Drax Exametazime (exametazime systemic intravenous use)

Drax Exametazime (kit for the preparation of technetium Tc 99m exametazime for leukocyte labeling) for intravenous use is a radioactive diagnostic agent indicated for leukocyte (white blood cell) labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.

Common side effects of Drax Exametazime include:

• temporary increase in blood pressure,
• rash,
• generalized skin redness,
• facial swelling,
• fever,
• hives,
• itching,
• fatigue,
• feeling unwell (malaise),
• headache,
• dizziness,
• numbness and tingling,
• flushing,
• nausea,
• or vomiting.

Recommended Dosage And Administration

For an adult patient the recommended intravenous injection dose range for technetium Tc 99m exametazime labeled leukocytes is 259 -925 Megabecquerels (MBq) [7-25 millicuries (mCi)].

Image Acquisition And Interpretation

Acquisition

• Instruct patients to empty their bladder prior to imaging.
• Obtain serial pelvic and abdominal images beginning at 0.5 – 1 hour post-injection and continue up to 4  hours.

Interpretation

• Accumulation of radioactivity in bowel seen in early images [less than 4 hours] with increasing intensity and/or no evidence of changing location secondary to GI motility likely represents inflammatory bowel disease or infection. Radioactivity from hepatic excretion detected in the bowel 4 hours post-injection and changing in GI location on serial/subsequent images is indicative of normal GI transit.

• Limited available data with technetium Tc 99m exametazime use in pregnant women are insufficient to inform a drug associated risk for major birth defects and miscarriage.
• Technetium Tc 99m exametazime is transferred across the placenta.
• Animal reproduction studies with technetium Tc 99m exametazime have not been conducted.
• However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
• If considering technetium Tc 99m exametazime administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from technetium Tc 99m exametazime and the gestational timing of exposure.
• There are limited data available in the scientific literature on the presence of technetium Tc 99m exametazime in human milk.
• There no data available on the effects of technetium Tc 99m exametazime on the breastfed infant or the effects on milk production.
• Exposure of technetium Tc 99m exametazine to a breast fed infant can be minimized by temporary discontinuation of breastfeeding.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for technetium Tc 99m exametazime, any potential adverse effects on the breastfed child from technetium Tc 99m exametazime or from the underlying maternal condition.