Izquierdo Iñaki, Casas Laia, Cabrera Susana, Fernandez Alberto
Medical Advice Department, BIOHORM S.L., Palau-Solità i Plegamans, Barcelona, Spain.
Clinical & Preclinical Development, Strategy and Innovation Department, BIOHORM S.L., Palau-Solità i Plegamans, Barcelona, Spain.
Drugs Context. 2024 Jan 18;13. doi: 10.7573/dic.2023-9-5. eCollection 2024.
The off-label use of second-generation antihistamines, used outside of the formal indications authorized by regulatory authorities, in different age groups, doses or in special populations, is very common for many allergic, autoimmune and dermatological diseases. The off-label use of rupatadine (a second-generation antihistamine with PAF antagonist activity) in these conditions is reviewed here, including in combination with immunotherapy in the treatment of food allergy or allergic rhinitis, at high doses in chronic urticaria, and with prescriptions of less common but challenging conditions such as skin pruritus or mast cell activation disorders like mastocytosis. Rupatadine use is reviewed herein to confirm if its off-label management is supported by well-designed clinical trials or by published real-world cases. This review will contribute to increasing compliance and achieving better results in clinical practice. Off-label use of rupatadine should be left to the discretion of the prescribing healthcare professional after careful clinical evaluation.
第二代抗组胺药在监管机构批准的正式适应症范围之外，用于不同年龄组、剂量或特殊人群，在许多过敏性、自身免疫性和皮肤病疾病中非常普遍。本文综述了卢帕他定（一种具有PAF拮抗剂活性的第二代抗组胺药）在这些情况下的非标签使用，包括与免疫疗法联合用于治疗食物过敏或过敏性鼻炎、在慢性荨麻疹中使用高剂量，以及用于一些不太常见但具有挑战性的病症，如皮肤瘙痒或肥大细胞活化障碍（如肥大细胞增多症）的处方。本文对卢帕他定的使用进行综述，以确认其非标签用药是否有精心设计的临床试验或已发表的真实病例支持。本综述将有助于提高临床实践中的依从性并取得更好的效果。卢帕他定的非标签使用应在经过仔细的临床评估后由开处方的医疗保健专业人员自行决定。
