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CYTALUX is an FDA approved prescription medication that is given prior to surgery to adult patients who have ovarian cancer or known or suspected cancer in the lung. It helps surgeons visualize ovarian and lung cancer lesions during surgery.
Infusion-Related Reactions
Adverse reactions including nausea, vomiting, abdominal pain, flushing, allergic reaction, elevation in blood pressure, indigestion, and chest discomfort were reported during the administration of CYTALUX. Your doctor may treat you with antihistamines and/or anti-nausea medication.
WHAT IS CYTALUX®?
CYTALUX is an FDA approved prescription medication that is given prior to surgery to adult patients who have ovarian cancer or known or suspected cancer in the lung. It helps surgeons visualize ovarian and lung cancer lesions during surgery.
IMPORTANT SAFETY INFORMATION
Infusion-Related Reactions
Adverse reactions including nausea, vomiting, abdominal pain, flushing, indigestion, chest discomfort, and allergic reactions were reported during the administration of CYTALUX. Your doctor may treat you with antihistamines and/or anti-nausea medication.
Risk of Misinterpretation
Errors may occur with the use of CYTALUX. Sometimes cells may light up even if they are not cancerous or those that are cancerous may not light up. Also, non-cancerous cells from other areas may light up, such as areas of the bowel, kidneys, lymph nodes, lungs, and inflamed tissue.
Pregnancy
CYTALUX may cause fetal harm when administered to a pregnant woman. There are no available human data to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Contact your healthcare provider with a known or suspected pregnancy.
Folate Supplementation Usage
Folic acid may reduce the detection of cancerous tissue with CYTALUX. Patients should stop taking folate, folic acid, or folate-containing supplements 48 hours before administration of CYTALUX.
Adverse Reactions
The most common side effects of CYTALUX reported in clinical trials were nausea (13%), vomiting (5%), abdominal pain (2%), flushing (2%), other infusion-related reactions (2%), allergic reaction (2%), elevation in blood pressure (1%), indigestion (1%), and chest discomfort (1%) during administration.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CYTALUX. For more information, ask your healthcare provider.
Call your doctor for medical advice about side effects. You may report side effects to On Target Laboratories at 1-844-434-9333 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See full Prescribing Information for more details