Technetium Tc 99M Mertiatide
FDA Drug Information • Also known as: Technetium Tc 99M Mertiatide
- Brand Names
- Technetium Tc 99M Mertiatide
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION 11.1 Chemical Characteristics Kit for the Preparation of Technetium Tc 99m Mertiatide Injection is a sterile, multiple-dose kit for the preparation of technetium Tc 99m mertiatide injection, a radioactive diagnostic agent for intravenous use. The active ingredient, betiatide, is N-[N-[N-[(benzoylthio) acetyl]glycyl]glycyl]-glycine and has a molecular weight of 367.38 g/mol. After reconstitution with sodium pertechnetate Tc 99m injection, the radioactive agent technetium Tc 99m mertiatide (disodium[N-[N-[N- (mercaptoacetyl) glycyl]glycyl] glycinato (2-) - N,N′,N″,S′]oxotechnetate (2-)) is formed in situ. Each 10 mL vial contains 1 mg betiatide, 20 mg lactose monohydrate, 40 mg sodium tartrate dihydrate, 0.07 mg (minimum) stannous chloride dihydrate and 0.2 mg (maximum) total tin expressed as stannous chloride dihydrate. Prior to lyophilization, hydrochloric acid is added for pH adjustment. The vial contents are sealed under argon. After radiolabeling with sodium pertechnetate Tc 99m injection, each vial contains up to 3,700 MBq (100 mCi) of technetium Tc 99m mertiatide in 0.9% sodium chloride injection in approximately 10 mL volume as a sterile, clear, and colorless solution with a pH between 5 and 6. betiatide-chem-stuct tc-99m-mertiatide 11.2 Physical Characteristics Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours. The principal photon that is useful for detection and imaging is listed in Table 2. Table 2. Principal Radiation Emission Data Radiation M Mean % per Disintegration Energy (keV) Gamma-2 89.07 140.5 To correct for physical decay of the radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in Table 3. Table 3. Physical Decay Chart: Technetium Tc 99m, Half-life 6.02 Hours Hours Fraction Remaining Hours Fraction Remaining 0* 1.000 7 0.447 1 0.891 8 0.398 2 0.794 9 0.355 3 0.708 10 0.316 4 0.631 11 0.282 5 0.562 12 0.251 6 0.501 * Calibration Time 11.3...
What Is Technetium Tc 99M Mertiatide Used For?
1 INDICATIONS AND USAGE Kit for the Preparation of Technetium Tc 99m Mertiatide Injection, after radiolabeling with technetium-99m, is indicated for use in the diagnosis of congenital and acquired renal abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients aged 30 days and older. The product is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex. Kit for the Preparation of Technetium Tc 99m Mertiatide Injection, after radiolabeling with technetium-99m, is a radioactive diagnostic agent indicated for use in the diagnosis of congenital and acquired renal abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients aged 30 days and older. The product is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Instruct patients to drink a sufficient amount of water before administration and continue to drink and to void frequently following administration. ( 2.2 ) Recommended dose in adult patients:185 MBq to 370 MBq (5 mCi to 10 mCi) as an intravenous bolus injection. ( 2.3 ) Recommended dose in pediatric patients aged 30 days and older: 2.6 MBq/kg to 5.2 MBq/kg (0.07 mCi/kg to 0.14 mCi/kg) with a minimum dose of 37 MBq (1 mCi) as an intravenous bolus injection. ( 2.3 ) See Full Prescribing Information for radiation safety, drug preparation, administration, and radiation dosimetry information. ( 2.1 , 2.4 , 2.5 , 2.6 , 2.7 ) 2.1 Radiation Safety – Drug Handling After radiolabeling, the kit produces Technetium Tc 99m Mertiatide Injection. Handle Technetium Tc 99m Mertiatide Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions ( 5.1 )] . Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Technetium Tc 99m Mertiatide Injection. Radiopharmaceuticals should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. 2.2 Patient Preparation Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Technetium Tc 99m Mertiatide Injection and to continue to drink and void frequently following administration to reduce radiation exposure. 2.3 Recommended Dosage Adult The recommended dose in adult patients is 185 MBq to 370 MBq (5 mCi to 10 mCi) as an intravenous bolus injection. Pediatric The recommended dose in pediatric patients aged 30 days and older is 2.6 MBq/kg to 5.2 MBq/kg (0.07 mCi/kg to 0.14 mCi/kg) of actual body weight with a minimum dose of 37 MBq (1 mCi) as an intravenous bolus injection. 2.4 Drug Preparation and Handling Procedural Precautions Contents of the vials are intended only for use in the preparation of Technetium Tc 99m Mertiatide Injection, and are NOT to be administered directly to the patient. Do not use Sodium Pertechnetate Tc 99m Injection USP more than 6 hours after its elution from the generator. Use aseptic techniques for all transfers and vial stopper entries. Wear waterproof gloves during the procedure, particularly during the heating of the sample with boiling water. Use suitable shielding to reduce radiation exposure. Use one lead shield for incubation with a water bath and another lead shield for dispensing as described in the Procedure for the Preparation of Technetium Tc 99m Mertiatide Injection section below. Make all transfers of sodium pertechnetate Tc 99m solution during the preparation procedure with an adequately shielded syringe. Procedure for the Preparation of Technetium Tc 99m...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following adverse reactions associated with the use of Technetium Tc 99m Mertiatide Injection were identified in clinical studies or postmarketing reports. Because some of these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac disorders : tachycardia. Gastrointestinal disorders : nausea, vomiting. General disorders and administration site conditions : shaking chills, fever. Nervous system disorders : seizure. Respiratory, thoracic and mediastinal disorders : wheezing, dyspnea. Skin and subcutaneous tissue disorders : itching, rash. Vascular disorders : elevation in blood pressure. Reported adverse reactions are: tachycardia, nausea, vomiting, shaking chills, fever, seizure, wheezing, dyspnea, itching, rash, and elevation in blood pressure. ( 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 There are no data with technetium Tc 99m mertiatide use in pregnant women to determine a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No animal reproductive studies have been conducted with technetium Tc 99m mertiatide. Although all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose, the radiation exposure to the fetus from technetium Tc 99m mertiatide is expected to be low (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, 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% to 4% and 15% to 20%, respectively. Data Human Data No adverse fetal effects of radiation risks have been identified for diagnostic procedures involving less than 50 mGy, which represents less than 10 mGy fetal doses.
Overdosage
10 OVERDOSAGE In the event of an overdose of technetium Tc 99m mertiatide, hydration and frequent micturition should be encouraged to minimize the absorbed radiation dose to patient. A diuretic might also be considered. If possible, an estimate of the radiation effective dose given to the patient should be made.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Kit for the Preparation of Technetium Tc 99m Mertiatide Injection containing 1 mg betiatide, is supplied as a white lyophilized powder packaged in a sterile, multiple-dose 10 mL vial as a carton of 5 vials (NDC 65174-261-05). The carton also contains: - 5 venting needles with filter. - 5 radioassay information labels for the radiolabeled product. The radionuclide is not part of Kit for the Preparation of Technetium Tc 99m Mertiatide Injection. Storage and Handling Before radiolabeling, store at controlled room temperature 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] and protect from light. After radiolabeling with sodium pertechnetate Tc 99m injection, store vial upright in shielding to protect from radiation at room temperature 15°C to 30°C (59°F to 86°F). Use within 6 hours of radiolabeling. Dispose of unused Technetium Tc 99m Mertiatide Injection in compliance with the regulations of the government agency authorized to license the use of this radionuclide. This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.
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.