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Adcetris (brentuximab vedotin): Drug Safety Communication - Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity
AUDIENCE: Oncology, Hematology, Neurology
FDA notified healthcare professionals that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin). Due to the serious nature of PML, a new Boxed Warning highlighting this risk has been added to the drug label.
In addition, a new Contraindication warning was added against use of Adcetris with the cancer drug bleomycin due to increased risk of pulmonary (lung) toxicity.
The signs and symptoms of PML may develop over the course of several weeks or months. They may include changes in mood or usual behavior, confusion, thinking problems, loss of memory, changes in vision, speech, or walking, and decreased strength or weakness on one side of the body.
BACKGROUND: Adcetris (brentuximab vedotin) is used to treat Hodgkin lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma. At the time of Adcetris' approval in August 2011, one case of PML was described in the Warnings and Precautions section of the label.
RECOMMENDATION: Patients who develop any signs and symptoms of PML should notify their healthcare professional immediately. Healthcare professionals should hold Adcetris dosing if PML is suspected and discontinue Adcetris if a diagnosis of PML is confirmed. See the Data Summary in the Drug Safety Communication for additional information.
Healthcare professionals and patients are encouraged to report adverse events or side effects 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 a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA提醒醫療人員，有2個使用Adcetris (brentuximab vedotin)的案例被通報發生progressive multifocal leukoencephalopathy (PML)的不良反應，PML是一種可能致死的罕見但嚴重腦部感染；因為PML的嚴重性，所以仿單新增了此風險的黑框警語。另外，因併用抗癌藥 bleomycin會增加肺毒性的風險，故仿單將其列為用藥禁忌。
PML的症狀可能會進展數星期或數月之久，可能改變情緒或日常行為，引起困惑、思考障礙或記憶喪失，並改變視覺、說話或行走，以及減弱身體單側的力量。
Adcetris被用於治療Hodgkin lymphoma及罕見的systemic anaplastic large cell lymphoma。在2011年8月Adcetris被核准時，已將一例PML註明在仿單的警示與注意事項。
建議病人有任何PML症狀時，應立即告知醫療人員。當醫療人員懷疑病人為PML時，應先暫停使用Adcetris，若確診為PML則應停用Adcetris。詳細資訊請見FDA網站上Drug Safety Communication。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
[Posted 01/13/2012]
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1763期）