Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Aflibercept
Drug ID BADD_D00048
Description Aflibercept is a recombinant protein composed of the binding domains of two human vascular endothelial growth factor (VEGF) receptors fused with the Fc region of human immunoglobulin gamma 1 (IgG1). Structurally, Aflibercept is a dimeric glycoprotein with a protein molecular weight of 96.9 kilo Daltons (kDa). It contains approximately 15% glycosylation to give a total molecular weight of 115 kDa. All five putative N-glycosylation sites on each polypeptide chain predicted by the primary sequence can be occupied with carbohydrate and exhibit some degree of chain heterogeneity, including heterogeneity in terminal sialic acid residues, except at the single unsialylated site associated with the Fc domain. Aflibercept, as an ophthalmic agent, is used in the treatment of macular edema following Central Retinal Vein Occlusion (CRVO) and neovascular Age-Related Macular Degeneration (AMD). Ziv-aflibercept, under the brand name Zaltrap, was developed as an injection for treatment of metastatic colorectal cancer. FDA approved in November 18, 2011 and EMA approved in November 2012.
Indications and Usage The opthalmic agent is used for the treatment of neovascular (wet) age-related mascular degeneration (AMD) and macular edema following central retinal vein occulsion (CRVO). The systemic injection, known as ziv-aflibercept, in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI), is for the treatment of metastatic colorectal cancer that is resistant to or progressed following treatment with oxaliplatin.
Marketing Status approved
ATC Code L01XX44; S01LA05
DrugBank ID DB08885
KEGG ID D09574
MeSH ID C533178
PubChem ID Not Available
TTD Drug ID D0C9ET
NDC Product Code 61434-007; 61755-005
UNII 15C2VL427D
Synonyms aflibercept | VEGF Trap - regeneron | VEGF Trap-Eye | VEGF-Trap | eylea | Zaltrap | AVE 0005 | AVE0005 | AVE-0005 | AVE 005 | AVE005 | AVE-005 | ZIV-aflibercept
Chemical Information
Molecular Formula Not Available
CAS Registry Number 862111-32-8
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)
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Alanine aminotransferase increased13.03.04.005--
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Anaphylactoid reaction10.01.07.003; 24.06.03.007---
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001---
Blood creatinine increased13.13.01.004--
Cataract06.06.01.001--
Conjunctival haemorrhage06.07.01.001; 24.07.05.001---
Corneal epithelium defect06.06.03.012---
Corneal erosion06.06.03.003---
Corneal oedema06.04.02.001---
Dehydration14.05.05.001--
Diarrhoea07.02.01.001--
Dysphonia17.02.08.004; 19.19.03.002; 22.12.03.006--
Dyspnoea02.11.05.003; 22.02.01.004--
Endophthalmitis06.04.05.009; 11.01.06.003--
Epistaxis22.04.03.001; 24.07.01.005--
Eye inflammation06.04.05.002---
Eye pain06.08.03.002--
Eyelid oedema06.04.04.004; 10.01.05.001; 23.04.01.003---
Fatigue08.01.01.002--
Haemorrhoids07.15.03.001; 24.10.02.002--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Injection site haemorrhage08.02.03.005; 12.07.03.005; 24.07.01.010---
Injection site pain08.02.03.010; 12.07.03.011---
Intraocular pressure increased13.07.04.002---
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