Drax Exametazime Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling .5 mg Injection, Powder, Lyophilized, For Solution, 5 vials — NDC 65174-200-05 (Billing 65174-0200-05)
This is a package of 5 vials of Drax Exametazime Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling .5 mg Injection, Powder, Lyophilized, For Solution from Jubilant DraxImage Inc., dba Jubilant Radiopharma, marketed since Aug 2017 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 65174-200-05 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 65174 labeler · 200 product · 05 package
- Package marketed since
- Aug 17, 2017
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 5 EA per package
- Barcode (UPC-A, from the NDC)
- 3 6517420005 3
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 077678
- GCN: 43775
- HICL (First Databank): 024613
- AHFS class code: 36:68.00.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 65174-0200-05 You're viewing this Main listing | 5 VIAL in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 2017-08-17 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Drax Exametazime .5 mgthis 65174-0200-05 | Jubilant | 5 vials | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII N762921K75
A colorless, odorless gas that makes up most of the air we breathe. In medicines, it's used as a packaging gas or propellant to protect products from oxidation and maintain freshness.
-
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
-
UNII 1BQV3749L5
Stannous chloride is a tin-based chemical compound used as a reducing agent and antioxidant in pharmaceuticals. It helps prevent oxidation of active ingredients and stabilizes certain formulations, particularly in products requiring preservation of potency.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Jubilant DraxImage Inc., dba Jubilant Radiopharm... labeler code 65174
- RUBY-FILL Rubidium Rb 82 100 mCi Injection, Solution NDC 65174-021-10
- Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Kit NDC 65174-179-01
- TECHNETIUM Tc 99m MERTIATIDE 1 mg Injection, Powder, Lyophilized, For Solution NDC 65174-261-05
- DRAXIMAGE MAA Kit for the preparation of Technetium Tc 99m Albumin aggregated 2.5 mg Injection, Powder, For Solution NDC 65174-270-30
- DRAXIMAGE DTPA Kit for the preparation of Technetium Tc 99m Pentetate 20 mg Injection, Powder, Lyophilized, For Solution NDC 65174-288-30
- Sodium Iodide I 131 Diagnostic 100 mCi Capsule NDC 65174-461-05
- Technetium Tc 99m Medronate 25 mg Injection, Powder, For Solution NDC 65174-660-30
- HICON Sodium Iodide I 131 1000 mCi/mL Solution NDC 65174-880-00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Drax Exametazime is indicated for leukocyte (white blood cell) labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease. Drax Exametazime 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. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Use careful handling with appropriate safety measures to minimize radiation exposure to both patients and healthcare professionals. ( 2.1 ) For an adult patient, recommended dose is 259 - 925 megabecquerels (MBq) [7-25 millicuries (mCi)]. ( 2.3 )
2.1Radiation Safety - Drug Handling Technetium Tc 99m exametazime is a radioactive solution and should be handled with appropriate safety measures to minimize radiation exposure. During handling use waterproof gloves and effective shielding, including syringe shields [see Warnings and Precautions (5.3) ] .
2.2Important Administration Instructions Use strict aseptic procedures throughout preparation and handling. Visually inspect the reconstituted technetium Tc 99m exametazime solution for particulate matter and discoloration prior to radiolabeling of white blood cells. Do not use the reconstituted solution if there is evidence of particulate matter or discoloration.
Follow the directions of drug preparation carefully to ensure efficient leukocytes labeling [see Dosage and Administration ( 2.5 , 2.6 )] . Measure patient dose with a suitable radioactivity calibration system immediately prior to administration. Instruct patients to hydrate, after administration of technetium Tc 99m exametazime labeled white blood cells and void frequently to minimize radiation dose to the kidneys and bladder [see Warnings and Precautions ( 5.3 )] .
2.3Recommended 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)].
2.4Image Acquisition and Inerpretation 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 [see Clinical Pharmacology ( 12.2 )]
2.5Preparation of Autologous Leukocytes IMPORTANT - Label all syringes and tubes used in this labeling procedure with the patient’s name and unique identification number. Leukocyte Harvest and Separation 1. Draw 2 mL of Heparin and 8 mL of 6% Hydroxyethyl starch into a 60 mL plastic 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 for 2 minutes. 4.
Clamp the syringe barrel to the ring stand in an upright (hub side up) position and tilt the syringe approximately 10-20 degrees from its position perpendicular to the bench. 5. Allow the syringe to stand a minimum of 60 minutes until the red blood cells sediment and the supernatant looks clear.
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). The WBC button often contains a small number of red blood cells and may appear red.
8. Transfer the leukocyte poor plasma (LPP) into another sterile centrifuge tube marked as "Plasma" tube, without disturbing the WBC button. Save the LPP in the Plasma tube for later use (Steps 16 and 19).
Red Blood Cell Lysis and Washing 9. Add 1 mL Sodium Chloride (Na Cl) Injection, USP (0.9%) to the WBC button and suspend. 10.
Add the following to the W… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Drax Exametazime is a kit containing five (5) single-dose vials. Each 10 mL, clear glass vial contains a non-radioactive lyophilized mixture of: 0.5 mg exametazime, 7.6 mcg stannous chloride dihydrate (minimum stannous tin 0.6 mcg; maximum total stannous and stannic tin 4 mcg per vial) and 4.5 mg sodium chloride, sealed under nitrogen atmosphere with a rubber closure. When reconstituted with the technetium Tc 99m eluate, each vial will contain a clear, colorless, and foreign particles-free solution of 370 MBq up to 2000 MBq (10 mCi up to 54 mCi) [74 - 370 MBq / mL (2 - 10 mCi / mL)].
The radioactive solution produced will be used for leukocyte labeling before intravenous administration to the patient. Five (5) single-dose vials, each vial contains: 370 MBq up to 2000 MBq (10 mCi up to 54 mCi) [74 - 370 MBq / mL (2 - 10 mCi / mL)] at time of preparation (reconstitution). ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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 )
5.1Hypersensitivity 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.
5.2Risk for Image Interpretation Error The interpretation of images can be affected by the presence of other pathophysiological processes within and outside of the abdominal cavity such as: tumor, infarction, trauma, and other inflammatory conditions.
5.3Radiation Exposure Risk Technetium Tc 99m contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation reconstitution procedures to protect patients and health care workers from unintentional radiation exposure.
Encourage patients to drink fluids and void as frequently as possible after administration [see Dosage and Administration ( 2.1, 2.2 )] .
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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.
Cardiovascular: transient blood pressure increase Skin and subcutaneous tissue disorders: rash, generalized erythema, urticaria, angioedema, pruritus. General disorders and administration site conditions: facial edema, fever, asthenic conditions (e.g., malaise, fatigue). Nervous system disorders: headache, dizziness, paraesthesia.
Vascular disorders: flushing. Gastrointestinal disorders: nausea, vomiting. Most common adverse reactions include transient increase in blood pressure, rash, generalized erythema, facial edema and fever.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc. at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS 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 ) Renal impairment: Increased radiation exposure in patients with impaired renal function. A reduction in administered Tc 99m can be considered provided adequate numbers of labeled WBCs are administered ( 8.6 )
8.1Pregnancy Risk Summary 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 [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 are 2-4% and 15-20%, respectively. Data Human Data Limited published literature describes Tc-99m exametazime crossing the placental barrier and accumulating in the fetal liver.
No adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50mGy, which represents less than 10mGy fetal doses.
8.2Lactation Risk Summary 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 [see Clinical Considerations] .
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. 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-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).
8.4Pediatric Use Safety and efficacy in pediatric patients have not been assessed.
8.6Renal Impairment Technetium Tc 99m exametazime is substantially excreted by the kidneys, so excretion is decreased / delayed and therefore radiation exposure is greater in patients with impaired renal function. A reduction in administered Tc 99m can be considered provided an adequate number of labeled WBCs are administered.
8.5Geriatric Use Clinical studies of Tc 99m exametazime did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary 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 [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 are 2-4% and 15-20%, respectively. Data Human Data Limited published literature describes Tc-99m exametazime crossing the placental barrier and accumulating in the fetal liver.
No adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50mGy, which represents less than 10mGy fetal doses.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and efficacy in pediatric patients have not been assessed.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of Tc 99m exametazime did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE In the event of the administration of a radiation overdose, hydration and frequent micturition should be encouraged in order to minimize the absorbed dose to patient.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action When technetium Tc 99m pertechnetate is added to exametazime in the presence of stannous reductant, a lipophilic technetium Tc 99m complex is formed. This lipophilic complex is the active moiety. The lipophilic technetium Tc 99m exametazime complex is taken up and retained in leukocytes.
12.2Pharmacodynamics The relationship between technetium Tc 99m exametazime labeled WBC concentrations and successful imaging was not explored in clinical trials. GI activity is typically not seen through the initial four (4) hours post-injection. By four (4) hours, the hepatobiliary excretion of the Tc 99m exametazime allows tracer (Tc 99m) accumulation in the hepatobiliary system and, hence bowel activity.
12.3Pharmacokinetics Distribution During 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 Excretion Tc 99m excretion occurs via urine and feces.
🧬 Mechanism of Action ▾
12.1Mechanism of Action When technetium Tc 99m pertechnetate is added to exametazime in the presence of stannous reductant, a lipophilic technetium Tc 99m complex is formed. This lipophilic complex is the active moiety. The lipophilic technetium Tc 99m exametazime complex is taken up and retained in leukocytes.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Drax Exametazime kit (NDC 65174-200-05) comprises: 5 Single-dose vials (0.5 mg/vial). Each vial contains a non-radioactive sterile, non-pyrogenic lyophilized mixture of: 0.5 mg of exametazime, 7.6 mcg stannous chloride dihydrate, and 4.5 mg sodium chloride (NDC 65174-200-01); 10 Radiation Labels/Radiolabeled Leukocytes Labels/Lead Pot Labels ; 5 Labeling Efficiency/Radiochemical Purity Testing Worksheets; 1 Leukocyte Labeling Schematic; 1 Package Insert. Sodium Pertechnetate Tc 99m is not part of Drax Exametazime kit.
Before reconstitution and radiolabeling with Tc 99m, the contents of the kit are not radioactive.
16.2Storage and Handling Store Drax Exametazime kit at 15°C - 25°C (59°F - 77°F). Drax Exametazime is for distribution to and use by persons licensed authorized by the U.S. Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State. Store and dispose of technetium Tc 99m exametazime in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.
16.1How Supplied Drax Exametazime kit (NDC 65174-200-05) comprises: 5 Single-dose vials (0.5 mg/vial). Each vial contains a non-radioactive sterile, non-pyrogenic lyophilized mixture of: 0.5 mg of exametazime, 7.6 mcg stannous chloride dihydrate, and 4.5 mg sodium chloride (NDC 65174-200-01); 10 Radiation Labels/Radiolabeled Leukocytes Labels/Lead Pot Labels ; 5 Labeling Efficiency/Radiochemical Purity Testing Worksheets; 1 Leukocyte Labeling Schematic; 1 Package Insert. Sodium Pertechnetate Tc 99m is not part of Drax Exametazime kit.
Before reconstitution and radiolabeling with Tc 99m, the contents of the kit are not radioactive.
📦 Storage and Handling ▾
16.2Storage and Handling Store Drax Exametazime kit at 15°C - 25°C (59°F - 77°F). Drax Exametazime is for distribution to and use by persons licensed authorized by the U.S. Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State. Store and dispose of technetium Tc 99m exametazime in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.
📋 Description ▾
11 DESCRIPTION
11.1Chemical Characteristics Drax Exametazime (kit for the preparation of technetium Tc 99m exametazime for leukocyte labeling) prepares a radioactive diagnostic agent. Each single-dose vial contains a sterile, non-pyrogenic, lyophilized mixture of 0.5 mg exametazime, 7.6 mcg stannous chloride dihydrate (minimum stannous tin 0.6 mcg; maximum total stannous and stannic tin 4 mcg per vial) and 4.5 mg sodium chloride, sealed under nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative.
The chemical formula of exametazime is C 13 H 28 N 4 O 2 , with the following structural formula: Prior to publication of the USAN, exametazime [also known as (RR,SS)-4.8-diaza-3,6,6,9-tetramethylundecane-2, 10-dione bisoxime] was known as hexamethylpropylene amine oxime (HM-PAO). The name HM-PAO appears in many publications. When Tc 99m pertechnetate in Sodium Chloride Injection, USP (0.9%) is added to Drax Exametazime vial, a Tc 99m complex of exametazime is formed. chemical formula
11.2Physical Characteristics Tc 99m decays by isomeric transition with a physical half-life of 6 hours. Photons that are useful for imaging studies are listed in Table 2. Table 2 Principal Radiation Emission Data - Tc 99m Radiation Mean %/Disintegration Mean Energy (keV) Gamma 2 88.5 140.5
11.3External Radiation The air-kerma-rate (exposure-rate) constant for technetium Tc 99m is 5.23 m 2 ·pGy·(MBq) -1 ·s -1 [0.795 cm 2 ·R·(mCi) -1 ·h -1 ]. The first half-value thickness of lead (Pb) for Tc 99m is 0.25 mm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 3.
For example, the use of a 3 mm thickness of Pb will decrease the external radiation exposure by a factor of approximately 1,000. Table 3 Radiation Attenuation by Lead Shielding Shield Thickness (Pb) mm Coefficient of Attenuation 0.25 0.5 1 10 -1 2 10 -2 3 10 -3 4 10 -4 5 10 -5 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 4. Table 4 Physical Decay Chart - Tc 99m half-life 6 hours Hours Fraction Remaining Hours Fraction Remaining 0 Calibration time (time of preparation) 1.00 7 0.45 1 0.89 8 0.4 2 0.79 9 0.35 3 0.71 10 0.32 4 0.63 11 0.28 5 0.56 12 0.25 6 0.50 24 0.063
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Administration Instructions: Advise patients to hydrate after administration of technetium Tc 99m exametazime labeled leukocytes and to void frequently to minimize radiation dose [see Dosage and Administration ( 2.2 )] . Pregnancy Advise pregnant women of the risk of fetal exposure to radiation doses if they undergo a radionuclide procedure [see Use in Specific Populations ( 8.1 )] . Lactation Advise lactating women that exposure of the infant to technetium Tc 99m through breast milk can be minimized if breastfeeding is interrupted when technetium Tc99m exametazime labeled leukocytes are administered.
Advise a lactating woman to pump and discard breast milk for 12 to 24 hours based on injected dose [see Use in Specific Populations ( 8.2 )] . Manufactured for: Jubilant DraxImage Inc., Kirkland, Quebec, Canada, H9H 4J4. Art rev.: 1.0
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Distribution During 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 Excretion Tc 99m excretion occurs via urine and feces.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics The relationship between technetium Tc 99m exametazime labeled WBC concentrations and successful imaging was not explored in clinical trials. GI activity is typically not seen through the initial four (4) hours post-injection. By four (4) hours, the hepatobiliary excretion of the Tc 99m exametazime allows tracer (Tc 99m) accumulation in the hepatobiliary system and, hence bowel activity.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES 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 by surgery, biopsy or other clinical data.
Based on the above 4 studies, between 2 to 4 hours Tc 99m labeled leukocytes had 95-100% sensitivity and 62-85% specificity. In all studies the false positive and false negatives relate to the bowel background, the location of the site of infection/inflammation and whether or not it is contiguous with the bowel. Images obtained at 24 hours can be unreliable because of a high bowel background.
The interpretation of the images could also be affected by the presence of tumors, infarction and peritonitis [See Warning and Precautions ( 5.2 )] . Liver abscess may be missed in planar imaging because of the bowel background.
📄 Package Label / Principal Display Panel ▾
Carton Label Rx only For Reconstitution and Radiolabelling Instructions: See package insert. Important: For intravenous use as directed. Use appropriate radiation shielding.
Use only for radiolabeling of leukocytes after reconstitution with technetium Tc 99m. Storage Conditions: Store the kit at 15°C-25°C (59°F-77°F) up to the expiry date. After reconsitution with technetium Tc 99m, store at 20°C-25°C (68°F-77°F) and use for labeling leukocytes within 30 minutes.
NDC 65174-200-05 5 single dose vials Drax Exametazime Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling 0.5 mg/vial Manufactured for Jubilant DraxImage Inc. Kirkland, Quebec H9H 4J4 Canada Contents: 5 single-dose vials each containing a sterile and non-pyrogenic lyophilized mixture of: 0.5 mg exametazime 7.6 mcg stannous chloride dihydrate (minimum stannous tin 0.6 mcg; maximum total stannous and stannic tin 4mcg per vial) 4.5 mg sodium chloride 10 Radiation Labels/Radiolabeled Leukocyte Labels/Lead Pot Labels 5 Labeling Efficiency/Radiochemical Purity Testing Worksheets 1 Leukocyte Labeling Schematic 1 Package Insert Made in Canada Vial Label Drax Exametazime Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling 0.5 mg/vial NDC 65174-200-01 Rx Only Single-dose vial Diagnostic agent for intravenous use after reconstitution with Technetium Tc 99m and radiolabeling of leukocytes.
For composition, reconstitution and radiolabeling instructions see package insert. Before reconstitution, store at 15°C-25°C (59°F-77°F) up to expirty date. After reconstitution store at 20°C-25°C (68°F-77°F) and use for labeling leukocytes within 30 minutes.
Manufactured for Jubilant DraxImage Inc. Kirkland, Quebec, Canada H9H 4J4 Contains 0.5 mg of exametazime per vial, 7.6 mcg stannous chloride dihydrate (minimum stannous tin 0.6 mcg; maximum total stannous and stannic tin 4 mcg per vial), and 4.5 mg sodium chloride. Radiation Label Drax Exametazime Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling Rx Only FOR INTRAVENOUS USE For preparation instructions see package insert.
Contains no antimicrobial preservative. Before reconstitution, store at 15°C-25°C (59°F-77°F) up to expiry date. After reconstitution store at 20°C-25°C (68°F-77°F) and use for labeling leukocytes within 30 minutes.
Radiolabeled Leukocyte Lead Pot Label Drax Exametazime Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling Rx Only FOR INTRAVENOUS USE Radiolabled Leukocytes For preparation instructions see package insert. Labeling Schematic Drax Exametazime (Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling) Leukocyte Preparation: see Package Insert for detailed instructions. 60 mL syringe Anticoagulant (see insert) Needle: 19- or 20-gauge Withdraw 40mL blood Gently Mix 2 min.
Clamp and tilt syringe 10°-20° Sedimentation: 60 minutes Transfer LRP in WBC tube Cap tube; centrifuge Transfer LPP to another tube Add 1 mL of NaCl to WBC; Swirl gently Multiple washings; see insert Centrifuge. Keep 0.5-1.0 mL supernate, discard rest Add 1.5 mL of NaCl to WBC; Swirl gently Reconstitute Exametazime with 30mCi 99m TcO 4 - in 5 mL NaCl 0.9% Add 99m Tc to Exametazime to WBC; swirl gently Incubate WBCs and swirl tube every 5 min. Add 5 mL LPP to WBC tube Cap WBC tube, swirl gently; centrifuge 400g Decant supernatant into a wash tube Measure radioactivity record on worksheet Add 5 to 10 mL of LPP to WBC While in suspension, withdraw cells in a syringe, cap and assay activity Verify the identity of the leukocyte recipient.
Inject 99m Tc WBC with 19-gauge as soon as possible Jubilant DraxImage Inc. 16751 TransCanada Hwy Kirkland, QC Canada H9H 4J4 1-888-633-5343 LPP: Leukocyte Poor Plasma, LRP: Leukocyte Rich Plasma RCP Efficiency Worksheets carton label vial label vial label 2 radiation label lead pot label labeling schematic 1 labeling schematic 2 worksheet page 1 worksheet page 2
Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Where does this data come from?
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |