Ceretec

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.
• You will need to empty your bladder often after the test is over as your doctor has told you. Talk with your doctor.
• Drink lots of noncaffeine liquids after using Ceretec unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

Rash with generalized erythema, facial edema and fever has been reported in less than 1% of patients. A transient increase in blood pressure was seen in 8% of patients.

Summary of Use during Lactation

Information in this record refers to the use of technetium Tc 99m exametazime (Tc 99m-hexamethylpropyleneamine oxime; Tc 99m HPAO; Tc 99m HMPAO) as a diagnostic agent. Breastfeeding need not be interrupted after administration of technetium Tc 99m exametazime in doses up to 500 MBq (15 mCi) to a nursing mother.[1][2][3][4] However, to follow the principle of keeping exposure "as low as reasonably achievable", some experts recommend nursing the infant just before administration of the radiopharmaceutical and interrupting breastfeeding for 3 to 6 hours after the dose, then expressing the milk completely once and discarding it. If the mother has expressed and saved milk prior to the examination, she can feed it to the infant during the period of nursing interruption.[3][5][6] Mothers need not refrain from close contact with their infants after usual clinical doses.[1]

Mothers concerned about the level of radioactivity in their milk could ask to have it tested at a nuclear medicine facility at their hospital. When the radioactivity is at a safe level she may resume breastfeeding. A method for measuring milk radioactivity and determining the time when a mother can safely resume breastfeeding has been published.[7]

Drug Levels

Tc 99m is a gamma emitter with a principal photon energy of 140.5 keV and a physical half-life of 6.024 hours.[8] The effective half-life of technetium Tc 99m exametazime leukocytes is 7.5 hours, and 0.11% of the administered dose appears in breastmilk.[9]

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1. Mountford PJ, O'Doherty MJ. Exposure of critical groups to nuclear medicine patients. Appl Radiat Isot. 1999;50:89-111. PMID: 10028630

2. Marshall DSC, Newberry NR, Ryan PJ. Measurement of the secretion of technetium-99m hexamethylpropylene amine oxime into breast milk. Eur J Nucl Med. 1996;23:1634-5. PMID: 8929318

3. Administration of Radioactive Substances Advisory Committee. Notes for guidance on the clinical administration of radiopharmaceuticals and use of sealed radioactive sources. 2006;25-7. http://www.arsac.org.uk

4. Mattsson S, Johansson L, Leide Svegborn S et al. Radiation dose to patients from radiopharmaceuticals: A compendium of current information related to frequently used substances. Annex D. Recommendations on breast-feeding interruptions. Ann ICRP. 2015;44 (2 Suppl):319-21. PMID: 26069086

5. Mountford PJ, Coakley AJ. A review of the secretion of radioactivity in human breast milk: data, quantitative analysis and recommendations. Nucl Med Commun. 1989;10:15-27. PMID: 2645546

6. Early PJ, Sodee DB. Principles and practice of nuclear medicine. 2nd ed. St. Louis. Mosby-Year Book, Inc. 1995:1380-1.

7. Stabin MG, Breitz HB. Breast milk excretion of radiopharmaceuticals: mechanisms, findings, and radiation dosimetry. J Nucl Med. 2000;41:863-73. PMID: 10809203

8. Howe DB, Beardsley M, Bakhsh S. Appendix U. Model procedure for release of patients or human research subjects administered radioactive materials. In, NUREG-1556. Consolidated guidance about materials licenses. Program-specific guidance about medical use licenses. Final report. U.S. Nuclear Regulatory Commission Office of Nuclear Material Safety and Safeguards. 2008;9, Rev. 2. http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v9/r2/

9. Leide-Svegborn S, Ahlgren L, Johansson L et al. Excretion of radionuclides in human breast milk after nuclear medicine examinations. Biokinetic and dosimetric data and recommendations on breastfeeding interruption. Eur J Nucl Med Mol Imaging. 2016;43:808-21. PMID: 26732471

Technetium Tc 99 Exametazime Preparation

Contents of vial are sterile and pyrogen free; vial contains no bacteriostatic preservative; follow the directions carefully and adhere to strict aseptic procedures during preparation of the radiopharmaceutical; see full prescribing information for detailed instructions

0.37 – 2 GBq (10 - 54 mCi) technetium Tc99m may be added to the vial

Before reconstitution the technetium Tc99m generator eluate may be adjusted to the correct radioactive concentration to a volume of 5 mL by dilution with preservative-free, nonbacteriostatic 0.9% sodium chloride for injection

Use only eluate from a technetium Tc99m generator which was previously eluted within 24 hr; generator eluate >2 hr old should not be used; for the highest radiochemical purity reconstitute with freshly eluted technetium Tc99m generator eluate

Radiochemical purity testing must be performed prior to patient administration; radiochemical purity >80% is necessary for product acceptance

Do not use the final radiopharmaceutical preparation more than 30 minutes after the time of reconstitution; discard any unused material

Ceretec preparation

• When reconstituting a vial of Ceretec with 31-54 mCi, generator eluate more than 30 minutes old should not be used
• Do not use methylene blue stabilizer for leukocyte labeling procedure

Administration for Leukocyte Labeled Scintigraphy

Use strict aseptic procedures throughout preparation and handling

Visually inspect reconstituted technetium Tc 99m exametazime solution for particulate matter and discoloration prior to radiolabeling of white blood cells

Do not use the reconstituted solution if there is evidence of particulate matter or discoloration

Follow the directions of drug preparation carefully to ensure efficient leukocytes labeling

Measure patient dose with a suitable radioactivity calibration system immediately prior to administration

Instruct patients to hydrate, after administration of technetium Tc 99m exametazime labeled white blood cells and void frequently to minimize radiation dose to the kidneys and bladder

Storage for All Formulations

Unopened kit

• Store in original packaging at controlled room temperature 15-25°C (59-77°F)

Reconstituted product

• Store reconstituted injection at 20-25°C (68-77°F) using appropriate radiation shielding
• Expiration of radiolabeled product
  • Ceretec with methylene blue stabilizer: 4 hr post-preparation
  • Ceretec without methylene blue stabilizer: 30 minutes post-preparation Drax Exemestane: 4 hr post-preparation