Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 22 February 2017

Indication(s)

INDICATIONS AND USAGE 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.

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Advisory information

contraindications
CONTRAINDICATIONS None known.
Special warnings and precautions

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 Pregnancy Category C. 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.

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

Usage information

Dosing and administration

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?Ci/kg) to 5.2 MBq/kg (140?Ci/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.

Pregnancy and lactation
Nursing Mothers Technetium Tc 99m is excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feeding.

More information

Category Value
Authorisation number NDA019882
Orphan designation No
Product NDC 69945-096
Date Last Revised 13-10-2015
Type HUMAN PRESCRIPTION DRUG
Storage and handling

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?Ci/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

Marketing authorisation holder MALLINCKRODT NUCLEAR MEDICINE LLC