Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Abatacept
Drug ID BADD_D00012
Description Abatacept 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. Although approved for the treatment of rheumatoid arthritis, Repligen has entered a slightly different formulation of CTLA4-Ig into clinical trials (RG2077).
Indications and Usage Abatacept is indicated in adult patients for the treatment of moderately-to-severely active rheumatoid arthritis and for the treatment of active psoriatic arthritis.[L20504] In patients two years of age and older, abatacept is also indicated for the treatment of moderately-to-severely active juvenile idiopathic arthritis.[L20504] Abatacept is also indicated for the prophylaxis of acute graft-versus-host disease, in combination with [methotrexate] and a calcineurin inhibitor such as [tacrolimus], in patients two years of age and older who are undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated donor.[L20504]
Marketing Status approved
ATC Code L04AA24
DrugBank ID DB01281
KEGG ID D03203
MeSH ID D000069594
PubChem ID Not Available
TTD Drug ID D0EW4L
NDC Product Code 0003-2814; 0003-2818; 70409-2187; 0003-2188; 0003-2187
UNII 7D0YB67S97
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 332348-12-6
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)
Back pain15.03.04.005--
Bronchitis22.07.01.001; 11.01.09.001--
Cellulitis11.02.01.001; 23.11.02.004--Not Available
Chronic obstructive pulmonary disease22.03.01.007--Not Available
Cough22.02.03.001--
Diverticulitis11.01.07.003; 07.10.02.001--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Headache17.14.01.001--
Herpes simplex23.11.05.004; 11.05.02.001--Not Available
Herpes zoster17.09.03.026; 11.05.02.003; 23.11.05.005--
Hypertension24.08.02.001--
Hypotension24.06.03.002--
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Localised infection11.01.08.006--Not Available
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Neoplasm malignant16.16.01.001--Not Available
Pain in extremity15.03.04.010--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pyelonephritis acute11.01.14.003; 20.01.09.002--Not Available
Rash23.03.13.001--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Rhonchi22.12.01.013--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
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