CYTALUX^® Product Information

Single intravenous
infusion

Prepare

the recommended dose of CYTALUX as a single intravenous infusion.

Adverse reactions including nausea, vomiting, abdominal pain, flushing, hypersensitivity, elevation in blood pressure, dyspepsia, and chest discomfort were reported in patients receiving CYTALUX in clinical studies. A total of 17% of patients experienced reactions during administration of CYTALUX. Reactions typically occurred within 15 minutes of the start of infusion. CYTALUX infusion interruption or discontinuation due to adverse reactions occurred in 11% of all patients. 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.

Prior to
surgery

Administer

CYTALUX during a 60-minute infusion, 1 to 9 hours prior to surgery for ovarian cancer and 1 to 24 hours prior to surgery for lung cancer.

Verify pregnancy status of females of reproductive potential prior to initiating CYTALUX treatment.

Illuminate with
near-infrared
imaging system

Illuminate

lesions intraoperatively using a near-infrared imaging system cleared for use with CYTALUX.

Non-fluorescing tissue in the surgical field does not rule out the presence of ovarian cancer or lesions in the lung.

See Prescribing Information for More Details

Imaging system information

A near-infrared imaging system is used to illuminate CYTALUX.

CYTALUX is to be used with a near infrared (NIR) imaging system cleared by the FDA for specific use with pafolacianine.

Clinical data demonstrates that NIR imaging devices which excite at 760 nm to 785 nm and detect emission at 790 nm to 815 nm are suitable for use with CYTALUX.

CYTALUX should only be used by surgeons who have completed a training program on the use of NIR imaging systems for fluorescence imaging during surgery. Training is provided by the device manufacturer.

WARNINGS AND PRECAUTIONS
Infusion-Related Reactions
Adverse reactions including nausea, vomiting, abdominal pain, flushing, hypersensitivity, elevation in blood pressure, dyspepsia, and chest discomfort were reported in patients receiving CYTALUX in clinical studies. A total of 17% of patients experienced reactions during administration of CYTALUX.

INDICATION AND USAGE
CYTALUX® is an FDA approved optical imaging agent indicated as an adjunct for intraoperative identification of:

Malignant lesions in adult patients with ovarian cancer.
Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Infusion-Related Reactions
Adverse reactions including nausea, vomiting, abdominal pain, flushing, hypersensitivity, elevation in blood pressure, dyspepsia, and chest discomfort were reported in patients receiving CYTALUX in clinical studies. A total of 17% of patients experienced reactions during administration of CYTALUX. Reactions typically occurred within 15 minutes of the start of infusion. CYTALUX infusion interruption or discontinuation due to adverse reactions occurred in 11% of all patients. 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 and lesions in the lung, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of ovarian cancer or lesions in the lung. Fluorescence may be seen in normal tissues including bowel, kidneys, lymph nodes, lungs, and inflamed tissue.

Embryo-Fetal Toxicity
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.

DRUG INTERACTIONS
Use of folate, folic acid, or folate-containing supplements may reduce binding of pafolacianine to folate receptors and could reduce the detection of lesions with CYTALUX. Avoid administration of folate, folic acid, or folate-containing supplements within 48 hours before administration of CYTALUX

ADVERSE REACTIONS
The safety of CYTALUX was evaluated in four open label clinical studies, two studies (N = 44 and N = 150) in patients with ovarian cancer and two studies (N = 100 and N = 112) in patients with known or suspected cancer in the lung. A total of 406 patients received 0.025 mg/kg of CYTALUX via intravenous administration.

Adverse reactions that occurred in > 1% of patients were: nausea (13%), vomiting (5%), abdominal pain (2%), flushing (2%), other infusion-related reactions (2%), hypersensitivity (2%), elevation in blood pressure (1%), dyspepsia (1%), and chest discomfort (1%). Adverse reactions occurred during the administration of CYTALUX in 17% of patients.

See full Prescribing Information to learn more.