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Boniva® Approved for Once Monthly use

The U.S. food and Drug Administration (FDA) approved once-monthly oral Boniva® (ibandronate sodium) 150mg tablets for the treatment and prevention of postmenopausal osteoporosis on March 25, 2005.¹ This is the first ever once-monthly single tablet for any disease.² Boniva® is a product of a collaboration between two drug companies – Roche and GlaxoSmithKline.

The Surgeon General’s Report on bone health and osteoporosis says that 10 million Americans over the age of 50 have osteoporosis, the most common bone disease, while another 34 million are at risk for developing osteoporosis. Each year roughly 1.5 million people suffer a bone fracture related to osteoporosis.³

Boniva® is a bisphosphonate in which patients would take 12 tablets a year versus 52 required with current weekly bisphosphonate treatments. Ibandronate inhibits osteoclast activity and reduces bone resorption and turnover. This new treatment option is a small, film-coated, 150mg tablet that should be taken on the same day each month. It carries the same dosing procedure as other drugs in the same class in that it must be taken with a full glass of water on an empty stomach upon rising in the morning. The patient should remain upright and avoid food, drink, and other medications for at least 60 minutes after ingestion of the medication. The option of a once monthly dosing regimen further limits the patient inconvenience with this dosing procedure.⁴

Boniva® is contraindicated in patients unable to stand or sit upright for at least 60 minutes, with hypocalcemia, or with known hypersensity to any component of the drug. Boniva® is not recommended in patients with severe renal impairment (crcl <30ml/min). The most commonly reported adverse effects associated with Boniva® are abdominal pain, hypertension, arthalgia, nausea and diarrhea.⁵

References:

1. FDA CDER Website http://www.fda.gov/cder/

2. Roche press release March 29,2005.

3. Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD: U.S. Department of Health and Human Services, Office of the Surgeon General; 2004.

4. BONIVA (ibandronate sodium) TABLETS [prescribing information] Roche Laboratories

Koleen Koast, PharmD. Candidate