Ado-trastuzumab emtansine (Kadcyla, Genentech) is an anti–HER-2 monoclonal antibody-drug conjugate indicated for the treatment of HER-2–positive breast cancer. The drug is infused intravenously. This section covers the common adverse reactions, warnings and precautions, drug interactions and other contraindications of ado-trastuzumab emtansine use.
Topics Covered:
Common adverse reactions
Warnings and precautions
Drug interactions and other contraindications
Ado-trastuzumab emtansine common adverse reactions
Drug reactions occurring at a frequency of more than 25% in clinical trials of ado-trastuzumab emtansine include fatigue, nausea, musculoskeletal pain, hemorrhage, thrombocytopenia, headache, elevated liver enzymes, constipation and epistaxis.
Ado-trastuzumab emtansine warnings and precautions
Because of the risk for hepatotoxicity, liver function should be tested before initiating ado-trastuzumab emtansine and, also, before administration of each dose. Elevated AST, ALT and bilirubin may require dose reduction or discontinuation of treatment.
Nodular regenerative hyperplasia (NRH), a rare liver condition, has been reported in clinical trials. The condition is characterized by the formation of benign regenerative nodules throughout the liver tissue and may lead to portal hypertension, the symptoms of which include abdominal pain and swelling, confusion and GI bleeding. Patients with NRH must immediately discontinue treatment with ado-trastuzumab emtansine.
Figure 3. A T2-weighted CT scan showing the diffuse multinodular appearance of the liver suggestive of Regenerative Nodular Hyperplasia (NRH). Imaging should be performed in cases of suspected NRH; the diagnosis is confirmed via a needle biopsy of the liver.
Source: The Korean Society of Gastroenterology
Additional adverse events associated with ado-trastuzumab emtansine include:
- left ventricular dysfunction;
- fetal toxicity;
- pulmonary toxicity (including ILD);
- infusion and hypersensitivity reactions;
- hemorrhage;
- thrombocytopenia; and
- neurotoxicity (including peripheral neuropathy).
Ado-trastuzumab emtansine drug interactions and other contraindications
Patients must have verified HER-2 positivity/overexpression to receive ado-trastuzumab emtansine. HER-2 testing should be performed by a reliable laboratory with demonstrated testing proficiency.
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