Kit For The Preparation Of Technetium Tc 99M Exametazime For Leukocyte Labeling
FDA Drug Information • Also known as: Drax Exametazime
- Brand Names
- Drax Exametazime
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION 11.1 Chemical 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 11.2 Physical 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 11.3 External 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...
What Is Kit For The Preparation Of Technetium Tc 99M Exametazime For Leukocyte Labeling Used For?
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 ) 2.1 Radiation 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) ] . 2.2 Important 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 )] . 2.3 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)]. 2.4 Image 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 )] 2.5 Preparation 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...
Side Effects (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.
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy and Breastfeeding
8.1 Pregnancy 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.
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.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How 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. 16.2 Storage 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. 16.1 How 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.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.