藥物警訊

Iclusig (Ponatinib): Drug Safety Communication - Increased Reports Of Serious Blood Clots In Arteries And Veins

AUDIENCE: Health Professional, Oncology

ISSUE: FDA is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels (arteries and veins) of patients taking the leukemia chemotherapy drug Iclusig (ponatinib). Data from clinical trials and postmarket adverse event reports show that serious adverse events have occurred in patients treated with Iclusig, including heart attacks resulting in death, worsening coronary artery disease, stroke, narrowing of large arteries of the brain, severe narrowing of blood vessels in the extremities, and the need for urgent surgical procedures to restore blood flow. FDA is actively working to further evaluate these adverse events and will notify the public when more information is available.

BACKGROUND: Iclusig is a prescription medicine used to treat adults diagnosed with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), who are no longer benefiting from previous treatment or who did not tolerate other treatment. At the time of Iclusig’s approval in December 2012, the drug label contained information about the risks of blood clots in the Boxed Warning and Warnings and Precautions sections. In clinical trials conducted before approval, serious arterial blood clots occurred in 8 percent of Iclusig-treated patients, and blood clots in the veins occurred in 3 percent of Iclusig-treated patients. In the most recent clinical trial data submitted by the manufacturer to FDA, at least 20 percent of all participants treated with Iclusig have developed blood clots or narrowing of blood vessels.

RECOMMENDATION: Health care professionals should consider for each patient, whether the benefits of Iclusig treatment are likely to exceed the risks of treatment. Patients taking Iclusig should seek immediate medical attention if they experience symptoms suggesting a heart attack such as chest pain or pressure, pain in their arms, back, neck or jaw, or shortness of breath; or symptoms of a stroke such as numbness or weakness on one side of the body, trouble talking, severe headache, or dizziness. FDA is providing this information to patients and health care professionals while it continues its investigation.

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 links to the FDA Drug Safety Communication at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

近來病人服用化療藥物Iclusig (ponatinib)後發生嚴重且危及生命的血栓及血管狹窄事件陸續增加，FDA目前正深入調查中。依據臨床試驗及上市後副作用回報資料，這些嚴重副作用發生於使用Iclusig治療之病人，包括心臟病發死亡、冠狀動脈疾病惡化、中風、腦部大動脈狹窄、四肢血管狹窄、及需要緊急手術以恢復血流。

Iclusig為用於治療已接受其他治療但無效或無法耐受之慢性骨髓性白血病及費城染色體陽性之急性淋巴性白血病。此藥於2012年12月於美國核准上市時，仿單中之加框警語及注意事項即標註有關產生血栓風險的資訊。在上市前之臨床試驗中，約有8%使用Iclusig的病人發生嚴重動脈血栓，而靜脈血栓為3%。另於廠商提供的最新臨床試驗資料顯示，有至少20%使用Iclusig的病人產生血栓或血管狹窄。

醫療專業人員在投藥前，應仔細評估病人使用Iclusig治療的利益是否大於風險。正在服用Iclusig的病人若自覺出現疑似心臟病發作之症狀，如胸痛、胸悶，手臂、背部、頸部或下顎疼痛，呼吸急促，或身體一側麻痺無力、講話困難、嚴重頭痛、暈眩等中風症狀時應立即尋求醫療協助。

相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

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