ABSTRACT
Our article "Fingolimod: Assay analysis of US generic capsule products reveals variation in fingolimod content beyond the recommended acceptance criteria" highlighted the variation of active ingredient in generic fingolimod capsule products. This analysis was prompted by reports of clinical adverse events and/or multiple sclerosis relapse in patients following transition from Gilenya® fingolimod capsules (Novartis) to generic fingolimod capsule products. Further assay analysis functioned to both confirm previous out-of-specification findings, and to identify an additional generic product that failed to comply with United States Pharmacopeia (USP) recommendations.
Subject(s)
Multiple Sclerosis, Relapsing-Remitting , Multiple Sclerosis , Humans , Fingolimod Hydrochloride/therapeutic use , Immunosuppressive Agents/therapeutic use , Multiple Sclerosis, Relapsing-Remitting/drug therapy , Multiple Sclerosis, Relapsing-Remitting/chemically induced , Multiple Sclerosis/drug therapy , Multiple Sclerosis/chemically inducedABSTRACT
The immunomodulating agent fingolimod is a sphingosine-1-phosphate receptor modulator used in the treatment of multiple sclerosis (MS). We analyzed three FDA approved fingolimod 0.5 mg generic capsule products for fingolimod content. Assay results demonstrated a wide variation in fingolimod content between manufacturers, with one product demonstrating a fingolimod content of 76.8 % of the approved dose. This falls significantly below the FDA acceptance criteria of 90.0-110.0 % of label claim.
