2013年3月13日，美国食品药监局（FDA）批准通过了Navidea生物医药公司的Lymphoseek注射剂，这是一种用于淋巴结成像的新型注射剂。
淋巴结成像通过活检淋巴结能够预测癌症扩散的初级肿瘤。
Lymphoseek是一种靶向受体的放射性药物产品，能够发现癌变淋巴结从而帮助医生的更加高效地治疗患者。
Navidea公司董事长兼首席执行官(CEO)马克说：“我们公司致力于提高诊断的准确性，相信我们的产品能够帮助成千上万的乳腺癌和黑素瘤患者。此次FDA的批准更加增强了我们的信心。”
此次批准基于包含332人的III期临床研究，研究中通过Lymphoseek能够发现97%的淋巴节点。 Lymphoseek将不久后在美国上市销售。

 
Radiation Safety—Drug Handling
•Lymphoseek® is a radioactive drug and should be prepared and handled with appropriate safety measures, including effective gloves and shielding, to minimize radiation exposure. Radiopharmaceuticals should be used by or under the control of physicians who are qualified, experienced and licensed by the appropriate governmental agency in the safe use of radionuclides.
Preparation of Lymphoseek®
•For each patient, the total injection volume and the number of sites to be injected should be known before preparing Lymphoseek.
•Each radiolabeled Lymphoseek vial contains sufficient amount to provide doses for up to four patients when prepared according to the instructions. The radiolabeled Lymphoseek is to be used within 6 hours of its preparation.
•In animal studies, locally injected anesthetics have been reported to reduce lymphatic flow. Co-injection (mixture) of local anesthetics with Lymphoseek is not recommended and may impair the lymph nodal mapping.
Recommended Dose of Lymphoseek®
•18.5 MBq (0.5 mCi) radioactivity dose
•50 mcg mass dose
Recommended Total Injection Volume
•0.1 mL in 1 syringe
•0.5 mL in 1 syringe or multiple syringes (0.1 or 0.25 mL each)
•1 mL in multiple syringes (0.2, 0.25 or 0.5 mL each)
Recommended Injection Routes
•Breast Cancer—intradermal, subcutaneous, subareolar, peritumoral
•Melanoma—intradermal, subcutaneous
Recommended Time from Administration to Lymphatic Mapping
•From 15 minutes up to 15 hours post-injection
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Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma.
Important Safety Information
In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.
The most common adverse reactions are injection site irritation and/or pain (<1%).
说明书阅览：http://www.drugs.com/pro/lymphoseek.html