Pafolacianine Dosage
Applies to the following strengths: 3.2 mg/1.6 mL
Usual Adult Dose for:
Additional dosage information:
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.
More about pafolacianine
- Check interactions
- Compare alternatives
- Side effects
- During pregnancy
- Drug class: malignancy photosensitizers
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Further information
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