FDA label ac453d98-2adb-d140-e053-2995a90a754e

WARNINGS None known

RADIATION DOSIMETRY The estimated absorbed radiation doses to an average human adult (70 kg) from intravenous injection of 185 MBq (5 mCi) and 370 MBq (10 mCi) of [18F]FDG are shown is Table 4. These estimates were calculated based on human1 data and using the data published by the International Commission on Radiological Protection2 for [18F]FDG. Table 4. Estimated Absorbed Radiation Doses after intravenous administration of 2-deoxy-2-[18F]fluoro-D-glucose, [18F]FDG to a 70 kg patient. Organ MgY/185MBq Rads/5mCi mGy/370MBq rads/10mCi Bladder Wall 31.45 3.15 62.90 6.29 Bladder* 11.00 1.10 22.00 2.20 Bladder** 22.00 2.20 44.00 4.40 Heart 12.03 1.20 24.05 2.41 Brain 4.81 .48 9.62 0.96 Kidneys 3.88 0.39 7.77 0.78 Uterus 3.70 3.7 7.40 0.74 Ovaries 2.78 0.28 5.55 0.56 Testes 2.78 0.28 5.55 0.56 Adrenals 2.59 0.26 5.18 0.52 Sm Intestine 2.40 0.24 4.81 0.48 ULI wall 2.40 0.24 4.81 0.48 LLI wall 2.96 0.30 5.92 0.59 Stomach wall 2.22 0.22 4.44 0.44 Liver 2.22 0.22 4.44 0.44 Pancreas 2.22 0.22 4.44 0.44 Spleen 2.22 0.22 4.44 0.44 Breast 2.04 0.20 4.07 0.41 Lungs 2.04 0.20 4.07 0.41 Red marrow 2.04 0.20 4.07 0.41 Other Tissue 2.04 0.20 4.07 0.41 Bone Surfaces 1.85 0.18 3.70 0.37 Thyroid 1.70 0.18 3.59 0.36 *With void 1 hour after administration **With void 2 hours after administration. The [18F]FDG Effective dose equivalent (Adult)2 is 0.027 mSv/MBq. 1 Jones, S.C. , Alavi, A., Christman, D., Montanez, I., Wolf, A.P., and Reivich, M. (1982). The Radiation Dosimetry of 2-F-18 fluoro-2-deoxy-D-glucose in man. J. Nucl. Med. 23, 613-617. 2 ICRP Publication 53, Volume 18, No. 1-4, 1987, page 76.

<table border="0" width="100%"><caption>Table 4. Estimated Absorbed Radiation Doses after intravenous administration of 2-deoxy-2-[18F]fluoro-D-glucose, [18F]FDG to a 70 kg patient.</caption><tbody><tr><td><paragraph>Organ</paragraph></td><td>MgY/185MBq</td><td>Rads/5mCi</td><td>mGy/370MBq</td><td>rads/10mCi</td></tr><tr><td>Bladder Wall</td><td>31.45</td><td>3.15</td><td>62.90</td><td>6.29</td></tr><tr><td>Bladder*</td><td>11.00</td><td>1.10</td><td>22.00</td><td>2.20</td></tr><tr><td>Bladder**</td><td>22.00</td><td>2.20</td><td>44.00</td><td>4.40</td></tr><tr><td>Heart</td><td>12.03</td><td>1.20</td><td>24.05</td><td>2.41</td></tr><tr><td>Brain</td><td>4.81</td><td>.48</td><td>9.62</td><td>0.96</td></tr><tr><td>Kidneys</td><td>3.88</td><td>0.39</td><td>7.77</td><td>0.78</td></tr><tr><td>Uterus</td><td>3.70</td><td>3.7</td><td>7.40</td><td>0.74</td></tr><tr><td>Ovaries</td><td>2.78</td><td>0.28</td><td>5.55</td><td>0.56</td></tr><tr><td>Testes</td><td>2.78</td><td>0.28</td><td>5.55</td><td>0.56</td></tr><tr><td>Adrenals</td><td>2.59</td><td>0.26</td><td>5.18</td><td>0.52</td></tr><tr><td>Sm Intestine</td><td>2.40</td><td>0.24</td><td>4.81</td><td>0.48</td></tr><tr><td>ULI wall</td><td>2.40</td><td>0.24</td><td>4.81</td><td>0.48</td></tr><tr><td>LLI wall</td><td>2.96</td><td>0.30</td><td>5.92</td><td>0.59</td></tr><tr><td>Stomach wall</td><td>2.22</td><td>0.22</td><td>4.44</td><td>0.44</td></tr><tr><td>Liver</td><td><paragraph>2.22</paragraph></td><td>0.22</td><td>4.44</td><td>0.44</td></tr><tr><td>Pancreas</td><td>2.22</td><td>0.22</td><td>4.44</td><td>0.44</td></tr><tr><td>Spleen</td><td>2.22</td><td>0.22</td><td>4.44</td><td>0.44</td></tr><tr><td>Breast</td><td>2.04</td><td>0.20</td><td>4.07</td><td>0.41</td></tr><tr><td>Lungs</td><td>2.04</td><td>0.20</td><td>4.07</td><td>0.41</td></tr><tr><td>Red marrow</td><td>2.04</td><td>0.20</td><td>4.07</td><td>0.41</td></tr><tr><td>Other Tissue</td><td>2.04</td><td>0.20</td><td>4.07</td><td>0.41</td></tr><tr><td>Bone Surfaces</td><td>1.85</td><td>0.18</td><td>3.70</td><td>0.37</td></tr><tr><td>Thyroid</td><td>1.70</td><td>0.18</td><td>3.59</td><td>0.36</td></tr></tbody></table>

ADVERSE REACTIONS The [18F]FDG safety data base was evaluated for 374 patients. Of these, 245 were male and 105 were female. For 24 patients, gender was not specified. The mean age was 47.8 years (range under 2 to over 65 years). Eighteen patients were between the age of 0 and 2 years; 42 patients were between the ages of 2 and 21 years old; 213 patients were between 21 and 65 years old and 98 patients were older than 65 years and the ages of 3 male patients were not specified. A racial distribution is not available. In this database, adverse drug reactions that required medical intervention were not reported. In a small, 42 patient subset of the 374 patients studied, 4 patients had transient hypotension, 6 had hypo- or hyperglycemia and 3 had transient increases in alkaline phosphatase.