FDA Label for Fludeoxyglucose F18

3  Dosage Forms And Strengths

Multiple-dose vial containing:

• 0.74 - 11.1 GBq/mL (20 - 300 mCi/mL) of Fludeoxyglucose F18 Injection and a 4.5 mg of sodium chloride in citrate buffer (approximately 27 mL volume), for intravenous administration

or

• 0.74 - 5.55 GBq/mL (20 - 150 mCi/mL) of Fludeoxyglucose F18 Injection and a 4.5 mg of sodium chloride in phosphate buffer (approximately 15 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.

Other

Manufactured and Distributed by:

The University of Texas MD Anderson Cancer Center

Cyclotron Radiochemistry Facility

1881 East Road

Houston, TX  77054

Final Product Labels

FDGC label update - compressed FDGC 2014120401 val

FDG Citrate Formulation

16  How Supplied/Storage And Handling

Fludeoxyglucose F 18 Injection is supplied in a multi-dose, 30 mL glass vial containing:

• between 0.740 - 11.1 GBq/mL (20 - 300 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 27 mL.    Citrate Buffer Formulation:  NDC 60215-411-30

or

• between 0.740 - 5.55 GBq/mL (20 - 150 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 15 mL.    Phosphate Buffer Formulation:  NDC 60215-411-15

The total volume and total radioactivity per vial are variable.  The contents of each vial are sterile, pyrogen-free and preservative free.  Each vial is enclosed in a shielding container of appropriate thickness.

Storage

Store the Fludeoxyglucose F 18 Injection vial upright in a shielded container at 10 - 25°C (68 - 77°F), excursions permitted to 15 - 30°C (59 - 86°F) [See USP Controlled Room Temperature].

Handling

Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate.

11.0  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 C₆H₁₁¹⁸FO₅ with a molecular weight of 181.26, and has the following chemical structure:

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 directions when the positron interacts with an electron (Table 2).