Cerebral perfusion imaging (stroke): Children ≥2 years and Adolescents: IV: 0.4 mCi/kg (14 MBq/kg); minimum dose: 3 mCi/dose (110 MBq/dose); do not exceed adult doses: 15 to 30 mCi/dose (555 to 1,110 MBq/dose). 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: 2 mCi/dose (74 MBq/dose); do not exceed adult doses: 5 to 10 mCi/dose (185 to 370 MBq/dose). 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.
Children ≥2 years and Adolescents: IV: 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.
(For additional information see "Technetium Tc-99m exametazime: Drug information")
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, nonstroke (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 (Ref).
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 nonabdominal 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 (Ref).
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.
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
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.
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.
Prior to preparation, store kit at 15°C to 25°C (59°F to 77°F). Visually inspect reconstituted material; do not use if evidence of foreign matter. Autologous Tc 99m labeled leukocytes should be administered as soon as possible after labeling (preferably within 20 minutes, but no later than 1 hour). Use preparations without cobalt stabilizer solution within 30 minutes after reconstitution. Use preparations with cobalt stabilizer solution within 5 hours after preparation; individual doses may be aseptically stored in a capped syringe. Discard unused material.
Cerebral scintigraphy as an adjunct in detection of altered regional cerebral perfusion in stroke patients (Ceretec: FDA approved in ages ≥2 years and adults); leukocyte-labeled scintigraphy as an adjunct in localization of intra-abdominal infection and inflammatory bowel disease (Ceretec: FDA approved in ages ≥2 years and adults; Drax Exametazime: FDA approved in adults).
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.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
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).
Signs/symptoms of hypersensitivity reactions.
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%)