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Technetium Tc-99m gluceptate (United States: Not available): Drug information

Technetium Tc-99m gluceptate (United States: Not available): Drug information
(For additional information see "Technetium Tc-99m gluceptate (United States: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • Draximage Gluceptate
Pharmacologic Category
  • Radiopharmaceutical
Dosing: Adult
Blood pool imaging

Blood pool imaging: IV: Stannous gluceptate complex: 0.03 mL/kg (16 micrograms Sn/kg) administered 10 to 30 minutes prior to 15 to 25 mCi (555 to 925 MBq) of sodium pertechnetate Tc 99m.

Brain imaging

Brain imaging: IV (based on 70 kg patient): 15 to 20 mCi (555 to 740 MBq).

Renal imaging

Renal imaging: IV (based on 70 kg patient): 10 to 15 mCi (370 to 555 MBq).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

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

<1%, postmarketing and/or case reports: Allergic dermatitis, dyspnea, erythema, flushing, hypersensitivity, nausea, pruritus, skin rash, vomiting

Contraindications

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

Warnings/Precautions

Disease-related concerns:

• Renal impairment: Patients with renal disease may have delayed elimination, therefore decreasing quality of images.

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: Blood pool imaging: Ensure patient is in stable cardiac condition prior to administering. Have resuscitative equipment readily available. If an imaging procedure with sodium pertechnetate Tc 99m is anticipated, that exam should be conducted prior to the use of stannous gluceptate or >1 week after the use of sodium pertechnetate Tc 99m.

• Appropriate use: Brain/kidney imaging: Patients should be adequately hydrated prior to and after dosing; instruct patients to void frequently for 4 to 6 hours following administration to decrease radiation exposure to the bladder.

Product Availability

Not available in the US

Dosage Forms: Canada

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

Kit, Intravenous:

Draximage Gluceptate: Calcium gluceptate 25 mg per vial (5s) [to be combined with sodium pertechnetate Tc99m injection solution (not included)]

Administration: Adult

IV: For IV administration. Radiopharmaceutical; use appropriate precautions for handling and disposal.

Blood pool imaging: Administer stannous gluceptate 10 to 30 minutes prior to injection of sodium pertechnetate Tc 99m by direct venipuncture; avoid heparinized catheter systems.

Brain/kidney imaging: Patients should be adequately hydrated prior to dosing; instruct patients to void frequently for 4 to 6 hours following administration to decrease radiation exposure to the bladder. Imaging may begin immediately after injection.

Use: Labeled Indications

Imaging agent: Brain imaging agent used for evaluation of brain perfusion; kidney imaging agent used for evaluation of renal perfusion; cardiac blood pool 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).

The manufacturer recommends elective studies be conducted during the first 10 days of the menstrual cycle in women of reproductive potential.

Pregnancy Considerations

Technetium Tc 99m can be detected in fetal tissue; the amount depends upon 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 excreted into breast milk.

In a case report, a breastfeeding mother was administered technetium Tc 99m glucoheptonate 550 mBq IV 1 month after delivery. Peak activity in the breast milk was detected 3 hours after the injection and the calculated effective dose (0.085 mSv) was low enough that an interruption of breastfeeding would not have been necessary (Mountford 1987).

Although the manufacturer recommends that breastfeeding be discontinued, available guidelines do not require interruption of breastfeeding following maternal use of technetium Tc 99m gluceptate for renal perfusion studies (ABM [Mitchell 2019]).

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)

Blood pool imaging: Excretion: Urine (~28% after 24 hours); delayed in patients with ischemic heart disease.

Brain/kidney imaging: Excretion: Urine (~70% after 24 hours); delayed in patients with renal impairment.

  1. American College of Radiology (ACR) and Society for Pediatric Radiology (SPR). ACR-SPR Practice Guideline for the Performance of Adult and Pediatric Renal Scintigraphy. 2014. http://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/Renal_Scintigraphy.pdf
  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. Adelstein SJ. Administered Radionuclides in Pregnancy. Teratology. 1999;59(4):236-239. [PubMed 10331526]
  4. Draximage Gluceptate (technetium Tc 99m gluceptate) [product monograph]. Kirkland, Quebec, Canada: Jubilant DraxImage Inc; May 2015.
  5. 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.
  6. International Commission on Radiological Protection (ICRP). Pregnancy and Medical Radiation. Ann ICRP. 2000;30(1):iii-viii, 1-43. [PubMed 11108925]
  7. 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]
  8. 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]
  9. Mountford PJ, Coakley AJ. Breast Milk Radioactivity Following Injection of 99Tcm-Pertechnetate and 99Tcm-Glucoheptonate. Nucl Med Commun. 1987;8(10):839-845. [PubMed 2829070]
  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 16812 Version 60.0

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