藥物警訊（藥師週刊 第1676期）

Exjade (deferasirox): Boxed Warning
Audience: Hematology-Oncology healthcare professionals
Novartis Oncology and FDA notified healthcare professionals about recent changes in the Prescribing Information (PI) for Exjade, indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. New language was added to the Contraindications, Warnings and Precautions, and Drug Interactions sections of the PI, including a Boxed Warning, that the product may cause:
* renal impairment, including failure
* hepatic impairment, including failure
* gastrointestinal hemorrhage
In some reported cases, these reactions were fatal. These reactions were more frequently observed in patients with advanced age, high risk myelodysplastic syndromes, underlying renal or hepatic impairment or low platelet counts. Exjade therapy requires close patient monitoring, including measurement of serum creatinine and/or creatinine clearance as specified in the PI and serum transaminases and bilirubin as specified in the PI.
Read the complete MedWatch 2010 Safety summary, including a link to the Dear Healthcare Professional letter and revised Prescribing Information, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
Novartis公司和FDA發佈藥物安全警訊，通知醫護人員和病人關於治療2歲和2歲以上接受輸血而造成鐵質過度沉積的Exjade針劑仿單最新的修訂。在Exjade仿單「使用禁忌」、「警訊與注意事項」和「藥品交互作用」的部分已新增新的訊息，也增加下述加框警語(Boxed Warning)，
Exjade藥品可能會引起：
* 腎臟的損傷，包括腎衰竭
* 肝臟的損傷，包括肝衰竭
* 腸胃道出血
有些不良反應的通報案例都有致命性的風險，且通常比較常發生在年齡較大的病人，有MDS (myelodysplastic syndromes)高風險的病人，已有潛在肝或腎功能損傷或血小板數量較低的病人。使用Exjade治療時需要密切地監測病人的各項狀況，包括仿單中特別提及的Scr、CCr、肝臟轉氨(transaminases)和膽黃素(bilirubin)。

相關訊息請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200850.htm
[Posted 2/18/2010]

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