Pharmacology Update Ibandronate Sodium Tablets (BonivaTM)
By William T. Elliott, MD, FACP, and James Chan, PharmD, PhD
Dr. Elliott is Chair, Formulary Committee, Northern California Kaiser Permanente; Asst. Clinical Professor of Medicine, University of California, San Francisco; Dr. Chan is Pharmacy Quality and Outcomes Manager, Kaiser Permanente, Oakland, CA
Drs. Chan and Elliott report no financial relationships to this field of study.
An oral, once monthly bisphosphonate has been approved by the FDA for the prevention and treatment of postmenopausal osteoporosis. Ibandronate is co-marketed by Roche Pharmaceuticals and GlaxoSmithKline as Boniva.
Indications
Ibandronate is indicated for the prevention and treatment of osteoporosis in postmenopausal
women.1
Dosage
Ibandronate may be taken as a 2.5 mg tablet daily or 150 mg tablet once monthly. As with other
bisphosphonates, it should be taken the first thing in the morning with 6-8 ounces of water in an upright position. The patient must not eat or drink or lie down for 60 minutes. The tablets should not be chewed or
sucked.1
Potential Advantages
Ibandronate is the first bisphosphonate to be approved for once monthly dosing. Both alendronate
and risedronate are currently approved for once weekly dosing.
Potential Disadvantages
The clinical experience of ibandronate is much less than alendronate or risedronate. There are currently no
published direct comparisons. The FDA-approved labeling recommends that the patient avoid lying down for 60 minutes
compared to 30 minutes for alendronate and risedronate. One of the studies that was part of the New Drug
Application showed that gain in bone mineral density (BMD) was significantly less when patients used a 30-minute compared
to 60-minute interval between dose and food or drink.3
Comments
The approval of the monthly formulation of ibandronate was based on a one-year comparative study with ibandronate taken daily in a noninferiority study (Monthly Oral Ibandronate in Ladies [MOBILE]).1,4 The mean BMD increases from baseline in lumbar spine, per protocol, were 4.41% for the monthly regimen (n = 327) and 3.86% for the daily regimen (n = 318) (P = 0.002). Superiority was demonstrated for the 150 mg monthly regimen to 2.5 mg once daily. Markers of bone remodeling decreased by 76% and 67% respectively. Abdominal pain was more frequent in the monthly regimen (7.8% vs 5.3%). In a 3-year study in patients with low BMD and at least one pre-existing vertebral fracture (n = 1952), ibandronate once-daily reduced the incidence of new fractures (45 new vertebral fractures occurred in 9.56% of placebo treated patients and 4.68% of ibandronate treated patients) (P < 0.001). Incidences of non-vertebral fractures were similar between ibandronate and placebo, 9.1% and 8.2% respectively. BMD increased by 6.5% vs 1.3% for placebo. Ibandronate’s side effect profile appears to be similar to other oral bisphosphonates. Ocular inflammation has been reported in two patients on the monthly regimen.2 There is a bisphosphonate class warning for osteonecrosis and musculoskeletal pain. Osteonecrosis appears to occur in patients with cancer undergoing dental procedures and more common with intravenous administration than oral.1,6 The wholesale cost of ibandronate is $771.36 per year. This is similar to risedronate ($779.76) and less than alendronate ($835.64).2
Clinical Implications
Ibandronate provides another effective bisphosphonate. It offers the advantage of once monthly dosing. It appears to be similar to alendronate and risedronate but with much less clinical experience.
References
1. Boniva Product Information. Roche Pharmaceuticals. March 2005.
2. The Medical Letter. 2005;47:33-35.
3. Center for Drug Evaluation and Research. Ibandronate Medical Review. April 23, 2003.
4. Miller PD, et al. J Bone Miner Res. 2005;March 15, epub.
5. Chestnut CH, et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res. 2004;19:1241-1249.
6. Ruggiero SL, et al. Osteonecrosis of the jaws associated with the use of bisphosphonates. J Oral Maxillofac Surg. 2004;62:527-534.
By William T. Elliott, MD, FACP, and James Chan, PharmD, PhD Dr. Elliott is Chair, Formulary Committee, Northern California Kaiser Permanente; Asst. Clinical Professor of Medicine, University of California, San Francisco; Dr. Chan is Pharmacy Quality and Outcomes Manager, Kaiser Permanente, Oakland, CA Drs. Chan and Elliott report no financial relationships to this field of study.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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