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Pafolacianine: Drug information

Pafolacianine: Drug information
(For additional information see "Pafolacianine: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Cytalux
Pharmacologic Category
  • Imaging Agent
Dosing: Adult

Note: Discontinue folate, folic acid, or folate-containing supplements 48 hours prior to pafolacianine administration. Consider administering an antihistamine and/or antiemetics as prophylaxis for infusion-related reactions. Use with a near-infrared (NIR) imaging device cleared for specific use with pafolacianine; clinical data demonstrates that NIR imaging devices that excite at 760 to 785 nm and detect emission at 790 to 815 nm are suitable for use with pafolacianine.

Optical imaging agent, lung cancer

Optical imaging agent, lung cancer (known or suspected): IV: 0.025 mg/kg as a single dose, administered 1 to 24 hours prior to surgery.

Optical imaging agent, ovarian cancer

Optical imaging agent, ovarian cancer: IV: 0.025 mg/kg as a single dose, administered 1 to 9 hours prior to surgery (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl ≥30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, mild or moderate kidney impairment had no clinically significant effect on pafolacianine pharmacokinetics.

CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

Mild or moderate impairment (total bilirubin <3 times ULN and AST > ULN): There are no dosage adjustments provided in the manufacturer's labeling; however, mild or moderate hepatic impairment had no clinically significant effect on pafolacianine pharmacokinetics.

Severe impairment (total bilirubin >3 times ULN and any AST): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Adjustment for Toxicity: Adult

Infusion reaction: Interrupt infusion and manage with antihistamines and/or antiemetic agents as clinically indicated; may resume infusion after treatment of reaction.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions (Significant): Considerations
Infusion-related reactions

Infusion-related reactions, consisting of nausea, vomiting, abdominal pain, flushing, hypersensitivity reactions, increased blood pressure, dyspepsia, and chest discomfort may occur.

Onset: Rapid; typically occurs within 15 minutes of infusion initiation.

Risk factors:

• Incorrect diluent to prepare infusion (only D5W should be used when diluting pafolacianine for infusion; the use of other solutions may result in pafolacianine aggregation, which may be associated with infusion reactions)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%:

Gastrointestinal: Nausea (13%)

Hypersensitivity: Infusion-related reaction (2% to 17%)

1% to 10%:

Cardiovascular: Chest discomfort (1%), flushing (2%), increased blood pressure (1%)

Gastrointestinal: Abdominal pain (2%), dyspepsia (1%), vomiting (5%)

Hypersensitivity: Hypersensitivity reaction (2%)

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Other warnings/precautions:

• Imaging interpretation risk: Interpretation errors may occur during intraoperative fluorescence imaging with pafolacianine to detect ovarian cancer and lung lesions, including false negatives and false positives. Nonfluorescing tissue in the surgical field does not rule out the presence of ovarian cancer or lung lesions. Fluorescence may be seen in normal tissue including areas of the bowel, kidneys, lymph nodes, lungs, and inflamed tissue.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as sodium:

Cytalux: 3.2 mg/1.6 mL (1.6 mL)

Generic Equivalent Available: US

No

Pricing: US

Solution (Cytalux Intravenous)

3.2 mg/1.6 mL (per mL): $3,187.50

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

IV: Infuse over 60 minutes, 1 to 9 hours prior to surgery (ovarian cancer) or 1 to 24 hours prior to surgery (lung cancer). Administer via a dedicated infusion line. Protect infusion bag from light during infusion using a light-blocking cover.

Consider administering an antihistamine and/or antiemetic medications as prophylaxis for infusion-related reactions. Monitor for signs/symptoms of infusion-related reactions.

Use: Labeled Indications

Optical imaging agent: As an adjunct for intraoperative identification of malignant lesions in adults with ovarian cancer, and malignant and nonmalignant pulmonary lesions in adults with known or suspected cancer in the lung.

Metabolism/Transport Effects

Substrate of OAT1/3, OATP1B1/1B3 (SLCO1B1/1B3)

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Folic Acid: May diminish the diagnostic effect of Pafolacianine. Risk X: Avoid combination

Food Interactions

Folic acid may reduce binding of pafolacianine to folate receptors on ovarian cancer cells and may interfere with the detection of cancer tissue when using pafolacianine. Management: Discontinue folate, folic acid, or folate-containing supplements 48 hours prior to pafolacianine administration.

Reproductive Considerations

Verify pregnancy status prior to therapy; pregnancy must be excluded prior to use in patients who could become pregnant.

Pregnancy Considerations

Based on the mechanism of action, in utero exposure to pafolacianine may cause fetal harm.

Breastfeeding Considerations

It is not known if pafolacianine is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

Verify pregnancy status prior to therapy (in patients who could become pregnant). Monitor for signs/symptoms of infusion-related reactions.

Mechanism of Action

Pafolacianine is a folate analog conjugated to a near-infrared (NIR) fluorescent dye (Hoogstins 2016). Pafolacianine is an imaging agent that targets folate receptor (FR), which is overexpressed in ovarian cancer; it binds to FR-expressing cells with ~1 nM affinity, internalizes via receptor mediated endocytosis, and concentrates intracellularly. The mechanism of pafolacianine detection of lung lesions is not well understood; the density of FR in malignant lung lesions is generally similar to that of normal lung tissue. Pafolacianine assists optical imaging during surgery by absorbing light in the NIR region within a range of 760 nm to 785 nm with peak absorption of 776 nm and emitting fluorescence within a range of 790 nm to 815 nm with a peak emission of 796 nm.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: 17.1 ± 5.99 L; distributes into tissues.

Protein binding: 93.7%.

Half-life elimination: 0.44 ± 0.23 hours.

Excretion: Urine (~19%); feces (~16%).

Clearance: Plasma: 28.6 ± 4.97 L/hour.

  1. Cytalux (pafolacianine) [prescribing information]. Grand Rapids MI: Grand River Aseptic Manufacturing; December 2022.
  2. Hoogstins CE, Tummers QR, Gaarenstroom KN, et al. A novel tumor-specific agent for intraoperative near-infrared fluorescence imaging: a translational study in healthy volunteers and patients with ovarian cancer. Clin Cancer Res. 2016;22(12):2929-2938. doi:10.1158/1078-0432.CCR-15-2640 [PubMed 27306792]
  3. Tanyi JL, Randall LM, Chambers SK, et al. A phase III study of pafolacianine injection (OTL38) for intraoperative imaging of folate receptor-positive ovarian cancer (study 006). J Clin Oncol. 2022;JCO2200291. doi:10.1200/JCO.22.00291 [PubMed 36070540]
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