Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine
AUDIENCE: Patient, Health Professional, Neurology, Pharmacy
ISSUE: FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.
BACKGROUND: Gilenya is one of several medicines approved to treat a form of MS called relapsing MS, which are periods of time when MS symptoms get worse. The medicine was approved in the United States in 2010.
RECOMMENDATION:
Healthcare professionals should:
．Inform patients before starting treatment about the potential risk of severe increase in disability after stopping Gilenya.
．Patients should be carefully observed for evidence of an exacerbation of their MS and treated appropriately when Gilenya is stopped.
．Patients should be advised to seek immediate medical attention if they experience new or worsened symptoms of MS after Gilenya is stopped.
．Test for new or enhancing lesions by magnetic resonance imaging (MRI) if an increase in disability occurs and begin appropriate treatment as needed.
．Encourage patients to read the patient Medication Guide they receive with their Gilenya prescriptions, which explains the benefits and risks of the medicine.
Patients who have been instructed to stop Gilenya, should contact your health professional immediately if you experience new or worsened symptoms such as:
．Weakness
．trouble using arms or legs
．changes in thinking, eyesight or balance.
Patients should not stop taking the medicine on their own and should speak to their health professional first, as stopping treatment can lead to worsening MS symptoms.
Gilenya (fingolimod)為治療復發性多發性硬化症(multiple sclerosis, 簡稱MS)之藥品。美國FDA發布藥物安全警訊，Gilenya一旦停藥，MS的症狀可能惡化，比開始用藥前或使用藥品期間更嚴重。這種多發性硬化症的惡化雖然罕見，但可能會造成永久性失能。
醫療專業人員應注意事項：
1. 開始使用藥品治療前應告知病人，停止使用Gilenya可能增加嚴重失能之潛在風險。
2. 當病人停止使用Gilenya時，應小心監測是否有出現MS惡化的徵兆，並接受適當的治療。
3. 應告知病人，Gilenya停止後若出現新的或惡化的症狀，應立即就醫。
4. 如果失能的狀況增加，需使用核磁共振（MRI）檢測是否有新的或增強的病灶，並開始適當的治療。
5. 鼓勵病人閱讀Gilenya之藥品說明書及用藥指南，以了解該藥的益處和風險。
病人應注意事項：
停止使用Gilenya的病人，如果出現新的或惡化的症狀，應立即聯繫醫療專業人員，例如：無力、無法順利執行手臂或腿部的動作或思維、視力、平衡的改變。停止治療會導致MS症狀惡化，因此病人不應該自行停止藥物，停藥前應該先與醫療專業人員確認。
相關訊息與其他完整的建議請參考FDA網址：
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm626264.htm?utm_campaign=FDA%20MedWatch%20-%20Gilenya%20%28fingolimod%29%3A&utm_medium=email&utm_source=Eloqua
[Posted 11/20/2018]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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