FLUDEOXYGLUCOSE F18 injection

Fludeoxyglucose by

Drug Labeling and Warnings

Fludeoxyglucose by is a Prescription medication manufactured, distributed, or labeled by Houston Cyclotron Partners LP dba Cyclotope. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

• 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:

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 Disintegration	Mean Energy
* Produced by positron annihilation. From: Kocher, D.C. Radioactive Decay Tables DOE/TIC-I 1026, 89 (1981)
Positron (β+)	96.73	249.8 keV
Gamma (±) *	193.46	511.0 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) mm	Coefficient of Attenuation
0	0.00
4	0.50
8	0.25
13	0.10
26	0.01
39	0.001
52	0.0001

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

Minutes	Fraction Remaining
* Calibration time
0 *	1.00
15	0.909
30	0.826
60	0.683
110	0.500
220	0.250

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

Label for Lead Pig Container

INGREDIENTS AND APPEARANCE

FLUDEOXYGLUCOSE  F18
fludeoxyglucose f18 injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 47584-001
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FLUDEOXYGLUCOSE F-18 (UNII: 0Z5B2CJX4D) (FLUDEOXYGLUCOSE F-18 - UNII:0Z5B2CJX4D)	FLUDEOXYGLUCOSE F-18	500 mCi  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47584-001-01	16 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product	12/08/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203665	12/08/2011

Labeler - Houston Cyclotron Partners LP dba Cyclotope (118258354)

Establishment
Name	Address	ID/FEI	Business Operations
Houston Cyclotron Partners LP dba Cyclotope		118258354	positron emission tomography drug production(47584-001)