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Abatacept - Drugbank 10/3/2018 Abatacept - DrugBank Abatacept Targets (2) Biointeractions (2) IDENTIFICATION Name Abatacept Accession Number DB01281 Type Biotech Groups Approved Biologic Classification Protein Based Therapies Fusion proteins 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). Protein chemical formula C3498H5458N922O1090S32 https://www.drugbank.ca/drugs/DB01281 1/14 10/3/2018 Abatacept - DrugBank Protein average weight 92300.0 Da (with glycosylation) Sequences >Abatacept monomer sequence MHVAQPAVVLASSRGIASFVCEYASPGKATEVRVTVLRQADSQVTEVCAATYMMGNELTF LDDSICTGTSSGNQVNLTIQGLRAMDTGLYICKVELMYPPPYYLGIGNGTQIYVIDPEPC PDSDQEPKSSDKTHTSPPSPAPELLGGSSVFLFPPKPKDTLMISRTPEVTCVVVDVSHED PEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPA PIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENN YKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK Download FASTA Format Synonyms Abatacept recombinant External IDs BMS-188667 / CTLA4-IGG4M / RG-1046 / RG-2077 / RG1046 / RG2077 Prescription Products Search MARKETING MARKETING NAME ↑↓ DOSAGE ↑↓ STRENGTH ↑↓ ROUTE ↑↓ LABELLER ↑↓ START ↑↓ END ↑↓ ↑↓ ↑↓ Orencia Injection, 250 mg/15mL Intravenous E.R. Squibb & 2009-01-01 Not applicable powder, Sons, L.L.C. lyophilized, for solution Orencia Powder, for 250 mg Intravenous Bristol Myers 2006-08-08 Not applicable solution Squibb Orencia Injection, 50 mg/0.4mL Subcutaneous E.R. Squibb & 2011-07-29 Not applicable solution Sons, L.L.C. Orencia Solution 125 mg Subcutaneous Bristol Myers Not applicable Not applicable Squibb Orencia Injection, 125 mg/1mL Subcutaneous E.R. Squibb & 2011-07-29 Not applicable solution Sons, L.L.C. Orencia Solution 125 mg Subcutaneous Bristol Myers 2013-05-09 Not applicable https://www.drugbank.ca/drugs/DB01281 2/14 10/3/2018 Abatacept - DrugBank Orencia Solution 125 mg Subcutaneous Bristol Myers 2013 05 09 Not applicable Squibb MARKETING MARKETING NAME ↑↓ DOSAGE ↑↓ STRENGTH ↑↓ ROUTE ↑↓ LABELLER ↑↓ START ↑↓ END ↑↓ ↑↓ ↑↓ Orencia Injection, 87.5 Subcutaneous E.R. Squibb & 2011-07-29 Not applicable solution mg/0.7mL Sons, L.L.C. Showing 1 to 7 of 7 entries ‹ › Categories Amino Acids, Peptides, and Proteins Antibodies Antineoplastic and Immunomodulating Agents Biologics for Rheumatoid Arthritis Treatment Blood Proteins Decreased Cytokine Activity Disease-modifying Antirheumatic Agents Globulins Immunoconjugates Immunologic Factors Immunoproteins Immunosuppressive Agents Proteins Recombinant Fusion Proteins Selective Immunosuppressants Selective T Cell Costimulation Modulator Serum Globulins UNII 7D0YB67S97 CAS number 332348-12-6 PHARMACOLOGY https://www.drugbank.ca/drugs/DB01281 3/14 10/3/2018 Abatacept - DrugBank Indication For the management of the signs and symptoms of moderate-to-severe active rheumatoid arthritis, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients. It is indicated both as a monotherapy and for use in combination with a continued regimen of DMARDs (not including TNF antagonists). Also used for the management of the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in children. Associated Conditions Moderate Juvenile idiopathic arthritis Moderate Rheumatoid arthritis Severe Juvenile idiopathic arthritis Severe Rheumatoid arthritis Pharmacodynamics Abatacept is the first in a new class of drugs known as Selective Co-stimulation Modulators. Known as a recombinant fusion protein, the drug consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to a modified Fc portion of human immunoglobulin G1 (IgG1. The Fc portion of the drug consists of the hinge region, the CH2 domain, and the CH3 domain of IgG1. Although there are multiple pathways and cell types involved in the pathogenesis of rheumatoid arthritis, evidence suggests that T-cell activation may play an important role in the immunopathology of the disease. Ordinarily, full T-cell activation requires binding of the T-cell receptor to an antigen-MHC complex on the antigen-presenting cell as well as a co-stimulatory signal provided by the binding of the CD28 protein on the surface of the T-cell with the CD80/86 proteins on the surface of the antigen-presenting cell. CTLA4 is a naturally occurring protein which is expressed on the surface of T-cells some hours or days aer full T-cell activation and is capable of binding to CD80/86 on antigen-presenting cells with much greater affinity than CD28. Binding of CTLA4-Ig to CD80/86 provides a negative feedback mechanism which results in T-cell deactivation. Abatacept was developed by Bristol-Myers-Squibb and is licensed in the US for the treatment of Rheumatoid Arthritis in the case of inadequate response to anti-TNF-alpha therapy. Mechanism of action Abatacept is a selective costimulation modulator, like CTLA-4, the drug has shown to inhibit T-cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking interaction with CD28. Blockade of this interaction has been shown to inhibit the delivery of the second co-stimulatory signal required for optimal activation of T-cells. This results in the inhibition of autoimmune T-Cell activation that has been implcated in the pathogenesis of rheumatoid arthritis. A T-lymphocyte activation antigen CD80 https://www.drugbank.ca/drugs/DB01281 4/14 10/3/2018 Abatacept - DrugBank A T lymphocyte activation antigen CD80 antagonist Human A T-lymphocyte activation antigen CD86 antagonist Human Absorption When a single 10 mg/kg intravenous infusion of abatacept is administered in healthy subjects, the peak plasma concentration (Cmax) was 292 mcg/mL. When multiple doses of 10 mg/kg was given to rheumatoid arthritis (RA) patients, the Cmax was 295 mcg/mL. The bioavailability of abatacept following subcutaneous administration relative to intravenous administration is 78.6%. Volume of distribution 0.07 L/kg [RA Patients, IV administration] 0.09 L/kg [Healthy Subjects, IV administration] 0.11 L/kg [RA patients, subcutaneous administration] Protein binding Not Available Metabolism Not Available Route of elimination kidney and liver Half life 16.7 (12-23) days in healthy subjects; 13.1 (8-25) days in RA subjects; 14.3 days when subcutaneously administered to adult RA patients. Clearance 0.23 mL/h/kg [Healthy Subjects aer 10 mg/kg Intravenous Infusion] 0.22 mL/h/kg [RA Patients aer multiple 10 mg/kg Intravenous Infusions] 0.4 mL/h/kg [juvenile idiopathic arthritis patients]. The mean systemic clearance is 0.28 mL/h/kg when a subcutaneously administered to adult RA patients. The clearance of abatacept increases with increasing body weight. Toxicity Most common adverse events (≥10%) are headache, upper respiratory tract infection, https://www.drugbank.ca/drugs/DB01281 5/14 10/3/2018 Abatacept - DrugBank Most common adverse events (≥10%) are headache, upper respiratory tract infection, nasopharyngitis, and nausea. Doses up to 50 mg/kg have been administered without apparent toxic effect. Affected organisms Humans and other mammals Pathways Not Available Pharmacogenomic Effects/ADRs Not Available INTERACTIONS Drug Interactions ALL DRUGS APPROVED VET APPROVED NUTRACEUTICAL ILLICIT WITHDRAWN INVESTIGATIONAL EXPERIMENTAL Search DRUG ↑↓ INTERACTION ↑↓ Adalimumab The risk or severity of infection can be increased when Adalimumab is combined with Abatacept. Afelimomab The risk or severity of infection can be increased when Afelimomab is combined with Abatacept. Alclometasone The risk or severity of adverse effects can be increased when Abatacept is combined with Alclometasone. Aldesleukin The risk or severity of adverse effects can be increased when Abatacept is combined with Aldesleukin. Alemtuzumab The risk or severity of adverse effects can be increased when Abatacept is combined with Alemtuzumab. Altretamine The risk or severity of adverse effects can be increased when Abatacept is combined with Altretamine. Amcinonide The risk or severity of adverse effects can be increased when Abatacept is combined with Amcinonide. Amsacrine The risk or severity of adverse effects can be increased when Abatacept is combined with Amsacrine. https://www.drugbank.ca/drugs/DB01281 6/14 10/3/2018 Abatacept - DrugBank DRUG ↑↓ INTERACTION ↑↓ Anthrax immune globulin The risk or severity of adverse effects can be increased when Abatacept is human combined with Anthrax immune globulin human. Antithymocyte The risk or severity of adverse effects can be increased when Abatacept is immunoglobulin (rabbit) combined with Antithymocyte immunoglobulin (rabbit). Showing 1 to 10 of 149 entries ‹ › Food Interactions Not Available REFERENCES Synthesis Reference Sang-Lin Kim, Hyun-Kwang Tan, Sang-Min Lim, Wuk-Sang Ryu, Hahn-Sun Jung, Song-Jae Lee, Cheon- Ik Park, Seung-Hoon Kang, Dong Il Kim, "Plant Recombinant Human CTLA4IG and a Method for Producing the Same."
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