infliximab (Remicade)
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Introduction
- FDA-approved April 2016 infliximab-dyyb (Inflectra)[11]
- FDA-approved April 2017 infliximab-abda (Renflexis)[12]
Indications
- Crohn's disease, ulcerative colitis[4][6][7][8]
- rheumatoid arthritis[8]
- severe psoriasis refractory to standard therapy[6]
- psoriatic arthritis[8]
- ankylosing spondylitis[8]
- subcorneal pustular dermatosis[9]
Contraindications
- hypersensitivity to murine proteins
- discontinue use in patients with serious infections or sepsis
- do not initiate therapy in patients with active infections, including chronic or localized infections*
- heart failure[3]
- concurrent use of other biologic agent (abatacept, rituximab, anakinra, other TNF inhibitor)
* Screening for tuberculosis recommended prior to initiating therapy
Precautions:
- may exacerbate multiple sclerosis
Dosage
- Crohn's disease:
- 5 mg/kg IV
- additional doses at 2 & 6 weeks after initial dose
- rheumatoid arthritis
- 10 mg/kg IV
- used in combination with methotrexate
- additional infusion(s) 6-12 weeks after initial infusion
- IV infusion over 2 hours
- normal saline is used as a diluent
Store lyophylized at 2-8 degrees C
Pharmacokinetics
- maximum concentration of 118 ug/mL
- median volume of distribution: 3 liters
- corticosteroid use increases volume of distribution from 2.8-3.3 liters
- terminal 1/2life of 9.5 days
Monitor
- screening for tuberculosis[8]
- CBC, LFTs, serum creatinine at baseline & every 2-3 months thereafter[8]
Adverse effects
- infusion-related reactions:
- may increase risk of tuberculosis[2]
- may worsen heart failure[3]
- may increase risk of serious infections[5][10]
- no increase in infections when given within 4 weeks of hip replacement or knee replacement[14]
- may increase risk of malignancy[5]
- drug-induced lupus erythematosus[8]
- serum sickness-like reaction to murine light & heavy chain variable regions
- drug adverse effects of immunosuppressive agents
- drug adverse effects of tumor necrosis factor (TNF) inhibitors
- drug adverse effects of biologic immunosuppressive agents
- drug adverse effects of pharmaceutical monoclonal antibodies
Drug interactions
- recommended that live vaccines NOT be given concurrently
- drug interaction(s) of methotrexate with biological response modifier
- drug interaction(s) of biologic immunosuppressive agents
Laboratory
Mechanism of action
- chimeric (mouse-human) monoclonal antibody to TNF-alpha (partially humanized mouse monoclonal Ab)[8]
- binds to both transmembrane & soluble TNF-alpha
- inhibits binding of TNF-alpha to TNFRSF1A/TNFRSF1B TNF receptors
Notes
- 2017 Medicare part D cost: $17,335/year, out of pocket $3432[15]
More general terms
- recombinant protein; chimer
- pharmaceutical monoclonal antibody
- tumor necrosis factor (TNF) inhibitor
More specific terms
Additional terms
References
- ↑ DrugDex Drug Evaluation, 2000
- ↑ 2.0 2.1 Prescriber's Letter 8(10):58 2001
- ↑ 3.0 3.1 3.2 Prescriber's Letter 10(7):39 2003
- ↑ 4.0 4.1 Prescriber's Letter 12(9): 2005 Drug Therapy for Ulcerative colitis Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=211112&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 5.0 5.1 5.2 Prescriber's Letter 13(7): 2006 Safety Concerns of Anti-TNF Antibody Therapy Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220711&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 6.0 6.1 6.2 Fidder H et al. Long-term safety of infliximab for the treatment of inflammatory bowel disease: A single-centre cohort study. Gut 2009 Apr; 58:501. PMID: https://www.ncbi.nlm.nih.gov/pubmed/18832524
- ↑ 7.0 7.1 FDA NEWS RELEASE: Sept. 23, 2011 FDA approves Remicade to treat ulcerative colitis in children older than 6 years http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm272997.htm
- ↑ 8.00 8.01 8.02 8.03 8.04 8.05 8.06 8.07 8.08 8.09 8.10 Medical Knowledge Self Assessment Program (MKSAP) 16, 17, 18, 19. American College of Physicians, Philadelphia 2012, 2015, 2018, 2022
- ↑ 9.0 9.1 Deprecated Reference
- ↑ 10.0 10.1 Kalb RE, Fiorentino DF, Lebwohl MG et al Risk of Serious Infection With Biologic and Systemic Treatment of Psoriasis: Results From the Psoriasis Longitudinal Assessment and Registry (PSOLAR). JAMA Dermatol. 2015 May 13 PMID: https://www.ncbi.nlm.nih.gov/pubmed/25970800
- ↑ 11.0 11.1 FDA News Release. April 5, 2016 FDA approves Inflectra, a biosimilar to Remicade http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm
- ↑ 12.0 12.1 Brooks M FDA Clears Second Remicade Biosimilar (Renflexis) Medscape. April 21, 2017 http://www.medscape.com/viewarticle/878963
- ↑ Keane J, Gershon S, Wise RP et al Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med. 2001 Oct 11;345(15):1098-104. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/11596589 Free Article <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa011110
- ↑ 14.0 14.1 George MD, Baker JF, Hsu JY et al. Perioperative timing of infliximab and the risk of serious infection after elective hip and knee arthroplasty. Arthritis Care Res (Hoboken) 2017 Dec; 69:1845 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28129484 <Internet> http://onlinelibrary.wiley.com/doi/10.1002/acr.23209/abstract
- ↑ 15.0 15.1 Yazdany J, Dudley RA, Lin GA et al Out-of-Pocket Costs for Infliximab and Its Biosimilar for Rheumatoid Arthritis Under Medicare Part D. JAMA. 2018;320(9):931-933 PMID: https://www.ncbi.nlm.nih.gov/pubmed/30193264 https://jamanetwork.com/journals/jama/fullarticle/2698912