Our neuroscience pharmacist is being inundated with queries concerning MD's post last week about liver abnormalities on Glatopa, the Copaxone biosimilar or generic, that has recently been launched in the US.
For all UK patients please note that this formulation of the the drug is not available in the UK. All people with MS who are being treated with glatiramer acetate in the UK will be receiving the innovator compound or Copaxone. This warning does not apply to Copaxone.
Although there have been several cases of autoimmune hepatitis described in patients on Copaxone (see below) I have interpreted these cases as simply indicating that pwMS are susceptible to other autoimmune diseases such as autoimmune hepatitis.
Please note if you are on Copaxone you don't require any specific blood monitoring and you don't have to contact our MS team about this issue.
Please note my use of both biosimilar and generic to describe Glatopa. Glatiramer acetate is a so called non-biological complex drug and sits in the gray area between a biological (protein-based therapy) and a small molecule (chemical). The regulatory requirements around non-biological complex drugs is quite complex and there are major differences in how the FDA and EMA deal with them.
Case reports of liver toxicity in relation to Glatiramer Acetate
Flaire A, Carra-Dalliere C, Ayrignac X, Blanc P, Labauge P. Glatiramer acetate-induced hepatitis in a patient with multiple sclerosis. Acta Neurol Belg. 2016 Mar;116(1):99-100.
La Gioia S, Bacis G, Sonzogni A, Frigeni B, Conti MZ, Vedovello M, Rottoli M. Glatiramer acetate-induced hepatitis in a young female patient with multiple sclerosis. Mult Scler Relat Disord. 2014 Nov;3(6):732-4.
Sinagra E, Raimondo D, Cottone S, Guddo F, Gabriele Rizzo A, Amvrosiadis G, Perricone G, Cottone M, Madonia S. Does glatiramer acetate provoke hepatitis in multiple sclerosis? Mult Scler Relat Disord. 2014 Mar;3(2):266-8.
Fernández Fernández N, Joao Matias D, Pisabarros Blanco C, Rodríguez Martín L, Aparicio Cabezudo M, Linares Torres P, Hernando Martín M, Olcoz Goñi JL. [Hepatitis induced by glatiramer acetate]. Gastroenterol Hepatol. 2015 Apr;38(4):280-1.
Onmez A, Eminler AT, Ergenç H, Baykara M, Uslan I, Tamer A. Drug-Induced Liver Injury by Glatiramer Acetate Used for Treatment of Multiple Sclerosis: A Case Report. J Investig Med High Impact Case Rep. 2013 Dec 17;1(4):2324709613517493.
Subramaniam K, Pavli P, Llewellyn H, Chitturi S. Glatiramer acetate induced hepatotoxicity. Curr Drug Saf. 2012 Apr;7(2):186-8.
Arruti M, Castillo-Triviño T, de la Riva P, Martí-Massó JF, López de Munain A, Olascoaga J [Autoimmune hepatitis in a patient with multiple sclerosis under treatment with glatiramer acetate]. Rev Neurol. 2012 Aug 1;55(3):190-2.
Deltenre P, Peny MO, Dufour A, Nady ME, Henrion J. Acute hepatitis induced by glatiramer acetate. BMJ Case Rep. 2009;2009. pii: bcr09.2008.0913.
von Kalckreuth V, Lohse AW, Schramm C. Unmasking autoimmune hepatitis under immunomodulatory treatment of multiple sclerosis--not only beta interferon. Am J Gastroenterol. 2008 Aug;103(8):2147-8; author reply 2148.
Neumann H, Csepregi A, Sailer M, Malfertheiner P. Glatiramer acetate induced acute exacerbation of autoimmune hepatitis in a patient with multiple sclerosis. J Neurol. 2007 Jun;254(6):816-7.
CoI: multiple