Kit For The Preparation Of Technetium Tc 99M Mebrofenin

FDA Drug Information • Also known as: Kit For The Preparation Of Technetium Tc 99M Mebrofenin

Brand Names: Kit For The Preparation Of Technetium Tc 99M Mebrofenin
Route: INTRAVENOUS
Dosage Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Type: HUMAN PRESCRIPTION DRUG

Description

DESCRIPTION Each multidose reaction vial contains a nonradioactive, sterile, nonpyrogenic mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF 2

2H 2 O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF 2

2H 2 O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH is adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7. The structure of mebrofenin (2,2'-[[2-[(3-Bromo-2,4,6-trimethylphenyl)-amino]-2-oxoethyl]imino] bisacetic acid) is shown below: Molecular Weight = 387.23 When sterile, pyrogen-free sodium pertechnetate Tc 99m injection is added to the vial, the diagnostic agent Technetium Tc 99m Mebrofenin is formed for administration by intravenous injection. PHYSICAL CHARACTERISTICS Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours. 1 The principal photon that is useful for detection and imaging studies is listed in Table 1. TABLE 1 Principal Radiation Emission Data Radiation Mean % per Disintegration Mean Energy (keV) Gamma-2 89.07 140.5 1 Kocher, David C., "Radioactive Decay Data Tables", DOE/TIC-11026, (1981) p. 108. External Radiation The specific gamma ray constant for Tc 99m is 0.78 R/hour-millicurie at 1 cm. The first half value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000. TABLE 2 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 To correct for...

What Is Kit For The Preparation Of Technetium Tc 99M Mebrofenin Used For?

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

Dosage 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. RADIATION DOSIMETRY The estimated absorbed radiation doses 1,2 to organs and tissues of an average subject (70 kg) from an intravenous injection of 370 MBq (10 millicuries) of Technetium Tc 99m Mebrofenin are shown in Table 4. TABLE 4 Estimated Absorbed Radiation Doses† Normal Subjects* Severely Jaundiced Patients** Tissue mGy/ 370 MBq rads/ 10 mCi mGy/ 370 MBq rads/ 10 mCi Total Body 2.0 0.2 1.7 0.17 Liver 4.7 0.47 8.1 0.81 Gallbladder Wall 13.7 1.37 12.5 1.25 Small Intestine 29.9 2.99 16.0 1.60 Upper Large Intestine Wall 47.4 4.74 24.8 2.48 Lower Large Intestine Wall 36.4 3.64 19.7 1.97 Kidney 2.2 0.22 1.9 0.19 Urinary Bladder Wall 2.9 0.29 24.2 2.42 Ovaries 10.1 1.01 6.4 0.64 Testes 0.5 0.05 1.1 0.11 Red Marrow 3.4 0.34 2.5 0.25 †Method of Calculation: (1) Loberg, M.D., Buddemeyer, E.V.: Application of pharmacokinetic modeling to the radiation dosimetry of hepatobiliary agents. In Third International Radiopharmaceutical Dosimetry Symposium, FDA No. 81-8166, U.S. Department of Health and Human Services, Public Health Service, FDA, Bureau of Radiological Health, Rockville, MD, (1981) pp. 318-332. (2) Values for S: "S", Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11 (1975). * Bilirubin <1.5 mg/dL Calculations assume that 98% of the injected activity is taken up by the liver; activity not removed in the urine in 24 hours is excreted in the intestines and no enterohepatic circulation of activity. ** Bilirubin >10 mg/dL (mean 21.8 mg/dL) Calculations assume that 66% of the injected activity is taken up by the liver; activity not removed in the urine in 24 hours is excreted in the intestines and no enterohepatic circulation of activity.

Side Effects (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.

Warnings and Precautions

WARNINGS The theoretical possibility of allergic reactions should be considered in patients who receive multiple doses.

Contraindications

CONTRAINDICATIONS Hypersensitivity to this compound.

Pregnancy and Breastfeeding

Pregnancy 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.

How Supplied

HOW SUPPLIED Kit for the Preparation of Technetium Tc 99m Mebrofenin is supplied in kits of 5 or 30 reaction vials. Each vial contains a sterile, nonpyrogenic lyophilized mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate SnF 2

2H 2 O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF 2

2H 2 O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH has been adjusted with hydrochloric acid or sodium hydroxide prior to lyophilization. The lyophilized vial contents are sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7. Sun Pharmaceutical Industries, Inc. 29 Dunham Rd. 781-275-7120 Kit Contents 5 or 30 sterile multidose reaction vials. 12 or 72 radiation labels for Technetium Tc 99m Mebrofenin (for 5 or 30 vial kits, respectively). 1 package insert. Preparation Preparation of Technetium Tc 99m Mebrofenin is done by the following aseptic procedure: 1. Waterproof gloves should be worn during the preparation procedure. 2. Place reaction vial in an appropriate lead shield. 3. Swab the rubber closure of the reaction vial with a germicide. 4. Inject 1 to 5 mL sterile additive free sodium pertechnetate Tc 99m injection containing up to 3700 MBq (100 mCi) Tc 99m into the reaction vial. Be sure to maintain a nitrogen atmosphere in the vial by not introducing air during reconstitution. NOTE: If sodium pertechnetate Tc 99m injection must be diluted for use with Kit for the Preparation of Technetium Tc 99m Mebrofenin, only preservative free Sodium Chloride Injection USP should be used. 5. Secure the lead shield cover. Swirl the vial gently to mix contents and let stand for 15 minutes. 6. Record the date and time of preparation on radiation label. 7. Affix radiation label to shield. 8. Examine vial contents. If the solution is not clear and free of particulate matter and discoloration on visual inspection, it should not be used. 9. Measure the radioactivity by a suitable...

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.