Technescan MAG3

Technescan Tc 99m Mertiatide · Injection, Powder, Lyophilized, For Solution · Intravenous

Prescription (Rx)

Uses

Technetium Tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (See Pediatric Use. ) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.

Dosage and administration

The suggested dose range employed in the average adult patient (70 kg) for renal function and imaging studies is 185 MBq (5 mCi) to 370 MBq (10 mCi). In pediatric patients the recommended dose range is 2.6 MBq/kg (70 μCi/kg) to 5.2 MBq/kg (140 μCi/kg) with a minimum dose of 37 MBq (1 mCi). The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Aseptic procedures and a shielded syringe should be employed in withdrawing doses for administration to patients. The user should wear waterproof gloves during the administration procedure.

Contraindications

None known.

Warnings

None known.

Precautions

General The contents of this kit are not radioactive. However, after sodium pertechnetate Tc 99m is added, adequate shielding of the final preparation must be maintained. Contents of the reaction vial are intended only for use in the preparation of technetium Tc 99m mertiatide and are NOT to be administered directly to the patient. To help reduce the radiation dose to the bladder, as well as other target organs, the patient should increase his or her fluid intake (unless medically contraindicated) and void as often as possible after the injection of technetium Tc 99m mertiatide for six hours after the imaging procedure. Technetium Tc 99m mertiatide should not be used more than six hours after preparation. The components of the kit are sterile and nonpyrogenic. It is essential that the user follow the directions carefully and use aseptic procedures normally employed in making additions and withdrawals from sterile, nonpyrogenic containers during the addition of pertechnetate solution and the withdrawal of doses for patient administration. The technetium Tc 99m labeling reactions involved in preparing Technescan MAG3 depend on maintaining the stannous ion in the reduced state. Any oxidant present in the sodium pertechnetate Tc 99m may adversely affect the quality of the radiopharmaceutical. Therefore, sodium pertechnetate Tc 99m containing oxidants should not be employed. As in the use of any other radioactive material, care should be taken to ensure minimum radiation exposure to the patient and to occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides. Carcinogenesis, Mutagenesis, Impairment of Fertility No long term animal studies have been performed to evaluate carcinogenic or mutagenic potential, or whether this drug affects fertility in males or females. Pregnancy Animal reproduction studies have not been conducted with technetium Tc 99m mertiatide. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Technetium Tc 99m mertiatide should be given to a pregnant woman only if clearly needed. Nursing Mothers Technetium Tc 99m is excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feeding. Pediatric Use Safety and effectiveness in pediatric patients under the age of 30 days have not been established.

Side effects

The following adverse reactions have been reported: nausea, vomiting, wheezing, dyspnea, itching, rash, tachycardia, hypertension, shaking chills, fever, and seizure.

Pregnancy

Pregnancy Animal reproduction studies have not been conducted with technetium Tc 99m mertiatide. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Technetium Tc 99m mertiatide should be given to a pregnant woman only if clearly needed.

Pediatric use

Pediatric Use Safety and effectiveness in pediatric patients under the age of 30 days have not been established.

Description

Technescan MAG3™ is a kit for the preparation of technetium Tc 99m mertiatide, a diagnostic radiopharmaceutical. It is supplied as a sterile, nonpyrogenic, lyophilized powder. Each vial contains betiatide (N-[N-[N-[(benzoylthio) acetyl]glycyl]glycyl]-glycine). After reconstitution with sterile sodium pertechnetate Tc 99m injection, the technetium Tc 99m mertiatide (disodium[N-[N-[N-(mercaptoacetyl) glycyl]glycyl] glycinato (2-) - N,N′,N″,S′]oxotechnetate (2-)) which is formed is suitable for intravenous administration. Each 10 milliliter vial contains 1 milligram betiatide, 0.05 milligram (minimum) stannous chloride dihydrate (SnCl 2
• 2H 2 O) and 0.2 milligram (maximum) total tin expressed as stannous chloride dihydrate (SnCl 2
• 2H 2 O), 40 milligrams sodium tartrate dihydrate (Na 2 C 4 H 2 O 6
• 2H 2 O), and 20 milligrams lactose monohydrate. Prior to lyophilization, sodium hydroxide or hydrochloric acid may be added for pH adjustment. The pH of the reconstituted drug is between 5.0 and 6.0. No bacteriostatic preservative is present. The contents are sealed under argon. Betiatide is light sensitive and must be protected from light. Betiatide and technetium Tc 99m mertiatide have the following structural formulas: image description image description

How supplied

Catalog Number 096. Technescan MAG3 is supplied as a lyophilized powder packaged in vials. Each reaction vial contains 1 mg betiatide, 0.05 mg (minimum) stannous chloride dihydrate (SnCl 2
• 2H 2 O), 0.2 mg (maximum) total tin expressed as stannous chloride dihydrate (SnCl 2
• 2H 2 O), 40 mg sodium tartrate dihydrate (Na 2 C 4 H 2 O 6
• 2H 2 O), and 20 mg lactose monohydrate. The pH of the reconstituted drug is between 5.0 and 6.0. No bacteriostatic preservative is present. Packages containing 5 reaction vials (NDC 69945-096-20) are available.

Storage

Technescan MAG3 should be stored at controlled room temperature 20° to 25°C (68° to 77°F) and protected from light until use. The reconstituted vial should be stored at room temperature (15° to 30°C) and must be used within six hours of preparation. Table 4. Radiation Dose Estimates for Tc 99m Mertiatide *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 ten normal volunteers using the Medical Internal Radiation Dose Committee (MIRD) schema. **Radioactive doses for 1-, 5-, and 10-year olds are based on a maximum dose of 7.4 MBq/kg (200 μCi/kg). 8-day Old 1-year Old** 5-year Old** 10-year Old** 15-year Old Adult Assumed Weight (kg) 3.4 9.8 19 32 57 70 Tc 99m Mertiatide Dose 37 MBq (1 mCi) 72.52 MBq (1.96 mCi) 140.6 MBq (3.8 mCi) 236.8 MBq (6.4 mCi) 370 MBq (10 mCi) 370 MBq (10 mCi) Organ mSv rem mSv rem mSv rem mSv rem mSv rem mSv rem Gallbladder Wall 2.701 0.27 2.466 0.235 1.547 0.160 1.658 0.166 1.961 0.200 1.628 0.160 Lower Large Intestine Wall 1.739 0.17 1.595 0.161 2.250 0.220 2.368 0.237 4.070 0.400 3.256 0.330 Small Intestine 0.518 0.052 0.5439 0.055 1.195 0.122 1.397 0.141 2.035 0.200 1.628 0.160 Upper Large Intestine Wall 0.962 0.096 0.943 0.096 1.828 0.186 2.0365 0.205 2.442 0.250 1.887 0.190 Kidneys 1.406 0.14 1.088 0.112 1.308 0.129 1.5155 0.154 1.739 0.180 1.443 0.140 Liver 0.3219 0.032 0.3046 0.031 0.394 0.038 0.4262 0.0435 0.481 0.048 0.3626 0.036 Ovaries 0.592 0.058 0.6164 0.061 1.322 0.133 1.5392 0.154 3.330 0.330 2.5900 0.260 Red Marrow 0.1628 0.016 0.1595 0.0161 0.281 0.0277 0.3552 0.0352 0.629 0.063 0.4810 0.050 Testes 0.518 0.051 0.5294 0.053 1.0826 0.110 1.1840 0.122 2.368 0.240 1.628 0.160 Urinary Bladder Wall 11.470 1.1 9.428 0.921 21.090 2.090 23.680 2.368 59.20 6.00 48.1000 4.80 Total Body 0.2405 0.024 0.2176 0.022 0.3656 0.0365 0.4026 0.0410 0.814 0.081 0.6660 0.065

Label text from the FDA structured product label by Curium US LLC (revised Jan 6, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Betiatide in 1 product

Technescan MAG3 NDC products (1)

NDC	Strength & form	Labeler	Type
69945-096	Betiatide 1 mg/1 Injection, Powder, Lyophilized, For Solution	Curium US LLC	NDA

Frequently asked questions

What is Technescan MAG3 used for?

What are the side effects of Technescan MAG3?

The following adverse reactions have been reported: nausea, vomiting, wheezing, dyspnea, itching, rash, tachycardia, hypertension, shaking chills, fever, and seizure. See the full label for the complete list.

Who makes Technescan MAG3?

Technescan MAG3 is listed by 1 labeler in the FDA NDC directory, including Curium US LLC.