For non-US healthcare professionals: Get information about ZOMETA and its product characteristics.
Osteonecrosis of the Jaw (ONJ)
This is an international site for Zometa® (zoledronic acid) and is intended for Health Care Professionals outside the U.S. The information on the site is not country-specific, and may contain information that is outside the approved indications in the country in which you are located. Please contact your local Novartis representative for the latest information specific to your country.
ZOMETA is approved for use in the following countries: Albania, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia-Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Mexico, Moldova, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Republic Srpska, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovak Republic, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, The Netherlands, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Uzbekistan, Venezuela.
Below is a list of the countries that host a ZOMETA website based on local label and in local language. They are intended for Healthcare Professional (HCPs) only. Click on any of the links to be redirected to that country-level website.
ZOMETA International Website
This website is intended for Healthcare Professionals (HCPs) outside the U.S. The information on this website is not country specific and may contain information that is outside the approved indication in the country in which you are located. Please contact your local representative for local prescribing information via www.novartisoncology.com/contactus.
IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EUSmPC)
With ZOMETA, ONJ is uncommon, may be prevented, and can be managed1-3
The causes of ONJ are not well understood1,4,5
There have been uncommon reports of ONJ in cancer patients receiving chemotherapy, radiation therapy, corticosteroids, RANKL inhibitors, or bisphosphonates6
A causal relationship between bisphosphonate therapy and ONJ has not been established5,6
ONJ is uncommon2,3,6
A 2008 comprehensive review by the MD Anderson Cancer Center revealed that ONJ is uncommon2,3
ONJ occurred in 0.73% of all cancer patients treated with bisphosphonates
The frequency was slightly higher in patients with breast cancer or multiple myeloma
A retrospective adjudication process applied to data from the ZOMETA clinical trial programme in tumour-induced hypercalcaemia, multiple myeloma, and bone metastases from solid tumours demonstrated a prevalence of 0.1% among 16,900 patients exposed to ZOMETA as of November 20063
ONJ may be prevented or managed through relatively simple, appropriate dental procedures1,5,7
Appropriate preventive dentistry, such as dental exams and good oral hygiene, should be performed prior to treatment with ZOMETA1,5
Once on treatment, patients should avoid invasive dental procedures and continue with dental cleanings and exams1,5,7
*Recommended treatment protocol per American Association of Oral and Maxillofacial Surgeons (AAOMS), updated January 2009. AAOMS has defined stage 0 as patients with no clinical evidence of exposed/necrotic bone but with nonspecific symptoms for which symptomatic treatment may be advisable.
References: 1. American Association of Oral and Maxillofacial Surgeons. Position paper on bisphosphonate-related osteonecrosis of the jaw—2009 update. http://www.aaoms.org/docs/position_papers/bronj_update.pdf. Accessed 24 November 2010. 2. Hoff AO, Toth BB, Altundag K, et al. Frequency and risk factors associated with osteonecrosis of the jaw in cancer patients treated with intravenous bisphosphonates. J Bone Miner Res. 2008;23:826-836. 3. Silverman SL, Landesberg R. Osteonecrosis of the jaw and the role of bisphosphonates: a critical review. Am J Med. 2009;122:S33-S45. 4. Ruggiero SL, Fantasia J, Carlson E. Bisphosphonate-related osteonecrosis of the jaw: background and guidelines for diagnosis, staging and management. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006;102:433-441. 5. Ruggiero S, Gralow J, Marx RE, et al. Practical guidelines for the prevention, diagnosis, and treatment of osteonecrosis of the jaw in patients with cancer. J Oncol Pract. 2006;2:7-14. 6. ZOMETA Summary of Product Characteristics. Novartis Pharma AG. 7. Weitzman R, Sauter N, Eriksen EF, et al. Critical review: updated recommendations for the prevention, diagnosis, and treatment of osteonecrosis of the jaw in cancer patients—May 2006. Crit Rev Oncol Hematol. 2007;62:148-152.
Disclaimer: This is an international website for ZOMETA® (zoledronic acid) and is intended for healthcare professionals outside the US. If you are a US resident, please click on the US Residents link at the top of this page. The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located.
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