Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Necitumumab
Drug ID BADD_D01543
Description Necitumumab is an intravenously administered recombinant monoclonal IgG1 antibody used in the treatment of non-small cell lung cancer (NSCLC) as an EGFR antagonist. It functions by binding to epidermal growth factor receptor (EGFR) and prevents binding of its ligands, a process that is involved in cell proliferation, metastasis, angiogenesis, and malignant progression. Binding of necitumumab to EGFR induces receptor internalization and degradation, thereby preventing further activation of EGFR which is beneficial in NSCLC as many patients have increased protein expression of EGFR. Necitumumab is approved for use in combination with cisplatin and gemcitabine as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC).
Indications and Usage Necitumumab is approved for use in combination with cisplatin and gemcitabine as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC). It is not indicated for treatment of non-squamous NSCLC.
Marketing Status approved; investigational
ATC Code L01FE03
DrugBank ID DB09559
KEGG ID D10018
MeSH ID C527969
PubChem ID Not Available
TTD Drug ID D03WPP
NDC Product Code 0002-7716; 0002-2412; 73424-0547
UNII 2BT4C47RUI
Synonyms necitumumab | Portrazza | IMC-11F8 | 11F8 | IMC-11F8 monoclonal antibody
Chemical Information
Molecular Formula Not Available
CAS Registry Number 906805-06-9
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)
Acne23.02.01.001--Not Available
Conjunctivitis06.04.01.002; 11.01.06.012--
Dermatitis acneiform23.02.01.004--
Diarrhoea07.02.01.001--
Dry skin23.03.03.001--
Dysphagia07.01.06.003--
Haemoptysis02.11.04.009; 24.07.01.006; 22.02.03.004--Not Available
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Hypocalcaemia14.04.01.004--
Hypokalaemia14.05.03.002--
Hypomagnesaemia14.04.02.001--
Hypophosphataemia14.04.03.001--
Muscle spasms15.05.03.004--
Paronychia23.11.04.006; 11.02.01.054--
Phlebitis24.12.03.004; 12.02.01.002--
Pruritus23.03.12.001--
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Rash23.03.13.001--Not Available
Skin fissures23.03.03.008--Not Available
Stomatitis07.05.06.005--
Venous thrombosis24.01.01.008--Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Oropharyngeal pain07.05.05.004; 22.12.03.016--
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