Fludeoxyglucose F-18 (Page 4 of 4)

14.3 Neurology

In a prospective, open label trial, Fludeoxyglucose F-18 Injection was evaluated in 86 patients with epilepsy. Each patient received a dose of Fludeoxyglucose F-18 Injection in the range of 185-370 MBq (5-10 mCi). The mean age was 16.4 years (range: 4 months — 58 years; of these, 42 patients were less than 12 years and 16 patients were less than 2 years old). Patients had a known diagnosis of complex partial epilepsy and were under evaluation for surgical treatment of their seizure disorder. Seizure foci had been previously identified on ictal EEGs and sphenoidal EEGs. Fludeoxyglucose F-18 Injection PET imaging confirmed previous diagnostic findings in 16% (14/87) of the patients; in 34% (30/87) of the patients, Fludeoxyglucose F-18 Injection PET images provided new findings. In 32% (27/87), imaging with Fludeoxyglucose F-18 Injection was inconclusive. The impact of these imaging findings on clinical outcomes is not known.

Several other studies comparing imaging with Fludeoxyglucose F-18 Injection results to subsphenoidal EEG, MRI and/or surgical findings supported the concept that the degree of hypometabolism corresponds to areas of confirmed epileptogenic foci. The safety and effectiveness of Fludeoxyglucose F-18 Injection to distinguish idiopathic epileptogenic foci from tumors or other brain lesions that may cause seizures have not been established.

15 REFERENCES

1.

Gallagher B.M., Ansari A., Atkins H., Casella V., Christman D.R., Fowler J.S., Ido T., MacGregor R.R., Som P., Wan C.N., Wolf A.P., Kuhl D.E., and Reivich M. “Radiopharmaceuticals XXVII. 18F-labeled 2-deoxy-2-fluoro-d-glucose as a radiopharmaceutical for measuring regional myocardial glucose metabolism in vivo: tissue distribution and imaging studies in animals,” J Nucl Med , 1977; 18, 990-6.

2.

Jones S.C., Alavi, A., Christman D., Montanez, I., Wolf, A.P., and Reivich M. “The radiation dosimetry of 2 [F-18] fluoro-2-deoxy-D-glucose in man,” J Nucl Med , 1982; 23, 613-617.

3.

Kocher, D.C. “Radioactive Decay Tables: A handbook of decay data for application to radiation dosimetry and radiological assessments,” 1981, DOE/TIC-I 1026, 89.

4.

ICRP Publication 53, Volume 18, No. l-4,1987, pages 75-76.

16 HOW SUPPLIED/STORAGE AND HANDLING

Fludeoxyglucose F-18 Injection is supplied in a multi-dose, capped 30 mL glass vial containing between 0.74 — 18.5 GBq (20 — 500 mCi/mL), of no carrier added 2-deoxy-2-[F-18] fluoro-D-glucose, at end of synthesis, in approximately 2 — 30 mL. The contents of each vial are sterile, pyrogen-free and preservative-free.

NDC 65857-150-30
0.74 — 18.5 GBq (20 — 500 mCi/mL)

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

Store the Fludeoxyglucose F-18 Injection vial upright in a lead or tungsten alloy shielded container at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

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

17 PATIENT COUNSELING INFORMATION

Instruct patients in procedures that increase renal clearance of radioactivity. Encourage patients to:

•

drink water or other fluids (as tolerated) in the 4 hours before their PET study.

•

void as soon as the imaging study is completed and as often as possible thereafter for at least one hour.

Manufactured and Distributed by:

Cardinal Health 414, LLC
7000 Cardinal PlaceDublin, OH 43017

PRINCIPAL DISPLAY PANEL — 20-500 mCi/mL Vial Label

20-500 mCi/mL Vial Label

NDC # 65857-150-30 30 mL Multiple-Dose Vial

Fludeoxyglucose F-18 Injection, USP
20 mCi/mL to 500 mCi/mL @ EOS*

Sterile, Non-pyrogenic
Date: / /
Exp: / / Time: :

CAUTION: RADIOACTIVE MATERIAL

Each mL Contains:
0.74 GBq to 18.5 GBq (20 mCi/mL to 500 mCi/mL) of
no-carrier added Fludeoxyglucose F-18 (2-deoxy-2-
[¹⁸ F]fluoro-D-glucose) @ EOS*; 4.5 mg of sodium
chloride in citrate buffer.
Do not use if cloudy or if it contains particulate matter.

Activity @ EOS* mCi

Diagnostic — For Intravenous Use Only
Lot #:
(Expires 12 hours after EOS*)
Store at 25°C (77°F) (see insert)
Store upright in a shielded container.
Aseptically withdraw and handle doses.
[¹⁸ F] Half-Life = 109.7 min
Calculate correct dosage from date and time of calibration.

*EOS = End of Synthesis Mfg by Cardinal Health 414, LLC-Dublin, OH 43017 Rx ONLY

FLUDEOXYGLUCOSE F-18 fludeoxyglucose f-18 injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65857-150 Route of Administration INTRAVENOUS DEA Schedule

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

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE DISODIUM CITRATE SESQUIHYDRATE TRISODIUM CITRATE DIHYDRATE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65857-150-30 30 mL in 1 VIAL, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203603 01/02/2019

Labeler — Cardinal Health 414, LLC (069410546)

Revised: 12/2020 Cardinal Health 414, LLC