CYTALUX™ is an optical imaging agent indicated in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Infusion-Related Reactions Adverse reactions consisting of nausea, vomiting, abdominal pain, flushing, dyspepsia,
Important Safety Information and Indication for Cytalux™
Important Safety Information for Cytalux™
INDICATION AND USAGE
CYTALUX™ is an FDA-approved optical imaging agent indicated in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions.
IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Infusion-Related Reactions
Adverse reactions consisting of nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, and pruritus were reported in patients receiving CYTALUX in clinical studies. 2.4% of patients experienced reactions during the period of administration of CYTALUX. Reactions typically occurred within 15 minutes of the start of infusion. Treatment with antihistamines and/or anti-nausea medication may be used. If an adverse reaction occurs during administration, the infusion can be interrupted and resumed after treatment of the reaction.
Risk of Misinterpretation
Errors may occur with the use of CYTALUX during intraoperative fluorescence imaging to detect ovarian cancer, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of ovarian cancer. Fluorescence may be seen in non-cancerous tissue including areas of the bowel, kidneys, lymph nodes and inflamed tissue.
Based on its mechanism of action, CYTALUX may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating CYTALUX treatment.
Risk of Pafolacianine Aggregation and Infusion Reactions
Use of the incorrect diluent to prepare the CYTALUX infusion solution can cause the aggregation of pafolacianine; aggregation may induce infusion reactions such as nausea, vomiting, abdominal pain or rash. Use only 5% Dextrose Injection to prepare the CYTALUX infusion solution. Do not use other diluents.
The safety of CYTALUX was evaluated in three open label clinical studies, two studies (N = 150 and N = 44) in patients with ovarian cancer and one study (N = 100) in patients with cancer in the lung. While patients with cancer in the lung were included in safety evaluation, CYTALUX is not approved for use in patients with cancer in the lung. A total of 294 patients received 0.025 mg/kg of CYTALUX via intravenous administration. The mean age of patients was 63.5 years; 51% were 65 years of age or older. 89% of patients were female and 84% of patients were White.
Adverse reactions that occurred in > 1% of patients were: nausea (15%), vomiting (5.8%), abdominal pain (2.7%), flushing (1.7%), dyspepsia (1%), chest discomfort (1%), pruritus (1%) and hypersensitivity (1%). In 2.4% of patients, these adverse reactions occurred during the administration of CYTALUX.