certolizumab pegol (Cimzia)
Jump to navigation
Jump to search
Indications
- rheumatoid arthritis[2]*
- ankylosing spondylitis[2]*
- psoriatic arthritis[2][3]*
- plaque psoriasis[4]
- Crohn's disease[2]
* FDA-approved indications according to[2]
Contraindications
- PEGylated & unlikely to cross placenta[5]
- pregnancy outcomes similar to those reported for general population[5]
Dosage
- requires 2 SC injections given by a health care provider every 4 weeks
Monitor
- screening for tuberculosis[2]
- CBC, LFTs, serum creatinine at baseline & every 3-6 month thereafter[2]
Laboratory
- certolizumab in serum/plasma (no Loinc as of Aug 2017)
Mechanism of action
- Fab' segment of humanized monoclonal antibody
- PEGylated to extend its half-life
- inhibitor of TNF-alpha[2]
Notes
Cost is about $1500 per month (same as Humira)
More general terms
- recombinant protein; chimer
- pharmaceutical monoclonal antibody
- tumor necrosis factor (TNF) inhibitor
References
- ↑ Prescriber's Letter 15(6): 2008 New Drug: Cimzia (Certolizumab Pegol) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=240607&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ Jump up to: 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 Medical Knowledge Self Assessment Program (MKSAP) 16, 17, 18, 19. American College of Physicians, Philadelphia 2012, 2015, 2018, 2022.
- ↑ Jump up to: 3.0 3.1 Cimzia (certolizumab pegol) approved by the U.S. FDA for treatment of adult patients with active psoriatic arthritis. http://www.prnewswire.com/news-releases/cimzia-certolizumab-pegol-approved-by-the-us-fda-for-treatment-of-adult-patients-with-active-psoriatic-arthritis-225778051.html
- ↑ Jump up to: 4.0 4.1 Bankhead C American Academy of Dermatology Meeting Coverage 2017 Cimzia Passes Muster in Two Psoriasis Trials - Met primary efficacy goals versus placebo; third trial still to come. http://www.medpagetoday.com/MeetingCoverage/AAD/63625?xid=nl_mpt_DHE_2017-03-07&eun=g1094596d0r&pos=4
Gottlieb AB, et al Certolizumab pegol treatment for chronic plaque psoriasis: 16-week primary results from two phase III, multicenter, randomized, placebo-controlled studies. American Academy of Dermatology (AAD) 2017; Abstract 5077. - ↑ Jump up to: 5.0 5.1 5.2 Clowse MEB, Scheuerle AE, Chambers C et al. Pregnancy outcomes after exposure to certolizumab pegol: Updated results from a pharmacovigilance safety database. Arthritis Rheumatol 2018 Sep; 70:1399-1407 PMID: https://www.ncbi.nlm.nih.gov/pubmed/29623679
- ↑ Cimzia Prescribing information http://www.cimzia.com/pdf/Prescribing_Information.pdf