Cerebral perfusion imaging, stroke: IV (based on a 70 kg patient): 15 to 30 mCi (555 to 1110 MBq). Perform imaging 30 to 90 minutes after administration and complete imaging within 4 hours after administration; planar or SPECT imaging techniques may be utilized.
Cerebral perfusion imaging, non-stroke (off- label use): IV: 15 to 30 mCi (555 to 1,110 MBq); images obtained after 40 minutes will be interpretable; however, images obtained after 90 minutes will provide the best quality (ACR/SPR 2016; Juni 2009).
Leukocyte-labeled scintigraphy in intra-abdominal infection/inflammatory bowel disease: IV: Tc 99m-labeled leukocytes: 5 to 10 mCi (185 to 370 MBq). Dynamic imaging may be performed for the first 60 minutes after administration; static imaging may be performed at 30 to 90 minutes, 2 to 4 hours, and if necessary, 18 to 24 hours after administration.
Leukocyte-labeled scintigraphy in non-abdominal infection/inflammation (off-label use): IV: Tc 99m-labeled leukocytes: 5 to 10 mCi (185 to 370 MBq); obtain delayed imaging at 4 to 8 hours; if early images are negative, longer imaging time (16 to 24 hours) may be necessary (Palestro 2004).
Risk for toxicities may be increased in patients with renal impairment; Tc 99m is substantially excreted by the kidney. There are no specific dosage adjustments provided in the manufacturer's labeling; however, dose reduction may be considered if an adequate number of labeled white blood cells are administered.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
Cerebral perfusion imaging (stroke): Children ≥2 years and Adolescents: IV: 0.4 mCi/kg (14 MBq/kg); minimum dose of 3 mCi (110 MBq); do not exceed maximum administered activity for an adult. Perform imaging 30 to 90 minutes after administration and complete imaging within 4 hours after administration; planar or SPECT imaging techniques may be utilized.
Leukocyte-labeled scintigraphy in intra-abdominal infection/inflammatory bowel disease: Children ≥2 years and Adolescents: IV: 0.2 mCi/kg (7.4 MBq/kg); minimum dose of 2 mCi (74 MBq); do not exceed maximum administered activity for an adult. Dynamic imaging may be performed for the first 60 minutes after administration; static imaging may be performed at 30 to 90 minutes, 2 to 4 hours, and if necessary, 18 to 24 hours after administration.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
Cardiovascular: Facial edema, transient hypertension
Dermatologic: Erythema, skin rash
Miscellaneous: Fever
There are no contraindications listed in the manufacturer’s labeling.
Concerns related to adverse effects:
• Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, may occur. Emergency resuscitation equipment and personnel should be immediately available.
• Radiation accumulation: Tc 99m administration contributes to the patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Risk is greater with pediatric patients due to greater radiosensitivity and longer life expectancy. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
Disease-related concerns:
• Renal impairment: Substantially excreted by the kidney; risk for toxicities may be increased in patients with renal impairment.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and health care personnel. Use under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority. Note: Contents of kit are not radioactive; however, adequate shielding is required after addition of radioactive material.
Other warnings/precautions:
• Appropriate use: Instruct patients to void when examination is completed, and frequently thereafter; encourage adequate hydration to facilitate frequent voiding.
• Risk for misinterpretation: Image interpretation errors may occur with Tc 99m exametazime; images may be affected by the presence of tumor, infarction, trauma, and other inflammatory conditions.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Kit, Intravenous [preservative free]:
Ceretec: (5s) [vial contents to be combined with sodium pertechnetate Tc 99m injection solution (not included)]
Drax Exametazime: (5s) [vial contents to be combined with sodium pertechnetate Tc 99m injection solution (not included)]
No
IV: Follow manufacturer's labeling for administration. Ensure adequate hydration after administration. Instruct patient to void within 2 hours after administration to minimize radiation exposure (Juni 2009); patients should void frequently to minimize kidney and bladder exposure.
Leukocyte-labeled scintigraphy: Administer using a 19-gauge needle as soon as possible (preferably within 20 minutes but no later than 1 hour) after preparation of the Tc 99m labeled leukocyte suspension.
Radiopharmaceutical; use appropriate precautions for handling and disposal. Ensure adequate hydration before and after administration.
Radiopharmaceutical; use appropriate precautions for handling and disposal. Use waterproof gloves and effective radiation shielding, including syringe shields, when handling.
IV: Contents of kit are used to prepare technetium Tc 99m exametazime and are not for direct IV injection; only reconstituted technetium Tc 99m exametazime may be administered IV. Follow manufacturer's labeling for administration. Ensure adequate hydration after administration. Instruct patient to void prior to and within 2 hours after administration to minimize radiation exposure (Juni 2009); patients should void frequently to minimize kidney and bladder exposure.
Leukocyte-labeled scintigraphy: Administer using a 19-gauge needle as soon as possible (preferably within 20 minutes but no later than 1 hour) after preparation of the Tc 99m labeled leukocyte suspension.
Imaging agent:
Leukocyte labeled scintigraphy: Adjunct in the localization of intra-abdominal infection and inflammatory bowel disease in adults (Ceretec and Drax Exametazime) and pediatric patients ≥2 years of age (Ceretec only).
Cerebral scintigraphy: Ceretec: Adjunct in the detection of altered regional cerebral perfusion in stroke patients ≥2 years of age.
Cerebral perfusion imaging (non-stroke); Non-abdominal infection sites (localization)
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.
None known.
There are no known significant interactions.
Pregnancy status should be evaluated prior to use in women of reproductive potential (SNM 2010).
Technetium Tc 99m exametazime crosses the placenta (Owunwanne 1998); the amount of technetium Tc 99m that can be detected in fetal tissue depends upon the specific formulation, route of administration, and stage of pregnancy (Adelstein 1999).
In general, the potential for a radiopharmaceutical to cause fetal harm depends on the dose absorbed by the fetus and the stage of pregnancy. High doses of radiopharmaceuticals used for therapeutic procedures are more likely to result in fetal harm. A medically required diagnostic procedure can usually be modified to decrease fetal risk. Elective diagnostic procedures should be delayed until after delivery (ACR-SPR 2018; Adelstein 1999; ICRP 2000; SNM 2010).
Technetium Tc 99m is present in breast milk.
In a case report, a breastfeeding mother was administered technetium Tc 99m exametazime 500 mBq IV for a brain perfusion study (postpartum age not presented). Peak activity in the breast milk was detected 6.5 hours after the injection, and the calculated effective dose (0.26 mSv) was low enough that an interruption of breastfeeding would not have been necessary (Marshall 1996).
Available guidance recommends that lactating women interrupt breastfeeding for a period of 12 to 24 hours after administration of Tc 99m exametazime (depending on the dose) (IAEA 2018). During this time, women can continue to express milk at normal feeding times and discard the milk until breastfeeding can be resumed. Alternatively, women can pump and store breast milk prior to the procedure, which can be bottle-fed (Harding 1995).
Elective diagnostic procedures should be delayed until breastfeeding has stopped (SNM 2010). Women who are breastfeeding and caring for individuals undergoing nuclear medicine procedures do not need any additional precautions (ABM [Mitchell 2019]).
Excretion of technetium Tc 99m into colostrum is widely variable and information is limited; therefore, recommendations related to early breastfeeding cannot be made (Mountford 1989; Rubow 1994).
Monitor for signs/symptoms of hypersensitivity
Radioactive diagnostic agent which decays by isomeric transition to emit a photon that can be detected by imaging
Distribution: Distributes to brain, muscle, and soft tissue
Half-life elimination: Physical: ~6 hours
Excretion: Feces (~50%); Urine (~40%)
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