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Technetium Tc-99m aggregated albumin: Drug information

Technetium Tc-99m aggregated albumin: Drug information
(For additional information see "Technetium Tc-99m aggregated albumin: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Draximage MAA;
  • Pulmotech MAA
Pharmacologic Category
  • Radiopharmaceutical
Dosing: Adult
Lung Imaging

Lung Imaging: IV (based on 70 kg patient): 1 to 4 mCi (37 to 148 MBq)

Peritoneovenous shunt patency evaluation

Peritoneovenous shunt patency evaluation:

Intraperitoneal injection (based on 70 kg patient): 1 to 3 mCi (37 to 111 MBq)

Percutaneous transtubal injection (based on 70 kg patient): 0.3 to 1 mCi (12 to 37 MBq); volume not to exceed 0.5 mL

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: Pediatric

(For additional information see "Technetium Tc-99m aggregated albumin: Pediatric drug information")

Lung imaging

Lung imaging: Note: Dosing ranges provided; the number of particles will vary with age and weight.

Infants, Children, and Adolescents: IV: 25 to 50 μCi/kg (0.925 to 1.85 MBq/kg); usual dose: 30 μCi/kg (1.11 MBq/kg).

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

Adverse Reactions

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

Postmarketing:

Hypersensitivity: Hypersensitivity reaction (including anaphylaxis)

Local: Injection-site reaction

Contraindications

Hypersensitivity (eg, anaphylaxis) to albumin; patients with severe pulmonary hypertension.

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Acute hypersensitivity reactions, including anaphylaxis, may occur; emergency treatment should be immediately available.

Disease-related concerns:

• Cor pulmonale: Use may be hazardous in patients with cor pulmonale or other conditions of severely impaired pulmonary blood flow due to interruption of blood flow.

• Heart shunts: In patients with right-to-left heart shunts, mechanical impediment of blood flow may occur due to an increased risk of rapid albumin aggregation into systemic circulation; administer the lowest possible number of particles in patients with right-to-left heart shunts.

• Pulmonary hypertension: Deaths have been reported after administration in patients with severe pulmonary hypertension; emergency treatment should be immediately available. Administer the lowest possible number of particles in patients with severe pulmonary hypertension.

Special populations:

• Neonates: The lowest possible number of particles should be used in right-to-left shunting and in severe pulmonary disease.

Special handling:

• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and health care 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: Patients should be adequately hydrated prior to dosing; instruct patients to void frequently following administration to decrease radiation exposure to the bladder.

Dosage Forms: US

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

Injection, powder for reconstitution [kit]:

Draximage MAA: Aggregated albumin 2.5 mg per vial (30s) [contains human albumin; vial contents to be combined with sodium pertechnetate Tc 99m injection solution (not included)]

Pulmotech MAA: Aggregated albumin 2 mg per vial (5s, 30s) [contains human albumin; vial contents to be combined with sodium pertechnetate Tc 99m injection solution (not included)]

Generic Equivalent Available: US

No

Administration: Adult

IV: Not for direct IV injection; only reconstituted technetium Tc 99m albumin aggregated may be administered IV. Ensure adequate hydration before and after administration; void frequently to minimize radiation exposure. See manufacturer’s prescribing information for complete administration procedure.

Radiopharmaceutical; use appropriate precautions for handling and disposal. Use waterproof gloves and effective radiation shielding when handling.

Administration: Pediatric

Radiopharmaceutical; use appropriate precautions for handling and disposal. Use waterproof gloves and effective radiation shielding when handling.

Parenteral: IV: Contents of kit are used to prepare technetium Tc 99m albumin aggregated and are not for direct IV injection; only reconstituted technetium Tc 99m albumin aggregated may be administered IV. Mix contents of dosing syringe by gentle inversion immediately prior to injection. Administer by slow IV injection. Imaging may begin immediately following injection. See manufacturer's labeling for complete administration procedure.

Use: Labeled Indications

Imaging agent: Lung imaging agent which may be used as an adjunct in the evaluation of pulmonary perfusion in adult and pediatric patients; imaging agent to aid in the evaluation of peritoneovenous (LeVeen) shunt patency in adults.

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 present in breast milk.

The manufacturer recommends lactating women interrupt breastfeeding for a period of 13 hours after receiving Tc99m albumin aggregated. During this time, women can continue to express milk. This milk can either be discarded or stored under refrigeration for later use when radioactivity is no longer present (~60 hours) (ABM [Mitchell 2019]; IAEA 2018). Patients can pump and store breast milk prior to the procedure, which can be bottle-fed during the period of interruption (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).

Monitoring Parameters

Assess for history or signs of pulmonary hypertension; signs and symptoms of hypersensitivity.

Mechanism of Action

The aggregated particles are formed by denaturation of Human Albumin in a heating and aggregation process.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Immediate.

Distribution: Pulmonary alveolar capillary bed (80%).

Metabolism: Decays by isomeric transition.

Half-life elimination: Lungs: 2 to 3 hours (Draximage MAA); 10.8 hours (range: 6.9 to 19 hours) (Pulmotech MAA).

Excretion: Urine (20% after 24 hours).

  1. Adelstein SJ. Administered radionuclides in pregnancy. Teratology. 1999;59(4):236-239. doi:10.1002/(SICI)1096-9926(199904)59:4<236::AID-TERA9>3.0.CO;2-6 [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. Draximage MAA (technetium Tc 99m albumin aggregated) [prescribing information]. Kirkland, Quebec, Canada: Jubilant DraxImage Inc; December 2023.
  4. Harding LK, Bossuyt S, Pellet C, et al. Recommendations for nuclear medicine physicians regarding breastfeeding mothers. Eur J Nucl Med. 1995;22(5)BP17.
  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. doi:10.1016/s0146-6453(00)00037-3 [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. doi:10.1097/00006231-198901000-00003 [PubMed 2645546]
  9. Pulmotech MAA (technetium Tc 99m albumin aggregated) [prescribing information]. Maryland Heights, MO: Curium US LLC; August 2023.
  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.
  11. 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. doi:10.1007/BF00175762 [PubMed 8162938]
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