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Cytalux Pafolacianine injection 3.2 mg/1.6mL Injection — NDC 81052-0138-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cytalux Pafolacianine injection 3.2 mg/1.6mL Injection — NDC 81052-138-10 (Billing 81052-0138-10)

by On Target Laboratories, Inc. · 10 CARTON in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1.6 mL in 1 VIAL, SINGLE-DOSE

This is a package of Cytalux Pafolacianine injection 3.2 mg/1.6mL Injection from On Target Laboratories, Inc., marketed since Nov 2021 and currently FDA-listed. It is this product's only package size.

NDC 81052-0138-10
🏷️ FDA NDC (as labeled) 81052-138-10 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 81052-138-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
81052 labeler · 138 product · 10 package
Package marketed since
Nov 29, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8105213810 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 81052-138-10
Product NDC 81052-138
11-digit billing NDC 81052013810
NCPDP billing unit ML — per mL (volume)
UNII 4HUF3V875C
Application # NDA214907
SPL Set ID d21952b9-7c4e-3a56-e053-2a95a90a0ab0
Established class (EPC) Optical Imaging Agent
Mechanism of action Fluorescence Contrast Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-11-29
Route INTRAVENOUS
Dosage form INJECTION
Substance PAFOLACIANINE SODIUM

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 082871
GCN 51632
HICL code 047696
Ingredient (HICL) Pafolacianine Sodium
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z7
Therapeutic class — intermediate (HIC2) Photoactivation Imaging And Diagnostic Agents
HIC3 code Z7A
Therapeutic class — specific (HIC3) Fluorescence Imaging Agents - Malignant Tissue
AHFS code 36:68.00.00
AHFS class Roentgenography And Other Imaging Agents
FDB label name CYTALUX 3.2 MG /1.6 ML VIAL
FDB brand name Cytalux
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 082871
  • GCN: 51632
  • HICL (First Databank): 047696
  • AHFS class code: 36:68.00.00
Why two NDCs? The FDA registers this code as 81052-138-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 81052-0138-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name CYTALUX 3.2 MG /1.6 ML VIAL Ingredient Pafolacianine Sodium

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
81052-0138-10 You're viewing this Main listing 10 CARTON in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1.6 mL in 1 VIAL, SINGLE-DOSE 2021-11-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cytalux 3.2 mg/1.6mLthis 81052-0138-10 On 1 vial — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
First FDA approval
Nov 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 29, 2021 RLD RS ⏳ ~9.2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9333270 — drug substance (U-3291)
US 9061057 — drug substance (U-3291)
US 10881747 — drug substance (U-3291)
US 9789208 — drug substance (U-3291)
US 9254341 — drug substance
US 9341629 — drug substance
Exclusivity NCE
Exclusivity ODE-390
2021 2023 2025 2027 2029 2031 2033 2035
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (6)
PatentTypeUse codeExpires
US 9333270 ↗ Drug substance U-3291 Aug 26, 2033
US 9061057 ↗ Drug substance U-3291 Nov 29, 2035
US 10881747 ↗ Drug substance U-3291 Aug 26, 2033
US 9789208 ↗ Drug substance U-3291 Aug 26, 2033
US 9254341 ↗ Drug substance — Oct 4, 2033
US 9341629 ↗ Drug substance — Aug 26, 2033
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Nov 29, 2026
ODE-390Orphan Drug Exclusivity (7-year)Nov 29, 2028
Common questions
Is there a generic version of CYTALUX 3.2 MG /1.6 ML VIAL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for CYTALUX 3.2 MG /1.6 ML VIAL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2035 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color green
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 4J9FJ0HL51
    Potassium phosphate, monobasic is a salt compound used in medicines as a pH buffer and electrolyte source. It helps stabilize the acidity level of liquid and powdered formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 70WT22SF4B
    A mineral salt that acts as a buffer to maintain the pH balance of the medication. It helps stabilize the drug's potency and prevents unwanted chemical changes during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerOn Target Laboratories, Inc.
Application holderON TARGET LABORATORIES INC
FDA applicationNDA214907 (NDA)
Labeler code81052
First marketedNov 2021
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 79 words ▾

1. INDICATIONS AND USAGE CYTALUX is indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung.

CYTALUX is an optical imaging agent indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For recommended testing, evaluations, and premedications, see Full Prescribing Information. ( 2.1 ) Recommended intravenous dosage of CYTALUX is: Adult Patients with Ovarian Cancer: 0.025 mg/kg over 60 minutes, 1 hour to 9 hours prior to surgery Adult Patients with Known or Suspected Cancer in the Lung: 0.025 mg/kg over 60 minutes, 1 hour to 24 hours prior to surgery. ( 2.2 ) For preparation, management of infusion-related reactions, and imaging information see Full Prescribing Information.

CYTALUX should only be used by trained surgeons using FDA cleared imaging systems. ( 2.3 , 2.4 , 2.5 )

2.1Recommended Testing, Evaluations and Premedications Prior to Administration of CYTALUX Obtain a pregnancy test in females of reproductive potential and verify the absence of pregnancy prior to administration of CYTALUX [ see Warnings and Precautions (5.3) and Use in Specific Populations ( 8.1 , 8.3 ) ]. Discontinue folate, folic acid, or folate containing supplements 48 hours before administration of CYTALUX [ see Drug Interactions (7) ]. Consider administering antihistamines and/or anti-nausea medication for prophylaxis against infusion related reactions [ see Warnings and Precautions (5.1) ].

2.2Recommended Dosage and Administration Adult Patients with Ovarian Cancer The recommended dose of CYTALUX is a single intravenous infusion of 0.025 mg/kg diluted in 250 mL of 5% Dextrose Injection, administered over 60 minutes using a dedicated infusion line, 1 hour to 9 hours prior to surgery. Adult Patients with Known or Suspected Cancer in the Lung The recommended dose of CYTALUX is a single intravenous infusion of 0.025 mg/kg diluted in 250 mL of 5% Dextrose Injection, administered over 60 minutes using a dedicated infusion line, 1 hour to 24 hours prior to surgery.

2.3Preparation and Storage Instructions Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. 1. Use aseptic technique for the preparation of CYTALUX infusion solution.

2. Only use 5% Dextrose Injection for dilution. Do not use other diluents due to incompatibility [see Warnings and Precautions ( 5.4 )] .

3. CYTALUX vials should be stored and thawed in the original carton protected from light. Remove carton containing one single vial of CYTALUX from freezer and record the date, time and thawing condition on the carton.

Thaw at room temperature between 20°C to 25°C (68°F to 77°F) for at least 60 minutes or under refrigerated conditions between 2°C to 8°C (36°F to 46°F) for at least 6 hours. When thawed under refrigerated conditions, allow the vial to stand at room temperature for 15 minutes before dilution. Once thawed, an individual CYTALUX vial may be stored at room temperature between 20°C to 25°C (68°F to 77°F) for a maximum single period of 24 hours or under refrigerated conditions between 2°C to 8°C (36°F to 46°F) for a maximum single period of up to 30 days, prior to preparation for infusion.

If CYTALUX vial is not used within the maximum single period at either room temperature or under refrigerated conditions, the vial may be refrozen up to three times. If the vial has been thawed after the third refreeze, it must be used. If not used after the third refreeze, do not use and discard the vial.

Each vial of CYTALUX may be penetrated only once at the time of preparation of infusion solution. Once penetrated, the vial may not be refrozen. 4.

Hand shake or vortex the thawed CYTALUX vial for 60 seconds. 5. Withdraw the calculated volume of CYTALUX for a dose of 0.025 mg/kg.

Discard any unused portion in the vial. 6. Add into a 250 mL of 5% Dextrose Injection, USP bag.

7. Gently swirl the bag by hand for 1 minute to mix the solution. 8.

Visually inspect the infusion bag. The solution should be light blue/green to clear in color and should not contain any visible particulate matter. 9.

Protect the infusion bag from light using a light-blocking c… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 45 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 3.2 mg/1.6 mL (2 mg/mL) pafolacianine (equivalent to 3.4 mg/1.6 mL pafolacianine sodium) supplied as a dark bluish green, clear aqueous solution in a single-dose vial. Injection: 3.2 mg/1.6 mL (2 mg/mL) of pafolacianine in a single-dose vial. (3)

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None. None. (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Infusion-Related Reactions: Interrupt the infusion and treat as necessary with antihistamines and/or nausea medications. ( 5.1 ) Risk of misinterpretation: Non-fluorescing tissue in the surgical field does not rule out the presence of tumor. Fluorescence may be seen in non-cancerous tissues.

( 5.2 ) Embryo-Fetal Toxicity: CYTALUX may cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus. ( 5.3 , 8.1 , 8.3 ) Risk of Pafolacianine Aggregation and Infusion Reactions: Use only 5% Dextrose Injection for dilution.

Do not use other diluents. ( 5.4 )

5.1Infusion-Related Reactions Adverse reactions including nausea, vomiting, abdominal pain, flushing, hypersensitivity, elevation in blood pressure, dyspepsia, and chest discomfort were reported in patients receiving CYTALUX in clinical studies. A total of 17% of patients experienced reactions during the administration of CYTALUX [see Adverse Reactions ( 6.1 )] . Reactions typically occurred within 15 minutes of the start of infusion.

CYTALUX infusion interruption or discontinuation due to adverse reactions occurred in 11% of all patients. Treatment with antihistamines and/or anti-nausea medication may be used. If an adverse reaction occurs during administration, the infusion can be interrupted and resumed after treatment of the reaction [see Dosage and Administration ( 2.1 , 2.4 )] .

5.2Risk of Misinterpretation Errors may occur with the use of CYTALUX during intraoperative fluorescence imaging to detect ovarian cancer and lesions in the lung, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of ovarian cancer or lesions in the lung [see Clinical Studies ( 14 )] . Fluorescence may be seen in normal tissues including bowel, kidneys, lymph nodes, and lungs as well as in inflamed tissues.

5.3Embryo-Fetal Toxicity Based on its mechanism of action, CYTALUX may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating CYTALUX treatment. [ see Use in Specific Populations ( 8.1 , 8.3 ), Clinical Pharmacology ( 12.1 ) ].

5.4Risk of Pafolacianine Aggregation and Infusion Reactions Use of the incorrect diluent to prepare the CYTALUX infusion solution can cause the aggregation of pafolacianine; aggregation may induce infusion reactions, such as nausea, vomiting, abdominal pain or rash. Use only 5% Dextrose Injection to prepare the CYTALUX infusion solution. Do not use other diluents. [see Dosage and Administration ( 2.3 )].

5.1Infusion-Related Reactions Adverse reactions including nausea, vomiting, abdominal pain, flushing, hypersensitivity, elevation in blood pressure, dyspepsia, and chest discomfort were reported in patients receiving CYTALUX in clinical studies. A total of 17% of patients experienced reactions during the administration of CYTALUX [see Adverse Reactions ( 6.1 )] . Reactions typically occurred within 15 minutes of the start of infusion.

CYTALUX infusion interruption or discontinuation due to adverse reactions occurred in 11% of all patients. Treatment with antihistamines and/or anti-nausea medication may be used. If an adverse reaction occurs during administration, the infusion can be interrupted and resumed after treatment of the reaction [see Dosage and Administration ( 2.1 , 2.4 )] .

5.2Risk of Misinterpretation Errors may occur with the use of CYTALUX during intraoperative fluorescence imaging to detect ovarian cancer and lesions in the lung, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of ovarian cancer or lesions in the lung [see Clinical Studies ( 14 )] . Fluorescence may be seen in normal tissues including bowel, kidneys, lymph nodes, and lungs as well as in inflamed tissues.

5.3Embryo-Fetal Toxicity… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reaction is described elsewhere in the labeling: • Infusion-Related Reactions [ see Warnings and Precautions ( 5.1 ) ] Most common adverse reactions (incidence ≥1%; ovarian and lung combined) included nausea, vomiting, abdominal pain, flushing, other infusion-related reactions, hypersensitivity, elevation in blood pressure, dyspepsia, and chest discomfort. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact On Target Laboratories at 1-844-434-9333 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of CYTALUX was evaluated in four open label clinical studies, two studies (N = 44 and N = 150) in patients with ovarian cancer and two studies (N = 100 and N = 112) in patients with known or suspected cancer in the lung.

A total of 406 patients received 0.025 mg/kg of CYTALUX via intravenous administration. The demographic characteristics of the study population were 82% female (66% female in lung studies), mean age 64 years (range 26 to 89 years), 85% White, 6% Black or African American, 5% Asian, and 4% other race, 5% Hispanic or Latino, 92% Not Hispanic or Latino, and 3% unreported ethnicity. Adverse reactions that occurred in > 1% of patients are presented in Table 1.

Table 1. Adverse Reactions from Clinical Studies Reported in ≥ 1% of CYTALUX Treated Patients with Ovarian Cancer or Known or Suspected Cancer in the Lung Adverse Reaction CYTALUX 0.025 mg/kg (N = 406) % Nausea 13 Vomiting 5 Abdominal pain 2 Flushing 2 Other infusion-related reactions 2 Hypersensitivity 2 Elevation in blood pressure 1 Dyspepsia 1 Chest discomfort 1 Adverse reactions occurred during the administration of CYTALUX in 17% of patients. Overall, the safety profile observed in patients treated with CYTALUX 0.025 mg/kg was similar between patients with ovarian cancer and patients with known or suspected cancer in the lung.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of CYTALUX was evaluated in four open label clinical studies, two studies (N = 44 and N = 150) in patients with ovarian cancer and two studies (N = 100 and N = 112) in patients with known or suspected cancer in the lung.

A total of 406 patients received 0.025 mg/kg of CYTALUX via intravenous administration. The demographic characteristics of the study population were 82% female (66% female in lung studies), mean age 64 years (range 26 to 89 years), 85% White, 6% Black or African American, 5% Asian, and 4% other race, 5% Hispanic or Latino, 92% Not Hispanic or Latino, and 3% unreported ethnicity. Adverse reactions that occurred in > 1% of patients are presented in Table 1.

Table 1. Adverse Reactions from Clinical Studies Reported in ≥ 1% of CYTALUX Treated Patients with Ovarian Cancer or Known or Suspected Cancer in the Lung Adverse Reaction CYTALUX 0.025 mg/kg (N = 406) % Nausea 13 Vomiting 5 Abdominal pain 2 Flushing 2 Other infusion-related reactions 2 Hypersensitivity 2 Elevation in blood pressure 1 Dyspepsia 1 Chest discomfort 1 Adverse reactions occurred during the administration of CYTALUX in 17% of patients. Overall, the safety profile observed in patients treated with CYTALUX 0.025 mg/kg was similar between patients with ovarian cancer and patients with known or suspected cancer in the lung.

🔄 Drug Interactions 77 words ▾

7 DRUG INTERACTIONS Use of folate, folic acid, or folate-containing supplements may reduce binding of pafolacianine to folate receptors and could reduce the detection of lesions with CYTALUX. Avoid administration of folate, folic acid, or folate-containing supplements within 48 hours before administration of CYTALUX [see Dosage and Administration (2.1) and Clinical Pharmacology (12.1) ]. Folate Supplements: Avoid folate, folic acid, or folate-containing supplements within 48 hours before administration of CYTALUX.

(7) See 17 for PATIENT COUNSELING INFORMATION.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Based on its mechanism of action, pafolacianine may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available human data to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No adverse developmental effects were observed in rats and rabbits with intravenous administration of pafolacianine during organogenesis (embryofetal development) at doses up to 158-fold (rat) and 570-fold (rabbit) the recommended human dose of 0.025 mg/kg based on AUC, otherwise 9.6 and 38.4-fold based on human equivalent dose (HED) ( see Data ).

The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data In the definitive embryo-fetal development (EFD) studies, pafolacianine was intravenously administered during the period of organogenesis as follows: 0.015, 0.15, and 1.5 mg/kg/day from gestational day (GD) 6 to GD17 in rats (HEDs of 0.002, 0.024 and 0.242 mg/kg/day), and 0.3, 1, and 3 mg/kg/day from GD7 to GD20 in rabbits (HEDs of 0.097, 0.323 and 0.968 mg/kg/day). No significant drug-related maternal toxicity and embryo-fetal development toxicity were observed. NOAELs were 1.5 mg/kg/day in rats and 3 mg/kg/day in rabbits.

Estimated systemic exposures were 158 times (rat) and 570 times (rabbit) the human exposure at a human dose of 0.025 mg/kg based on plasma AUC comparison.

8.2Lactation Risk Summary There are no data on the presence of pafolacianine in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CYTALUX and any potential adverse effects on the breastfed infant from CYTALUX or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential CYTALUX may cause fetal harm if administered to a pregnant woman [see Warnings And Precautions ( 5.3 ) and Use in Specific Populations ( 8.1 )] . Pregnancy Testing Obtain a pregnancy test in females of reproductive potential and verify the absence of pregnancy prior to administration of CYTALUX [see Dosage and Administration ( 2.1 )] .

8.4Pediatric Use Safety and effectiveness of CYTALUX in pediatric patients have not been established.

8.5Geriatric Use Of the total number of patients in clinical studies of CYTALUX, 221 patients (54%) were 65 years of age and older: 153 (38%) were 65 to 74 years of age, 66 (16%) were 75 to 84 years of age, and 2 (0.5%) were 85 years of age and older. No overall differences in safety, effectiveness, or pharmacokinetics were observed between patients 65 years of age and older and younger adult patients.

8.1Pregnancy Risk Summary Based on its mechanism of action, pafolacianine may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available human data to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No adverse developmental effects were observed in rats and rabbits with intravenous administration of pafolacianine during organogenesis (embryofetal development) at doses up to 158-fold (rat) and 570-fold (rabbit) the recommended human dose of 0.025 mg/kg based on AUC, otherwise 9.6 and 38.4-fold based on human equivalent dose (HED) ( see Data ).

The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.… [Excerpted — this section continues on DailyMed.]

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Pafolacianine binds to alpha and beta folate receptors (FR) on cells, is internalized via receptor-mediated endocytosis, and accumulates intracellularly. Pafolacianine enhances lesion visualization through the differential level of expression and accessibility of folate receptors within lesions relative to normal tissue. Pafolacianine absorbs light in the near-infrared (NIR) region within a range of 760 nm to 785 nm with peak absorption of 776 nm and emits fluorescence within a range of 790 nm to 815 nm with peak emission of 796 nm.

12.2Pharmacodynamics Tumor to background ratios of fluorescence intensity changed with different mass doses studied in patients with ovarian cancer. High tumor to background ratio was observed with 0.025 mg/kg dose. CYTALUX exposure-response relationships and the time course of pharmacodynamic responses are unknown.

12.3Pharmacokinetics The mean C max of pafolacianine was 59.1 ± 5.94 ng/mL and AUC inf was 63.6 ± 12.6 ng.hr/mL. Distribution The mean volume of distribution (V z ) is 17.1 ±

5.99L, indicating distribution into tissues. Plasma protein binding of pafolacianine is 93.7%. No notable partitioning into red blood cells has been observed. Elimination The elimination half-life of pafolacianine is 0.44 ± 0.23 hours and mean plasma clearance is 28.6 ±

4.97L/hr. Metabolism Pafolacianine sodium is not metabolized by cytochrome P450 (CYP) enzymes. Excretion Following a single IV infusion of radiolabeled pafolacianine sodium, approximately 35% of the dose was recovered in urine (19.1%) and in feces (15.8%) after approximately 3-5 weeks.

Specific Populations No clinically significant differences in pharmacokinetics of pafolacianine were identified based on age 18 to 89 years, weight 41.6 to 133.6 kg, mild to moderate renal impairment (CLcr 30 to 89 mL/min), mild to moderate hepatic impairment (total bilirubin < 3 ULN and AST > ULN). The effect of severe renal impairment (CLcr < 30 mL/min) and severe hepatic impairment (total bilirubin > 3 ULN and any AST value) on the pharmacokinetics of pafolacianine have not been studied. Drug Interaction Studies No clinical studies evaluating the drug interaction potential of pafolacianine have been conducted.

In Vitro Studies CYP Enzymes: Pafolacianine is not an inhibitor of CYPs 1A2, 2B6, 2C8, 2C9, 2C19 2D6, 3A4/5. UDP-glucuronosyltransferase (UGT) Enzymes: Pafolacianine is not an inhibitor of UGT1A1. Transporter Systems: Pafolacianine is a substrate for OATP1B1, OATP1B3, and OAT1.

Pafolacianine is not an inhibitor of OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1, MATE2-K, P-gp, or BCRP

12.1Mechanism of Action Pafolacianine binds to alpha and beta folate receptors (FR) on cells, is internalized via receptor-mediated endocytosis, and accumulates intracellularly. Pafolacianine enhances lesion visualization through the differential level of expression and accessibility of folate receptors within lesions relative to normal tissue. Pafolacianine absorbs light in the near-infrared (NIR) region within a range of 760 nm to 785 nm with peak absorption of 776 nm and emits fluorescence within a range of 790 nm to 815 nm with peak emission of 796 nm.

12.2Pharmacodynamics Tumor to background ratios of fluorescence intensity changed with different mass doses studied in patients with ovarian cancer. High tumor to background ratio was observed with 0.025 mg/kg dose. CYTALUX exposure-response relationships and the time course of pharmacodynamic responses are unknown.

12.3Pharmacokinetics The mean C max of pafolacianine was 59.1 ± 5.94 ng/mL and AUC inf was 63.6 ± 12.6 ng.hr/mL. Distribution The mean volume of distribution (V z ) is 17.1 ±

5.99L, indicating distribution into tissues. Plasma protein binding of pafolacianine is 93.7%. No notable partitioning into red blood cells has been observed. Elimination The elimination half-life of pafolacianine is 0.44 ± 0.23 hours and mean plasma clearance is 28.6 ±

4.97L/hr. Metaboli… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 152 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied CYTALUX (pafolacianine) injection, 3.2 mg /1.6 mL (2 mg/mL), is a dark bluish green, clear aqueous solution packaged in a sealed amber glass single-dose vial. It is supplied in a carton containing 10 vials (NDC 81052-138-10) individually packaged. Storage and Handling Store vials in their original cartons to protect from light.

CYTALUX may be stored according to the table below. If CYTALUX vial is not used within the maximum single period at either room temperature or under refrigerated conditions the vial may be refrozen up to three time.​ Storage Condition​ Condition Temperature Range​ Maximum Single Period Permissible Freeze-Thaw Cycles​ Frozen -25°C to -15°C (-13°F to 5°F) Until Expiration Date Not applicable Refrigeration 2°C to 8°C (36°F to 46°F) Up to 30 days Three Room Temperature 20°C to 25°C (68°F to 77°F) Up to 24 hours Three Do not use the product past the expiration date

📋 Description 124 words ▾

11 DESCRIPTION CYTALUX contains pafolacianine, an optical imaging agent, as a tetrasodium salt referred to as pafolacianine sodium. Chemically, pafolacianine sodium is (S)-2-(4-(((2-amino-4-oxo-3,4- dihydropteridin-6-yl)methyl)amino)benzamido)-3-(4-(((E)-2-((E)-2-(3,3-dimethyl-5-sulfonato-1-(4- sulfonatobutyl)-3H-indol-1-ium-2-yl)vinyl)-6-((E)-2-(3,3-dimethyl-5-sulfonato-1-(4- sulfonatobutyl)indolin-2-ylidene)ethylidene)cyclohex-1-en-1-yl)oxy)phenyl)propanoate hydrate tetrasodium. Pafolacianine sodium has a molecular formula of C 61 H 63 N 9 Na 4 O 17 S 4 , a molecular mass of 1414.42 g/mol and has the following structure: CYTALUX (pafolacianine) injection is a sterile, non-pyrogenic, dark bluish green, clear aqueous solution for intravenous use.

Each vial contains 3.2 mg (2 mg/mL) pafolacianine (equivalent to 3.4 mg pafolacianine sodium),14.4 mg sodium chloride, 0.23 mg potassium phosphate monobasic, 1.27 mg sodium phosphate dibasic heptahydrate in 1.6 mL volume. The pH is adjusted with sodium hydroxide and/or hydrochloric acid and is between 7.1 to 7.8. 214907s000lbl.jpg

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Patients with Known or Suspected Ovarian Cancer The safety and efficacy of CYTALUX were evaluated in a randomized, multicenter, open-label study (NCT03180307). The study enrolled 178 women with a diagnosis or high clinical suspicion of ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery. One hundred and fifty women received CYTALUX (dosed at 0.025 mg/kg at least 1 hour before initiation of fluorescence imaging).

Among them, 134 women underwent both normal light and CYTALUX evaluation (Intent-to-Image Set). The demographic characteristics were mean age 60 (range 33 to 81) years, 85% White, 4% Asian, 5% Black or African American, 3% American Indian or Alaska native, 3% other races, 11% Hispanic or Latino, and 2% unreported ethnicity. Table 2 shows the proportion of patients with at least one evaluable ovarian cancer lesion confirmed by central histopathology that was detected with CYTALUX but not with normal light or palpation and not otherwise identified for resection prior to surgery.

The detection performance met the pre-specified success threshold. Table 2: Detection Proportion with CYTALUX but Not with Normal Light or Palpation in the Intent-To-Image Set N=134 patients Patients with at least one confirmed ovarian cancer evaluable lesion Number (n) 36 Proportion (%) 95% CI 0.269 (26.9%) (0.196*, 0.352) *The pre-specified lower bound of the 95% confidence interval (CI) was 0.10. In 20.2% (95% CI: 13.7%, 28.0%) of patients, all lesions detected by CYTALUX alone were negative by central histopathology (false positive).

14.2Patients with Known or Suspected Cancer in the Lung The safety and efficacy of CYTALUX were evaluated in a randomized, multicenter, open-label study (NCT04241315). The study enrolled 140 patients scheduled to undergo thoracoscopic or open segmental or subsegmental resection for primary lung lesions that were either confirmed or suspected to be cancer. One hundred and twelve patients received CYTALUX (dosed at 0.025 mg/kg between 1 and 24 hours before initiation of fluorescence imaging).

Among them, 100 patients underwent both normal light and CYTALUX evaluation (Intent-to-Image Set). The demographic characteristics were 61% female, mean age 66 (range 26 to 83) years, 88% White, 8% Black or African American, 2% Asian, 2% other races, 99% Not Hispanic or Latino, and 1% unreported ethnicity. Histopathology of the primary lung lesions in these 100 patients showed primary lung cancer in 65%, metastasis to the lung in 21%, benign lung lesions in 11%, and other/unknown cancer in 3%.

Among the primary lung cancers, 86% were adenocarcinoma, 8% were squamous cell carcinoma, 3% were adeno-squamous carcinoma, and 3% were atypical carcinoid. Table 3 shows the proportion of patients in whom at least one of the following clinically significant events (CSE) occurred with CYTALUX but not with normal light or palpation: localization of the primary lung lesion, whether benign or malignant (CSE A), and detection of one or more synchronous malignant lung lesions (CSE B). Synchronous lesions were not identified prior to surgery.

The combined CSE A and CSE B detection performance met the pre-specified success threshold. Table 3: Proportion of Clinically Significant Events Occurring with CYTALUX but Not with Normal Light or Palpation in the Intent-To-Image Set N=100 patients Primary Lung Lesion (CSE A) Synchronous Malignant Lung Lesion (CSE B) Patients with CSE A and/or CSE B Number (n) 19* 8 24** Proportion (%) 95% CI 0.19 (19%) (0.118, 0.281) 0.08 (8%) (0.035, 0.152) 0.24 (24%) (0.160***, 0.336) * Including two subjects with benign primary lesions. ** Three patients had both primary lesion localization and synchronous malignant lesion detection, resulting in 27 events in 24 unique patients. *** The pre-specified lower bound of the 95% confidence interval (CI) was 0.10.

CYTALUX did not identify the primary lung lesion in 23% (95% CI:15… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 175 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No carcinogenicity studies of pafolacianine have been conducted. Mutagenesis No genotoxic hazards were identified when pafolacianine was evaluated in a standard testing battery consisting of a bacterial reverse mutation assay, an in vitro micronucleus study conducted in Chinese Hamster Ovary (CHO) cells, and a rat bone marrow micronucleus study. Impairment of Fertility Reproductive and developmental toxicity (fertility and embryonic development, pre- and postnatal development) studies in animals have not been performed to evaluate the effects of pafolacianine on fertility.

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No carcinogenicity studies of pafolacianine have been conducted. Mutagenesis No genotoxic hazards were identified when pafolacianine was evaluated in a standard testing battery consisting of a bacterial reverse mutation assay, an in vitro micronucleus study conducted in Chinese Hamster Ovary (CHO) cells, and a rat bone marrow micronucleus study. Impairment of Fertility Reproductive and developmental toxicity (fertility and embryonic development, pre- and postnatal development) studies in animals have not been performed to evaluate the effects of pafolacianine on fertility.

📄 Recent Major Changes 14 words ▾

RECENT MAJOR CHANGES Dosage and Administration, 7/2025 Preparation and Storage Instructions ( 2.3 )

📄 Package Label / Principal Display Panel 214 words ▾

10 Vial Carton NDC 81052-138-10 cytalux ® (pafolacianine) injection 3.2 mg / 1.6 mL (2 mg/mL) 10 x 1.6 mL Single-Dose Vials. Discard Unused Portion For Intravenous Infusion After Dilution Store vials in original carton to protect from light. Store frozen at -25° to -15°C (-13° to 5°F) until expiration date.

Once thawed, vials may be stored refrigerated at 2° to 8°C (36° to 46°F) up to 30 days or at room temperature at 20° to 25°C (68° to 77°F) up to 24 hours. Rx only ON TARGET LABORATORIES 10 Vial Carton

Single Vial Carton Label NDC 81052-138-01 cytalux ® (pafolacianine) injection 3.2 mg / 1.6 mL (2 mg/mL) For Intravenous Infusion After Dilution Store vials in original carton to protect from light. Store frozen at -25° to -15°C (-13° to 5°F) until expiration date. Once thawed, vials may be stored refrigerated at 2° to 8°C (36° to 46°F) up to 30 days or at room temperature at 20° to 25°C (68° to 77°F) up to 24 hours.

Rx only ON TARGET LABORATORIES Single Vial Carton Label

Vial Label NDC 81052-138-00 Sterile cytalux ® (pafolacianine) injection 3.2 mg / 1.6 mL (2 mg/mL) For Intravenous Infusion After Dilution Discard Unused Portion Single-Dose Vial Rx only ON TARGET LABORATORIES 19086 LOT: EXP: YYYY/MM Vial Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Cytalux (this brand).

Top reported reactions

Nausea32
Vomiting18
Chest Discomfort5
Dyspnoea5
Pruritus5
Drug Effect Less Than Expected4
Flushing4

Age at onset

Adult1

Reporter sex

58 reports
Male · 33%
Female · 67%

Serious outcomes

Hospitalization8
Death2
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 24 13
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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← 81050-0108-00 · No 81066-0001-01 · Siegfried →
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