• Imaging agents

Cytalux Generic Name & Formulations

General Description

Pafolacianine 3.2mg/1.6mL (2mg/mL); soln for IV infusion after dilution.

Pharmacological Class

Optical imaging agent.

How Supplied

Single-dose vials—10


Generic Availability


Mechanism of Action

Pafolacianine is a fluorescent drug that targets folate receptor (FR). Pafolacianine binds to FR-expressing cancer cells with ~1nM affinity, internalizes via receptor mediated endocytosis, and concentrates in FR-positive cancer tissues.

Cytalux Indications


As an adjunct for intraoperative identification of: malignant lesions in adults with ovarian cancer; or malignant and non-malignant pulmonary lesions in adults with known or suspected lung cancer.

Cytalux Dosage and Administration


See full labeling. Give as a single IV infusion of 0.025mg/kg diluted in 250mL of 5% Dextrose Injection, over 60mins (using dedicated infusion line), at 1–9hrs (ovarian cancer) or 1–24hrs (known or suspected lung cancer) prior to surgery. To be used with a near infrared (NIR) imaging system cleared by the FDA for specific use with pafolacianine.


Not established.

Cytalux Contraindications

Not Applicable

Cytalux Boxed Warnings

Not Applicable

Cytalux Warnings/Precautions


Should only be used by trained surgeons. Infusion-related reactions. Treat or prophylaxis with antihistamines and/or anti-nausea medication may be used. Interrupt if infusion-related reactions develop; resume after resolved. Risk of misinterpretation (including false [–] and [+]). False (+) fluorescence may be seen in areas of the bowel, kidneys, lymph nodes, and inflamed tissue. Risk of pafolacianine aggregation and infusion reactions; use only 5% Dextrose Injection for dilution. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Nursing mothers.

Cytalux Pharmacokinetics


93.7% plasma protein bound.


Renal (19.1%), fecal (15.8%). Half-life: 0.44 ± 0.23 hours.

Cytalux Interactions


Avoid concomitant folate, folic acid, or folate-containing supplements within 48hrs prior to Cytalux administration.

Cytalux Adverse Reactions

Adverse Reactions

Nausea, vomiting, abdominal pain, flushing, other infusion-related reactions, hypersensitivity, elevation in blood pressure, dyspepsia, chest discomfort.

Cytalux Clinical Trials

See Literature

Cytalux Note

Not Applicable

Cytalux Patient Counseling

See Literature