Pafolacianine Dosage

Applies to the following strengths: 3.2 mg/1.6 mL

Usual Adult Dose for:

Ovarian Cancer

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Precautions
Dialysis
Other Comments

Usual Adult Dose for Ovarian Cancer

0.025 mg/kg IV over 60 minutes, 1 to 9 hours prior to surgery

Comments:

Folate, folic acid, or folate containing supplements should be discontinued 48 hours before administration.
Patients may receive antihistamines and/or anti-nausea medications as prophylaxis against infusion related reactions.
This drug should be used with an FDA-approved NIR (near infrared) imaging system.
This drug should only be used by surgeons who have completed a training program on the use of the NIR imaging systems for fluorescence imaging during surgery.

Use: For intraoperative identification of malignant lesions in patients with ovarian cancer.

Renal Dose Adjustments

Mild to moderate renal impairment: No adjustment recommended
Severe renal impairment: Data not available

Liver Dose Adjustments

Mild to moderate hepatic dysfunction: No adjustment recommended
Severe hepatic dysfunction: Data not available

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Administer via IV infusion (diluted in 250 mL of 5% Dextrose) over 60 minutes
Infuse using a dedicated infusion line, 1 to 9 hours prior to surgery
Folate, folic acid, or folate containing supplements should be discontinued at least 48 hours before administration
Verify pregnancy status in females of reproductive potential prior to infusion
Consider premedication with antihistamines and/or anti-nausea medications as prophylaxis against infusion reactions; if an infusion reaction occurs, interrupt infusion and treat as necessary

Storage requirements:

Store frozen (-13F to 5F [-25C to -15C]) in original carton to protect from light
Once diluted, store refrigerated 36F to 46F [2C to 8C]) for no more than 24 hours; once bag is removed from refrigeration, infusion must be completed within 3 hours; protect infusion bag from light using a light-blocking cover

Reconstitution/preparation techniques:

Thaw frozen drug in original carton at controlled room temperature (68F to 77F [20C to 25C]) for at least 90 minutes
Hand shake or vortex the thawed vial for 60 seconds
Add prescribed dose to 250 mL of 5% Dextrose; discard unused portion of vial
Gently swirl bag by hand for 1 minute to mix solution
Inspect bag; solution should be light blue/green to clear in color without any visible particulate matter
Protect infusion bag from light using a light-blocking cover during infusion and storage

IV compatibility: Only compatible with Dextrose 5%; must be infused using a dedicated infusion line

General:

This drug 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.
Folate, folic acid, or folate-containing supplements may reduce binding of this drug to folate receptors overexpressed on ovarian cancer cells and could reduce the detection of malignant lesions. Therefore, folate, folic acid, or folate-containing supplements should be avoided within 48 hours of administering this drug.

Monitoring:

Obtain a pregnancy test prior to use in women of reproductive potential

Patient advice:

Patients should be instructed to read the US FDA-approved patient labeling.
Patients should be instructed to avoid folate, folic acid, or folate-containing supplements 48 hours prior to administration of this drug.
Females of reproductive potential should be advised of a potential risk to a fetus and instructed to contact their healthcare provider if they suspect they are pregnant.