Fludeoxyglucose F18 (Page 4 of 4)

14.3 Neurology

In a prospective, open label trial, Fludeoxyglucose F18 Injection USP was evaluated in 86 patients with epilepsy. Each patient received a dose of Fludeoxyglucose F18 Injection USP 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 F18 Injection USP PET imaging confirmed previous diagnostic findings in 16% (14/87) of the patients; in 34% (30/87) of the patients, Fludeoxyglucose F18 Injection USP PET images provided new findings. In 32% (27/87), imaging with Fludeoxyglucose F18 Injection USP was inconclusive. The impact of these imaging findings on clinical outcomes is not known.

Several other studies comparing imaging with Fludeoxyglucose F18 Injection USP 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 F18 Injection USP to distinguish idiopathic epileptogenic foci from tumors or other brain lesions that may cause seizures have not been established.

16. How supplied/storage and handling

Fludeoxyglucose F18 Injection USP is supplied in a multi-dose, capped 30 mL glass vial containing between 0.740 – 11.1GBq/mL (20 — 300 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D- glucose, at end of synthesis, in approximately 25 — 30 mL. The contents of each vial are sterile, pyrogen- free and preservative-free.

Store the Fludeoxyglucose F18 Injection USP vial upright in a lead shielded container at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Store and dispose of Fludeoxyglucose F18 Injection USP 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 F18 Injection USP within 12 hours from the EOS time.

17. Pateient 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.

Pregnancy: Advise pregnant women of the risk of fetal exposure to radiation with Fludeoxyglucose F 18 Injection USP [see Use in Specific Populations ( 8.1)].

Lactation: Advise lactating women that exposure to Fludeoxyglucose F 18 Injection USP through breast milk can be minimized by pumping and discarding breast milk and avoiding close (breast) contact with the infant for 9 hours after Fludeoxyglucose F 18 Injection [see Use in Specific Populations ( 8.2)].

Manufactured by: The Methodist Hospital Research Institute Cyclotron/Radiochemistry Facility

6670 Bertner Avenue

Houston, TX 77030

Distributed by: The Methodist Hospital Research Institute

Cyclotron/Radiochemistry Facility 6670 Bertner Avenue

Houston, TX 77030

F18 FDG bulk vial label
(click image for full-size original)

FLUDEOXYGLUCOSE F18
fludeoxyglucose f18 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69864-001
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 0.3 Ci in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69864-001-30 30 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203904 04/23/2012
Labeler — The Methodist Hospital Research Institute (185641052)
Establishment
Name Address ID/FEI Operations
The Methodist Hospital Research Institute 185641052 positron emission tomography drug production (69864-001)

Revised: 08/2021 The Methodist Hospital Research Institute

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