ.

Important Safety Information for BONIVA Injection
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.

GlaxoSmithKline