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<p>Numerous antiseizure medications (ASM) are available for the treatment of epilepsy and are approved for specific indications and age groups based on clinical studies; however, the wide variety of epilepsy types and syndromes often requires off-label use of ASM when patients do not achieve freedom from seizures under the current treatment or cannot tolerate it. The same is true for the use of various immunosuppressive drugs for the treatment of seizures and epilepsy as a result of autoimmune encephalitis, with the difference that no approved drugs are currently available. Off-label use refers to the administration of a&#xa0;medication outside its approved indications, dosages or age groups. This occurs particularly often in epilepsy treatment, such as in children below the approved age, in generalized epilepsies or in developmental and epileptic encephalopathies. Although the off-label use provides additional treatment options it leads to several challenges in the clinical practice. Clinical data on safety and efficacy are often lacking leading to uncertainties regarding dosage and potential adverse events. Patients and caregivers should be informed about the benefits and risks, accompanied by comprehensive documentation of the decision-making process. As off-label use is not routinely covered by health insurance companies, prior clarification of cost coverage is important, especially for expensive novel substances under patent protection, to avoid financial risks.</p>

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Off-label-Use von anfallssuppressiver und immunsuppressiver Medikation bei Epilepsien

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年1月15日

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  • Adam Strzelczyk,
  • Sebastian von Stuckrad-Barre,
  • Gerhard Kurlemann,
  • Thomas Bast,
  • Nico Melzer,
  • Felix Rosenow,
  • Susanne Schubert-Bast

摘要

Numerous antiseizure medications (ASM) are available for the treatment of epilepsy and are approved for specific indications and age groups based on clinical studies; however, the wide variety of epilepsy types and syndromes often requires off-label use of ASM when patients do not achieve freedom from seizures under the current treatment or cannot tolerate it. The same is true for the use of various immunosuppressive drugs for the treatment of seizures and epilepsy as a result of autoimmune encephalitis, with the difference that no approved drugs are currently available. Off-label use refers to the administration of a medication outside its approved indications, dosages or age groups. This occurs particularly often in epilepsy treatment, such as in children below the approved age, in generalized epilepsies or in developmental and epileptic encephalopathies. Although the off-label use provides additional treatment options it leads to several challenges in the clinical practice. Clinical data on safety and efficacy are often lacking leading to uncertainties regarding dosage and potential adverse events. Patients and caregivers should be informed about the benefits and risks, accompanied by comprehensive documentation of the decision-making process. As off-label use is not routinely covered by health insurance companies, prior clarification of cost coverage is important, especially for expensive novel substances under patent protection, to avoid financial risks.