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Yervoy (ipilimumab): Risk Evaluation and Mitigation Strategy (REMS) - Severe Immune-Mediated Adverse Reactions
AUDIENCE: Hematology-Oncology
ISSUE: [Posted 04/06/2011] Bristol-Myers Squibb informed healthcare professionals about the risk evaluation and mitigation strategy (REMS), developed in collaboration with FDA, that is required to ensure that the benefits of Yervoy outweigh the risks of severe and fatal immune-mediated adverse reactions. The Yervoy REMS consists of a Communication Plan to inform healthcare professionals of the serious risks of Yervoy, to facilitate early identification of these risks, and an overview of recommended management of patients with moderate or more severe immune-mediated adverse reactions.
BACKGROUND: Yervoy was approved March 2011 with the Prescribing Information including a Boxed Warning stating that use of the product can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of Yervoy.
RECOMMENDATION: Healthcare providers were advised to read the boxed warning and accompanying full Prescribing Information for a complete description of these risks and their management and were advised to discuss the risks that may be associated with therapy with patients and their caregivers. Clinicians were advised to:
permanently discontinue Yervoy and initiate systemic high dose corticosteroid therapy for indentified severe immune-mediated reactions.
assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy and endocrinopathy and evaluate clinical chemistries including liver function tests and thyroid function tests at baseline and before each dose.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including links to the "Dear Heathcare Professional" Letter and the product label, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
必治妥施貴寶股份有限公司(Bristol-Mayers Squibb)提醒醫療人員，必治妥與FDA制定了對Yervoy的風險評估暨管控計畫，以確保服用Yervoy的益處大過於發生嚴重致死性免疫反應的風 險。其中包含溝通計劃來告知並幫助醫療人員及早發現Yervoy的嚴重風險，以及建議發生中度或嚴重免疫反應時的處理措施。
Yervoy在2011年3月被核准時，其藥品仿單中的加框警語提到，使用此產品可能會因為造成T細胞活化及增生，而導致嚴重且致死性的免疫相關副作用。 這些免疫相關的副作用可能涉及任何一個器官系統；然而，最常見的嚴重副作用有：腸炎、肝炎、皮膚炎(包括毒性表皮溶解壞死(toxic epidermal necrolysis))、神經性病變及內分泌疾病。這些和免疫相關的反應大部分在使用Yervoy的治療期間就會發生，不過也有少部份會在停藥後數週到 數個月才會發生。
建議醫護人員應事先閱讀加框警語及這些不良反應之詳細資訊與處理方法，並與病人及其照護者說明治療之風險。建議醫師可採取下列措施：
* 停止使用Yervoy並開始全身性高劑量類固醇治療來確認不良反應是否為嚴重免疫反應。
* 評估病人是否出現腸炎、皮膚炎、神經或內分泌病變的徵兆及症狀，且同時在每次給藥前檢驗肝功能與甲狀腺功能。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm249770.htm
[Posted 04/06/2011]
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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資料來源：藥師週刊（第1728期）
