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

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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

                    Adding plans allows you to compare formulary status to other drugs in the same class.

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                    • Compare formulary status to other drugs in the same class.
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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.