ADReCS

Pharmaceutical Information

Drug Name	Afatinib
Drug ID	BADD_D00047
Description	Afatinib is a 4-anilinoquinazoline tyrosine kinase inhibitor in the form of a dimaleate salt available as Boehringer Ingelheim's brand name Gilotrif [FDA Label]. For oral use, afatinib tablets are a first-line (initial) treatment for patients with metastatic non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test [L2939]. Gilotrif (afatinib) is the first FDA-approved oncology product from Boehringer Ingelheim [L2939].
Indications and Usage	Afatinib is a kinase inhibitor indicated for the first-line treatment of patient with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
Marketing Status	Prescription
ATC Code	L01EB03
DrugBank ID	DB08916
KEGG ID	D09724
MeSH ID	D000077716
PubChem ID	10184653
TTD Drug ID	D05UFG
NDC Product Code	0597-0138; 0597-0141; 0597-0137
Synonyms	Afatinib \| (2E)-N-(4-(3-Chloro-4-fluoroanilino)-7-(((3S)-oxolan-3-yl)oxy)quinoxazolin-6-yl)-4-(dimethylamino)but-2-enamide \| BIBW-2992-MA2 \| BIBW 2992 MA2 \| BIBW-2992MA2 \| BIBW 2992MA2 \| BIBW2992 MA2 \| Afatinib Maleate \| BIBW 2992 \| BIBW2992 \| BIBW-2992 \| Gilotrif \| Afatinib Dimaleate

Chemical Information

Molecular Formula	C24H25ClFN5O3
CAS Registry Number	850140-72-6
SMILES	CN(C)CC=CC(=O)NC1=C(C=C2C(=C1)C(=NC=N2)NC3=CC(=C(C=C3)F)Cl)OC4CCOC4
Chemical Structure

ADRs Induced by Drug

ADR Term	ADReCS ID	ADR Frequency (FAERS)	ADR Severity Grade (FAERS)	ADR Severity Grade (CTCAE)
Dermatitis acneiform	23.02.01.004	0.013054%
Diarrhoea	07.02.01.001	0.185688%
Diarrhoea haemorrhagic	07.02.01.002; 24.07.02.004	0.000799%		Not Available
Dilatation ventricular	02.04.02.026	0.000533%		Not Available
Diplopia	06.02.06.002; 17.17.01.005	-	-	Not Available
Disorientation	17.02.05.015; 19.13.01.002	0.001598%		Not Available
Disseminated intravascular coagulation	01.01.02.002; 24.01.01.010	0.000208%
Dizziness	02.01.02.004; 17.02.05.003; 24.06.02.007	-	-
Drug eruption	08.01.06.015; 10.01.01.005; 23.03.05.001	0.002398%		Not Available
Dry eye	06.08.02.001	0.002131%
Dry mouth	07.06.01.002	0.002398%
Dry skin	23.03.03.001	0.006394%
Duodenal ulcer	07.04.02.002	0.001066%
Duodenal ulcer haemorrhage	07.04.02.004; 24.07.02.020	0.000533%		Not Available
Dysgeusia	07.14.03.001; 17.02.07.003	0.003463%
Dyspepsia	07.01.02.001	0.002131%
Dysphagia	07.01.06.003	0.006394%
Dysphonia	17.02.08.004; 19.19.03.002; 22.02.05.005	0.001332%
Dyspnoea	02.01.03.002; 22.02.01.004	-	-
Dyspnoea exertional	02.01.03.003; 22.02.01.005	0.002131%		Not Available
Eating disorder	14.03.01.008; 19.09.01.008	0.002131%		Not Available
Eczema	23.03.04.006	0.000799%
Electrolyte imbalance	14.05.01.002	0.002398%		Not Available
Embolic stroke	17.08.01.032; 24.01.04.010	0.000533%		Not Available
Empyema	11.01.08.020	0.001865%		Not Available
Encephalitis	11.01.03.008; 17.06.05.001	0.000139%
Enterocolitis	07.08.03.003	0.001598%
Epilepsy	17.12.03.002	0.002131%		Not Available
Epistaxis	22.04.03.001; 24.07.01.005	0.006660%
Erythema	23.03.06.001	-	-	Not Available

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