Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: FDA is warning health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir.
The agency is not aware of instances of this reduced activity occurring in the clinical setting but, is continuing to evaluate all data related to remdesivir.
BACKGROUND: Following an evaluation of the emergency use authorization criteria and the scientific evidence available, the FDA issued an emergency use authorization (EUA) in May 2020 allowing for remdesivir to be distributed in the U.S. and to be administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and pediatric patients hospitalized with severe disease. The safety and efficacy of remdesivir for the treatment of COVID-19 continue to be evaluated, and preliminary clinical trial results have shown that on average, patients treated with remdesivir had more rapid time to recovery.
RECOMMENDATION: It is recommended that health care providers read the most up-to-date fact sheet when prescribing remdesivir. These fact sheets include information on possible side effects such as: increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and allergic reactions, which may include low blood pressure, high heart rate, low heart rate, shortness of breath, wheezing, angioedema (for example, lip or tongue swelling), difficulty swallowing, rash, nausea, vomiting, sweating, shivering and respiratory distress.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/safety/medical-product-safety-information/remdesivir-gilead-sciences-fda-warns-newly-discovered-potential-drug-interaction-may-reduce?utm_campaign=FDA%20MedWatch%20Remdesivir%20by%20Gilead%20Sciences%3A%20FDA%20Warns%20of%20Newly&utm_medium=email&utm_source=Eloqua
美國FDA提醒醫療專業人員，不建議將remdesivir與chloroquine phosphate或hydroxychloroquine sulfate併用，因在體外試驗中發現，此併用可能導致remdesivir的抗病毒活性降低。美國FDA尚無法得知臨床實際合併使用時，此抗病毒活性降低是否會降低，與remdesivir相關的資訊仍持續評估中。
根據緊急使用授權（emergency use authorization, EUA）之標準及相關科學證據，美國FDA在2020年5月發布緊急使用授權，允許remdesivir在美國使用，由醫療專業人員於適當情況下使用remdesivir靜脈注射，治療疑似或檢驗結果證實因COVID-19感染而住院之嚴重成人和兒童患者。Remdesivir之安全性和療效仍持續評估中，初步臨床試驗結果證實，接受remdesivir治療的患者平均恢復時間更快。
建議醫療專業人員在處方remdesivir時閱讀最新的仿單或藥品使用說明。這些使用說明包含可能出現的副作用，例如：肝臟酵素數值上升（可能為肝細胞受損或發炎之徵兆）；和過敏反應（徵兆包括低血壓，心跳太快或太慢，呼吸急促，喘鳴，血管性水腫（例如嘴唇或舌頭腫脹），吞嚥困難，皮疹，噁心，嘔吐，出汗，發抖和呼吸困難。
更多相關訊息與連結請參考FDA網址：
https://reurl.cc/pdzajQ
[Posted 06/15/2020]
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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