TECHNETIUM Tc 99m MERTIATIDE by is a Prescription medication manufactured, distributed, or labeled by Jubilant DraxImage Inc., dba Jubilant Radiopharma, Jubilant HollisterStier General Partnership. Drug facts, warnings, and ingredients follow.
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)
Kit for the Preparation of Technetium Tc 99m Mertiatide Injection: 1 mg betiatide as a lyophilized powder in 10 ml glass multiple-dose vial. Upon radiolabeling with technetium-99m, it contains up to 3,700 MBq (100 mCi) technetium Tc 99m mertiatide in approximately 10 mL volume at calibration time. (3)
None. (4)
Radiation risks: Ensure safe handling to minimize radiation exposure to patients and healthcare providers. (5.1)
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.
Lactation: Temporarily discontinue breastfeeding. A lactating woman should pump and discard breast milk for at least 24 hours after Technetium Tc99m Mertiatide administration. (8.2)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 1/2023
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.
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.
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.
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.
Procedural Precautions
Procedure for the Preparation of Technetium Tc 99m Mertiatide Injection
Required Materials
Preparation of Sep-Pak Cartridge
Sample Analysis
Counting
Calculations
1. Percent Technetium Tc 99m Mertiatide =
Activity of 2nd (1:1 ethanol: 0.9% Sodium Chloride Injection) fraction x 100%
Total activity of all 3 fractions
Note: Not less than 90% of the activity must be Technetium Tc 99m Mertiatide.
2. Percent hydrophilic impurities =
Activity of 1st (0.001N hydrochloric acid) fraction x 100%
Total activity of all 3 fractions
3. Percent non-elutable impurities =
Activity remaining on Sep-Pak cartridge x 100%
Total activity of all 3 fractions
Note: Total impurities must not be more than 10%.
The estimated radiation doses per injected activity of Technetium Tc 99m Mertiatide Injection by an intravenous administration are presented in Table 1.
Table 1. Estimated Radiation Equivalent Dose for Intravenously Administered Technetium Tc 99m Mertiatide*
Organ | Adult | 15 Years | 10 Years | 5 Years | 1 Year | 8 Days** |
Gallbladder Wall | 0.0044 | 0.0053 | 0.007 | 0.011 | 0.034 | 0.073 |
Lower Large Intestine Wall | 0.0088 | 0.011 | 0.01 | 0.016 | 0.022 | 0.047 |
Small Intestine | 0.0044 | 0.0055 | 0.0059 | 0.0085 | 0.0075 | 0.014 |
Upper Large Intestine Wall | 0.0051 | 0.0066 | 0.0086 | 0.013 | 0.013 | 0.026 |
Kidneys | 0.0039 | 0.0047 | 0.0064 | 0.0093 | 0.015 | 0.038 |
Liver | 0.00098 | 0.0013 | 0.0018 | 0.0028 | 0.0042 | 0.0087 |
Ovaries | 0.007 | 0.009 | 0.0065 | 0.0094 | 0.0085 | 0.016 |
Red Marrow | 0.0013 | 0.0017 | 0.0015 | 0.002 | 0.0022 | 0.0044 |
Testes | 0.0044 | 0.0064 | 0.005 | 0.0077 | 0.0073 | 0.014 |
Urinary Bladder Wall | 0.13 | 0.16 | 0.1 | 0.15 | 0.13 | 0.31 |
Total Body | 0.0018 | 0.0022 | 0.0017 | 0.0026 | 0.003 | 0.0045 |
*Calculated by Oak Ridge Associated Universities, based upon the pediatric phantom series of Christy and Eckerman of Oak Ridge National Laboratories. The adult radiation absorbed doses were calculated based on data from 10 healthy subjects using the Medical Internal Radiation Dose Committee (MIRD) schema.
** Technetium Tc 99m Mertiatide Injection is not approved for pediatric patients younger than 30 days old [see Indications and Usage (1)].
Kit for the Preparation of Technetium Tc 99m Mertiatide Injection contains 1 mg betiatide supplied as a white lyophilized powder packaged in 10 mL glass multiple-dose vials. Radiolabeling with sodium pertechnetate Tc 99m injection provides a clear, colorless solution containing up to 3,700 MBq (100 mCi) technetium Tc 99m mertiatide in approximately 10 mL volume at calibration time..
Technetium Tc 99m Mertiatide Injection contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration (2.2)].
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.
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.
Risk Summary
There are no data on the presence of technetium Tc 99m mertiatide in breast milk, however, published case reports describe the presence of technetium Tc 99m in breast milk. There are no data on the effects of technetium Tc 99m mertiatide on the breastfed infant or the effects on milk production. Based on clinical guidelines, exposure of technetium Tc 99m mertiatide to a breastfed infant may be minimized by advising a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for a minimum of 24 hours after administration of Technetium Tc 99m Mertiatide Injection. The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for Technetium Tc 99m Mertiatide Injection and any potential adverse effects on the breastfed child from technetium Tc 99m mertiatide or from the underlying maternal condition.
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 pediatric patients aged 30 days and older.
The safety and effectiveness of Kit for the Preparation of Technetium Tc 99m Mertiatide Injection have not been established in pediatric patients younger than 30 days old.
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.
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.
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.
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
The specific gamma ray constant for technetium-99m is 0.78 R/mCi-hr at 1 cm. The first half-value thickness of lead (Pb) for technetium-99m is 0.017 cm. The use of 0.25 cm of Pb, for example, will decrease the external radiation exposure by a factor of about 1,000. Table 4 displays the radiation attenuation by lead shielding.
Shield Thickness (Pb) cm | Coefficient of Attenuation |
0.017 | 0.5 |
0.08 | 10-1 |
0.16 | 10-2 |
0.25 | 10-3 |
0.33 | 10-4 |
Following intravenous administration for renal imaging, Technetium Tc 99m Mertiatide is rapidly cleared from the blood. It is cleared by the kidneys and excreted in the urine.
Following intravenous injection of technetium Tc 99m mertiatide, the uptake, concentration, and excretion of the tracer by the kidney can be monitored to assess renal function.
Distribution
After an intravenous administration in healthy adult subjects, 89% of technetium Tc 99m mertiatide was plasma-protein bound. The protein binding is reversible.
Elimination
Excretion
In healthy subjects, the plasma clearance was approximately 0.3 liters/minute and the amount of technetium Tc 99m mertiatide excreted in the urine in 3 hours was nearly 90% of the injected dose.
Specific Populations
Patients with Renal Impairment
In a study performed in three patients with renal impairment (serum creatinine greater than 6.3 mg/dL), 78% of the tracer was plasma protein bound after intravenous injection. The mean plasma clearance of technetium Tc 99m mertiatide was 0.03 liters/minute and 21.3% was excreted in 3 hours on average. In both healthy subjects and patients with renal impairment, the plasma concentration-time profile showed a biexponential decline.
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.
Adequate Hydration
Advise patients to drink sufficient amount of water to ensure adequate hydration before administration of Technetium Tc 99m Mertiatide Injection and to continue to drink and void frequently following administration to minimize radiation dose [see Dosage and Administration (2.2) and Warning and Precautions (5.1)].
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 a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for at least 24 hours after Technetium Tc 99m Mertiatide Injection administration to minimize radiation exposure to a breastfed infant [see Use in Specific Populations (8.2)].
Manufactured for:
Jubilant DraxImage Inc., dba Jubilant Radiopharma™
16 751 TransCanada Highway
Kirkland, Quebec H9H 4J4 Canada
1-888-633-5343
www.jubilantradiopharma.com
Art Rev.: 3.0
Sep-Pak™ is a trademark of Waters Technologies Corporation.
Jubilant Radiopharma™ is a trademark used under license by Jubilant DraxImage Inc.
NDC: 65174-261-05
Kit for the Preparation of Technetium Tc 99m Mertiatide
1 mg Betiatide per Vial
Rx only
For intravenous use only after radiolabeling with
Sodium Pertechnetate Tc 99m Injection, USP
DIAGNOSTIC - For Renal Imaging
Manufactured for:
Jubilant DraxImage Inc., dba Jubilant Radiopharma™
Kirkland, Quebec H9H 4J4 Canada
1-888-633-5343, www.jubilantradiopharma.com
CONTENTS:
Five (5) sterile, non-pyrogenic multiple-dose vials of Kit for the preparation of technetium Tc 99m mertiatide, 5 radioassay information labels, 5 venting needles (filter containing) and 1 prescribing information.
Each 10 mL multiple dose vial contains: 1 mg betiatide, 20 mg lactose monohydrate, 40 mg tartrate dihydrate, 0.07 (minimum) stannous chloride dihydrate, and 0.2 mg (maximum) total tin as stannous chloride dihydrate. Hydrochloric acid is added for pH adjustment, prior to lyophilization.
The pH of the reconstituted drug is between 5 and 6.
The contents are sealed under argon.
Rx only
Recommended Dosage: See Prescrbing Information.
Storage: Before radiolabeling, store at 20 °C to 25 °C (68 °F to 77 °F) and protect from light.
After radiolabeling, store upright inappropriate shielding to protect from radiation at 15°C to 30°C (59°F to 86°F). Use within 6 hours of radiolabeling.
Preservative-free.
Sterile NDC: 65174-261-01
Kit for the Preparation of Technetium Tc 99m Mertiatide Injection
1 mg Betiatide per Vial Rx only
Multiple-dose reaction vial
For intravenous use only after radiolabeling with Sodium Pertechnetate Tc 99m Injection USP.
Recommended Dosage: See Prescribing information.
Store at 20 °C to 25 °C (68 °F to 77 °F) and protect from light. Use within 6 hours of radiolabeling.
Manufactured for:
Jubilant DraxImage Inc.
Kirkland, Quebec, Canada H9H 4J4
TECHNETIUM TC 99M MERTIATIDE
technetium tc 99m mertiatide injection, powder, lyophilized, for solution |
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Labeler - Jubilant DraxImage Inc., dba Jubilant Radiopharma (243604761) |
Registrant - Jubilant DraxImage Inc., dba Jubilant Radiopharma (243604761) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Jubilant DraxImage Inc., dba Jubilant Radiopharma | 243604761 | analysis(65174-261) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Jubilant HollisterStier General Partnership | 246762764 | manufacture(65174-261) |