ST LOUIS (MD Consult) - On February 16, 2010, the US Food and Drug Administration (FDA) announced that it is now requiring that all drugs known as erythropoiesis-stimulating agents (ESAs) be prescribed and used under the agency's risk management program known as REMS (risk evaluation and mitigation strategy) to ensure their safe use. The ESAs referenced in this announcement are manufactured by Amgen and include Epogen, Procrit, and Aranesp.

The FDA is taking this action because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer. Studies also show that ESA use for conditions other than cancer is associated with an increased risk of myocardial infarction, heart failure, stroke, and thrombosis.

Erythropoiesis-stimulating agents are approved for the treatment of anemia resulting from chronic kidney failure, chemotherapy, and certain treatments for patients infected with human immunodeficiency virus. They are also approved as a means to reduce the number of blood transfusions needed during and after certain major surgical procedures. The drugs are not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless they are receiving concomitant myelosuppressive chemotherapy.

As part of the REMS, a medication guide explaining the risks and benefits of ESAs must be provided to all patients receiving ESAs. In addition to the medication guide, Amgen was required to develop the ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs) oncology program for health care professionals who prescribe ESAs for patients with cancer. As part of this program, Amgen is obligated to ensure that only those hospitals and health care professionals who have enrolled and completed training in the program will prescribe and dispense ESAs to patients with cancer. Amgen is required to oversee and monitor the program for compliance.

Prescribers of ESAs must attest to their understanding that ESAs shorten overall survival and/or increase the risk of tumor progression or recurrence in clinical studies in patients with breast, non–small-cell lung, head and neck, lymphoid, and cervical cancer. Clinicians must express their understanding that the lowest dose of ESA needed to avoid blood transfusion is the dose that should be prescribed. ESAs should be discontinued after the completion of a chemotherapy course of treatment.

Hospitals and health care providers who fail to comply with the REMS requirements will be denied access to ESAs.

Health care professionals who prescribe ESAs for anemia not caused by cancer chemotherapy also are required to provide a copy of the medication guide to each patient when an ESA is dispensed. However, clinicians who prescribe ESAs only for non-cancer uses need not enroll in the ESA APPRISE oncology program.

 

圣路易斯(MD Consult)——2010年2月16日，美国食品药品管理局(FDA)宣布，当局目前要求所有的促红细胞生成素类药物(ESA)的处方和使用均遵照FDA的REMS(风险评估与减轻策略)风险管理计划，以确保其安全使用。该公告中提及的ESA由安进公司生产，包括Epogen、Procrit及Aranesp。

 

FDA采取此措施的原因为，有研究显示ESA可增加肿瘤生长的风险，缩短癌症患者的生存期。研究还表明，使用ESA治疗癌症以外的其他疾病与心肌梗死、心力衰竭、卒中以及血栓的发病风险增加有关。

促红细胞生成素类药物已获准用于治疗由慢性肾衰、化疗所导致的贫血，以及用作人类免疫缺陷病毒感染者某些方面的治疗用药，此外，这类药物还获准作为某些大手术过程中及之后减少所需输血量的一种方法。ESA禁用于接受激素类药物、治疗用生物制品或放疗治疗的患者，除非患者联用骨髓抑制性化疗。

必须向所有接受ESA治疗的患者提供解释ESA风险与收益的用药指南，这是REMS的一部分内容。除用药指南外，FDA还要求安进公司针对为癌症患者开ESA处方的医务人员制订ESA  APPRISE(促进医生与癌症患者安全使用ESA的风险说明)肿瘤学计划。作为该计划的一部分，安进公司还必须确保为癌症患者开ESA处方及发药的医院和医务人员参加并完成了该计划中的培训。FDA还要求安进公司监督并监察该计划的执行情况。

ESA的处方者必须证明其本人知道，在对乳腺癌、非小细胞肺癌、头颈部癌、淋巴癌以及宫颈癌患者进行的临床试验中，ESA可缩短患者的总体生存期，并可能增加肿瘤进展或复发的风险。

未能遵守REMS要求的医院和医务人员将不能拥有ESA的处方权。

对于由非癌症化疗所致的贫血，医护人员若开ESA对其进行治疗，在发放ESA之前，需向每例患者提供一个用药指南副本。然而，仅作为非癌症治疗用途而处方ESA的医生无需参与ESA APPRISE肿瘤学计划。