Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Belatacept
Drug ID BADD_D00223
Description Belatacept is a soluble fusion protein, which links the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Structurally, abatacept is a glycosylated fusion protein with a MALDI-MS molecular weight of 92,300 Da and it is a homodimer of two homologous polypeptide chains of 357 amino acids each. It is produced through recombinant DNA technology in mammalian CHO cells. The drug has activity as a selective co-stimulation modulator with inhibitory activity on T lymphocytes. It is approved for the treatment of rheumatoid arthritis. Belatacept selectively blocks the process of T-cell activation. It was developed by Bristol-Myers-Squibb. Belatacept is only 2 amino acids different from abatacept (Orencia). FDA approved on June 15, 2011.
Indications and Usage For prophylaxis of organ rejection. It is also used concomitantly with basiliximumab for induction therapy, mycophenolate, and corticosteriods in kidney transplant recepients that are seropositive for the Epstein-Barr virus.
Marketing Status approved; investigational
ATC Code L04AA28
DrugBank ID DB06681
KEGG ID D03222
MeSH ID D000069594
PubChem ID Not Available
TTD Drug ID D0N4HB
NDC Product Code 83157-0371; 0952-0371; 0003-0371
UNII E3B2GI648A
Synonyms Abatacept | CTLA-4-Ig | Cytotoxic T Lymphocyte-Associated Antigen 4-Immunoglobulin | Cytotoxic T Lymphocyte Associated Antigen 4 Immunoglobulin | CTLA4-Ig | CTLA4-Ig Immunoconjugate | CTLA4 Ig Immunoconjugate | Immunoconjugate, CTLA4-Ig | CTLA4-Fc | BMS224818 | BMS-224818 | BMS 224818 | Belatacept | Orencia | BMS 188667 | BMS-188667 | BMS188667 | LEA29Y | Nulojix
Chemical Information
Molecular Formula Not Available
CAS Registry Number 706808-37-9
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)
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Acne23.02.01.001--Not Available
Alopecia23.02.02.001--
Anaemia01.03.02.001--
Anxiety19.06.02.002--
Arteriovenous fistula thrombosis24.01.01.017; 12.02.01.006--Not Available
Arthralgia15.01.02.001--
Atrial fibrillation02.03.03.002--
Back pain15.03.04.005--
Blood creatinine increased13.13.01.004--
Bronchitis11.01.09.001; 22.07.01.001--
Complications of transplanted kidney20.01.02.005; 12.02.09.011--Not Available
Constipation07.02.02.001--
Cough22.02.03.001--
Cytomegalovirus infection11.05.01.002--
Diabetes mellitus14.06.01.001; 05.06.01.001--Not Available
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dyspnoea02.11.05.003; 22.02.01.004--
Dysuria20.02.02.002--
Guillain-Barre syndrome10.04.10.005; 17.09.01.001; 11.07.01.001--
Haematoma24.07.01.001--
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.006--
Headache17.14.01.001--
Herpes virus infection11.05.02.008--Not Available
Hydronephrosis20.01.05.001--Not Available
Hypercholesterolaemia14.08.01.001--Not Available
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hyperhidrosis23.02.03.004; 08.01.03.028--
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