Home Product Information Mechanism of Action

Mechanism of Action

CYTALUX^® is a proprietary folic acid analog conjugated with a fluorescent dye which binds to folate receptor positive cells.

Certain cancers overexpress high-affinity folate receptors to increase folate uptake for tumor growth.^1,2

WATCH THE CYTALUX MECHANISM OF
ACTION AT WORK

Why Folate

Folate is an essential vitamin required for cell growth and DNA replication.³

Rapidly dividing cancer cells requires an abundant supply of folate, therefore, it is consumed in elevated quantities.³

cytalux
molecule

cytalux
molecule

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 expressed
on cells.

It is targeted, preferentially
binding to FR+ cells.

CYTALUX is
endocytosed and
concentrates in folate
receptor positive (FR+)
ovarian and lung cancer
tissue.

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.¹

Ovarian Cancer Trial Details Lung Cancer Trial Details

1 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.
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 Markert S, et al. Alpha-folate receptor expression in epithelial ovarian carcinoma and nonneoplastic ovarian tissue. Anticancer Res. 2008 (28): 3568-3572.

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about CYTALUX and how to bring this technology to your OR.

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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.

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