Technetium Tc-99M Exametazime And Cobaltous Chloride

FDA Drug Information • Also known as: Ceretec

Brand Names: Ceretec
Dosage Form: KIT
Product Type: HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION 11.1 Chemical Characteristics Ceretec (kit for the preparation of technetium Tc 99m exametazime injection) prepares a radioactive diagnostic agent for intravenous use. Each unit consists of the following: One 10 mL vial of exametazime containing 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. One vial of cobalt stabilizer containing a sterile, non-pyrogenic solution of 200 mcg cobaltous chloride 6-hydrate in 2 mL of Water for Injection. The chemical name for Exametazime is [(RR,SS)-4.8-diaza-3,6,6,9-tetramethylundecane-2, 10-dione bisoxime]. The molecular formula of exametazime is C 13 H 28 N 4 O 2 , with the following structural formula: Prior to publication of the USAN, exametazime was known as hexamethylpropylene amine oxime (HM-PAO). The name HM-PAO appears in many publications. When sterile pyrogen-free sodium pertechnetate Tc 99m in isotonic saline is added to the vial of exametazime, a Tc 99m complex of exametazime is formed. Chemical Structure 11.2 Physical Characteristics Technetium 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 3. Table 3: Principal Radiation Emission Data-technetium 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 technetium 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 4. For example, the...

What Is Technetium Tc-99M Exametazime And Cobaltous Chloride Used For?

1 INDICATIONS AND USAGE 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 ) Cerebral Scintigraphy – As an adjunct in the detection of altered regional cerebral perfusion in stroke. ( 1.2 ) 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. 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.

Dosage and Administration

2 DOSAGE AND ADMINISTRATION Do not use cobalt stabilizer solution for leukocyte labeled scintigraphy. ( 2.1 ) Use appropriate radiation safety measures and aseptic technique during preparation and handling. ( 2.1 ) 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 ) Cerebral Scintigraphy - The recommended adult dose is 555 MBq to 1110 MBq (15 mCi to 30 mCi) by intravenous injection. ( 2.2 ) See full prescribing information for preparation and administration, interpretation of chromatograms and radiation dosimetry. ( 2 ) 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...

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS The following serious 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 Ceretec were identified in clinical studies or postmarketing reports. Because some of these reactions were 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 disorders: Reversible increase in blood pressure, flushing Gastrointestinal disorders: Nausea, vomiting General disorders and administration site conditions: Malaise, fatigue, fever Immune system disorders: Hypersensitivity reactions: anaphylactic reactions including shock, facial edema, rash, pruritus or erythema Nervous system disorders: Headache, dizziness, paresthesia Most common adverse reactions include a reversible increase in blood pressure . ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 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 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.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How supplied Each Ceretec Kit (NDC 17156-025-05) contains: Five 10mL vials of 0.5 mg exametazime Five 10mL vials of 200 mcg Cobalt stabilizer solution Ten radiation labels One package insert Sodium Pertechnetate Tc 99m is not part of the Ceretec kit. Before reconstitution and radiolabeling with Tc 99m, the contents of the kit are not radioactive. 16.2 Storage and Handling Store Ceretec kits at controlled room temperature 15°C to 25°C (59°F to 77°F). This reagent kit is approved for use by persons licensed by the U.S. Nuclear Regulatory Commission or the relevant Agreement State. Store and dispose of technetium Tc 99m exametazime in compliance with the regulations of the government agency authorized to license the use of this radionuclide.

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.