Data from FDA - Curated by EPG Health - Last updated 21 December 2016


INDICATIONS AND USAGE Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.

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Advisory information

CONTRAINDICATIONS Hypersensitivity to this compound.
Special warnings and precautions

PRECAUTIONS General Contents of the reaction vial are intended only for use in the preparation of Technetium Tc 99m Mebrofenin and are not to be administered directly to the patient.

Delayed or non-visualization of the gallbladder may occur in the immediate post-prandial period or after prolonged fasting or parenteral feeding.

Functional biliary obstruction may accompany chronic cholecystitis or pancreatitis.

In addition, patients with hepatocellular disease may show non-visualization or delayed visualization of the gallbladder.

Delayed intestinal transit may also be noted in such patients.

Juvenile hepatitis may be associated with gallbladder non-visualization and the failure to visualize activity in the intestine.

Administration of meperidine or morphine may delay intestinal transit of the imaging agent and may result in nonvisualization.

Septic patients may show absent or delayed hepatobiliary clearance.

Thus, a positive finding does not of itself permit a differential diagnosis of any of the above conditions and should be evaluated in the light of the total clinical picture and results of other diagnostic modalities.

The components of the kit are supplied sterile and nonpyrogenic.

Aseptic procedures normally employed in making additions and withdrawals from sterile, nonpyrogenic containers should be used during the addition of the pertechnetate solution and the withdrawal of doses for patient administration.

The Technetium Tc 99m labeling reactions involved in preparing the agent depend on maintaining the stannous ion in the reduced state.

Any oxidant present in the sodium pertechnetate Tc 99m supply may, thus, adversely affect the quality of the radiopharmaceutical.

Hence, sodium pertechnetate Tc 99m containing oxidants should not be employed.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides.

As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to ensure minimum radiation exposure to occupational workers.

Tc 99m Mebrofenin should be formulated no more than 18 hours prior to clinical use.

Carcinogenesis, Mutagenesis, Impairment of Fertility No long term animal studies have been performed to evaluate carcinogenic potential or whether Technetium Tc 99m Mebrofenin may affect fertility in males or females.

Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Technetium Tc 99m Mebrofenin.

It is also not known whether Technetium Tc 99m Mebrofenin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.

Technetium Tc 99m Mebrofenin should be given to a pregnant woman only if the expected benefits to be gained clearly outweigh the potential hazards.

Nursing Mothers Technetium Tc 99m is excreted in human milk during lactation.

Therefore, formula feedings should be substituted for breast feedings.

Pediatric Use Safety and effectiveness in children below the age of 18 have not be established.

Adverse reactions
ADVERSE REACTIONS Urticaria and rash have been rarely reported with the use of Technetium Tc 99m Mebrofenin since market introduction. Rare cases of chills and nausea have been reported with related compounds. Infrequently, death has been reported in association with the use of this class of agents.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION The suggested intravenous dose range of Technetium Tc 99m Mebrofenin in the average patient (70 kg) is: Nonjaundiced patient: 74-185 MBq (2-5 mCi) Patient with serum bilirubin level greater than 1.5 mg/dL: 111-370 MBq (3-10 mCi) The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

The patient should be in a fasting state, 4 hours is preferable.

False positives (non-visualization) may result if the gallbladder has been emptied by ingestion of food.

An interval of at least 24 hours should be allowed before repeat examination.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

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

More information

Category Value
Authorisation number NDA018963
Orphan designation No
Product NDC 0270-0083
Date Last Revised 17-05-2015
Storage and handling

Storage Store the kit as supplied at 20-25°C (68-77°F) [See USP] prior to and following reconstitution.

Use within 18 hours of reconstitution.

The U.S. Nuclear Regulatory Commission has approved this reagent kit for distribution to persons licensed to use byproduct material identified in §35.200 of 10 CFR Part 35, to persons who hold an equivalent license issued by an Agreement State, and, outside the United States, to persons authorized by the appropriate authority.

Marketing authorisation holder Bracco Diagnostics Inc