DRAX EXAMETAZIME

DistributionDuring the first hour following the injection, radioactivity is seen in the lungs, liver, gall bladder, spleen, blood pool, bone marrow, kidneys, and bladder. Over the first 1-6 hours, the Tc 99m is visualized in the bowel. At 24 hours post-injection substantial colonic activity is seen. The normal areas visualized in earlier scans are still visible.

Elimination

ExcretionTc 99m excretion occurs via urine and feces.

Two clinical trials of technetium Tc 99m exametazime were performed in a total of 88 patients who had suspected intra-abdominal infection or inflammation. Subjects received both Tc 99m labeled leukocytes and a radiolabeled comparator. Images were obtained at 2 and 30 minutes and at 2, 4 and 24 hours. In two other clinical trials, a total of 127 patients with suspected abdominal inflammation or infection received Tc 99m labeled leukocytes. Imaging was at 24 hours in one study and at 1, 3 and 24 hours in the other. In all four studies images were blindly evaluated and the findings were confirmed...

The following adverse reactions are described elsewhere in the labeling; Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] . The following adverse reactions associated with the use of technetium Tc 99m exametazime have been identified in clinical trials or post-marketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. C...

None. None. ( 4 )

Hypersensitivity Reactions: Hypersensitivity reactions, including serious signs and symptoms of anaphylaxis, following administration of Tc 99m labeled leukocytes prepared using Tc 99m exametazime have been reported. Always have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions. ( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including serious signs and symptoms of anaphylaxis, following administration of Tc...