Lani
05-07-2013, 11:37 AM
FDA Warns of Name Confusion for 2 Breast Cancer Drugs
Robert Lowes
May 06, 2013
Trastuzumab for Breast Cancer Linked to CNS Metastases
FDA Approves New Treatment for Metastatic HER2 Breast Cancer
Breast Cancer News & Perspectives
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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Information from Industry
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.
Robert Lowes
May 06, 2013
Trastuzumab for Breast Cancer Linked to CNS Metastases
FDA Approves New Treatment for Metastatic HER2 Breast Cancer
Breast Cancer News & Perspectives
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.
Reduce your medical billing costs
Medical-Billing.com can help you decrease billing costs while helping you get paid faster and with fewer payment denials.
Find out how
Information from Industry
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.