Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Trastuzumab
Drug ID BADD_D02264
Description Produced in CHO cell cultures, trastuzumab is a recombinant IgG1 kappa, humanized monoclonal antibody [A40276] that selectively binds with high affinity in a cell-based assay (Kd = 5 nM) to the extracellular domain of the human epidermal growth factor receptor protein (HER2).[L14015] It is used as a treatment of human epidermal growth factor receptor (HER)-2+ metastatic breast cancer, where there is a proven amplification of the HER-2 oncogene or over-expression of the HER-2 protein in tumours. It is suggested that the overexpression or gene amplification of HER2 has been found in about 20–30% of breast cancers and elevated activation of HER2 triggers multiple downstream pathways leading to abnormal proliferation of cancer cells [A121]. Trastuzumab binds to HER2 and suppresses cancer cells growth, proliferation, and survival directly and indirectly [A121]. In December 2017, FDA approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). It displays biosimilar properties as Herceptin according to clinical data. While Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer, it is the second biosimilar approved in the U.S. for the treatment of cancer. Herzuma (trastuzumab-pkrb) is a biosimilar drug approved in December 2018 for the treatment of HER2-overexpressing breast cancer. KANJINTI (trastuzumab-anns) is another biosimilar approved by the FDA in June 2019.[L14135]
Indications and Usage For treatment of early stage HER2-positive breast cancer, or metastatic breast cancer that substantially overexpress HER2.
Marketing Status Prescription
ATC Code L01FD01
DrugBank ID DB00072
KEGG ID D03257
MeSH ID D000068878
PubChem ID Not Available
NDC Product Code 68225-106; 67643-0010; 63552-037; 69438-0002; 50242-133; 67457-847; 67457-991; 78848-007; 63459-305; 63459-303; 67457-845; 78206-147; 0006-5033; 50242-132; 78848-006
Synonyms Trastuzumab | Trastuzumab beta | beta, Trastuzumab | Herceptin | Trazimera | Trastuzumab-qyyp | Trastuzumab qyyp
Chemical Information
Molecular Formula Not Available
CAS Registry Number 180288-69-1
SMILES Not Available
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Neoplasm related morbiditiesReceptor tyrosine-protein kinase erbB-2P04626T1459712938263; 11790161; 16133791; 15143970
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Acne23.02.01.001--Not Available
Anaesthesia17.02.07.002--Not Available
Anaphylactic reaction24.06.03.006;
Angioedema23.04.01.001; Available
Arrhythmia02.03.02.001--Not Available
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Bone pain15.02.01.001--
Cardiac failure02.05.01.001--
Cardiac failure congestive02.05.01.002--Not Available
Cardiomyopathy02.04.01.001--Not Available
Fluid overload14.05.06.001; Available
Glomerulonephritis membranous20.05.01.007--Not Available
Herpes simplex23.09.03.001; Available
The 1th Page    1 2 3    Next   Last    Total 3 Pages