Technetium Tc 99m Albumin Aggregated (Systemic )


VA CLASSIFICATION
Primary: DX201

Commonly used brand name(s): AN-MAA; Frosstimage MAA; MPI MAA; Macrotec; Pulmolite; TechneScan MAA.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Diagnostic aid, radioactive (pulmonary disease; vascular disorders)—

Chemotherapy adjunct—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Lung imaging, radionuclide—Technetium Tc 99m albumin aggregated is indicated in adult and pediatric patients as a lung imaging agent to be used as an adjunct in the assessment of regional lung perfusion, primarily to screen for pulmonary emboli. It is also useful in the evaluation of the status of pulmonary circulation in such conditions as pulmonary neoplasm, pulmonary tuberculosis, and emphysema. {01} {02} {16} {18} {19}

Venography, radionuclide—Technetium Tc 99m albumin aggregated is indicated to visualize specific regions of the vascular system and the blood flow in such areas, primarily to localize deep venous thrombosis in the lower extremities. Combined radionuclide venography of the lower extremities and pulmonary perfusion imaging may be performed with technetium Tc 99m albumin aggregated. {01} {05} {19} {21}

LeVeen peritoneovenous shunt patency assessment1—Intraperitoneal technetium Tc 99m albumin aggregated is indicated in adults to determine the patency of a peritoneovenous shunt in patients with ascites. The appearance of lung activity is used as the criterion for shunt patency. {01} {05} {08} {09} {17} {18}

[Chemotherapy, intra-arterial, infusion adjunct]1—Technetium Tc 99m albumin aggregated is used as an adjunct to intra-arterial chemotherapy infusion for neoplasms (e.g., hepatic tumors) to assess blood flow, to evaluate catheter placement and tumor perfusion, and to visualize the area of distribution of the infused chemotherapeutic agent. {10} {11}

1 Not included in Canadian product labeling.



Physical Properties

Nuclear data:



Radionuclide
(half-life)
Decay
constant
Mode
of
decay
Principal
photon
emissions
(keV)
Mean
number of
emissions/
disintegration
(³0.01)
Tc 99m
(6.0 hr)
0.1151 h -1
Isomeric
transition to
Tc 99
Gamma
(18)
0.062
Gamma
(140.5)
0.891


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Diagnostic aid (pulmonary disease)—The intravenously injected albumin particles labeled with technetium Tc 99m are temporarily trapped by the capillary bed of the lungs, making it possible to obtain an image of patent blood flow distribution within lungs. {01} {02} {16} {21}


Diagnostic aid (vascular disorders)—After injection into the dorsal pedal veins, technetium Tc 99m–labeled albumin particles are transported by the blood flow to the lungs where they are trapped in the capillary bed. However, if lower extremity venous thrombosis or obstruction is present, the albumin particles show retention and/or abnormal movement (delayed or collateral flow) in the peripheral veins. {21}


LeVeen peritoneovenous shunt patency assessment—After intraperitoneal injection, clearance of technetium Tc 99m albumin aggregated from the peritoneal cavity may be insignificant, which occurs with peritoneovenous shunt blockage, or it may be very rapid, as with subsequent transfer into the systemic circulation when the shunt is patent. Visualization of radioactivity in lungs indicates shunt patency. {01} {08} {09} {21}


Intra-arterial chemotherapy, infusion adjunct—Albumin particles labeled with technetium Tc 99m infused through an intra-arterial catheter directly into the arterial supply of a neoplasm (or of the organ containing the neoplasm), at the same rate at which the chemotherapeutic agent is to be delivered, are trapped in the capillary bed allowing visualization of the perfusion pattern. {21}


Absorption:

80 to 90% of the technetium Tc 99m albumin aggregated particles are trapped in the arterioles and capillaries of the lung during the first circulatory transit through the lungs after intravenous injection. {01} {17} {21}

Distribution:

Dependent on particle size—Particles > 10 to 15 microns: Trapped in pulmonary arterioles and capillaries. {17}

Distribution of particles in the lungs is dependent on regional pulmonary blood flow. {01} {17}


Half-life:

Biological elimination (from lungs)—Approximately 1 to 10 hours. {17} {21}

Radiation dosimetry:


Estimated absorbed radiation dose*
Organ
mGy/MBq
rad/mCi
Lungs
0.067
0.25
Liver
0.016
0.059
Bladder wall
0.010
0.037
Adrenals
0.0058
0.021
Pancreas
0.0058
0.021
Breast
0.0056
0.021
Red marrow
0.0044
0.016
Spleen
0.0044
0.016
Stomach wall
0.0040
0.015
Kidneys
0.0037
0.014
Bone surfaces
0.0035
0.013
Uterus
0.0024
0.0089
Large intestine
wall (upper)

0.0022

0.0081
Small intestine
0.0021
0.0078
Thyroid
0.0020
0.0074
Ovaries
0.0018
0.0067
Large intestine
wall (lower)

0.0016

0.0059
Testes
0.0011
0.0041
Other tissue
0.0029
0.011
Effective dose: 0.012 mSv/MBq (0.044 rem/mCi)
* For adults; intravenous injection. Data based on the International Commission on Radiological Protection (ICRP) Publication 53— Radiation dose to patients from radiopharmaceuticals. {15}

Elimination:
    Renal, 40 to 75% of injected technetium Tc 99m eliminated within 24 hours. {01}


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to human serum albumin products may be sensitive to this radiopharmaceutical also. {01} {14}

Carcinogenicity/Mutagenicity

Long-term animal studies to evaluate carcinogenic or mutagenic potential of technetium Tc 99m albumin aggregated have not been performed.

Pregnancy/Reproduction

Pregnancy—
Tc 99m (as free pertechnetate) crosses the placenta. Studies have not been done in humans with technetium Tc 99m albumin aggregated.

The possibility of pregnancy should be assessed in women of child-bearing potential. Clinical situations exist where the benefit to the patient and fetus, based on information derived from radiopharmaceutical use, outweighs the risks from fetal exposure to radiation. In these situations, the physician should use discretion and reduce the radiopharmaceutical dose to the lowest possible amount. {12}

Studies have not been done in animals.

FDA Pregnancy Category C. {17} {18}

Breast-feeding

Although it is not known whether technetium Tc 99m albumin aggregated is distributed into breast milk, it is known that Tc 99m as free pertechnetate is distributed into breast milk. It has been estimated that, without discontinuation of breast-feeding, the radiation dose to the breast-fed infant will be less than 20 mrems after the mother receives a 4-millicurie dose of technetium Tc 99m albumin aggregated, assuming that all of the radioactive dose is in the form of Tc 99m pertechentate. Because of the potential risk to the infant from radiation exposure, temporary discontinuation of nursing is recommended for 6 to 12 hours. {07} {16} {21} {22} {23} {24} {25}

Pediatrics

Although appropriate studies have not been performed in the pediatric population, the number of particles administered should be reduced to the lowest possible level (£ 50,000 particles for newborns, £ 165,000 particles for 1 year-old infants) in these patients since the pulmonary capillary beds in children do not develop fully for several years after birth. {01} {05} {16} {17} {21}


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problem exists:
» Pulmonary hypertension, severe    (deaths associated with administration of aggregated albumin have been reported {01} {14})


Risk-benefit should be considered when the following medical problems exist
Cardiac shunt, right-to-left    (may increase risk because of rapid entry of aggregated albumin into the systemic circulation; it is recommended that the number of particles administered be reduced to 60,000 to 125,000 particles {01} {14} {21})


Cor pulmonale, acute or
Other states of severely impaired pulmonary blood flow    (aggregated albumin may cause further impairment of blood flow; it is recommended that the number of particles administered be reduced to 125,000 particles or less {01} {14} {21})


» Sensitivity to human serum albumin or to the radiopharmaceutical preparation


Side/Adverse Effects

Note: There are reports of hemodynamic or idiosyncratic reactions associated with the administration of technetium Tc 99m albumin aggregated.
As with any protein-containing preparation, allergic reactions are possible with the use of technetium Tc 99m albumin aggregated.

The following side/adverse effects have been selected on the basis of their potential clinical significance and/or frequency of occurrence (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent or rare
    
Cyanosis (bluish discoloration of skin)
    
wheezing, tightness in chest, or troubled breathing
Note: Wheezing, tightness in chest, or troubled breathing may be initial manifestations of more severe respiratory distress. {01}





Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Flushing or redness of face

Incidence less frequent
    
Increased sweating
    
nausea





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Radiopharmaceuticals (Diagnostic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Description of use
Action in the body: Radioactive albumin particles temporarily trapped in capillaries of lungs

Tracing of radioactivity demonstrates the distribution of blood flow in lungs

Small amounts of radioactivity used in diagnosis; radiation received is low and considered safe

Before having this test
»   Conditions affecting use, especially:
Sensitivity to albumin products or to the radiopharmaceutical preparation

Pregnancy—Technetium Tc 99m (as free pertechnetate) crosses placenta; risk to fetus from radiation exposure as opposed to benefit derived from use should be considered





Breast-feeding—Not known if distributed into breast milk; temporary discontinuation of nursing may be recommended because of risk to infant from radiation exposure





Use in children—Risk from radiation exposure as opposed to benefit derived from use should be considered


Preparation for this test
Special preparatory instructions may be given; patient should inquire in advance

Precautions after having this test
No special precautions


Side/adverse effects
Signs of potential side effects, especially allergic reaction or respiratory distress


General Dosing Information
Radiopharmaceuticals are to be administered only by or under the supervision of physicians who have had extensive training in the safe use and handling of radioactive materials and who are authorized by the Nuclear Regulatory Commission (NRC) or the appropriate Agreement State agency if required, or, outside the U.S., the appropriate authority.

Technetium Tc 99m albumin aggregated should be administered by slow intravenous injection with the patient in a recumbent position. During injection, the aspiration of blood into the syringe should be avoided since this can cause the formation of blood clots (containing the radioactive material) in the syringe, which may result in focal areas of increased radioactivity later on during lung imaging. {01} {16} {18} {19} {21}

125,000 to 2,000,000 particles of aggregated albumin should be administered to adults per dosage. {16} {21}

Pediatric dosages must contain significantly fewer particles than adult dosages since the pulmonary capillary beds in pediatric patients are not as developed. It has been suggested that if 500,000 particles are considered safe in an adult, a newborn should not receive more than 50,000 particles, and a one-year-old no more than 165,000 particles. {16} {17}

Epinephrine, antihistamines, and corticosteroid agents should be available during the administration of technetium Tc 99m albumin aggregated because of the possibility of allergic reactions.

For lung imaging, it is recommended that the patient be positioned under the imaging apparatus before administration of technetium Tc 99m albumin aggregated and that imaging begin immediately after injection. {19}

Safety considerations for handling this radiopharmaceutical
Improper handling of this radiopharmaceutical may cause radioactive contamination. Guidelines for handling radioactive material have been prepared by scientific, professional, state, federal, and international bodies and are available to the specially qualified and authorized users who have access to radiopharmaceuticals. {26}


Parenteral Dosage Forms

TECHNETIUM Tc 99m ALBUMIN AGGREGATED INJECTION USP

Usual adult and adolescent administered activity
Lung imaging
Intravenous, 37 to 148 megabecquerels (1 to 4 millicuries). {01} {17} {19}

Venography
Intravenous, 74 to 148 megabecquerels (2 to 4 millicuries) per extremity. {01}

LeVeen shunt patency1
Intraperitoneal, 37 to 111 megabecquerels (1 to 3 millicuries). {01}

Percutaneous transtubal, 12 to 37 megabecquerels (0.3 to 1 millicurie) in a volume not to exceed 0.5 mL. {01}


Note: The lowest possible number of particles per dosage (60,000 to 125,000) should be administered to patients with right-to-left cardiac shunt or with states of severely impaired pulmonary blood flow. {21}


Usual pediatric administered activity
Lung imaging
Intravenous, 0.925 to 1.85 megabecquerels (25 to 50 microcuries) per kg of body weight. {01} {17}

Note: In newborns, the total dosage should be at least 7.4 megabecquerels (200 microcuries). {01} {17} {21}



Usual geriatric administered activity
See Usual adult and adolescent administered activity .

Strength(s) usually available
U.S.—


0.11 mg albumin aggregated, 0.09 mg stannous tartrate, and 0.3 mL isotonic saline, per reaction vial (Rx)[Generic]


1.0 mg albumin aggregated, 10.0 mg albumin human, 0.02 mg stannous chloride, 0.12 mg total tin, 10 mg sodium chloride, with 3.6 to 6.5 × 10 6 particles, per 10-mL reaction vial (Rx) [Pulmolite]


1.5 mg albumin aggregated, 10.0 mg albumin human, 0.07 mg stannous chloride, 0.19 mg total tin, 1.8 mg sodium chloride, with 1.0 to 8.0 × 10 6 particles, per 5-mL reaction vial (Rx) [Macrotec]


2.0 mg albumin aggregated, 0.5 mg albumin human, 0.12 mg stannous chloride, 80 mg lactose, 24 mg succinic acid, and 1.4 mg sodium acetate, with 8±4 × 10 6 particles, per 10-mL reaction vial (Rx) [TechneScan MAA]


2.0 mg albumin aggregated, 0.16 mg stannous chloride, and 17 mg sodium chloride, with 6.8±0.8 × 10 6 particles, per reaction vial (Rx) [AN-MAA]


2.5 mg albumin aggregated, 5.0 mg albumin human, 0.06 mg stannous chloride, and 1.2 mg sodium chloride, with 4.0 to 8.0 × 10 6 particles, per 10-mL reaction vial (Rx) [MPI MAA][Generic]

Canada—


2.5 mg albumin aggregated, 5.0 mg albumin human, 0.1 mg stannous chloride (dihydrate), and 1.2 mg sodium chloride, with 4.0 to 8.0 × 10 6 particles, per 10-mL reaction vial (Rx) [Frosstimage MAA]

Packaging and storage:
Store between 2 and 8 °C (36 and 46 °F). Protect from freezing.

Preparation of dosage form:
To prepare injection, an oxidant-free sodium pertechnetate Tc 99m solution is used. See manufacturer's package insert for instructions.

Stability:
Preparations in which clumping or foaming of contents are observed should not be used.

Injection should be administered within 3, 6, or 8 hours after preparation, depending on product used.

Incompatibilities:
If oxidants such as peroxides and hypochlorites are present in the sodium pertechnetate Tc 99m used for labeling, the final preparation may be adversely affected and should be discarded.

Note: Caution—Radioactive material.
Agitate gently before using.




Revised: 08/02/1994



References

Note: All references used in the development and earlier revisions of this monograph have not yet been incorporated into the computer database and, therefore, are not listed below. Citations for information not yet referenced in the monograph will be provided upon request.

  1. Macrotec package insert (Squibb—US), Rev 3/87; Technetium Tc 99m MAA (Medi-Physics—US), Rev 7/87.
  1. Chilton HM, Witcofski RL. Nuclear pharmacy—An introduction to the clinical application of radiopharmaceuticals. Philadelphia: Lea & Febiger, 1986: 127.
  1. Fleeger CA, editor. USAN and USP dictionary of drug names. Rockville, MD, 1993: 617.
  1. MIRD Pamphlet No. 10.
  1. Panelist comments.
  1. MIRD Pamphlet No. 11.
  1. USP Radiopharmaceutical Advisory Panel (as per 1/88 meeting).
  1. Algeo JH, Powell M, Couacaud J. LeVeen shunt visualization without function using technetium 99m macroaggregated albumin. Clin Nucl Med 1987; 12(9): 741-3.
  1. Stewart CA, Sakimura IT, Applebaum DM, et al. Evaluation of peritoneovenous shunt patency by intraperitoneal Tc-99m macroaggregated albumin—clinical experience. AJR 1986; 147(1): 177-80.
  1. JAMA 1983; 250(7): 941.
  1. AJR Oct 1983: 139.
  1. Hladik WB, Saha GB, Study KT. Essentials of nuclear medicine science. Baltimore: Williams & Wilkins, 1987: 26, 29, 30 120, 415.
  1. Mountford PJ, Coakley AJ. A review of the secretion of radioactivity in human breast milk: data, quantitative analysis and recommendations 1989; Nucl Med Commun 10: 15-27.
  1. MPI MAA package insert (Medi-Physics—US), Rev 02/89.
  1. Task Group of Committee 2 of the International Commission on Radiological Protection. Annals of the ICRP. ICRP Publication 53—Radiation dose to patients from radiopharmaceuticals. New York: Pergamon Press, 1988: 223-4.
  1. Swanson DP, Chilton HM, Thrall JH, editors. Pharmaceuticals in medical imaging. New York: Macmillan Publishing Company, 1990: 394-401.
  1. MPI MAA Kit package insert (Medi-Physics—US), Rev 10/90.
  1. TechneScan MAA package insert (Mallinckrodt—US), Rev 1/91.
  1. Frosstimage MAA Kit package insert (Frosst—Canada).
  1. USP Radiopharmaceuticals Panel meeting on 08/04/92.
  1. Reviewers' comments per monograph revision of 11/02/92.
  1. Rose MR, Prescott MC, Herman KJ. Excretion of iodine-123-hippuran, technetium-99m-red blood cells and technetium-99m-macroaggregated albumin into breast milk. J Nucl Med 1990; 31(6): 978-84.
  1. Ahlgren L, Ivarsson S, Johansson L, et al. Excretion of radionuclides in human breast milk after the administration of radiopharmaceuticals. J Nucl Med 1985; 26(9): 1085-90.
  1. Mountform PJ, Hall FM, Wells CP, et al. Breast-milk radioactivity after a Tc-99m DTPA aerosol/Tc-99m MAA lung study. J Nucl Med 1984; 25(10): 1108-10.
  1. Cranage R, Palmer M. Breast-milk radioactivity after Tc 99m-MAA lung studies. Eur J Nucl Med 1985; 11(6-7): 257-9.
  1. Reviewers' responses to Ballot of 5/11/94.
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