Narrator: Welcome to the FDA Drug Safety Podcast from the Division of Drug Information. Today’s topic: FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla, active ingredient ado-trastuzumab emtansine.
Joan Powers, a Consumer Safety Officer in the Division, will provide you with additional information about this Communication.
Joan Powers: On May 6, 2013 the FDA alerted health care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla in some medication-related electronic systems poses a risk of mix-up with Herceptin, active ingredient 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, 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.
Health care professionals should use both the FDA-approved proprietary or 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.
It is important for drug information content publishers to identify drug products by the FDA-approved proprietary 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.
At this time FDA recommends Healthcare Professionals be mindful of the following:
- Be aware of the potential for the nonproprietary name for Kadcyla, ado-trastuzumab emtansine, to be listed both with and without the prefix “ado” in third-party publications, health information systems, and on the Internet.
- Use both “Kadcyla,” the FDA-approved proprietary name, and “ado-trastuzumab emtansine,” the product’s nonproprietary name, when communicating medication orders, on preprinted order sets, and computerized order entry systems, including both prescriber and pharmacy.
- Employ strategies to warn against confusion between Kadcyla, ado-trastuzumab emtansine, and Herceptin, trastuzumab, in medication-related computer systems.
- If the nonproprietary name for Kadcyla is incorrectly identified as “trastuzumab emtansine,” manually correct the nonproprietary name for Kadcyla to ado-trastuzumab emtansine in your information systems. Keep in mind that routine automated updates from drug information content publishers that do not list the prefix “ado” may override and reverse the manual correction.
- Kadcyla and Herceptin are not the same product. Kadcyla, ado-trastuzumab emtansine, should not be substituted for or used with Herceptin, trastuzumab. Please refer to the manufacturer’s website at: www.kadcyla.com for a detailed comparison of these products.
- The recommended dose of Kadcyla is 3.6 mg/kg administered as a single agent by intravenous infusion every 3 weeks for a total 21-day cycle. Doses greater than 3.6 mg/kg should not be administered. In contrast, the recommended dose of Herceptin is significantly higher, up to 8 mg/kg per loading dose, followed by a maintenance dose of 6 mg/kg every 3 weeks.
- Report medication errors and adverse events involving Kadcyla to the FDA MedWatch program at www.fda.gov/medwatch.
Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to previous communications and this communication, including the complete Data Summary and a link to the Kadcyla manufacturer’s detailed product comparison, can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at email@example.com.
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FDA Drug Safety Podcast: FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine) mp3(MP3 - 5.9MB) [ARCHIVED] Drug Safety Communication: FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine)