Prescription Drug Information: Ammonia N 13 (Page 2 of 2)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term animal studies have not been performed to evaluate the carcinogenic potential of Ammonia N 13 Injection. Genotoxicity assays and impairment of male and female fertility studies with Ammonia N 13 Injection have not been performed.

14 CLINICAL STUDIES


In a descriptive, prospective, blinded image interpretation study2 of adult patients with known or suspected coronary artery disease, myocardial perfusion deficits in stress and rest PET images obtained with Ammonia N 13 (N=111) or Rubidium 82 (N=82) were compared to changes in stenosis flow reserve (SFR) as determined by coronary angiography. The principal outcome of the study was the evaluation of PET defect severity relative to SFR.

PET perfusion defects at rest and stress for seven cardiac regions(anterior, apical, anteroseptal, posteroseptal, anterolateral, posterolateral, and inferior walls) were graded on a 0 to 5 scale defined as normal (0), possible (1), probable (2), mild (3), moderate (4), and severe (5) defects. Coronary angiograms were used to measure absolute and relative stenosis dimensions and to calculate stenosis flow reserve defined as the maximum value of flow at maximum coronary vasodilatation relative to rest flow under standardized hemodynamic conditions. SFR scores ranged from 0 (total occlusion) to 5 (normal).

With increasing impairment of flow reserve, the subjective PET defect severity increased. A PET defect score of 2 or higher was positively correlated with flow reserve impairment (SFR<3).

15 REFERENCES

  1. Annals of the ICRP. Publication 53. Radiation dose to patients from radiopharmaceuticals. New York: Pergamon Press, 1988.
  2. Demer, L.L.K.L.Gould, R.A.Goldstein, R.L.Kirkeeide, N.A.Mullani, R.W. Smalling, A.Nishikawa, and M.E.Merhige. Assessment of coronary artery disease severity by PET: Comparison with quantitative arteriography in 193 patients. Circulation 1989; 79: 825-35.

16 HOW SUPPLIED/STORAGE AND HANDLING

Ammonia N 13 Injection is packaged in 10 mL mulitiple dose glass vial containing between 1.11 GBq to 11.1 GBq (30 mCi to 300 mCi) of [13 N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution in approximately 8 mL volume. The recommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.5-1 picomoles (8.47-16.94 picograms) of Ammonia.

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).Use the solution within 35 minutes of the End of Synthesis (EOS) calibration.

17 PATIENT COUNSELING INFORMATION

17.1 Pre-study Hydration

Instruct patients to drink plenty of water or other fluids (as tolerated) in the 4 hours before their PET study.

17.2 Post-study Voiding

Instruct patients to void after completion of each image acquisition session and as often as possible for one hour after the PET scan ends.

17.3 Post-study Breastfeeding Avoidance

Instruct nursing patients to substitute stored breast milk or infant formula for breast milk for 2 hours after administration of Ammonia N 13 Injection.

Manufactured and Distributed by:

University of Wisconsin Radiopharmaceutical Production Facility

Madison, Wisconsin 53705

PRINCIPAL DISPLAY PANEL

Drug Product Vial Label

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Drug Product Shield Label

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AMMONIA N 13 ammonia n 13 injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72333-001
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMMONIA N-13 (AMMONIA N-13) AMMONIA N-13 37.5 mCi in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72333-001-10 1 VIAL, GLASS in 1 CONTAINER contains a VIAL, GLASS
1 10 mL in 1 VIAL, GLASS This package is contained within the CONTAINER (72333-001-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211740 09/09/2020
Labeler — University of Wisconsin System (161202122)
Registrant — University of Wisconsin System (161202122)
Establishment
Name Address ID/FEI Operations
UW Radiopharmaceutical Production Facility 117218915 positron emission tomography drug production (72333-001)

Revised: 09/2020 University of Wisconsin System

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