Cytalux
(Pafolacianine Injection)Dosage & Administration
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Cytalux Prescribing Information
CYTALUX is 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.
- 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.
Injection: 3.2 mg/1.6 mL (2 mg/mL) pafolacianine (equivalent to 3.4 mg/1.6 mL pafolacianine sodium)
supplied as a dark bluish green, clear aqueous solution in a single-dose vial.
Of the total number of patients in clinical studies of CYTALUX, 221 patients (54%) were 65 years of
age and older: 153 (38%) were 65 to 74 years of age, 66 (16%) were 75 to 84 years of age, and 2
(0.5%) were 85 years of age and older. No overall differences in safety, effectiveness, or
pharmacokinetics were observed between patients 65 years of age and older and younger adult
patients.
None.
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.
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.
- Remove carton containing one single vial of CYTALUX from freezer and record the date, time and thawing condition on the carton.
- Thaw at room temperature between 20°C to 25°C (68°F to 77°F) for at least 60 minutes or under refrigerated conditions between 2°C to 8°C (36°F 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.
- Once thawed, an individual CYTALUX vial may be stored at room temperature between 20°C to 25°C (68°F to 77°F) for a maximum single period of 24 hours or under refrigerated conditions between 2°C to 8°C (36°F to 46°F) for a maximum single period of up to 30 days, prior to preparation for infusion.
- 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 three times.
- If the vial has been thawed after the third refreeze, it must be used. If not used after the third refreeze, do not use and discard the vial.
- Each vial of CYTALUX may be penetrated only once at the time of preparation of infusion solution. Once penetrated, the vial may not be refrozen.
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°C to 8°C (36°F to 46°F) for not more than 24 hours. Once the bag is removed from refrigeration, infusion must be completed within 3 hours.