CYTALUX- pafolacianine injection injection

Cytalux by

Drug Labeling and Warnings

Cytalux by is a Prescription medication manufactured, distributed, or labeled by On Target Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 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.
  • 2 DOSAGE AND ADMINISTRATION

    2.1 Recommended 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)].

    2.2 Recommended 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.

    2.3 Preparation 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.

    a. Thaw at room temperature between 20° to 25°C (68° to 77°F) for at least 60 minutes or under refrigerated conditions between 2° to 8°C (36° 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.

    b. Once thawed, an individual CYTALUX vial may be stored at room temperature between 20° to 25°C (68° to 77°F) for a maximum single period of 24 hours or under refrigerated conditions between 2° to 8°C (36° to 46°F) for a maximum single period of up to 30 days, prior to preparation for infusion.

    c. 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 one time.

    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 cover during infusion and storage.

    10. If not immediately used, store the diluted CYTALUX infusion solution in a refrigerator at 2 o to 8 oC (36 o to 46 oF) for not more than 24 hours. Once the bag is removed from refrigeration, infusion must be completed within 3 hours.

    2.4 Management of Infusion-Related Reactions

    If the patient develops an infusion reaction during administration, interrupt the infusion and treat with
    antihistamines and/or anti-nausea medication as necessary, based on clinical decision. Complete the
    infusion within 3 hours of the start of the initial administration [ see Warnings and Precautions (5.1)].

    2.5 Imaging

    • Clinical data demonstrate that near infrared (NIR) imaging devices that excite at 760 nm to 785 nm and detect emission at 790 nm to 815 nm are suitable for use with CYTALUX.
    • CYTALUX is to be used with an NIR imaging system cleared by the FDA for specific use with pafolacianine.
    • CYTALUX 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.
  • 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.

  • 4 CONTRAINDICATIONS

    None.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Infusion-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)] .

    5.2 Risk 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.

    5.3 Embryo-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)     ].

    5.4 Risk 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)].

  • 6 ADVERSE REACTIONS

    The following clinically significant adverse reaction is described elsewhere in the labeling:
    Infusion-Related Reactions [ see Warnings and Precautions ( 5.1) ]

    6.1 Clinical 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
    Vomiting5
    Abdominal pain2
    Flushing

    2
    Other infusion-related reactions2
    Hypersensitivity2
    Elevation in blood pressure1
    Dyspepsia1
    Chest discomfort1

    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.

  • 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)].

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy


    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.

    8.2 Lactation


    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.

    8.3 Females 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)].

    8.4 Pediatric Use


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

    8.5 Geriatric 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.

  • 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 61H 63N 9Na 4O 17S 4, a molecular mass
    of 1414.42 g/mol and has the following structure:

    214907s000lbl.jpg

    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.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Pafolacianine binds to folate receptor (FR)-expressing cells with ~1 nM affinity, internalizes via receptor-mediated endocytosis, and accumulates intracellularly. 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 a peak emission of 796 nm.

    CYTALUX is a fluorescent drug that targets FR, which are overexpressed in ovarian cancer. The mechanism of CYTALUX detection of lung lesions is not well understood. The density of FR in malignant lesions in the lung is generally similar to that of normal lung tissue.

    12.2 Pharmacodynamics

    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.

    12.3 Pharmacokinetics

    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 ± 5.99 L, 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 ±
    4.97 L/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

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, 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.

  • 14 CLINICAL STUDIES

    14.1 Patients 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).

    14.2 Patients 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 patientsPrimary Lung Lesion (CSE A)Synchronous Malignant Lung Lesion (CSE B)Patients with CSE A and/or CSE B
    Number (n)19*824**

    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%, 32%) of patients. Among the 20 patients who had synchronous lesions detected only by CYTALUX, 12 patients had only benign synchronous lesions.

    The depth of primary lung lesions detected by CYTALUX ranged from 0 to 38 mm from the lung surface (mean depth 6 mm).

  • 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 one time.​

    Storage Condition

    Condition Temperature Range

    		Maximum Single Period

    Permissible Freeze-Thaw Cycles

    Frozen

    -25° to -15°C (-13° to 5°F)

    Until Expiration Date

    Not applicable

    Refrigeration

    2° to 8°C (36° to 46°F)

    		Up to 30 days

    One

    Room Temperature

    20° to 25°C (68° to 77°F)

    Up to 24 hours

    One

    Do not use the product past the expiration date.

  • 17 PATIENT COUNSELING INFORMATION

    Embryo-Fetal Toxicity
    Advise females of reproductive potential of the potential risk to a fetus and to contact their healthcare
    provider with a known or suspected pregnancy
    [ see Warnings and Precautions ( 5.3) and Use In Specific Populations ( 8.1) ].

    Folate Supplements Usage
    Inform patients that folic acid may reduce the detection of cancer tissue with CYTALUX. Advise the
    patient to stop taking folate, folic acid, or folate-containing supplements 48 hours before
    administration of CYTALUX [ see Dosage and Administration ( 2.1) and Drug Interactions ( 7) ].

    Manufactured by:


    Grand River Aseptic Manufacturing
    140 Front Ave SW
    Grand Rapids, MI 49506

    Distributed by:


    Patheon Logistics
    100 Berkeley Dr.
    Swedesboro, NJ 08085

    Packaged by:

    Fisher Clinical Services Inc.
    7554 Schantz Rd.
    Allentown, PA 18100-9032

  • PACKAGING - PRINCIPAL DISPLAY PANEL

    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: 81052-138-10

    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

    Vial Label

    NDC: 81052-138-10

    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

    14372

    LOT:
    EXP: YYYY/MM

    Vial Label

  • INGREDIENTS AND APPEARANCE
    CYTALUX 
    pafolacianine injection injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 81052-138
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PAFOLACIANINE SODIUM (UNII: 4HUF3V875C) (PAFOLACIANINE - UNII:F7BD3Z4X8L) PAFOLACIANINE3.2 mg  in 1.6 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    Colorgreen (Dark Bluish) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 81052-138-1010 in 1 CARTON11/29/2021
    11 in 1 CARTON
    11.6 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21490711/29/2021
    Labeler - On Target Laboratories, Inc. (968729181)

    • Trademark Results [Cytalux]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CYTALUX
    CYTALUX
    88890150 not registered Live/Pending
    ON TARGET LABORATORIES, INC.
    2020-04-27
    CYTALUX
    CYTALUX
    88890147 not registered Live/Pending
    ON TARGET LABORATORIES, INC.
    2020-04-27
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