Axumin TM (fluciclovine F 18) 是一种获美国FDA批准的新型放射性注射性诊断剂，用于正电子发射断层扫描（PET）显像。根据曾经治疗前列腺特定抗原（PSA）水平，检查疑似前列腺癌复发的患者。
FDA的药品评价和研究中心医学影像产品部主任Libero Marzella，M.D.，Ph.D.说：“当PSA处在非常低水平时，影像测试不能确定复发前列腺癌的位置，”。“对这些患者Axumin是提供显示另一个准确影像的方法。”
批准日期：2016年5月27日；公司：Blue Earth Diagnostics，Ltd.
AXUMIN(fluciclovine F 18)注射液，为静脉使用
美国初次批准：2016
作用机制
Fluciclovine F 18是一种合成氨基酸通过氨基酸转运蛋白跨越哺乳动物细胞膜转运，例如LAT-1和ASCT2，它们在前列腺癌细胞中被上调。在前列腺癌细胞与周围正常组织比较，Fluciclovine F 18被摄取程度较大。
适应证和用途
Axumin是一种放射性诊断剂适用为在男性根据升高的血前列腺抗原抗原(PSA)水平以前治疗后正电子发射断层扫描(PET)影像有怀疑的前列腺癌复发。
剂量和给药方法
⑴使用适当的辐射安全处置措施。
⑵从其容器无菌地抽吸Axumin和作为静脉推注注射给予370 MBq(10 mCi)(2.2).
⑶给药后3-5分钟开始影像。应从大腿-中段和至颅底进行扫描，有一个总扫描时间接近20-30 分钟。
⑷在一名成年中伴随Axumin 370 MBq(10 mCi)被注射的活性有效(辐射吸收)剂量接近8 mSv(0.8 rem)。
剂型和规格
注射液：透明，无色溶液一个30mL多-剂量小瓶在校正时间和日期含335-8200 MBq/mL(9-221mCi/mL) fluciclovine F18。
禁忌证
无。
警告和注意事项
用Axumin影像可能发生影像解释错误.
辐射风险：Axumin对患者的长期累计辐射暴露贡献。确保安全处置以保护患者和卫生保健工作者来自无意的辐射暴露。
不良反应
最常见报道不良反应是注射部位疼痛，红斑，和味觉障碍。
供应/贮存和处置
供应
Axumin是作为一个透明，无色注射液在一个30mL多-剂量玻璃小瓶含在校正时间和日期时约26mL溶液的335-8200 MBq/mL(9-221mCi/mL) fluciclovine F 18供应。
30mL无菌多-剂量小瓶：NDC 69932-001-030
贮存和处置
贮存Axumin在控制室温(USP)20°C至25°C(68°F至77°F)。Axumin不含防腐剂。贮存Axumin在原始容器内在辐射屏蔽中。
这个制备物是被批准由经核管理委员会或有关监管机构的协议状态在许可下人员使用。
U.S. FDA Approves Blue Earth Diagnostics’ Axumin (Fluciclovine F 18) Injection after Priority Review for PET Imaging of Recurrent Prostate Cancer
- First FDA-Approved F18 PET Imaging Agent Indicated for Use in Patients with Suspected Recurrent Prostate Cancer -
Indication and Important Safety Information About Axumin
INDICATION
Axumin™ (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
IMPORTANT SAFETY INFORMATION
Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.