Menu

Mechanism of Action

CYTALUX™ is a proprietary folic acid analog conjugated with a fluorescent dye which binds to folate receptor positive ovarian cancer cells.

Watch an Animation Describing the
CYTALUX Mechanism of Action

CYTALUX molecule

Folate

Folate is an essential vitamin required for cell growth and DNA replication1

Rapidly dividing cancer cells requires an abundant supply of folate, therefore, it is consumed in elevated quantities1

Most ovarian cancers overexpress high-affinity folate receptors to increase folate uptake for tumor growth2

How CYTALUX Works

CYTALUX is a small
molecule that
circulates quickly
through the body
It can be infused
intravenously in as little as
an hour before imaging.
CYTALUX binds to the
folate receptors on
ovarian cancer cells
It is targeted, preferentially
binding to FR+ ovarian
cancer cells.
CYTALUX is
endocytosed
and concentrates in
folate receptor
positive (FR+) ovarian
cancer tissues
Endocytosis allows it to be
concentrated in the tissues
throughout the entire
surgical procedure.
CYTALUX contains a
bright fluorophore which is
illuminated via near-infrared light
Imaging under near-infrared
light enhances intraoperative
visualization in challenging
environments and below the tissue surface.3

View Efficacy & Safety Data

Speak with a representative about CYTALUX and how to bring this technology to your OR.

1 Markert S, et al. Alpha-folate receptor expression in epithelial ovarian carcinoma and nonneoplastic ovarian tissue. Anticancer Res. 2008 (28): 3568-3572.
2 Kalli KR, Oberg AL, Keeney GL, et al. Folate receptor alpha as a tumor target in epithelial ovarian cancer. Gynecologic Oncology. 2008;108(3):619-626.
3 Predina JD, Newton AD, Connolly C, Dunbar A, Baldassari M, Deshpande C, Cantu E 3rd, Stadanlick J, Kularatne SA, Low PS, Singhal S. Identification of a Folate Receptor-Targeted Near-Infrared Molecular Contrast Agent to Localize Pulmonary Adenocarcinomas. Mol Ther. 2018 Feb 7;26(2):390-403. doi: 10.1016/j.ymthe.2017.10.016. Epub 2017 Oct 26. PMID: 29241970; PMCID: PMC5835020.

INDICATION

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.

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.

ADVERSE REACTIONS
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.

See full Prescribing Information to learn more.