Label: FLUDEOXYGLUCOSE F18 injection

  • NDC Code(s): 47584-001-01
  • Packager: Houston Cyclotron Partners LP dba Cyclotope
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 12, 2018

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use Fludeoxyglucose F18 Injection safely and effectively. See full prescribing information for Fludeoxyglucose F18 Injection.



    Fludeoxyglucose F18 Injection

    Initial U.S. Approval: 2005

    DOSAGE FORMS AND STRENGTHS

    Multiple-dose glass vial containing 0.74-18.5 GBq/mL (20-500 mCi/mL) of Fludeoxyglucose F18 Injection and 4.5 mg of sodium chloride in citrate buffer (approximately 16 – 17 mL volume), for intravenous administration (3).

    ADVERSE REACTIONS

    Hypersensitivity reactions have occurred; have emergency resuscitation equipment and personnel immediately available (6).

    To report SUSPECTED ADVERSE REACTIONS, contact CYCLOTOPE at 1-713-747-5686 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Revised: 8/2012

  • Table of Contents

    FULL PRESCRIBING INFORMATION: CONTENTS*

    3 DOSAGE FORMS AND STRENGTHS

    6 ADVERSE REACTIONS

    11 DESCRIPTION

    11.1 Chemical Characteristics

    11.2 Physical Characteristics

    16 HOW SUPPLIED / STORAGE AND DRUG HANDLING

    *
    Sections or subsections omitted from the full prescribing information are not listed.
  • 3 DOSAGE FORMS AND STRENGTHS

    Multiple-dose glass vial containing 0.74-18.5 GBq/mL (20-500 mCi/mL) of Fludeoxyglucose F 18 Injection and 4.5 mg of sodium chloride in citrate buffer (approximately 16 - 17 mL volume) for intravenous administration.

  • 6 ADVERSE REACTIONS

    Hypersensitivity reactions with pruritus, edema and rash have been reported in the post-marketing setting. Have emergency resuscitation equipment and personnel immediately available.

  • 11 DESCRIPTION

    11.1 Chemical Characteristics

    Fludeoxyglucose F 18 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient 2-deoxy-2-[ 18F]fluoro-D-glucose has the molecular formula of C 6H 1118FO 5with a molecular weight of 181.26, and has the following chemical structure:

    Image of chemical structure

    Fludeoxyglucose F 18 Injection is provided as a ready to use sterile, pyrogen free, clear, colorless citrate buffered solution. Each mL contains between 0.740 to 18.5 GBq (20.0-500 mCi) of 2-deoxy-2-[ 18F]fluoro-D-glucose at the EOS, 4.5 mg of sodium chloride in citrate buffer. The pH of the solution is between 4.5 and 7.5. The solution is packaged in a multiple-dose glass vial and does not contain any preservative.

    11.2 Physical Characteristics

    Fluorine F 18 has a physical half-life of 109.7 minutes and decays to Oxygen O 18 (stable) by positron decay. The principal photons useful for imaging are the dual 511 keV "annihilation" gamma photons, that are produced and emitted simultaneously in opposite direction when the positron interacts with an electron (Table 2).

    Table 2: Principal Emission Data for Fluoride F18
    Radiation/Emission% per DisintegrationMean Energy
    *
    Produced by positron annihilation. From: Kocher, D.C. Radioactive Decay Tables DOE/TIC-I 1026, 89 (1981)
    Positron (β+)96.73249.8 keV
    Gamma (±) *193.46511.0 keV

    The specific gamma ray constant (point source air kerma coefficient) for fluorine F 18 is 5.7 R/hr/mCi (1.35 x 10 -6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4 mm lead (Pb). The range of attenuation coefficients for this radionuclide as a function of lead shield thickness is shown in Table 3. For example, the interposition of an 8 mm thickness of Pb, with a coefficient of attenuation of 0.25, will decrease the external radiation by 75%.

    Table 3:Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding
    Shield Thickness (Pb) mmCoefficient of Attenuation
    00.00
    40.50
    80.25
    130.10
    260.01
    390.001
    520.0001

    For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4.

    Table 4: Physical Decay Chart for Fluoride F18
    MinutesFraction Remaining
    *
    Calibration time
    0 *1.00
    150.909
    300.826
    600.683
    1100.500
    2200.250
  • 16 HOW SUPPLIED / STORAGE AND DRUG HANDLING

    Fludeoxyglucose F 18 Injection is supplied in a multi-dose, capped 30 mL glass vial containing between 0.740 – 18.5 GBq/mL (20 - 500 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 16 - 17 mL. The contents of each vial are sterile, pyrogen-free and preservative-free.

    NDC 47584-001-01

    Store the Fludeoxyglucose F 18 Injection vial upright in a lead shielded container at 20º to 25°C (68º to 77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

    Distribute, store and dispose of Fludeoxyglucose F 18 Injection in accordance with the regulations and a general license, or its equivalent, of an Agreement State or a Licensing State.

    The expiration date and time are provided on the container label. Use Fludeoxyglucose F 18 Injection within 12 hours from the EOS time.

  • SPL UNCLASSIFIED SECTION

    Manufactured and distributed by:

    Cyclotope

    Accelerated Medicine

    8285 El Rio Suite 160

    Houston, TX 77054

    USA

  • PRINCIPAL DISPLAY PANEL

    Label for Container Closure System: 30 ml Vial

    Vial label

    Label for Lead Pig Container

    Container label

  • INGREDIENTS AND APPEARANCE
    FLUDEOXYGLUCOSE  F18
    fludeoxyglucose f18 injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:47584-001
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FLUDEOXYGLUCOSE F-18 (UNII: 0Z5B2CJX4D) (FLUDEOXYGLUCOSE F-18 - UNII:0Z5B2CJX4D) FLUDEOXYGLUCOSE F-18500 mCi  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47584-001-0116 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product12/08/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20366512/08/2011
    Labeler - Houston Cyclotron Partners LP dba Cyclotope (118258354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Houston Cyclotron Partners LP dba Cyclotope118258354positron emission tomography drug production(47584-001)