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Certolizumab Pegol - Drugbank 9/19/2018 Certolizumab pegol - DrugBank Certolizumab pegol Targets (1) Biointeractions (1) IDENTIFICATION Name Certolizumab pegol Accession Number DB08904 Type Biotech Groups Approved Biologic Classification Protein Based Therapies Monoclonal antibody (mAb) / Fusion proteins Description Certolizumab pegol is a recombinant Fab' antibody fragment against tumor necrosis factor alpha which is conjugated to an approximately 40kDa polyethylene glycol (PEG2MAL40K). Polyethylene glycol helps to delay the metabolism and elimination of the drugs. Chemically, the light chain is made up of 214 amino acid residues while the heavy chain is composed of 229 amino acid residues. The molecular mass of the Fab' antibody fragment itself is 47.8 kDa. It is used for the treatment of rheumatoid arthritis and Crohn’s disease. FDA approved on April 22, 2008 Protein chemical formula C2115H3252N556O673S16 Protein average weight 91000 0 Da https://www.drugbank.ca/drugs/DB08904 1/13 9/19/2018 Certolizumab pegol - DrugBank 91000.0 Da Sequences >Amino acid sequence of the light chain DIQMTQSPSSLSASVGDRVTITCKASQNVGTNVAWYQQKPGKAPKALIYSASFLYSGVPY RFSGSGSGTDFTLTISSLQPEDFATYYCQQYNIYPLTFGQGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC >Amino acid sequence of the heavy chain EVQLVESGGGLVQPGGSLRLSCAASGYVFTDYGMNWVRQAPGKGLEWMGWINTYIGEPIY ADSVKGRFTFSLDTSKSTAYLQMNSLRAEDTAVYYCARGYRSYAMDYWGQGTLVTVSSAS TKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGL YSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCAA Download FASTA Format Synonyms Not Available External IDs CDP 870 / CDP-870 / CDP870 / PHA-738144 Prescription Products Search MARKETING MARKETING NAME ↑↓ DOSAGE ↑↓ STRENGTH ↑↓ ROUTE ↑↓ LABELLER ↑↓ START ↑↓ END ↑↓ ↑↓ ↑↓ Cimzia Injection, 200 mg Subcutaneous Ucb Pharma 2009-10-01 Not applicable solution Sa Cimzia Injection, 200 mg Subcutaneous Ucb Pharma 2009-10-01 Not applicable solution Sa Cimzia Solution 200 mg Subcutaneous Ucb Inc 2017-08-04 Not applicable Cimzia Injection, 200 mg Subcutaneous Ucb Pharma 2009-10-01 Not applicable solution Sa Cimzia Injection, 200 mg/1mL Subcutaneous Ucb Inc 2009-05-14 Not applicable solution Cimzia Solution 200 mg Subcutaneous Ucb Inc 2009-08-31 Not applicable Cimzia Injection, 200 mg Subcutaneous Ucb Pharma 2009-10-01 Not applicable solution Sa https://www.drugbank.ca/drugs/DB08904 2/13 9/19/2018 Certolizumab pegol - DrugBank MARKETING MARKETING Cimzia Kit 200 mg/1mL Ucb Inc 2008-04-20 Not applicable NAME ↑↓ DOSAGE ↑↓ STRENGTH ↑↓ ROUTE ↑↓ LABELLER ↑↓ START ↑↓ END ↑↓ ↑↓ ↑↓ Showing 1 to 8 of 8 entries ‹ › Categories Alcohols Amino Acids, Peptides, and Proteins Antibodies Antibodies, Monoclonal Antibodies, Monoclonal, Humanized Antineoplastic and Immunomodulating Agents Biologics for Rheumatoid Arthritis Treatment Biomedical and Dental Materials Blood Proteins Disease-modifying Antirheumatic Agents Ethylene Glycols Globulins Glycols Immunoglobulin Fab Fragments Immunoglobulin Fragments Immunoglobulins Immunologic Factors Immunoproteins Immunosuppressive Agents Macromolecular Substances Miscellaneous GI Drugs Peptide Fragments Peptides Polyethylene Glycols Polymers Proteins https://www.drugbank.ca/drugs/DB08904 3/13 9/19/2018 Certolizumab pegol - DrugBank Proteins Serum Globulins Tumor Necrosis Factor Alpha (TNF-α) Inhibitors Tumor Necrosis Factor Blocker Tumor Necrosis Factor Receptor Blocking Activity UNII G6ADW90R16 CAS number 428863-50-7 PHARMACOLOGY Indication Reducing signs and symptoms of Crohn's disease and treatment of moderately to severely active rheumatoid arthritis (RA). Associated Conditions Ankylosing Spondylitis (AS) Psoriatic arthritis aggravated Severe Crohn's Disease Moderate Crohn's disease Moderate Rheumatoid arthritis Severe Rheumatoid arthritis Pharmacodynamics TNFα is a key pro-inflammatory cytokine with a central role in inflammatory processes. Biological activity associated to TNFα include the upregulation of cellular adhesion molecules and chemokines, upregulation of major histocompatibility complex (MHC) class I and class II molecules, and direct leukocyte activation. TNFα stimulates the production of downstream inflammatory mediators, including interleukin-1, prostaglandins, platelet activating factor, and nitric oxide. Aer treatment with certolizumab pegol, patients with Crohn's disease demonstrated a decrease in the levels of C-reactive protein (CRP). Mechanism of action Certolizumab pegol binds to free and membrane-bound human TNFα with a KD of 90pM and https://www.drugbank.ca/drugs/DB08904 4/13 9/19/2018 p g Certolizumab pegol - DrugBank p neutralizes its activity. Extent of neutralization is also dose-dependent. It also inhibited the release of lipopolysaccharide-induced IL-1β from monocytes. TNFα is a key pro-inflammatory cytokine with a central role in inflammatory processes in which elevated levels have been observed in patients with RA and Crohn's. Certolizumab pegol selectively neutralizes TNFα (IC90 of 4 ng/mL for inhibition of human TNFα in the in vitro L929 murine fibrosarcoma cytotoxicity assay). It does not bind to TNF-β. As certolizumab is only a Fab' fragment and thus missing the Fc region, it does not fix complement or cause antibody-dependent cell-mediated cytotoxicity. Furthermore, apoptosis of monocytes or lymphocytes, or neutrophil degranulation have not been observed in vitro. A Tumor necrosis factor neutralizer Human Absorption There is a linear relationship between dose administered and Cmax and AUC. A mean Cmax of approximately 43 to 49 mcg/mL occurred at Week 5 during the initial loading dose period using the recommended dose regimen for the treatment of patients with rheumatoid arthritis (400 mg sc at Weeks 0, 2 and 4 followed by 200 mg every other week). Tmax, SubQ dose = 54 - 171 hours; Bioavailability, SubQ dose = 80% (range of 76% - 88%) Volume of distribution Vd, steady state, Crohn's and RA patients = 6 - 8 L Protein binding Not Available Metabolism Metabolism has not been studied in humans. Route of elimination The route of elimination of certolizumab pegol has not been studied in human subjects. Studies in animals indicate that the major route of elimination of the PEG component is via urinary excretion. Half life Terminal plasma elimation half-life = 14 days (for all doses); Clearance https://www.drugbank.ca/drugs/DB08904 5/13 9/19/2018 Certolizumab pegol - DrugBank Clearance IV dose, healthy subjects = 9.21 mL/h to 14.38 mL/h; SC dose, Crohn's disease patients = 17 mL/h; SC dose, RA patients = 21.0 mL/h; Toxicity The most common adverse reactions (incidence ≥7% and higher than placebo): upper respiratory tract infection, rash, and urinary tract infection. 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 ↑↓ Abatacept The risk or severity of infection can be increased when Certolizumab pegol is combined with Abatacept. Abciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Certolizumab pegol. Adalimumab The risk or severity of infection can be increased when Adalimumab is combined with Certolizumab pegol. Afelimomab The risk or severity of infection can be increased when Afelimomab is combined with Certolizumab pegol. Alclometasone The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Alclometasone. https://www.drugbank.ca/drugs/DB08904 6/13 9/19/2018 Certolizumab pegol - DrugBank DRUG ↑↓ INTERACTION ↑↓ Aldesleukin The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Aldesleukin. Alemtuzumab The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Alemtuzumab. Amcinonide The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Amcinonide. Amsacrine The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Amsacrine. Anakinra The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Anakinra. Showing 1 to 10 of 122 entries ‹ › Food Interactions Not Available REFERENCES General References 1. Chimenti MS, Saraceno R, Chiricozzi A, Giunta A, Chimenti S, Perricone R: Profile of certolizumab and its potential in the treatment of psoriatic arthritis. Drug Des Devel Ther. 2013 Apr 15;7:339-48. doi: 10.2147/DDDT.S31658. Print 2013. [PubMed:23620660] 2. Ferrante M, Vermeire S, Rutgeerts P: Certolizumab pegol in the treatment of Crohn's disease. Expert Opin Biol Ther. 2013 Apr;13(4):595-605. doi: 10.1517/14712598.2013.777039. Epub 2013 Mar 4. [PubMed:23451881] 3. Link [Link] External Links KEGG Drug D03441 PubChem Substance 347910385 ChEMBL CHEMBL1201831 PharmGKB PA165107055 RxList RxList Drug Page https://www.drugbank.ca/drugs/DB08904 7/13 9/19/2018 Certolizumab pegol - DrugBank RxList Drug Page Drugs.com Drugs.com Drug Page Wikipedia Certolizumab_pegol ATC Codes L04AB05 — Certolizumab pegol L04AB — Tumor necrosis factor alpha (TNF-α) inhibitors L04A — IMMUNOSUPPRESSANTS L04 — IMMUNOSUPPRESSANTS L — ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS AHFS Codes 92:36.00 — Disease-modifying Antirheumatic Agents 56:92.00 — Miscellaneous GI Drugs FDA label Download (595 KB) MSDS Download (479 KB) CLINICAL TRIALS Clinical Trials Search PHASE ↑↓ STATUS ↑↓ PURPOSE ↑↓ CONDITIONS ↑↓ COUNT ↑↓ 1 Active Not Treatment Adenocarcinoma of Lung
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