Label: CYTALUX- pafolacianine injection injection

  • NDC Code(s): 81052-138-10
  • Packager: On Target Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 31, 2022

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use CYTALUX safely and effectively. See full prescribing information for CYTALUX.

    CYTALUX™ (pafolacianine) injection, for intravenous use

    Initial U.S. Approval: 2021

    INDICATIONS AND USAGE

    CYTALUX is an optical imaging agent indicated in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. ( 1)

    DOSAGE AND ADMINISTRATION

    For recommended testing, evaluations, and premedications, see Full

    Prescribing Information. (2.1)
    • Recommended dosage of CYTALUX is 0.025 mg/kg administered

    intravenously over 60 minutes 1 hour to 9 hours prior to surgery (2.2)
    • For preparation, management of infusion-related reactions, and

    imaging information see Full Prescribing Information. Should only be

    used by trained surgeons using FDA cleared imaging systems. ( 2.3,

    2.4,2.5)

    DOSAGE FORMS AND STRENGTHS

    Injection: 3.2 mg/1.6 mL (2 mg/mL) of pafolacianine in a single-dose
    vial. (3)

    CONTRAINDICATIONS

    None. (4)

    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)

    ADVERSE REACTIONS

    Most common adverse reactions (incidence ≥1%) are nausea,
    vomiting, abdominal pain, flushing, dyspepsia, chest discomfort,
    pruritus and hypersensitivity. ( 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.

    DRUG INTERACTIONS

    Folate Supplements: Avoid folate, folic acid, or folate-containing
    supplements within 48 hours before administration of CYTALUX. (7)

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 12/2021

  • Table of Contents
  • 1. INDICATIONS AND USAGE

    CYTALUX™ is an optical imaging agent indicated in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions.

  • 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

    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.

    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. Thaw frozen CYTALUX vial in original carton at controlled room temperature between 20°
    to 25°C (68° to 77°F) for at least 90 minutes.
    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°C
    to 8°C (36°F to 46°F) 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 demonstrates that near infrared (NIR) imaging devices which excite at 760 nm to
    785 nm and detect emission at 794 nm to 796 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 consisting of nausea, vomiting, abdominal pain, flushing, dyspepsia, chest
    discomfort, and pruritus were reported in patients receiving CYTALUX in clinical studies. 2.4 % of
    patients experienced reactions during the period of administration of CYTALUX. [ see Adverse
    Reactions (6.1)
    ]. Reactions typically occurred within 15 minutes of the start of infusion. 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, including false negatives and false positives. Non-fluorescing tissue in the surgical
    field does not rule out the presence of ovarian cancer [ see Clinical Studies ( 14) ]. Fluorescence may
    be seen in non-cancerous tissue including areas of the bowel, kidneys, lymph nodes and inflamed
    tissue.

    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 three open label clinical studies, two studies (N = 150 and
    N = 44) in patients with ovarian cancer and one study (N = 100) in patients with cancer in the lung.
    While patients with cancer in the lung were included in safety evaluation, CYTALUX is not approved
    for use in patients with cancer in the lung. A total of 294 patients received 0.025 mg/kg of CYTALUX
    via intravenous administration. The mean age of patients was 63.5 years; 51% were 65 years of age
    or older. 89% of patients were female and 84% of patients were White.
    Adverse reactions that occurred in > 1 % of patients were: nausea (15%), vomiting (5.8%), abdominal
    pain (2.7%), flushing (1.7%), dyspepsia (1%), chest discomfort (1%), pruritus (1%) and
    hypersensitivity (1%). In 2.4 % of patients, these adverse reactions occurred during the
    administration of CYTALUX.

  • 7 DRUG INTERACTIONS

    Use of folate, folic acid, or folate-containing supplements may reduce binding of pafolacianine to
    folate receptors overexpressed on ovarian cancer cells and could reduce the detection of malignant
    lesions with 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 at doses of, during the period of organogenesis namely, 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 in ovarian cancer surgeries, 40% were
    65 and over, while 11% were 75 and over. No overall differences in safety, effectiveness or
    pharmacokinetics were observed between these patients and younger 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

    CYTALUX is a fluorescent drug that targets folate receptor (FR) which may be overexpressed in
    ovarian cancer. Pafolacianine binds to FR-expressing cancer cells with ~1 nM affinity, internalizes via
    receptor mediated endocytosis, and concentrates in FR-positive cancer tissues. 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.

    12.2 Pharmacodynamics

    Tumor to background ratios changed with different mass doses studied. 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 – 89 years, weight 41.6 – 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

    The safety and efficacy of CYTALUX was evaluated in a randomized, multicenter, open-label study
    (NCT03180307). The study enrolled 178 women diagnosed with ovarian cancer or with high clinical
    suspicion of ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking,
    or recurrent ovarian cancer surgery. One hundred and fifty women highly suspicious for or with
    confirmed ovarian cancer received CYTALUX (dosed at 0.025 mg/kg at least 1 hour before initiation
    of fluorescence imaging). Among them, 134 women with mean age 60 (range 33 to 81) years
    received both normal light imaging evaluation and fluorescence imaging evaluation (the Intent to
    Image set).
    The study assessed the proportion of patients with at least one evaluable ovarian cancer lesion
    confirmed by central pathology that was detected with CYTALUX under fluorescent light but not under
    normal light or palpation and not otherwise identified for resection prior to surgery. The detection
    proportion was estimated in women who underwent both normal light and fluorescent light (Intent-to-
    Image Set), see Table 1. The detection performance for the Intent to Image set met the pre-specified
    success threshold.


    Table 1: Detection Proportion with CYTALUX Under Fluorescent Light but Not Under Normal
    Light or Palpation In the Intent-To-Image Set

    (N=134)
    Patients with at least one confirmed ovarian cancer evaluable lesion
    Number (n)36
    Proportion (%)0.269 (26.9%)
    95% Cl (proportion)(0.196*, 0.352)


    *The lower bound of the 95% confidence interval based on exact binomial exceeds the prespecified proportion of 0.10.


    Patient-level false positive rate of CYTALUX with NIR fluorescent light with respect to the detection of
    ovarian cancer lesions confirmed by central pathology was 20.2% with 95% confidence interval
    (13.7%, 28.0%).

  • 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), vials are individually packaged.

    Storage and Handling
    Store frozen between -25° to -15°C (-13° to 5°F). Store in original carton to protect from light.

  • 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:

    Thermofisher Allentown Packaging Facility
    Or 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

    Carton-label

    NDC 81052-138-10
    Rx only

    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 at -25° to -15°C ( -13° to 5°F)

    Store in original carton to protect from light.

    ON TARGET LABORATORIES

    Contains:
    3.2 mg pafolacianine (equivalent to 3.4 mg
    pafolacianine sodium)
    14.4 mg sodium chloride, USP
    0.23 mg potassium phosphate monobasic
    1.27 mg potassium phosphate dibasic heptahydrate
    Thaw at room temperature, 20° to 25°C (68° to 77°F),
    for at least 90 minutes in the carton prior to preparation.
    Must dilute with 5% dextrose injection, USP only
    before use. Store diluted solution in dark in refrigerator
    and use within 24 hrs. of preparation.
    Recommended Dosage: See Prescribing Information
    Manufactured for:
    On Target Laboratories
    West Lafayette, IN 47906
    For more information, visit www.CYTALUX.com
    or call 1.844.434.9333.

    LOT:
    EXP: YYYY-MMM-DD

    10-Vials-Carton

    Single Vial carton Label

    NDC 81052-138-10

    Rx only

    cytalux™
    (pafolacianine) injection

    3.2 mg / 1.6 mL
    (2 mg/mL)


    For Intravenous Infusion After Dilution
    Store in freezer at -25° to -15°C (-13° to 5°F)

    Store in original carton to
    protect from light.

    ON TARGET LABORATORIES

    Contains:
    3.2 mg pafolacianine (equivalent
    to 3.4 mg pafolacianine sodium)
    14.4 mg sodium chloride, USP
    0.23 mg potassium phosphate
    monobasic
    1.27 mg potassium phosphate
    dibasic heptahydrate
    Thaw at room temperature, 20° to 25°C
    (68° to 77°F), for at least 90 minutes
    in the carton prior to preparation.
    Must dilute with 5% dextrose
    injection, USP only before use.
    Store diluted solution in dark in
    refrigerator and use within 24 hrs.
    of preparation.
    Recommended Dosage:
    See Prescribing Information
    Manufactured for:
    On Target Laboratories
    West Lafayette, IN 47906
    For more information,
    visit www.CYTALUX.com
    or call 1.844.434.9333.

    LOT:
    EXP: YYYY-MMM-DD

    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)