ST LOUIS (MD Consult) - On February 18, 2010, the US Food and Drug Administration (FDA) issued a notice about recent changes in the prescribing information for Exjade (deferasirox), an agent indicated for the treatment of chronic iron overload resulting from blood transfusions (transfusional hemosiderosis) in patients aged 2 years and older.
New language was added to the Contraindications, Warnings and Precautions, and Drug Interactions sections of the prescribing information. A boxed warning was added. The warnings state that use of the product may cause renal impairment (including failure), hepatic impairment (including failure), and gastrointestinal hemorrhage.
Some of the reports on which the FDA based the new labeling requirements detailed fatalities. The FDA notice states that adverse reactions were more frequently observed in patients with advanced age, high-risk myelodysplastic syndromes, underlying renal or hepatic impairment, or low platelet counts (ie, <50 × 109/L). Most of the fatalities reported occurred within 6 months of Exjade initiation and generally involved worsening of the underlying condition.
Clinicians need to be aware that Exjade therapy requires close patient monitoring (per label specifications) including measurement of serum creatinine and/or creatinine clearance, as well as serum transaminases and bilirubin.
圣路易斯(MD Consult)——2010年2月18日，美国食品药品管理局(FDA)发布了有关近期Exjade (地拉罗司)处方信息变更的通知。该药适用于治疗因输血引起慢性铁超负荷(输血性含铁血黄素沉着症)的2岁以上儿童患者。
该药处方信息的禁忌证、警告与注意事项及药物相互作用部分新增了其他语言。另外，还新增了一个黑框警告，提醒应用该产品可引起肾损害(包括肾功能衰竭)、肝损害(包括肝功能衰竭)和胃肠道出血。
FDA此次要求新增标签内容所依据的一些报告指出，该药还可引起死亡。FDA通知称，不良反应更常见于高龄、高危骨髓增生异常综合征、基础肾或肝损害、或低血小板计数(即<50 × 109/L)的患者。所报告的多数死亡病例在Exjade治疗6月内出现，并通常涉及基础疾病的加重。
按照标签说明，需提醒临床医生注意的是，在进行Exjade治疗时，应密切监测患者，包括测定血清肌酐和(或) 肌酐清除率，以及血清转氨酶和胆红素。
