CYTALUXTM Product Information

Single intravenous
infusion

Prepare

the recommended dose of CYTALUX as a single intravenous infusion.

Adverse reactions consisting of nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, and pruritus were reported in patients receiving CYTALUX in clinical studies. 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.

1-9 hours prior
to imaging

Administer

CYTALUX during a 60-minute infusion, 1 to 9 hours prior to surgery.

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

Illuminate with
near-infrared
imaging system

Illuminate

ovarian cancer 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.

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 794 nm to 796 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.

Get more information on
Near-
Infrared Imaging Systems
FDA-
cleared for use with CYTALUX:

Medtronic EleVision™ IR Platform