Ceretec

(Technetium Tc-99m Exametazime And Cobaltous Chloride)

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Ceretec Prescribing Information

Ceretec is a radioactive diagnostic agent, indicated in adults and pediatric patients age 2 to 17 for:

Leukocyte Labeled Scintigraphy – As an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. (
1.1 Leukocyte Labeled Scintigraphy
Ceretec, when reconstituted with technetium Tc 99m exametazime (without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for leukocyte labeled scintigraphy as an adjunct in the localization of intraabdominal infection and inflammatory bowel disease.
)
Cerebral Scintigraphy – As an adjunct in the detection of altered regional cerebral perfusion in stroke. (
1.2 Cerebral Scintigraphy
Ceretec, when reconstituted with technetium Tc 99m exametazime (with or without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for cerebral scintigraphy as an adjunct in the detection of altered regional cerebral perfusion in stroke.
)

Do not use cobalt stabilizer solution for leukocyte labeled scintigraphy. (
2.1 Important Preparation and Radiation Safety Instructions
- The Ceretec kit includes a cobalt stabilizer solution, which is optional for cerebral scintigraphy.
  DO NOT USE COBALT STABILIZER SOLUTION FOR LEUKOCYTE LABELED Scintigraphy
  [see Dosage and Administration (2.4, 2.6)]
  .
- Technetium Tc 99m exametazime injection is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure
  [see Warnings and Precautions (5.3)]
  . Use waterproof gloves and effective shielding, including syringe shields, when preparing and administering technetium Tc 99m exametazime injection.
)
Use appropriate radiation safety measures and aseptic technique during preparation and handling. (
2.1 Important Preparation and Radiation Safety Instructions
- The Ceretec kit includes a cobalt stabilizer solution, which is optional for cerebral scintigraphy.
  DO NOT USE COBALT STABILIZER SOLUTION FOR LEUKOCYTE LABELED Scintigraphy
  [see Dosage and Administration (2.4, 2.6)]
  .
- Technetium Tc 99m exametazime injection is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure
  [see Warnings and Precautions (5.3)]
  . Use waterproof gloves and effective shielding, including syringe shields, when preparing and administering technetium Tc 99m exametazime injection.
)
Leukocyte Labeled Scintigraphy - The recommended adult dose is 185 MBq to 370 MBq (5 mCi to 10 mCi) of Tc 99m exametazime labeled leukocytes by intravenous injection. Administer as soon as possible after labeling, preferably within 20 minutes but no later than 1 hour. (
2.2 Recommended Dosing and Imaging Procedures
Leukocyte Labeled Scintigraphy
Dosing
Adults: The recommended dose is 185 MBq to 370 MBq (5 mCi to 10 mCi) of Tc 99m exametazime labeled leukocytes by intravenous injection. Administer using a 19G needle as soon as possible, preferably within 20 minutes but no later than 1 hour, after preparing the Tc 99m labeled leukocyte suspension.
Pediatric patients age 2 to 17: The recommended dose is 7.4 MBq/kg (0.2 mCi/kg); with a minimum of 74 MBq (2 mCi). Do not exceed the maximum administered activity for an adult.
Imaging Procedures
Instruct patients to empty their bladder prior to imaging.
Dynamic imaging may be performed for the first 60 minutes after injection to assess lung clearance and to visualize cell migration.
Perform static imaging at 0.5-1.5 hours
,
2-4 hours and if necessary, at 18-24 hours after administration to detect focal accumulation of activity.
Cerebral Scintigraphy
Dosing
Adults: The recommended dose is 555 MBq to 1110 MBq (15 mCi to 30 mCi) by intravenous injection.
Pediatric patients age 2 to 17: The recommended dose is 14.0 MBq/kg (0.4 mCi/kg); with a minimum of 110 MBq (3.0 mCi). Do not exceed the maximum administered activity for an adult.
Imaging Procedures
Images may be acquired by planar or SPECT imaging techniques.
Perform imaging 30-90 min. after administration and complete imaging within 4 hrs after administration.
)
Cerebral Scintigraphy - The recommended adult dose is 555 MBq to 1110 MBq (15 mCi to 30 mCi) by intravenous injection. (
2.2 Recommended Dosing and Imaging Procedures
Leukocyte Labeled Scintigraphy
Dosing
Adults: The recommended dose is 185 MBq to 370 MBq (5 mCi to 10 mCi) of Tc 99m exametazime labeled leukocytes by intravenous injection. Administer using a 19G needle as soon as possible, preferably within 20 minutes but no later than 1 hour, after preparing the Tc 99m labeled leukocyte suspension.
Pediatric patients age 2 to 17: The recommended dose is 7.4 MBq/kg (0.2 mCi/kg); with a minimum of 74 MBq (2 mCi). Do not exceed the maximum administered activity for an adult.
Imaging Procedures
Instruct patients to empty their bladder prior to imaging.
Dynamic imaging may be performed for the first 60 minutes after injection to assess lung clearance and to visualize cell migration.
Perform static imaging at 0.5-1.5 hours
,
2-4 hours and if necessary, at 18-24 hours after administration to detect focal accumulation of activity.
Cerebral Scintigraphy
Dosing
Adults: The recommended dose is 555 MBq to 1110 MBq (15 mCi to 30 mCi) by intravenous injection.
Pediatric patients age 2 to 17: The recommended dose is 14.0 MBq/kg (0.4 mCi/kg); with a minimum of 110 MBq (3.0 mCi). Do not exceed the maximum administered activity for an adult.
Imaging Procedures
Images may be acquired by planar or SPECT imaging techniques.
Perform imaging 30-90 min. after administration and complete imaging within 4 hrs after administration.
)

See full prescribing information for preparation and administration, interpretation of chromatograms and radiation dosimetry. (

2 DOSAGE AND ADMINISTRATION

Do not use cobalt stabilizer solution for leukocyte labeled scintigraphy.
Use appropriate radiation safety measures and aseptic technique during preparation and handling.
Leukocyte Labeled Scintigraphy - The recommended adult dose is 185 MBq to 370 MBq (5 mCi to 10 mCi) of Tc 99m exametazime labeled leukocytes by intravenous injection. Administer as soon as possible after labeling, preferably within 20 minutes but no later than 1 hour.
Cerebral Scintigraphy - The recommended adult dose is 555 MBq to 1110 MBq (15 mCi to 30 mCi) by intravenous injection.
See full prescribing information for preparation and administration, interpretation of chromatograms and radiation dosimetry.

2.1 Important Preparation and Radiation Safety Instructions

The Ceretec kit includes a cobalt stabilizer solution, which is optional for cerebral scintigraphy.
DO NOT USE COBALT STABILIZER SOLUTION FOR LEUKOCYTE LABELED Scintigraphy
[see Dosage and Administration (2.4, 2.6)]
.
Technetium Tc 99m exametazime injection is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure
[see Warnings and Precautions (5.3)]
. Use waterproof gloves and effective shielding, including syringe shields, when preparing and administering technetium Tc 99m exametazime injection.

2.2 Recommended Dosing and Imaging Procedures

Leukocyte Labeled Scintigraphy

Dosing

Adults: The recommended dose is 185 MBq to 370 MBq (5 mCi to 10 mCi) of Tc 99m exametazime labeled leukocytes by intravenous injection. Administer using a 19G needle as soon as possible, preferably within 20 minutes but no later than 1 hour, after preparing the Tc 99m labeled leukocyte suspension.

Pediatric patients age 2 to 17: The recommended dose is 7.4 MBq/kg (0.2 mCi/kg); with a minimum of 74 MBq (2 mCi). Do not exceed the maximum administered activity for an adult.

Imaging Procedures

Instruct patients to empty their bladder prior to imaging.
Dynamic imaging may be performed for the first 60 minutes after injection to assess lung clearance and to visualize cell migration.
Perform static imaging at 0.5-1.5 hours
,
2-4 hours and if necessary, at 18-24 hours after administration to detect focal accumulation of activity.

Cerebral Scintigraphy

Dosing

Adults: The recommended dose is 555 MBq to 1110 MBq (15 mCi to 30 mCi) by intravenous injection.

Pediatric patients age 2 to 17: The recommended dose is 14.0 MBq/kg (0.4 mCi/kg); with a minimum of 110 MBq (3.0 mCi). Do not exceed the maximum administered activity for an adult.

Imaging Procedures

Images may be acquired by planar or SPECT imaging techniques.
Perform imaging 30-90 min. after administration and complete imaging within 4 hrs after administration.

2.3 Preparation and Administration Instructions

General Preparation and Administration Instructions

Use aseptic procedures throughout preparation and handling.
Visually inspect the reconstituted technetium Tc 99m exametazime injection prior to use and do not use if there is evidence of particulate matter or discoloration.
Measure patient dose with a dose calibrator immediately prior to administration.
Instruct patients to maintain adequate hydration, after administration of technetium Tc 99m exametazime labeled white blood cells or Tc 99m exametazime injection and void frequently to minimize radiation dose to the kidneys and bladder
[see Warnings and Precautions (5.3)].

Reconstitution Instructions

Elute the technetium Tc 99m generator according to the manufacturer's instructions.
Only use eluate from a technetium Tc 99m generator which has been eluted within the previous 24 hours.
For the highest radiochemical purity reconstitute with freshly eluted technetium 99m generator eluate.
- To prepare technetium Tc 99m exametazime injection for
  white blood cell labeling
  , use generator elute that is
  not more than 2 hours old.
- To prepare technetium Tc 99m exametazime injection
  with cobalt stabilizer
  for
  cerebral imaging
  , use generator eluate that is
  not more than 4 hours old.

2.4 Preparation of Autologous Leukocytes

Leukocyte Harvest and Separation

1) Draw up 10 mL acid citrate dextrose solution into a 60 mL syringe.

2) Withdraw approximately 40 mL whole blood from the patient into the syringe using a 19-gauge butterfly needle infusion set. Close the syringe with a sterile hub.

3) Gently mix the contents of the syringe for 20 seconds.

4) Clamp the syringe barrel to the ring stand in an upright (hub side up) position and tilt the syringe 10-20 degrees from its position perpendicular to the bench.

5) Allow the red cells to sediment 30-60 minutes, until the supernatant [leukocyte rich plasma (LRP)] looks clear of red blood cells.

6) Using an infusion set, transfer the leukocyte-rich plasma (LRP), the supernatant, from the previous step, into a sterile, conical centrifuge tube marked "WBC" (white blood cell) and assure that only a minimum amount of red cells enter the centrifuge tube.

7) Immediately centrifuge the capped WBC tube at 400-450 g for 5 minutes. The plasma will separate out into a liquid [leukocyte poor plasma (LPP)] and a solid (WBC button). (Note: The button often contains a small number of red cells and may appear red).

8) Transfer the supernatant into another sterile tube marked "LPP" leaving enough supernatant to cover the white cell button.

Reserve LPP for later use (steps 11,15,18).

Washing and Radiolabeling

9) Add approximately 5 mL Sodium Chloride Injection, USP (0.9%) to the WBC button. Cap the "WBC" tube and resuspend the button by gently swirling.

10) Centrifuge the capped "WBC" tube at 150 g for 8 minutes and discard all but 0.5 to 1 mL of the supernatant to cover the cells.

11) Add 1 mL of "LPP" (from Step 9) to the white cell button and resuspend the cells by gentle swirling.

12) Reconstitute technetium Tc 99m exametazime from Ceretec with generator eluate

[see Dosage and Administration (2.6)]

13) Within 30 minutes of preparation, add the reconstituted Tc 99m exametazime (do not use cobalt stabilizer solution) to the "WBC" tube. Swirl gently to mix.

14) Set a lab timer for 15 minutes and allow the white cells to incubate. Swirl at 30 second intervals during the incubation.

15) After incubation, add 10 mL of the LPP (from Step 9) to the "WBC" tube.

16) Cap the "WBC" tube, gently swirl, and then centrifuge at 450 g for 5 minutes.

17) Transfer the supernatant in the "WBC" tube into the "Wash" tube and leave the labeled white cells in the "WBC" tube.

18) Add approximately 5 mL of LPP (from Step 9) to the "WBC" tube. Gently swirl to resuspend the cells.

19) Draw the labeled cells into a syringe. Cap the syringe and assay the amount of radioactivity in a dose calibrator. Place the syringe in a shielded container.

20)

Verify the identity of the labeled leukocyte recipient.

21) Administer the Tc 99m labeled leukocyte suspension using a 19G needle as soon as possible, preferably within 1-2 hours after labeling.

2.5 Preparation of Tc 99m Exametazime Injection with Cobalt Stabilizer Solution

The preparation may be used in cerebral scintigraphy

1)Add up to 370 MBq to 2000 MBq (10 mCi to 54 mCi) sodium pertechnetate Tc 99m eluate to the shielded Ceretec vial.
2)Before reconstitution, the technetium Tc 99m generator eluate may be adjusted to the correct radioactive concentration [74 to 400 MBq/mL (2 to 10.8 mCi/mL)] by dilution with a volume of 5 mL preservative-free, non-bacteriostatic 0.9% sodium chloride for injection.
3)Between 1 and 5 minutes after reconstitution, inject 2 mL of cobalt stabilizer solution into the vial. Shake the shielded vial for 10 seconds to ensure complete mixing.
4)The cobalt stabilized technetium 99m exametazime is a pale straw-colored solution and the pH is in the range 5 to 8.
5)Use a Sample for Radiochemical Purity measurement.
6)Assay the vial for total radioactivity. Calculate the volume to be injected. Complete the label provided and attach to the vial.
7)Use the stabilized product within 5 hours after preparation. Individual patient doses may be stored aseptically in a capped syringe if required.
8)Discard any unused material.

Radiochemical Purity Measurement Tc 99m Exametazime Injection with Cobalt Stabilizer Solution

Obtain the Following Materials:

Two GMCP-SA (Glass Microfiber Chromatography Paper impregnated with Silicic Acid) strips (2 cm (±2 mm) × 20 cm)
Ascending chromatography development tanks
MEK [methyl ethyl ketone (butanone)]
0.9 % sodium chloride

A combination of two chromatographic systems is necessary for the determination of the radiochemical purity of the injection:

System 1
GMCP-SA: MEK [methyl ethyl ketone (butanone)]
System 2
GMCP-SA:0.9% sodium chloride

Three potential radiochemical impurities may be present in prepared Technetium (^99mTc) Exametazime Injection

secondary Tc 99m exametazime complex
free Tc 99m pertechnetate
reduced-hydrolyzed Tc 99m

Method

1)Perform radiochemical purity testing as soon as possible after preparation.
2)Prepare the two Chromatographic Systems
(System 1
and
System 2).
3)Apply test samples by needle approximately 2.5 cm from the bottom of each GMCP-SA strip.
4)Immediately place each strip in prepared ascending chromatography development tanks. After the solvent has travelled to the 14 cm mark, remove the strips and mark the solvent fronts.
5)Allow the strips to dry.
6)Determine the distribution of activity determined using suitable equipment.
7)Chromatogram Interpretation:

System 1 (GMCP-SA: MEK [butanone])
Origin	Secondary Tc 99m exametazime complex and reduced-hydrolyzed Tc 99m
Migrate at R_f0.8-1	Lipophilic Tc 99m exametazime complex and Tc 99m pertechnetate

System 2 (GMCP-SA:0.9% sodium chloride)
Origin	Lipophilic Tc 99m exametazime complex, secondary Tc 99m exametazime complex, and reduced-hydrolyzed Tc 99m
Migrate at R_f0.8-1	Tc 99m pertechnetate

8)Calculate the percentage of activity due to both secondary Tc 99m exametazime complex and reduced-hydrolyzed Tc 99m from
System 1 (A %)
.
9)Calculate the percentage of activity due to Tc 99m pertechnetate from
System 2 (B %)
.
10)Calculate the radiochemical purity:

% lipophilic Tc 99m exametazime complex = 100 - (A %+B %)
- A %
  represents the level of secondary Tc 99m exametazime complex plus reduced-hydrolyzed Tc 99m.
- B %
  represents the level of Tc 99m pertechnetate.

11)
Do not use if radiochemical purity of lipophilic Tc 99m exametazime is less than 80%.

2.6 Preparation of Technetium Tc 99m Exametazime Injection Without Cobalt Stabilizer Solution

The preparation may be used in cerebral scintigraphy or for use in the preparation of Tc 99m labeled leukocytes.

1)Add 370 MBq to 2000 MBq (10 mCi up to 54 mCi) of sodium pertechnetate Tc 99m eluate.
2)Before reconstitution, the technetium Tc 99m generator eluate may be adjusted to the correct radioactive concentration [74 to 400 MBq/mL (2 to 10.8 mCi/mL)] by dilution with a volume of 5 mL preservative-free, non-bacteriostatic 0.9 % sodium chloride for injection.
3)The pH of the prepared injection is 9 to 9.8.
4)Use a sample for Radiochemical Purity Measurement.
5)Assay the total activity.
6)Calculate the volume to be injected and complete the label provided and attach to the vial shield.
7)Use the preparation within 30 minutes after reconstitution.
8)Discard any unused material.

Radiochemical Purity Measurement Tc 99m Exametazime Injection without Cobalt Stabilizer Solution

Perform radiochemical purity testing of technetium Tc 99m exametazime within 2 minutes of reconstitution.
The entire procedure takes approximately 15 minutes.

Obtain the Following Materials:

2 SA ITLC strips 20 cm × 2 cm
1 Whatman No. 1 strips 6 cm × 0.7 cm
MEK (methyl ethyl ketone [butanone])
0.9% aqueous sodium chloride (non-bacteriostatic)
50% aqueous acetonitrile
Dilute with non-bacteriostatic Water for Injection
Glass test tubes (12 × 75 mm)
Glass measuring cylinders (100 mL) with covers
1 mL syringes with 25-gauge needles

A combination of 3 chromatographic systems is necessary for the complete definition of the radiochemical composition of the injection.
- System 1
  : MEK (methyl ethyl ketone [butanone]) + SA ITLC strip
- System 2
  : 0.9% non-bacteriostatic sodium chloride solution + SA ITLC strip
- System 3
  : 50% acetonitrile solution + Whatman No. 1 paper strip

Three potential radiochemical impurities may be present in the prepared injection of the lipophilic Tc 99m exametazime complex.
- a secondary Tc 99m exametazime complex
- free Tc 99m pertechnetate
- reduced-hydrolyzed Tc 99m

Method

1) Prepare chromatography tubes (Identify the solvent in each cylinder).

System 1 - 100 mL cylinder containing a 1 cm depth of fresh MEK.

System 2 - 100 mL cylinder containing a 1 cm depth of 0.9% sodium chloride.

System 3 - 1 chromatography tube containing 0.2-0.3 mL of 50% acetonitrile, respectively.

2) Prepare 2 SA ITLC strips and 1 Whatman No. 1 paper strip.

Mark the SA ITLC strips 2.5 cm from the bottom as the point of origin.

Mark both the SA ITLC strips at 14 cm above the origin (solvent front).

Mark the Whatman strip 1 cm from the bottom as the point of origin.

3) Apply at least 5 microliter samples of freshly prepared Tc 99m exametazime solution to the origin of the 3 strips (within 2 minutes of reconstitution). Do not allow to dry.

4) Immediately place 1 SA ITLC strip into the MEK tank (System 1), the second SA ITLC strip into the saline tank (System 2), and the Whatman No. 1 paper strip into the 50% acetonitrile tube (System 3).

5) The SA ITLC MEK strip takes approximately 15 minutes to run. When the eluate has reached the solvent front remove the strip from the tube with forceps and immediately cut 1 cm above the origin.

6) The SA ITLC saline strip takes approximately 15 minutes to run. When the eluate has reached the solvent front remove the strip from the tube with forceps and immediately cut 2.5 cm above the origin.

7) The Whatman No. 1 paper CH3CN strip takes approximately 100 seconds to run. When the eluate has reached the solvent front mark remove the strip from the tube with forceps and immediately cut 0.5 cm above the origin.

8) Chromatogram Interpretation:

System 1 (SA ITLC: MEK (methyl ethyl ketone [butanone])
Origin	Secondary Tc 99m exametazime complex and reduced-hydrolyzed Tc 99m
Migrate at R_f0.8-1	Lipophilic Tc 99m exametazime complex and Tc 99m pertechnetate

System 2 (SA ITLC: 0.9% sodium chloride)
Origin	Lipophilic Tc 99m exametazime complex, secondary Tc 99m, exametazime complex and reduced-hydrolyzed Tc 99m
Migrate at R_f0.8-1	Tc 99m pertechnetate

System 3 (Whatman No. 1: 50% aqueous acetonitrile)
Origin	Reduced-hydrolyzed Tc 99m
Migrate at R_f0.8-1	Lipophilic Tc 99m exametazime complex, secondary Tc 99m exametazime complex and Tc 99m pertechnetate

9) Count the separate sections of each strip to determine the activity distribution. Calculate:

% origin of saline strip (system 2)
% origin of MEK strip (system 1)
% solvent front of saline strip (= % Tc 99m pertechnetate)
% origin of Whatman No. 1 paper strip (= % reduced-hydrolyzed Tc 99m)

10) Calculate Radiochemical Purity

% lipophilic Tc 99m exametazime complex

= % origin of saline strip (system 2) – % origin of MEK strip (system 1)

11)

Do not use if the radiochemical purity of the lipophilic Tc 99m exametazime complex is less than 80%.

2.7 Radiation Dosimetry

Tc 99m Exametazime labeled leukocytes for leukocyte labeled scintigraphy

Radiation absorbed dose per unit activity (microGy/MBq) administered to average-size adults (70 kg) and pediatric patients from an intravenous injection of Tc 99m Exametazime labeled leukocytes is estimated in Table 1.

Table 1: Estimated Radiation Absorbed Dose for Tc 99m exametazime labeled white blood cells (leukocytes)
Organ	Absorbed dose per unit activity administered (microGy / MBq)
Organ	Adult	15 years	10 years	5 years	1 year
*International Commission on Radiological Protection, Radiation Dose to Patients from Radiopharmaceuticals: A Compendium of Current Information Related to Frequently Used Substances, Ann ICRP 2015)., ICRP Publication 128, Ann ICRP 2015).
Adrenals	12	12	18	26	43
Bone surfaces	16	21	34	61	150
Brain	2.3	2.9	4.4	7	13
Breast	2.4	2.9	4.9	7.6	13
Gallbladder wall	8.4	10	16	25	36
Gastrointestinal tract
Esophagus	3.5	4.2	5.8	8.6	15
Stomach wall	8.1	9.6	14	20	32
Small intestine wall	4.6	5.7	8.7	13	21
Colon wall	4.3	5.4	8.4	12	21
Upper large intestine wall	4.7	5.9	9.3	14	23
Lower large intestine wall	3.7	4.8	7.3	10	18
Heart wall	9.4	12	17	25	44
Kidneys	12	14	22	32	54
Liver	20	26	38	54	97
Lungs	7.8	9.9	15	23	41
Muscles	3.3	4.1	6	8.9	16
Ovaries	3.9	5	7.2	11	18
Pancreas	13	16	23	34	53
Red marrow	23	25	40	71	140
Skin	1.8	2.1	3.4	5.5	10
Spleen	150	210	310	480	850
Testes	1.6	2.1	3.2	5.1	9.2
Thymus	3.5	4.2	5.8	8.6	15
Thyroid	2.9	3.7	5.8	9.3	17
Urinary bladder wall	2.6	3.5	5.2	7.8	14
Uterus	3.4	4.3	6.5	9.7	16
Remaining organs	3.4	4.2	6.3	9.5	16
Effective dose per unit activity	11 microSv/MBq	14 microSv/MBq	22 microSv/MBq	34 microSv/MBq	62 microSv/MBq

Tc 99m Exametazime Injection for Cerebral Scintigraphy

Based on human data, the radiation absorbed doses to average sized adults (70kg) and pediatric patients from an intravenous injection of Tc 99m exametazime injection are estimated in Table 2.

Table 2: Estimated Radiation Absorbed Dose for Tc 99m Exametazime Injection
Organ	Absorbed dose per unit activity administered (microGy / MBq)
Organ	Adult	15 years	10 years	5 years	1 year
*International Commission on Radiological Protection, Radiation Dose to Patients from Radiopharmaceuticals: A Compendium of Current Information Related to Frequently Used Substances, Ann ICRP 2015)., ICRP Publication 128, Ann ICRP 2015).
Adrenals	5.3	6.7	9.9	14	24
Bone surfaces	5.1	6.4	9.4	14	24
Brain	6.8	11	16	21	37
Breast	2	2.4	3.7	5.6	9.5
Gallbladder wall	18	21	28	48	140
Gastrointestinal tract
Esophagus	2.6	3.3	4.7	6.9	11
Stomach wall	6.4	8.5	12	19	36
Small intestine wall	12	15	24	36	65
Colon wall	17	22	35	55	100
Upper large intestine wall	18	24	38	60	110
Lower large intestine wall	15	19	31	48	90
Heart wall	3.7	4.7	6.7	9.7	16
Kidneys	34	41	57	81	140
Liver	8.6	11	16	23	40
Lungs	11	16	22	34	63
Muscles	2.8	3.5	5	7.3	13
Ovaries	6.6	8.3	12	17	27
Pancreas	5.1	6.5	9.7	14	23
Red marrow	3.4	4.1	5.9	8	14
Skin	1.6	1.9	2.9	4.5	8.3
Spleen	4.3	5.4	8.2	12	20
Testes	2.4	3	4.4	6.1	11
Thymus	2.6	3.3	4.7	6.9	11
Thyroid	26	42	63	140	260
Urinary bladder wall	23	28	33	33	56
Uterus	6.6	8.1	12	15	25
Remaining organs	3.2	4	6	9.2	17
Effective dose per unit activity	9.3 microSv/MBq	11 microSv/MBq	17 microSv/MBq	27 microSv/MBq	49 microSv/MBq

The effective dose resulting from the administration of a (maximal recommended) activity of 1110 MBq for an adult weighing 70 kg is about 10.3 mSv. For an administered activity of 740 MBq the typical radiation dose to the target organ (brain) is 5 mGy and the typical radiation dose to the critical organ (kidneys) is 25 mGy.

)

Pregnancy - Advise the pregnant woman of the potential risk to the fetus based on the radiation dose from the Technetium Tc 99m exametazime injection and the gestational timing of exposure. (
8.1 Pregnancy
Risk Summary
Limited available data with technetium Tc 99m exametazime use in pregnant women are insufficient to inform any drug associated risks for major birth defects and miscarriage. Technetium Tc 99m exametazime is transferred across the placenta
[see Data].
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.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data
Human Data
Limited published literature describes Tc 99m exametazime crossing the placental barrier and visualization of radioactivity in the fetal liver. No adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50 mGy, which represents less than 10 mGy fetal doses.
)
Lactation – Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Technetium Tc 99m Exametazime labeled leukocyte administration. (
8.2 Lactation
Risk Summary
There are limited data available in the scientific literature on the presence of technetium Tc 99m exametazime in human milk. There are no data available regarding the effects of technetium Tc 99m exametazime on the breastfed infant or on milk production. Exposure of technetium Tc 99m exametazime to a breast fed infant can be minimized by temporary discontinuation of breastfeeding [
see Clinical Considerations
]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Ceretec and any potential adverse effects on the breastfed child from Ceretec or from the underlying maternal condition.
Clinical Considerations
To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk after the administration of technetium Tc 99m exametazime injection or technetium Tc 99m exametazime-labeled leukocytes for 12 to 24 hours, where the duration corresponds to the typical range of administered activity, 259 MBq to 925 MBq (7 mCi to 25 mCi).
)

Hypersensitivity reactions: Have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions (

5.1 Hypersensitivity Reactions

Hypersensitivity reactions have been reported following the administration of Tc 99m exametazime injection and Tc 99m exametazime labeled leukocytes including serious signs and symptoms of anaphylaxis following administration

[see Adverse Reactions (6)]

. Always have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions.

)

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