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Technetium Tc-99m bicisate: Drug information

Technetium Tc-99m bicisate: Drug information
For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Neurolite
Pharmacologic Category
  • Radiopharmaceutical
Dosing: Adult
Imaging

Imaging (localization of stroke; adjunct to CT or MRI): IV (based on 70 kg patient): 10 to 30 mCi (370 to 1,110 MBq) as a single dose. Measure dose by a suitable radioactivity calibration system immediately prior to administration.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution (primarily excreted by the kidney).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

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%:

Cardiovascular: Angina pectoris, cardiac failure, hypertension, syncope

Central nervous system: Agitation, altered sense of smell, anxiety, dizziness, drowsiness, hallucination, headache, malaise, seizure

Dermatologic: Skin rash

Gastrointestinal: Nausea

Respiratory: Apnea, cyanosis

Frequency not defined: Abnormal serum calcium, phosphate imbalance

Contraindications

There are no contraindications listed in the manufacturer’s labeling.

Warnings/Precautions

Disease-related concerns:

• Renal impairment: Primarily excreted by the kidney; use with caution in patients with renal impairment.

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: Instruct patients to void frequently for 2 to 6 hours after the completion of the injection; encourage adequate hydration to facilitate frequent voiding.

Dosage Forms: US

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

Kit, for Injection:

Neurolite: Bicisate dihydrochloride 0.9 mg per vial (2s, 5s) [to be combined with sodium pertechnetate Tc99m injection solution (not included)]

Generic Equivalent Available: US

No

Administration: Adult

IV: For IV administration. Ensure adequate hydration prior to administration and encourage patient to drink fluids following administration. To minimize bladder exposure, patients should void frequently, especially during the 2 to 6 hours following administration.

Radiopharmaceutical; use appropriate precautions for handling and disposal.

Use: Labeled Indications

Imaging agent: Adjunct to conventional CT or MRI imaging in localization of stroke in patients in whom stroke has been diagnosed

Limitations of use: Not indicated for assessment of functional viability of brain tissue and not indicated for distinguishing between stroke and other brain lesions

Medication Safety Issues
Other safety concerns:

Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and health care 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 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 present in breast milk.

Available guidelines recommend lactating women interrupt breastfeeding for a period of 4 hours after receiving technetium Tc 99m bicisate (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: 10 minutes

Duration of Action: 6 hours

Distribution: Distributes to brain

Metabolism: Metabolized by endogenous enzymes to the mono- and di-acids of Technetium Tc99m bicisate

Time to peak: 30-60 minutes

Excretion: Urine (74% after 24 hours); feces (12.5% after 48 hours)

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

  • (FR) France: Neurolite;
  • (JP) Japan: Neurolite;
  • (PT) Portugal: Neurolite
  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. Harding LK, Bossuyt S, Pellet C, et al. Recommendations for nuclear medicine physicians regarding breastfeeding mothers. Eur J Nucl Med. 1995;22(5):BP17.
  4. 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.
  5. International Commission on Radiological Protection (ICRP). Pregnancy and medical radiation. Ann ICRP. 2000;30(1):iii-viii, 1-43. doi:10.1016/s0146-6453(00)00037-3 [PubMed 11108925]
  6. 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]
  7. Mountford PJ and 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]
  8. Neurolite (technetium Tc 99m bicisate) [prescribing information]. N Billerica, MA: Lantheus Medical Imaging; July 2019.
  9. 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]
  10. 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 93715 Version 53.0

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