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 the adjuvant treatment of HER2-overexpressing breast cancer, trastuzumab is indicated in several clinical settings: as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; as part of a treatment regimen with docetaxel and carboplatin; or as monotherapy following multi-modality anthracycline-based therapy.[L14015] Trastuzumab is indicated as a first-line treatment, in combination with paclitaxel, for metastatic HER2-overexpressing breast cancer, and as monotherapy in patients who have previously received one or more chemotherapy regimens in the metastatic setting.[L14015] Trastuzumab is also indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.[L14015] Trastuzumab is indicated for subcutaneous administration - in combination with either [hyaluronidase][L14132] or both hyaluronidase and [pertuzumab][L14510] - for the treatment of adults with HER-2 positive breast cancers.
Marketing Status approved; investigational
ATC Code L01FD01
DrugBank ID DB00072
KEGG ID D03257
MeSH ID D000068878
PubChem ID Not Available
TTD Drug ID D04WFL
NDC Product Code 50242-133; 63459-303; 63459-305; 67457-991; 69438-0008; 78848-007; 0006-5033; 67457-847; 63552-037; 50242-132; 78206-147; 67643-0022; 68225-106; 78848-006
UNII P188ANX8CK
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Hypervolaemia02.05.04.019; 14.05.06.003---
Infection11.01.08.002---
Influenza11.05.03.001; 22.07.02.001---
Influenza like illness08.01.03.010--
Injury12.01.08.004---
Insomnia17.15.03.002; 19.02.01.002--
Interstitial lung disease10.02.01.033; 22.01.02.003---
Laryngeal pain22.12.03.010--
Leukopenia01.02.02.001---
Muscle spasms15.05.03.004--
Myalgia15.05.02.001--
Nail disorder23.02.05.002--
Nasopharyngitis11.01.13.002; 22.07.03.002---
Nausea07.01.07.001--
Nephrotic syndrome20.05.01.002--
Neuropathy peripheral17.09.03.003---
Neutropenia01.02.03.004---
Oedema08.01.07.006; 14.05.06.010---
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Oligohydramnios18.05.01.001---
Pain08.01.08.004--
Palpitations02.11.04.012--
Paraesthesia17.02.06.005; 23.03.03.094--
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
Pruritus23.03.12.001--
Pulmonary hypertension22.06.01.001; 24.08.03.002--
Pyrexia08.05.02.003--
Rash23.03.13.001---
Rhinitis11.01.13.004; 22.07.03.006--
Sinusitis11.01.13.005; 22.07.03.007--
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ADReCS-Target
Drug Name ADR Term Target
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