Peringatan Keamanan

The oral ld50 observed in mice is determined to be of 300 mg/kg.MSDS To this date, there have not been reports of overdosage, however, in case of accidental overexposure close monitoring is recommended.FDA label

Certolizumab pegol does not present mutagenic potential nor presents effects in fertility and reproductive performance. On the other hand, carcinogenicity studies have not been performed.FDA label

Certolizumab pegol

DB08904

biotech approved

Deskripsi

Certolizumab pegol is a pegylated monoclonal antibody against the tumor necrosis factor-alpha (TNF-alpha).A176585 It is formed with a humanized Fab fragment of 50 kDa, from an IgG 1 isotype, fused to a 40 kDa polyethylene glycol moiety replacing the Fc antibody region. The absence of the Fc region was ideated to prevent complement fixation and antibody-mediated cytotoxicity as well as to markedly increase its half-life.A176606

Certolizumab does not require glycosylation for active function and hence, its production is significantly more affordable when compared to other existing TNF-alpha therapies as it can be done directly in bacterial hosts such as E. coli.A176606 It was developed and manufactured by UCB Pharma, first FDA approved in 2008L45018 and updated for a new indication on March 28, 2019.L5819

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: Obat • Target • Gen • Enzim • (Panah → menunjukkan arah efek / relasi) • Transporter • Carrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) The circulatory half-life of certolizumab is of 14 days.[A176606]
Volume Distribusi Certolizumab pegol volume of distribution is reported to be in the range of 4-8 L.[A176666] It is known to have a very good distribution in the joints when compared to other TNF-alpha inhibitors.[A176645]
Klirens (Clearance) The clearance rate of certolizumab pegol ranged between 9-14 ml/h when administered intravenously. However, when administered subcutaneously, the clearance rate is estimated to range between 14-21 ml/h depending on the patient condition.[F4232]

Absorpsi

After subcutaneous administration, the peak plasma concentration is reached between 54 and 171 hours with a bioavailability of 80%.A176606 Certolizumab presents a linear pharmacokinetic profile with a peak plasma concentration of 43-49 mcg/ml.F4232

Metabolisme

The presence of PEG group in certolizumab pegol delays the metabolism and elimination of this drug. However, once under metabolism, the PEG group gets cleaved from the parent compound and the antibody section is thought to be internalized cells and rescued from metabolism by recycling. Later, it is degraded in the reticuloendothelial system to small peptides and amino acids which can be used for de-novo protein synthesis.A31470 On the other hand, the PEG section is processed normally by the action of the alcohol dehydrogenase to the formation of carboxylic acid.A176672

Rute Eliminasi

As certolizumab is a monoclonal antibody, the elimination route is not widely studied. However, it is known that the elimination of the PEG moiety is dependent on the renal function which links it directly with a high portion of renal elimination.A176606

Interaksi Obat

1869 Data
Denosumab The risk or severity of adverse effects can be increased when Denosumab is combined with Certolizumab pegol.
Peginterferon alfa-2a The risk or severity of adverse effects can be increased when Peginterferon alfa-2a is combined with Certolizumab pegol.
Interferon alfa-n1 The risk or severity of adverse effects can be increased when Interferon alfa-n1 is combined with Certolizumab pegol.
Interferon alfa-n3 The risk or severity of adverse effects can be increased when Interferon alfa-n3 is combined with Certolizumab pegol.
Peginterferon alfa-2b The risk or severity of adverse effects can be increased when Peginterferon alfa-2b is combined with Certolizumab pegol.
Interferon gamma-1b The risk or severity of adverse effects can be increased when Interferon gamma-1b is combined with Certolizumab pegol.
Interferon alfa-2a The risk or severity of adverse effects can be increased when Interferon alfa-2a is combined with Certolizumab pegol.
Aldesleukin The risk or severity of adverse effects can be increased when Aldesleukin is combined with Certolizumab pegol.
Gemtuzumab ozogamicin The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Certolizumab pegol.
Pegaspargase The risk or severity of adverse effects can be increased when Pegaspargase is combined with Certolizumab pegol.
Interferon beta-1b The risk or severity of adverse effects can be increased when Interferon beta-1b is combined with Certolizumab pegol.
Interferon alfacon-1 The risk or severity of adverse effects can be increased when Interferon alfacon-1 is combined with Certolizumab pegol.
Basiliximab The risk or severity of adverse effects can be increased when Basiliximab is combined with Certolizumab pegol.
Muromonab The risk or severity of adverse effects can be increased when Muromonab is combined with Certolizumab pegol.
Ibritumomab tiuxetan The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Certolizumab pegol.
Tositumomab The risk or severity of adverse effects can be increased when Tositumomab is combined with Certolizumab pegol.
Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Certolizumab pegol.
Alefacept The risk or severity of adverse effects can be increased when Alefacept is combined with Certolizumab pegol.
Efalizumab The risk or severity of adverse effects can be increased when Efalizumab is combined with Certolizumab pegol.
Antithymocyte immunoglobulin (rabbit) The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Certolizumab pegol.
Interferon alfa-2b The risk or severity of adverse effects can be increased when Interferon alfa-2b is combined with Certolizumab pegol.
Daclizumab The risk or severity of adverse effects can be increased when Daclizumab is combined with Certolizumab pegol.
Phenylalanine The risk or severity of adverse effects can be increased when Phenylalanine is combined with Certolizumab pegol.
Cladribine Certolizumab pegol may increase the immunosuppressive activities of Cladribine.
Amsacrine The risk or severity of adverse effects can be increased when Amsacrine is combined with Certolizumab pegol.
Bleomycin The risk or severity of adverse effects can be increased when Bleomycin is combined with Certolizumab pegol.
Chlorambucil The risk or severity of adverse effects can be increased when Chlorambucil is combined with Certolizumab pegol.
Raltitrexed The risk or severity of adverse effects can be increased when Raltitrexed is combined with Certolizumab pegol.
Mitomycin The risk or severity of adverse effects can be increased when Mitomycin is combined with Certolizumab pegol.
Floxuridine The risk or severity of adverse effects can be increased when Floxuridine is combined with Certolizumab pegol.
Tioguanine The risk or severity of adverse effects can be increased when Tioguanine is combined with Certolizumab pegol.
Dexrazoxane The risk or severity of adverse effects can be increased when Dexrazoxane is combined with Certolizumab pegol.
Streptozocin The risk or severity of adverse effects can be increased when Streptozocin is combined with Certolizumab pegol.
Trifluridine The risk or severity of adverse effects can be increased when Trifluridine is combined with Certolizumab pegol.
Gemcitabine The risk or severity of adverse effects can be increased when Gemcitabine is combined with Certolizumab pegol.
Epirubicin The risk or severity of adverse effects can be increased when Epirubicin is combined with Certolizumab pegol.
Chloramphenicol The risk or severity of adverse effects can be increased when Chloramphenicol is combined with Certolizumab pegol.
Lenalidomide The risk or severity of adverse effects can be increased when Lenalidomide is combined with Certolizumab pegol.
Altretamine The risk or severity of adverse effects can be increased when Altretamine is combined with Certolizumab pegol.
Cisplatin The risk or severity of adverse effects can be increased when Cisplatin is combined with Certolizumab pegol.
Oxaliplatin The risk or severity of adverse effects can be increased when Oxaliplatin is combined with Certolizumab pegol.
Propylthiouracil The risk or severity of adverse effects can be increased when Propylthiouracil is combined with Certolizumab pegol.
Pentostatin The risk or severity of adverse effects can be increased when Pentostatin is combined with Certolizumab pegol.
Linezolid The risk or severity of adverse effects can be increased when Linezolid is combined with Certolizumab pegol.
Clofarabine The risk or severity of adverse effects can be increased when Clofarabine is combined with Certolizumab pegol.
Methimazole The risk or severity of adverse effects can be increased when Methimazole is combined with Certolizumab pegol.
Sulfasalazine The risk or severity of adverse effects can be increased when Sulfasalazine is combined with Certolizumab pegol.
Temozolomide The risk or severity of adverse effects can be increased when Temozolomide is combined with Certolizumab pegol.
Penicillamine The risk or severity of adverse effects can be increased when Penicillamine is combined with Certolizumab pegol.
Mechlorethamine The risk or severity of adverse effects can be increased when Mechlorethamine is combined with Certolizumab pegol.
Azacitidine The risk or severity of adverse effects can be increased when Azacitidine is combined with Certolizumab pegol.
Carboplatin The risk or severity of adverse effects can be increased when Carboplatin is combined with Certolizumab pegol.
Dactinomycin The risk or severity of adverse effects can be increased when Dactinomycin is combined with Certolizumab pegol.
Hydroxyurea The risk or severity of adverse effects can be increased when Hydroxyurea is combined with Certolizumab pegol.
Mycophenolic acid The risk or severity of adverse effects can be increased when Mycophenolic acid is combined with Certolizumab pegol.
Topotecan The risk or severity of adverse effects can be increased when Topotecan is combined with Certolizumab pegol.
Mercaptopurine The risk or severity of adverse effects can be increased when Mercaptopurine is combined with Certolizumab pegol.
Melphalan The risk or severity of adverse effects can be increased when Melphalan is combined with Certolizumab pegol.
Fludarabine The risk or severity of adverse effects can be increased when Fludarabine is combined with Certolizumab pegol.
Flucytosine The risk or severity of adverse effects can be increased when Flucytosine is combined with Certolizumab pegol.
Procarbazine The risk or severity of adverse effects can be increased when Procarbazine is combined with Certolizumab pegol.
Arsenic trioxide The risk or severity of adverse effects can be increased when Arsenic trioxide is combined with Certolizumab pegol.
Mitoxantrone The risk or severity of adverse effects can be increased when Mitoxantrone is combined with Certolizumab pegol.
Lomustine The risk or severity of adverse effects can be increased when Lomustine is combined with Certolizumab pegol.
Eculizumab The risk or severity of adverse effects can be increased when Eculizumab is combined with Certolizumab pegol.
Decitabine The risk or severity of adverse effects can be increased when Decitabine is combined with Certolizumab pegol.
Nelarabine The risk or severity of adverse effects can be increased when Nelarabine is combined with Certolizumab pegol.
Stepronin The risk or severity of adverse effects can be increased when Stepronin is combined with Certolizumab pegol.
Castanospermine The risk or severity of adverse effects can be increased when Castanospermine is combined with Certolizumab pegol.
Vorinostat The risk or severity of adverse effects can be increased when Vorinostat is combined with Certolizumab pegol.
2-Methoxyethanol The risk or severity of adverse effects can be increased when 2-Methoxyethanol is combined with Certolizumab pegol.
Brequinar The risk or severity of adverse effects can be increased when Brequinar is combined with Certolizumab pegol.
Interferon alfa The risk or severity of adverse effects can be increased when Interferon alfa is combined with Certolizumab pegol.
Glatiramer The risk or severity of adverse effects can be increased when Glatiramer is combined with Certolizumab pegol.
Briakinumab The risk or severity of adverse effects can be increased when Briakinumab is combined with Certolizumab pegol.
Human interferon omega-1 The risk or severity of adverse effects can be increased when Human interferon omega-1 is combined with Certolizumab pegol.
Mepolizumab The risk or severity of adverse effects can be increased when Mepolizumab is combined with Certolizumab pegol.
Abetimus The risk or severity of adverse effects can be increased when Abetimus is combined with Certolizumab pegol.
Belatacept The risk or severity of adverse effects can be increased when Belatacept is combined with Certolizumab pegol.
Pralatrexate The risk or severity of adverse effects can be increased when Pralatrexate is combined with Certolizumab pegol.
Wortmannin The risk or severity of adverse effects can be increased when Wortmannin is combined with Certolizumab pegol.
Eribulin The risk or severity of adverse effects can be increased when Eribulin is combined with Certolizumab pegol.
Belimumab The risk or severity of adverse effects can be increased when Belimumab is combined with Certolizumab pegol.
Teriflunomide The risk or severity of adverse effects can be increased when Teriflunomide is combined with Certolizumab pegol.
Carfilzomib The risk or severity of adverse effects can be increased when Carfilzomib is combined with Certolizumab pegol.
Dimethyl fumarate The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Dimethyl fumarate.
Obinutuzumab The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Obinutuzumab.
Secukinumab The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Secukinumab.
Siltuximab The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Siltuximab.
Blinatumomab The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Blinatumomab.
Dinutuximab The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Dinutuximab.
Tixocortol The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Tixocortol.
Peginterferon beta-1a The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Peginterferon beta-1a.
Antilymphocyte immunoglobulin (horse) The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Antilymphocyte immunoglobulin (horse).
Tepoxalin The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Tepoxalin.
Ixekizumab The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Ixekizumab.
Ravulizumab The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Ravulizumab.
Pirarubicin The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Pirarubicin.
Voclosporin The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Voclosporin.
Peficitinib The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Peficitinib.

Target Protein

Tumor necrosis factor TNF

Referensi & Sumber

Artikel (PubMed)
  • PMID: 28976302
    Corbett M, Chehadah F, Biswas M, Moe-Byrne T, Palmer S, Soares M, Walton M, Harden M, Ho P, Woolacott N, Bojke L: Certolizumab pegol and secukinumab for treating active psoriatic arthritis following inadequate response to disease-modifying antirheumatic drugs: a systematic review and economic evaluation. Health Technol Assess. 2017 Oct;21(56):1-326. doi: 10.3310/hta21560.
  • PMID: 28550592
    Bermejo I, Stevenson M, Archer R, Stevens JW, Goka E, Clowes M, Scott DL, Young A: Certolizumab Pegol for Treating Rheumatoid Arthritis Following Inadequate Response to a TNF-alpha Inhibitor: An Evidence Review Group Perspective of a NICE Single Technology Appraisal. Pharmacoeconomics. 2017 Nov;35(11):1141-1151. doi: 10.1007/s40273-017-0521-5.
  • PMID: 27843368
    Acosta-Felquer ML, Rosa J, Soriano ER: An evidence-based review of certolizumab pegol in the treatment of active psoriatic arthritis: place in therapy. Open Access Rheumatol. 2016 Mar 30;8:37-44. doi: 10.2147/OARRR.S56837. eCollection 2016.
  • PMID: 16478695
    Tabrizi MA, Tseng CM, Roskos LK: Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov Today. 2006 Jan;11(1-2):81-8. doi: 10.1016/S1359-6446(05)03638-X.
  • PMID: 28280401
    D'Angelo S, Tramontano G, Gilio M, Leccese P, Olivieri I: Review of the treatment of psoriatic arthritis with biological agents: choice of drug for initial therapy and switch therapy for non-responders. Open Access Rheumatol. 2017 Mar 2;9:21-28. doi: 10.2147/OARRR.S56073. eCollection 2017.
  • PMID: 28124979
    Lee JU, Shin W, Son JY, Yoo KY, Heo YS: Molecular Basis for the Neutralization of Tumor Necrosis Factor alpha by Certolizumab Pegol in the Treatment of Inflammatory Autoimmune Diseases. Int J Mol Sci. 2017 Jan 23;18(1). pii: ijms18010228. doi: 10.3390/ijms18010228.
  • PMID: 18161752
    Bradley JR: TNF-mediated inflammatory disease. J Pathol. 2008 Jan;214(2):149-60. doi: 10.1002/path.2287.
  • PMID: 28353055
    Vande Casteele N, Mould DR, Coarse J, Hasan I, Gils A, Feagan B, Sandborn WJ: Accounting for Pharmacokinetic Variability of Certolizumab Pegol in Patients with Crohn's Disease. Clin Pharmacokinet. 2017 Dec;56(12):1513-1523. doi: 10.1007/s40262-017-0535-3.
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