Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ado-trastuzumab emtansine
Drug ID BADD_D00046
Description Trastuzumab emtansine, formerly called Trastuzumab-DM1 (T-DM1) is a first-in-class HER2 antibody drug conjugate (ADC) comprised of Genentech's trastuzumab antibody linked to ImmunoGen's cell-killing agent, DM1. T-DM1 combines two strategies-- anti-HER2 activity and targeted intracellular delivery of the potent anti-microtubule agent, DM1 (a maytansine derivative)--to produce cell cycle arrest and apoptosis. Trastuzumab emtansine is marketed under the brand name Kadcyla and is indicated for use in HER2-positive, metastatic breast cancer patients who have already used taxane and/or trastuzumab for metastatic disease or had their cancer recur within 6 months of adjuvant treatment. The FDA label has two precautions. First that trastuzumab emtansine and trastuzumab cannot be interchanged. Second that there is a black box warning of serious side effects such as hepatotoxicity, embryo-fetal toxicity, and cardiac toxicity.
Indications and Usage Not Available
Marketing Status Prescription
ATC Code L01FD03
DrugBank ID DB05773
KEGG ID D09980
MeSH ID D000080044
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 50242-088; 50242-087; 50242-089
Synonyms Ado-Trastuzumab Emtansine | Ado Trastuzumab Emtansine | Trastuzumab Emtansine | Kadcyla | huN901-DM1 | huN901 DM1 | huN901DM1 | Trastuzumab-DM1 Conjugate | Trastuzumab DM1 Conjugate | Trastuzumab-DM1 | Trastuzumab DM1
Chemical Information
Molecular Formula Not Available
CAS Registry Number 1018448-65-1
SMILES Not Available
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Alanine aminotransferase increased13.03.01.003--
Anaemia01.03.02.001--
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Blood bilirubin increased13.03.01.008--
Blood potassium decreased13.11.01.010--Not Available
Chills15.05.03.016; 08.01.09.001--
Conjunctivitis11.01.06.012; 06.04.01.002--
Constipation07.02.02.001--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Drug hypersensitivity10.01.01.001--Not Available
Dry eye06.08.02.001--
Dry mouth07.06.01.002--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspepsia07.01.02.001--
Dyspnoea22.02.01.004; 02.01.03.002--
Epistaxis24.07.01.005; 22.04.03.001--
Fatigue08.01.01.002--
Haemoglobin decreased13.01.05.003--Not Available
Headache17.14.01.001--
Hypertension24.08.02.001--
Hypokalaemia14.05.03.002--
Insomnia19.02.01.002; 17.15.03.002--
Lacrimation increased06.08.02.004--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
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