Mavenclad 用於治療具有高度活動性之復發型多發性硬化症 (RMS) 的成人患者。
Mavenclad is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) to include relapsing-remitting disease and active secondary progressive disease, to reduce the frequency of clinical exacerbations and delay the progression of physical disability.Mavenclad 是一種選擇性免疫重建療法 (Selective Immune Reconstitution Therapy),其有效成分 Cladribine 是一種去氧腺?類似物。
Mavenclad is a selective immune reconstitution therapy. Its active ingredient, Cladribine, is a nucleoside analogue of deoxyadenosine.口服給藥後,Cladribine 吸收迅速,絕對生物利用度約為 40%。藥物廣泛分布於組織,並能穿透血腦屏障。主要經由細胞內磷酸化代謝,並透過腎臟排泄。
Following oral administration, cladribine is rapidly absorbed with an absolute bioavailability of approximately 40%. It is widely distributed into tissues and crosses the blood-brain barrier. It is primarily metabolized by intracellular phosphorylation and excreted renally.禁忌症包括對 Cladribine 過敏者、感染人類免疫缺乏病毒 (HIV)、活動性慢性感染(如結核病或肝炎)、免疫功能低下者、惡性腫瘤患者、中度至重度肝功能不全者,以及懷孕或哺乳中女性。
Contraindications include hypersensitivity to cladribine, HIV infection, active chronic infections (e.g., tuberculosis or hepatitis), immunocompromised status, current malignancy, moderate to severe hepatic impairment, and pregnancy or breastfeeding.懷孕分級為 X 級。由於該藥物具有致畸胎性,育齡婦女在治療期間及最後一次給藥後至少 6 個月內必須採取有效避孕措施。
Pregnancy Category X. Due to the teratogenic potential, women of childbearing potential must use effective contraception during treatment and for at least 6 months after the last dose.哺乳期婦女禁用。若必須使用,應停止哺乳,且需於最後一次給藥後至少 1 週內避免哺乳。
Use is contraindicated during lactation. If treatment is necessary, breastfeeding must be discontinued and avoided for at least 1 week after the last dose.常見副作用包括上呼吸道感染、頭痛、淋巴球減少症。嚴重副作用包括帶狀?疹病毒再活化、惡性腫瘤風險增加及肝毒性。
Common side effects include upper respiratory tract infections, headache, and lymphopenia. Serious adverse reactions include varicella-zoster virus reactivation, increased risk of malignancy, and hepatotoxicity.建議累積劑量為 3.5 mg/kg,分為兩個療程(每年各治療兩個週次)。醫師需根據體重計算劑量,並評估淋巴球計數。
The recommended cumulative dosage is 3.5 mg/kg, administered over two treatment courses (two treatment weeks per year). Dosing is based on body weight and clinical assessment of lymphocyte counts.未確立18歲以下兒童及青少年使用本藥之安全性與有效性,不建議用於小兒族群。
The safety and efficacy of Mavenclad in children and adolescents under 18 years of age have not been established; use in the pediatric population is not recommended.
輕度腎功能不全患者無須調整劑量。中度至重度腎功能不全患者之安全性尚未評估,不建議使用。
No dose adjustment is required for patients with mild renal impairment. The safety of Mavenclad in patients with moderate to severe renal impairment has not been established and its use is not recommended.
輕度肝功能不全患者無須調整劑量。中度至重度肝功能不全患者之安全性尚未評估,不建議使用。
No dose adjustment is required for patients with mild hepatic impairment. The safety of Mavenclad in patients with moderate to severe hepatic impairment has not been established and its use is not recommended.