BE FOREWARNED--FDA ALERT regarding herceptin/TDM! infusion MIX-UP!!!!
reposted as forgot the Warning symbol
the strength/toxicity of TDM1 is such an equivalent dose of TDM1 (as herceptin) would be much too high
FDA Warns of Name Confusion for 2 Breast Cancer Drugs
Robert Lowes
May 06, 2013
The US Food and Drug Administration (FDA) today warned that clinicians may confuse a recently approved breast cancer drug called ado-trastuzumab emtansine (Kadcyla, Genentech) with a predecessor called trastuzumab (Herceptin, Genentech), possibly leading to patient harm.
The mix-up, said the agency, stems from some electronic health record systems, pharmacy software, compendia references, Internet sites, and other parties shortening ado-trastuzumab emtansine, the name approved by the FDA, to trastuzumab emtansine.
The FDA approved ado-trastuzumab emtansine, also known as T-DM1, on February 22 to treat patients with HER2-positive metastatic breast cancer who had previously received the anti-HER2 therapy trastuzumab and taxane-based chemotherapy. Since the newer drug's approval, the FDA has not received any reports of medication errors caused by a name mix-up.
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However, such medication errors did occur during the clinical trials for ado-trastuzumab emtansine, according to the agency. Four patients received the new cancer drug at a dose of 6 mg/kg when the intended drug was trastuzumab; 6 mg/kg every 3 weeks is the recommended maintenance dose for trastuzumab but exceeds the recommended dose for ado-trastuzumab emtansine, which is 3.6 mg/kg administered as a single agent by intravenous infusion every 3 weeks.
The label of the new drug warns that clinicians should not substitute it for trastuzumab.
The original name of ado-trastuzumab emtansine had been trastuzumab emtansine, as established by the US Adopted Name Council. Anticipating a name mix-up, the FDA required the addition of the prefix "ado" followed by a hyphen.
The FDA advises all healthcare professionals to use both the approved generic name as well as the approved brand name, Kadcyla, when they prescribe ado-trastuzumab emtansine.
More information on today's announcement is available on the FDA Web site.
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