Ibandronic acid

Ibandronic acid
Clinical data
AHFS/Drugs.com International Drug Names
License data
Pregnancy
category
  • US: C (Risk not ruled out)
Routes of
administration
Oral, intravenous
ATC code M05BA06 (WHO)
Legal status
Legal status
  • ℞ (Prescription only)
Pharmacokinetic data
Bioavailability 0.6%
Protein binding 90.9 to 99.5%
(concentration-dependent)
Metabolism Nil
Biological half-life 10 to 60 hours
Excretion Renal
Identifiers
CAS Number 114084-78-5 YesY
PubChem (CID) 60852
IUPHAR/BPS 3059
DrugBank DB00710 N
ChemSpider 54839 YesY
UNII UMD7G2653W YesY
KEGG D08056 YesY
ChEMBL CHEMBL997 YesY
ECHA InfoCard 100.214.537
Chemical and physical data
Formula C9H23NO7P2
Molar mass 319.229 g/mol
3D model (Jmol) Interactive image
 NYesY (what is this?)  (verify)

Ibandronic acid (INN) or ibandronate sodium (USAN) is a potent bisphosphonate drug developed by Hoffman La Roche and used in the prevention and treatment of osteoporosis and metastasis-associated skeletal fractures in people with cancer.[1] It may also be used to treat hypercalcemia (elevated blood calcium levels). Global sales in 2008 were 1.1B CHF ($1.0B USD at 01/01/2009 exchange rates).[2]

Medical uses

Ibandronate is indicated for the treatment and prevention of osteoporosis in post-menopausal women.[3] In May 2003, the U.S. Food and Drug Administration (FDA) approved Ibandronate as a daily treatment for post-menopausal osteoporosis. The basis for this approval was a three-year, randomized, double-blind, placebo-controlled trial women with post-menopausal osteoporosis. Every participant also received daily oral doses of calcium and 400IUs [international units] of vitamin D. At the study's conclusion, both doses significantly reduced the occurrence risk of new vertebral fractures by 50–52 percent when compared to the effects of the placebo drug.

Ibandronate is efficacious for the prevention of metastasis-related bone fractures in multiple myeloma, breast cancer, and certain other cancers.[4]

Adverse effects

In 2008, the U.S Food and Drug Administration (FDA) issued a communication warning of the possibility of severe and sometimes incapacitating bone, joint and/or muscle pain.[5] A study conducted by the American Society of Bone and Mineral Research concluded that long-term use of bisphosphonates, including Boniva, may increase the risk of a rare but serious fracture of the femur. [6]

Brand names

Ibandronic acid is marketed under the trade names Boniva in the USA, Bondronat in Europe, Bonviva in Asia, Ibandrix in Ecuador and Bondrova in Bangladesh.

References

  1. Bauss F, Schimmer RC (March 2006). "Ibandronate: the first once-monthly oral bisphosphonate for treatment of postmenopausal osteoporosis". Therapeutics and clinical risk management. 2 (1): 3–18. PMC 1661644Freely accessible. PMID 18360577.
  2. "Roche 2008 Annual Report" (PDF). Roche. Retrieved 2009-08-13.
  3. "boniva". The American Society of Health-System Pharmacists. Retrieved 3 April 2011.
  4. Sittig HB (2012). "Pathogenesis and bisphosphonate treatment of skeletal events and bone pain in metastatic cancer: focus on ibandronate". Onkologie. 35 (6): 380–7. doi:10.1159/000338947. PMID 22722461.
  5. "Information for Healthcare Professionals: Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa)". U.S. Food and Drug Administration. Retrieved 27 October 2010.
  6. "Drugs Commonly Prescribed for Osteoporosis Patients are Effective at Reducing Risk of Hip and Spine Fractures, But Panel Says May be Related to Unusual Thigh Bone Fractures When Used Long Term". Journal of Bone and Mineral Research=27 October 2010.
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