Cytalux Dosage

Recommended Testing, Evaluations and Premedications Prior to Administration of
CYTALUX

Obtain a pregnancy test in females of reproductive potential and verify the absence of pregnancy
prior to administration of CYTALUX [ see Warnings and Precautions (5.3) and Use in Specific
Populations ( 8.1, 8.3) ].
Discontinue folate, folic acid, or folate containing supplements 48 hours before administration of
CYTALUX [ see Drug Interactions (7)].
Consider administering antihistamines and/or anti-nausea medication for prophylaxis against infusion related
reactions [ see Warnings and Precautions (5.1)].

Recommended Dosage and Administration

Adult Patients with Ovarian Cancer

The recommended dose of CYTALUX is a single intravenous infusion of 0.025 mg/kg diluted in 250 mL of 5% Dextrose Injection, administered over 60 minutes using a dedicated infusion line, 1 hour to 9 hours prior to surgery.

Adult Patients with Known or Suspected Cancer in the Lung

The recommended dose of CYTALUX is a single intravenous infusion of 0.025 mg/kg diluted in 250 mL of 5% Dextrose Injection, administered over 60 minutes using a dedicated infusion line, 1 hour to 24 hours prior to surgery.

Preparation and Storage Instructions

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

1. Use aseptic technique for the preparation of CYTALUX infusion solution.

2. Only use 5% Dextrose Injection for dilution. Do not use other diluents due to incompatibility .

​3. CYTALUX vials should be stored and thawed in the original carton protected from light.

​a. Thaw at room temperature between 20° to 25°C (68° to 77°F) for at least 60 minutes or under refrigerated conditions between 2° to 8°C (36° to 46°F) for at least 6 hours. When thawed under refrigerated conditions, allow the vial to stand at room temperature for 15 minutes before dilution.

​b. Once thawed, an individual CYTALUX vial may be stored at room temperature between 20° to 25°C (68° to 77°F) for a maximum single period of 24 hours or under refrigerated conditions between 2° to 8°C (36° to 46°F) for a maximum single period of up to 30 days, prior to preparation for infusion.

​c. If CYTALUX vial is not used within the maximum single period at either room temperature or under refrigerated conditions the vial may be refrozen up to one time.

4. Hand shake or vortex the thawed CYTALUX vial for 60 seconds.

5. Withdraw the calculated volume of CYTALUX for a dose of 0.025 mg/kg. Discard any unused portion in the vial.

6. Add into a 250 mL of 5% Dextrose Injection, USP bag.

7. Gently swirl the bag by hand for 1 minute to mix the solution.

8. Visually inspect the infusion bag. The solution should be light blue/green to clear in color and should not contain any visible particulate matter.

9. Protect the infusion bag from light using a light-blocking cover during infusion and storage.

10. If not immediately used, store the diluted CYTALUX infusion solution in a refrigerator at 2 o to 8 oC (36 o to 46 oF) for not more than 24 hours. Once the bag is removed from refrigeration, infusion must be completed within 3 hours.

Management of Infusion-Related Reactions

If the patient develops an infusion reaction during administration, interrupt the infusion and treat with
antihistamines and/or anti-nausea medication as necessary, based on clinical decision. Complete the
infusion within 3 hours of the start of the initial administration [ see Warnings and Precautions (5.1)].

Imaging

• Clinical data demonstrate that near infrared (NIR) imaging devices that excite at 760 nm to 785 nm and detect emission at 790 nm to 815 nm are suitable for use with CYTALUX.
• CYTALUX is to be used with an NIR imaging system cleared by the FDA for specific use with pafolacianine.
• 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.