|Other names||Pafolacianine sodium, OTL38, OTL-0038|
|Main uses||Detecting ovarian cancer during surgery|
|Side effects||Nausea, vomiting, abdominal pain, flushing, chest discomfort, itching, allergic reactions|
|Chemical and physical data|
|Molar mass||1326.49 g·mol−1|
|3D model (JSmol)|
Pafolacianine, sold under the brand name Cytalux, is an imaging agent used in fluorescence-guided surgery. Specifically it is used to find areas of ovarian cancer. It is given by injection into a vein.
Common side effects include nausea, vomiting, abdominal pain, flushing, chest discomfort, itching, and allergic reactions. Use during pregnancy may harm the baby. It is a fluorescent medication that binds to the folate receptor, which often occurs in high amounts in ovarian cancer.
It is generally given as 0.025 mg/kg one to nine hours before surgery.
The safety and effectiveness of pafolacianine was evaluated in a randomized, multi-center, open-label study of women diagnosed with ovarian cancer or with high clinical suspicion of ovarian cancer who were scheduled to undergo surgery. Of the 134 women (ages 33 to 81 years) who received a dose of pafolacianine and were evaluated under both normal and fluorescent light during surgery, 26.9% had at least one cancerous lesion detected that was not observed by standard visual or tactile inspection.
The U.S. Food and Drug Administration (FDA) granted the application for pafolacianine orphan drug, priority review, and fast track designations. The FDA granted the approval of Cytalux to On Target Laboratories, LLC.
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