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Technetium Tc-99m mebrofenin: Drug information

Technetium Tc-99m mebrofenin: Drug information
(For additional information see "Technetium Tc-99m mebrofenin: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Choletec
Brand Names: Canada
  • Choletec
Pharmacologic Category
  • Radiopharmaceutical
Dosing: Adult
Hepatobiliary imaging

Hepatobiliary imaging: IV (based on 70 kg patient): 2 to 5 mCi (74 to 185 MBq)

Dosing: Kidney Impairment: Adult

No dosage adjustment provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

Serum bilirubin >1.5 mg/dL: 3 to 10 mCi (111 to 370 MBq)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined: Dermatologic: Skin rash, urticaria

Contraindications

Hypersensitivity to technetium Tc 99m mebrofenin or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Potential of allergic reactions in patients receiving multiple doses.

Concurrent drug therapy issues:

• Meperidine or morphine sulfate use: Recent use may delay intestinal transit of imaging agent resulting in nonvisualization of intestinal activity.

Disease-related concerns:

• Hepatic impairment: Delayed visualization or nonvisualization of the gallbladder may occur.

Special handling:

• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority. Note: Contents of kit are not radioactive; however, adequate shielding is required after addition of radioactive material.

Other warnings/precautions:

• Appropriate use: Patient should be fasting (at least 4 hours) prior to administration to prevent a false positive result (nonvisualization of gallbladder).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Kit, Intravenous:

Choletec: [contains methylparaben, propylparaben]

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Kit, Intravenous:

Choletec: [contains methylparaben, propylparaben]

Administration: Adult

IV: For IV administration. Test should be performed while patient is fasting; avoid interference with opioids by delaying the study for 4 hours after the last dose. Radiopharmaceutical; use appropriate precautions for handling and disposal.

Use: Labeled Indications

Imaging agent: Hepatobiliary imaging agent

Medication Safety Issues
Other safety concerns:

Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Reproductive Considerations

Pregnancy status should be evaluated prior to use in women of reproductive potential (SNM 2010).

Pregnancy Considerations

Technetium Tc 99m can be detected in fetal tissue; the amount depends on the specific formulation, route of administration, and stage of pregnancy (Adelstein 1999).

In general, the potential for a radiopharmaceutical to cause fetal harm depends on the dose absorbed by the fetus and the stage of pregnancy. High doses of radiopharmaceuticals used for therapeutic procedures are more likely to result in fetal harm. A medically required diagnostic procedure can usually be modified to decrease fetal risk. Elective diagnostic procedures should be delayed until after delivery (ACR-SPR 2018; Adelstein 1999; ICRP 2000; SNM 2010).

Breastfeeding Considerations

Technetium Tc 99m is present in breast milk.

Available guidelines recommend lactating women interrupt breastfeeding for a period of 4 hours after receiving technetium Tc 99m mebrofenin for hepatobiliary imaging (IAEA 2018). During the period of breastfeeding interruption, the manufacturer recommends substituting formula for breast milk. Alternatively, women can pump and store breast milk prior to the procedure, which can be bottle-fed (Harding 1995).

Elective diagnostic procedures should be delayed until breastfeeding has stopped (SNM 2010). Women who are breastfeeding and caring for individuals undergoing nuclear medicine procedures do not need any additional precautions (ABM [Mitchell 2019]).

Excretion of technetium Tc 99m into colostrum is widely variable and information is limited; therefore, recommendations related to early breastfeeding cannot be made (Mountford 1989; Rubow 1994).

Mechanism of Action

Radioactive diagnostic agent which decays by isomeric transition to emit a photon that can be detected by imaging

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Detectable in hepatic duct and gallbladder within 10 to 15 minutes and in intestinal tract within 30 to 60 minutes

Half-life elimination: 6.02 hours

Excretion: Urine (1% within 3 hours; 3% within 3 hours in patients with elevated serum bilirubin)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (ES) Spain: Bridatec;
  • (MY) Malaysia: Bridatec
  1. Adelstein SJ. Administered Radionuclides in Pregnancy. Teratology. 1999;59(4):236-239. [PubMed 10331526]
  2. American College of Radiology (ACR), Society for Pediatric Radiology (SPR). ACR–SPR practice parameter for imaging pregnant or potentially pregnant adolescents and women with ionizing radiation (resolution 39). Revised 2018. https://www.acr.org/-/media/ACR/Files/Practice-Parameters/Pregnant-Pts.pdf?la=en. Accessed February 24, 2020.
  3. Balon HR, Brill DR, Fink-Bennett DM, et al. Society of Nuclear Medicine Procedure Guideline for Hepatobiliary Scintigraphy. 2001. http://interactive.snm.org/docs/pg_ch11_0703.pdf. Accessed August 30, 2011.
  4. Choletec (technetium Tc 99m mebrofenin) [prescribing information]. Monroe Township, NJ: Bracco Diagnostics Inc; April 2018.
  5. Harding LK, Bossuyt S, Pellet C, et al. Recommendations for Nuclear Medicine Physicians Regarding Breastfeeding Mothers. Eur J Nucl Med. 1995;22(5)BP17.
  6. International Atomic Energy Agency. IAEA Safety Standards for Protecting People and the Environment: Radiation Protection and Safety in Medical Uses of Ionizing Radiation. Specific Safety Guide No. SSG-46. IAEA; 2018. https://www​.iaea.org​/publications/11102/radiation-protection-and-safety-in-medical-uses-of-ionizing-radiation.
  7. International Commission on Radiological Protection (ICRP). Pregnancy and Medical Radiation. Ann ICRP. 2000;30(1):iii-viii, 1-43. [PubMed 11108925]
  8. Mitchell KB, Fleming MM, Anderson PO, Giesbrandt JG; Academy of Breastfeeding Medicine. ABM Clinical Protocol #31: radiology and nuclear medicine studies in lactating women. Breastfeed Med. 2019;14(5):290‐294. doi:10.1089/bfm.2019.29128.kbm [PubMed 31107104]
  9. Mountford PJ, Coakley AJ. A Review of the Secretion of Radioactivity in Human Breast Milk: Data, Quantitative Analysis and Recommendations. Nucl Med Commun. 1989;10(1):15-27. [PubMed 2645546]
  10. Rubow S, Klopper J, Wasserman H, et al. The Excretion of Radiopharmaceuticals in Human Breast Milk: Additional Data and Dosimetry. Eur J Nucl Med. 1994;21(2):144-153. [PubMed 8162938]
  11. Society of Nuclear medicine (SNM). Society of Nuclear Medicine procedure guideline for general imaging. Version 6.0. Revised 2010. http://s3.amazonaws.com/rdcms-snmmi/files/production/public/docs/General_Imaging_Version_6.0.pdf. Accessed July 22, 2019.
Topic 16814 Version 68.0

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