Your browser doesn't support javascript.
loading
Appropriate use of generic and branded antiseizure medications in epilepsy: Updated recommendations from the Italian League Against Epilepsy (LICE).
Roberti, Roberta; Casarella, Alessandro; Iudice, Alfonso; La Neve, Angela; Beghi, Ettore; Capovilla, Giuseppe; Di Bonaventura, Carlo; Giorgi, Filippo S; Grosso, Salvatore; Iannone, Luigi F; Romigi, Andrea; Specchio, Luigi M; Zaccara, Gaetano; Mecarelli, Oriano; Russo, Emilio.
Afiliação
  • Roberti R; Science of Health Department, School of Medicine, University of Catanzaro, Italy.
  • Casarella A; Science of Health Department, School of Medicine, University of Catanzaro, Italy.
  • Iudice A; Department of Clinical and Experimental Medicine, Section of Neurology, University of Pisa, Pisa, Italy.
  • La Neve A; Department of Neurological and Psychiatric Sciences, Centre for Epilepsy, University of Bari, Bari, Italy.
  • Beghi E; Laboratory of Neurological Disorders, Department of Neuroscience, Institute for Pharmacological Research, IRCCS-Mario Negri Milan, Italy.
  • Capovilla G; Department of Mental Health, Epilepsy Center, C. Poma Hospital, Mantua, Italy and Fondazione Poliambulanza, Brescia, Italy.
  • Di Bonaventura C; Neurology Unit, Department of Human Neurosciences, "Sapienza" University, Rome, Italy.
  • Giorgi FS; Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy; Neurology, Pisa University Hospital, Pisa, Italy.
  • Grosso S; Clinical Pediatrics, Department of Pediatrics, University of Siena.
  • Iannone LF; Science of Health Department, School of Medicine, University of Catanzaro, Italy.
  • Romigi A; Department of Neurology, Mediterranean Neurological Institute, Pozzilli, Italy.
  • Specchio LM; University of Foggia, Foggia, Italy.
  • Zaccara G; Regional Health Agency of Tuscany, Firenze, Italy.
  • Mecarelli O; Neurology Unit, Human Neurosciences Department, Sapienza University, Umberto 1 Hospital, Rome, Italy.
  • Russo E; Science of Health Department, School of Medicine, University of Catanzaro, Italy. Electronic address: erusso@unicz.it.
Epilepsy Behav ; 116: 107804, 2021 03.
Article em En | MEDLINE | ID: mdl-33581599
Generic drugs are increasingly used to treat many diseases including epilepsy. The growing importance of generic antiseizure medications (ASMs) has led the ASMs commission of the Italian League Against Epilepsy (LICE) to review current evidence in the literature about efficacy and safety of these products. Recommendations from other scientific organizations have also been considered to provide an update of the LICE position about their utilization (List of Recommendations). Compared with the previous literature review, randomized controlled trials assessing bioequivalence among branded drugs and generics are currently available. Although some contrasting results have been reported, brand-to-generic switching was effective and tolerable in real-life settings, with similar adverse event ratios. Based on these findings, LICE concluded that, conforming to the rigorous regulation of USA and EU markets, generic ASMs are not inferior to the respective branded, providing a cost advantage for patients starting or replacing monotherapy or add-on, and for those with incomplete seizure control. Branded-to-generic (and vice versa) switching is not recommended (although applicable) during seizure remission, as well as the generic-to-other generic switching. Other recommendations focus on the appropriateness of therapeutic drug monitoring (TDM) when switching is required, paying attention to avoiding the erroneous switch between modified and immediate-release formulations during dispensation. Finally, to support patients' compliance, they should be assured of generics' safety and efficacy and carefully informed with practical advice, particularly when the switching is associated with aspect modifications (e.g. color and shape changes) of the pill or the packaging.
Assuntos
Palavras-chave

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Epilepsia / Ftirápteros Idioma: En Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Epilepsia / Ftirápteros Idioma: En Ano de publicação: 2021 Tipo de documento: Article