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Kadcyla(ado-trastuzumab emtansine): Drug Safety Communication - Potential Medication Errors Resulting from Name Confusion
AUDIENCE: Risk Manager, Pharmacy, Oncology
ISSUE: The FDA notified health care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla（ado-trastuzumab emtansine）in some medication-related electronic systems poses a risk of mix-up with Herceptin（trastuzumab）and may result in medication errors. The dosing and treatment schedules for Kadcyla and Herceptin, another breast cancer drug, are quite different, so confusion between these products could lead to dosing errors and potential harm to patients.
The FDA-approved nonproprietary name for Kadcyla, ado-trastuzumab emtansine, should be used. However, some third-party publications, compendia references, health information systems（e.g., electronic health record systems and systems used for pharmacy prescription processing, wholesaler ordering, pharmacy ordering, etc.）, and sites on the Internet are incorrectly using the United States Adopted Name（USAN）, which is “trastuzumab emtansine,” and omitting the “ado” prefix and hyphen. Use of this truncated version of Kadcyla's nonproprietary name may cause confusion with Herceptin（trastuzumab）.
It is important for drug information content publishers to identify drug products by the FDA-approved proprietary（brand）and nonproprietary names that are used in FDA-approved drug labels. This will help prevent medication errors and ensure adverse events are reported for the correct product.
No medication errors related to confusion between Kadcyla and Herceptin have been reported to FDA since approval of Kadcyla on February 22, 2013; however medication errors did occur during the clinical trials that evaluated its safety and efficacy prior to approval.
BACKGROUND: Kadcyla is used to treat HER2-positive breast cancer that has spread to other parts of the body in patients who have received prior treatment with Herceptin（trastuzumab）and a taxane chemotherapy. Kadcyla is made up of trastuzumab, an anti-HER2 therapy, connected to a drug called DM1 that interferes with cancer cell growth.
RECOMMENDATION: Health care professionals should use both the FDA-approved proprietary（brand）name Kadcyla and its nonproprietary name（ado-trastuzumab emtansine）when communicating medication orders, on preprinted order sets, and in computerized order entry systems. Such redundancy may help to reduce the potential for medication errors. Additionally, strategies should be employed to warn against confusion between Kadcyla（ado-trastuzumab emtansine）and Herceptin（trastuzumab）in medication-related computer systems.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
‧ Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
‧ Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA提醒醫療人員，乳癌藥品Kadcyla（ado-trastuzumab emtansine），可能會因為使用不正確的學名而與Herceptin（trastuzumab）混淆，導致用藥錯誤。Kadcyla和 Herceptin皆為乳癌標靶藥物，其使用劑量與療程相當不同，故兩者混淆誤用可能會造成給藥劑量錯誤和造成病人潛在的傷害。
Kadcyla應使用FDA核准的學名ado-trastuzumab emtansine。然而，有些第三方出版物、參考文獻、醫療資訊系統（例如：電子病歷系統、開方系統、採購系統、藥局作業系統等）及網路會使用錯誤的學 名「trastuzumab emtansine」，省略了「ado-」。該名稱易與Herceptin（trastuzumab）產生混淆。
發布藥品資訊時應使用FDA核准之商品名（Kadcyla）和學名（ado-trastuzumab emtansine），避免發生用藥錯誤以及確保發生藥物不良反應時可以正確通報。
而Kadcyla自2013/2/22通過FDA核可迄今，尚未出現因Kadcyla和Heceptin名稱混淆而造成的給藥錯誤，但於臨床試驗階段時確實有發生用藥錯誤的案例。
背景：Kadcyla為治療曾使用Herceptin（trastuzumab）和化學藥物taxane治療之HER2（+）乳癌轉移病人，此藥由 trastuzumab（抗HER2標靶藥物）和DM1（細胞毒殺藥物）組成，可干擾腫瘤細胞生長。
建議：醫療人員應使用FDA核准通過的商品名（Kadcyla）和學名（ado-trastuzumab emtansine），減少用藥錯誤之發生。此外，在藥品相關的電子系統上可標註警示以避免Kadcyla（ado-trastuzumab emtansine）和Herceptin（trastuzumab）之誤用。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
[Posted 05/07/2013]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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資料來源：藥師週刊（第1825期）
