Kit For The Preparation Of Technetium Tc 99M Pentetate
FDA Drug Information • Also known as: Draximage Dtpa, Kit For The Preparation Of Technetium Tc 99M Pentetate
- Brand Names
- Draximage Dtpa, Kit For The Preparation Of Technetium Tc 99M Pentetate
- Drug Class
- Lead Chelator [EPC]
- Route
- INTRAVENOUS, RESPIRATORY (INHALATION)
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION 11.1 Chemical Characteristics DRAXIMAGE ® DTPA is a kit for the preparation of Technetium Tc 99m pentetate injection, a radioactive diagnostic agent, for intravenous or inhalation use. Each multiple-dose 10 mL glass vial contains a sterile, non-pyrogenic, non-radioactive lyophilized powder of 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg maximum tin expressed as stannous chloride dihydrate. The lyophilized product is sealed under an atmosphere of nitrogen. No bacteriostatic preservative is present. Its chemical name is: Technetate (1-)99mTc,[N,N-bis[2-[bis(carboxymethyl)amino]ethyl]-glycinato(5-)]-, sodium. The structure of the technetium labeled form is: The pH is adjusted with HCl and/or NaOH prior to lyophilization so that the pH range of the reconstituted radiopharmaceutical is 6.5 to 7.5. structure 11.2 Physical Characteristics Technetium Tc 99m decays by isomeric transition with a physical half-life of 6 hours. The principal photon that is useful for detection and imaging studies is listed in Table 7 . Table 7 Principal Radiation Emission Data Radiation Mean % per Disintegration Mean Energy (keV) Gamma-2 88.5 140.5 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 ]. A range of values for the relative radiation attenuation by the various thicknesses of lead is shown in Table 8 . For example, the use of a 3 mm thickness of lead will attenuate the radiation emitted by a factor of about 1,000. Table 8 Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.25 0.5 1 10 -1 2 10 -2 3 10 -3 4 10 -4 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 9 . Table 9 Physical Decay Chart of Technetium 99m Tc, Half Life:...
What Is Kit For The Preparation Of Technetium Tc 99M Pentetate Used For?
1 INDICATIONS AND USAGE DRAXIMAGE ® DTPA, after radiolabeling with Technetium Tc 99m, is indicated for DRAXIMAGE ® DTPA is a kit for the preparation of Technetium Tc 99m pentetate injection. Technetium Tc 99m pentetate is a radioactive diagnostic agent indicated for: Brain imaging in adults ( 1.1 ). Renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in adult and pediatric patients ( 1.2 ). Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients ( 1.3 ). 1.1 Brain Imaging Brain imaging in adults by intravenous administration. 1.2 Renal Scintigraphy Renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in adult and pediatric patients by intravenous administration. 1.3 Lung Ventilation Imaging Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients when administered by nebulizer for inhalation.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION During preparation and handling, use water proof gloves and effective shielding, to minimize radiation exposure ( 2.1 , 5.3 ). See the Full Prescribing Information for detailed information regarding recommended Dosage and Image Acquisition Instructions ( 2.2 ) and Instructions for Drug Preparation ( 2.4 ). Do not administer more than one dose ( 2.2 ). 2.1 Radiation Safety – Drug Handling Tc 99m labeled DRAXIMAGE ® DTPA injection is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure to the patient and healthcare worker. During preparation and handling, use water proof gloves and effective shielding, including syringe shields [see Warnings and Precautions ( 5.3 )] . 2.2 Recommended Dosage and Image Acquisition Instructions The recommended dose ranges for intravenous or inhalation administration of DRAXIMAGE® DTPA, after reconstitution, are presented in Table 1 through Table 3. Do not administer more than one dose. Table 1 Tc 99m Labeled DRAXIMAGE ® DTPA Injection – Intravenous Administration, Adults Indication Route of Administration Dose Image Acquisition Brain Imaging Intravenous Injection 370 MBq to 740 MBq (10 mCi to 20 mCi) Immediate dynamic imaging. Obtain at least one blood-pool image in same position as flow. Delayed images can be obtained 1 hour later. Renal Visualization and Perfusion Assessment Intravenous Injection 370 MBq to 740 MBq (10 mCi to 20 mCi) Immediate dynamic imaging. Static imaging 1 to 30 minutes after injection. Renal Visualization with Estimation of Glomerular Filtration Rate Intravenous Injection 111 MBq to 185 MBq (3 mCi to 5 mCi) Immediate dynamic imaging. Static imaging 1 to 30 minutes after injection. Estimation of Glomerular Filtration Rate (with no renal imaging) Intravenous Injection 7.4 MBq to 18.5 MBq (0.2 mCi to 0.5 mCi) Blood sampling only is performed. Table 2 Tc 99m Labeled DRAXIMAGE ® DTPA Injection – Intravenous Administration, Pediatric Patients Indication Route of Administration Dose Image Acquisition Renal Visualization and Perfusion Assessment Intravenous Injection 3.7 MBq/kg to 7.4 MBq/kg (0.1 mCi/kg to 0.2 mCi/kg) Minimum 37 MBq (1 mCi) Maximum 185 MBq (5 mCi) Immediate dynamic imaging. Static imaging 1 to 30 minutes after injection. Estimation of Glomerular Filtration Rate (with no renal imaging) Intravenous Injection 7.4 MBq to 18.5 MBq (0.2 mCi to 0.5 mCi) Blood sampling only is performed. Table 3 Tc 99m Labeled DRAXIMAGE ® DTPA – Aerosol Inhalation Administration * For lung imaging performed after perfusion imaging, target count rate should be approximately three times that of perfusion count rate. Indication Route of Administration Dose Image Acquisition Lung Ventilation Adults Aerosol Inhalation 925 MBq to 1850 MBq (25 mCi to 50 mCi) in the nebulizer to achieve a lung dose of approximately 18.5 MBq to 37 MBq (0.5 mCi to 1.0 mCi) For lung imaging performed prior to perfusion imaging, the target administered dose...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following adverse reactions have been identified post-approval. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their exact frequency or establish a causal relationship to Technetium Tc 99m pentetate exposure. Adverse reactions are presented in decreasing order of reported frequency: Immune system disorders: allergic reaction, anaphylactic reaction, angioedema. Skin and subcutaneous tissue disorders: rash, itching, hives, erythema. Respiratory, thoracic and mediastinal disorders: throat irritation, wheezing. Vascular disorders: hypotension, hypertension. Nervous system disorders: headache, fainting, dizziness. General disorders and administration site conditions: chills. Gastrointestinal disorders: nausea, vomiting. Cardiac disorders: cyanosis, tachycardia. Most common adverse reactions reported with Technetium Tc 99m pentetate injection include allergic reactions, rash, itching ( 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 Hypersensitivity to the active ingredient or to any component of the product [see Warnings and Precautions ( 5.1 )]. Hypersensitivity to the active ingredient or any component of this product ( 4 ).
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary Limited available data with Technetium Tc 99m pentetate use in pregnant women are insufficient to inform a drug associated risk for major birth defects and miscarriage. Technetium Tc 99m pentetate is transferred across the placenta (see Data ) . No animal reproductive studies have been conducted with Technetium Tc 99m pentetate. 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 pentetate administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Technetium Tc 99m pentetate and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S., general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. Data Human Data Limited published literature describes Technetium Tc 99m pentetate crossing the placental barrier. 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 DRAXIMAGE ® DTPA is supplied as multiple dose kits consisting of 10 mL reaction vials containing a white, lyophilized powder with 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg tin expressed as stannous chloride dihydrate. The radionuclide is not part of the kit. Before reconstitution and radiolabeling with sodium pertechnetate Tc 99m injection USP, the contents of the kit are not radioactive. The kits are supplied in the following formats: Carton containing 30 (thirty) kits NDC 65174.288.30 16.2 Storage and Handling Store the unreconstituted reaction vials at 25 °C (77 °F); excursions permitted between 15 °C and 30 °C (59 °F and 86 °F). This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State. 16.1 How Supplied DRAXIMAGE ® DTPA is supplied as multiple dose kits consisting of 10 mL reaction vials containing a white, lyophilized powder with 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg tin expressed as stannous chloride dihydrate. The radionuclide is not part of the kit. Before reconstitution and radiolabeling with sodium pertechnetate Tc 99m injection USP, the contents of the kit are not radioactive. The kits are supplied in the following formats: Carton containing 30 (thirty) kits NDC 65174.288.30
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.