Ixekizumab Overdose: A Case Report

Main Article Content

Margaret L. Snyder, MD
Mark G. Lebwohl, MD

Keywords

biologic overdose, ixekizumab overdose

Abstract

Biologics, defined as medicinal products derived from living cells, are currently some of the most studied pharmaceutical agents and constitute a large portion of recent therapeutic breakthroughs in clinical trials. Relatively novel to the scientific and medical community, insulin was the first biologic agent to be FDA-approved in the 1980’s.1 Since that time, the development of therapeutic monoclonal antibodies by Milstein and Kohler has revolutionized modern medicine, with over 100 products currently on the market for the prevention and treatment of infectious, neoplastic, autoimmune, and inflammatory diseases.2,3 Despite the remarkable clinical success that monoclonal antibodies have achieved since their development, safety data is still limited due to the relatively short duration of time these products have been available. Specifically, there is a considerable paucity of information regarding inadvertent biologic overdose, with most package inserts simply advising clinicians to monitor their patients for symptoms. Due to complex dosing schedules as well as increasing use of these agents, it is likely that healthcare providers will encounter cases of patients accidentally self-administering larger than recommended doses. It is thus imperative to have more data on maximum tolerated doses in order for clinicians to educate and care for their patients in the case of accidental biologic overdose. We therefore present a case of inadvertent administration of a higher than recommended dose of ixekizumab and review the available literature on biologic overdoses.

References

1. Refs Vecchio I, Tornali C, Bragazzi NL, Martini M. The Discovery of Insulin: An Important Milestone in the History of Medicine. Frontiers in Endocrinology 2018;9:613.

2. Kohler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 1975;256:495–7.

3. Kohler G, Milstein C. Derivation of specific antibody-producing tissue culture and tumor lines by cell fusion. Eur J Immunol 1976;6:511–9.

4. Emery P, Rondon J, Parrino J, Lin Y, Pena-Rossi C, Van Hoogstraten H, et al. Safety and tolerability of subcutaneous sarilumab and intravenous tocilizumab in patients with rheumatoid arthritis. Rheumatology (Oxford, England) 2019; 58(5):849-858.

5. Tocilizumab [package insert]. South San Francisco, CA: Genentech, Inc.; 2010.

6. Infliximab [package insert]. Thousand Oaks, CA: Amgen, Inc.; 2019.

7. Secukinumab [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2015.

8. Taliercio M, Alessa D, Kessler DB. Inadvertent Overdose of Secukinumab, Consequences, and Cautions. Journal of Psoriasis and Psoriatic Arthritis 2016; 1(4):147-9.

9. Navarini AA, Muster MA, Kolios AG, Frische P, Glatz M, French LE, et al. Weight-Based Adaptation of TNF-Antagonist Induction versus Maintenance Dose. Case Reports in Dermatology 2011; 3(2):124-9.

10. Molimard M, de Blay F, Didier A, Le Gros V. Effectiveness of omalizumab (Xolair) in the first patients treated in real-life practice in France. Respiratory Medicine 2008; 102(1):71-6.

11. Alemtuzumab [package insert]. Cambridge, MA: Genzyme Corporation; 2001.

12. Chung ES, Packer M, Hung Lo K, Fasanmade AA, Willerson JT. Randomized, double-blind, placebo-controlled, pilot trial of infliximab, a chimeric monoclonal antibody to tumor necrosis factor-alpha, in patients with moderate-to-severe heart failure: results of the anti-TNF Therapy Against Congestive Heart Failure (ATTACH) trial. Circulation 2003;107(25):3133-40.

13. Belimumab [package insert]. Rockville, MA: Human Genome Sciences, Inc.; 2018.

14. Certolizumab [package insert]. Smyrna, GA: UCB, Inc.; 2008.

15. Golimumab [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2009.

16. Omalizumab [package insert]. South San Francisco, CA: Genentech, Inc.; 2003.