pafolacianine (Rx)

Brand and Other Names:Cytalux
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2mg/mL (3.2mg/1.6mL single-dose vial); equivalent to 3.4 mg/1.6 mL pafolacianine sodium

Ovarian Cancer Imaging

Indicated for ovarian cancer as an adjunct for intraoperative identification of malignant lesions

0.025 mg/kg IV x 1 dose; administer 1-9 hr before surgery

Dosage Modifications

Infusion-related reactions

  • If infusion reaction develops, interrupt infusion and treat with antihistamines and/or antinausea medication as necessary, based on clinical decision
  • Complete infusion within 3 hr of the start of initial administration

Renal impairment

  • Mild-to-moderate (CrCl 30-89 mL/min): No dosage adjustment necessary
  • Severe (CrCl <30 mL/min): Not studied

Hepatic impairment

  • Mild-to-moderate (total bilirubin <3x ULN and AST > ULN): No dosage adjustment necessary
  • Severe (total bilirubin >3x ULN and any AST): Not studied

Dosing Considerations

Consider administering antihistamines and/or antinausea medication for prophylaxis against infusion-related reactions

Before administration

  • Verify pregnancy status in females of reproductive potential
  • Discontinue folate, folic acid, or folate-containing supplements 48 hr before administration

Safety and efficacy not established

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Interactions

Interaction Checker

and pafolacianine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (2)

              • folic acid

                folic acid decreases effects of pafolacianine by receptor binding competition. Avoid or Use Alternate Drug. Avoid coadministration with folic acid or folic acid-containing supplements for 48 hr before administering pafolacianine. Use of folate, folic acid, or folate-containing supplements may reduce binding of pafolacianine to folate receptors overexpressed on ovarian cancer cells and could reduce the detection of malignant lesions with. .

              • iron/folic acid/vitamin/mineral

                iron/folic acid/vitamin/mineral decreases effects of pafolacianine by receptor binding competition. Avoid or Use Alternate Drug. Avoid coadministration with folic acid or folic acid-containing supplements for 48 hr before administering pafolacianine. Use of folate, folic acid, or folate-containing supplements may reduce binding of pafolacianine to folate receptors overexpressed on ovarian cancer cells and could reduce the detection of malignant lesions with. .

              Monitor Closely (0)

                Minor (0)

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                  Adverse Effects

                  >10%

                  Nausea (15%)

                  1-10%

                  Vomiting (5.8%)

                  Abdominal pain (2.7%)

                  Flushing (1.7%)

                  Dyspepsia (1%)

                  Chest discomfort (1%)

                  Pruritus (1%)

                  Hypersensitivity (1%)

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                  Warnings

                  Contraindications

                  None

                  Cautions

                  Infusion-related reactions consisting of nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, and pruritus reported; reactions typically occurred within 15 min after starting infusion

                  Errors may occur during intraoperative fluorescence imaging to detect ovarian cancer, including false negatives and false positives; nonfluorescing tissue in the surgical field does not rule out the presence of ovarian cancer

                  Based on its mechanism of action, fetal harm may occur when administered to pregnant females

                  Use only D5W to dilute drug; using an incorrect diluent to prepare infusion solution can cause aggregation of pafolacianine; aggregation may induce infusion reactions, such as nausea, vomiting, abdominal pain, or rash

                  Drug interactions overview

                  • Folate, folic acid, or folate-containing supplements
                    • Avoid use within 48 hr before administration
                    • Use of folate, folic acid, or folate-containing supplements may reduce binding of pafolacianine to folate receptors overexpressed on ovarian cancer cells and could reduce the detection of malignant lesion
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                  Pregnancy & Lactation

                  Pregnancy

                  Based on its mechanism of action, fetal harm may occur when administer to pregnant females

                  No human data are available to evaluate for drug-associated risk of major birth defects, miscarriage, or other adverse maternal fetal outcomes

                  Verify pregnancy status of females of reproductive potential before administration

                  Lactation

                  There are no data on the presence of pafolacianine in either human or animal milk, effects on breastfed infants, or effects on milk production

                  Pregnancy Categories

                  A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                  B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                  C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                  D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                  X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                  NA: Information not available.

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                  Pharmacology

                  Mechanism of Action

                  Fluorescent drug; targets folate receptor, which may be overexpressed in ovarian cancer

                  Binds to folate receptors, overexpressed in ovarian cancer and absorbs light near-infrared region, thereby serving as an adjunct to provide greater certainty during surgery of complete resection

                  Absorption

                  Peak plasma concentration: 59.1 ng/mL

                  AUC: 63.6 ng⋅hr/mL

                  Distribution

                  Vd: 17.1 L

                  Protein bound: 93.7%; no notable partitioning into red blood cells observed

                  Metabolism

                  Not metabolized by CYP enzymes

                  Elimination

                  Half-life: 0.44 hr

                  Plasma clearance: 28.6 L/hr

                  Excretion: ~35% of dose was recovered in urine (19.1%) and in feces (15.8%) after ~3-5 weeks

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                  Administration

                  IV Incompatibilities

                  Do not use other diluents

                  IV Compatibilities

                  D5W

                  IV Preparation

                  Use aseptic technique to prepare solution

                  Thaw frozen vials in original carton at controlled room temperature of 20-25ºC (68-77ºF) for at least 90 min

                  Hand shake or vortex thawed vial for 60 seconds

                  Withdraw calculated drug volume; discard any unused portion in vial

                  Add to 250-mL D5W infusion bag; do NOT use other diluents

                  Gently swirl bag by hand for 1 min to mix solution

                  Visually inspect infusion bag; diluted solution is light-blue/green to clear in color and should not contain any visible particulate matter

                  Protect infusion bag from light using light-blocking cover during infusion and storage

                  If not immediately used, refrigerate diluted solution at 2-8ºC (36-46ºF) for up to 24 hr

                  Once bag removed from refrigeration, infusion must be completed within 3 hr

                  IV Administration

                  Consider administering antihistamines and/or antinausea medication for prophylaxis against infusion-related reactions

                  Infuse over 60 min using dedicated infusion line, 1-9 hr before surgery

                  Imaging

                  • Clinical data demonstrate that NIR imaging devices that excite at 760-785 nm and detect emission at 794-796 nm are suitable for use
                  • Use with an NIR imaging system cleared by the FDA for specific use with pafolacianine
                  • Use only 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

                  Storage

                  Unopened vials

                  • Freeze at -25º to -15ºC (-13ºto 5ºF)
                  • Store in original carton to protect from light

                  Diluted solution

                  • If not immediately used, refrigerate at 2-8°C (36-46°F) for up to 24 hr
                  • Once bag removed from refrigeration, complete infusion within 3 hr
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                  Images

                  No images available for this drug.
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.