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Technetium Tc 99m Pentetate (Systemic)

VA CLASSIFICATION
Primary: DX201

Commonly used brand name(s): AN-DTPA; DTPA (Chelate) Multidose; Frosstimage DTPA; TechneScan DTPA; Techneplex.

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



Category:


Diagnostic aid, radioactive (renal disorders; intracranial lesions; cerebrospinal fluid disorders; pulmonary disease)—

Indications

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

Accepted

Renal imaging, radionuclide—Technetium Tc 99m pentetate is indicated as a renal imaging agent to evaluate kidney size, position, configuration, and function, especially in parenchymal disorders. ^{{01} {20} {21} {22} {23} {35} {36} {37}}

Renal perfusion studies—Technetium Tc 99m pentetate is indicated to assess renal perfusion. ^{{01} {20} {21} {22} {23} {35} {36}}

Glomerular filtration rate determination—Technetium Tc 99m pentetate is indicated in excretion studies to estimate glomerular filtration rate (GFR). ^{{01} {12} {20} {21} {22} {23} {31} {35} {36}}

Brain imaging, radionuclide—Technetium Tc 99m pentetate is indicated as a brain imaging agent to detect and evaluate intracranial lesions. Although technetium Tc 99m pentetate is an acceptable brain imaging agent, it is being replaced by computed tomography (CT) and magnetic resonance imaging (MRI). ^{{01} {20} {21} {22} {23} {31} {35} {36}}

[Cisternography, radionuclide]¹—Technetium Tc 99m pentetate is used to evaluate cerebrospinal fluid (CSF) flow through ventriculoperitoneal and lumboperitoneal shunts. ^{{14} {19} {24} {26} {28} {31}}

[Lung imaging, radionuclide]¹—Technetium Tc 99m pentetate administered by inhalation as an aerosol is used to assess airway patency, especially in conjunction with perfusion lung imaging to evaluate pulmonary embolism. ^{{13} {14}}

¹ Not included in Canadian product labeling.

Physical Properties

Nuclear data: ^{{35} {36}}

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 (renal function)—The use of technetium Tc 99m pentetate as a renal imaging agent is based on its clearance through the urinary tract by glomerular filtration. ^{35}

Diagnostic aid (intracranial lesions)—Technetium Tc 99m pentetate normally is prevented by the blood-brain barrier from entering the brain; however, it accumulates by passive diffusion in intracranial lesions that have altered blood-brain barrier. ^{{31} {35}}

Diagnostic aid (CSF flow disorders)—Technetium Tc 99m pentetate, when injected intrathecally or intraventricularly mixes and flows with the CSF. ^{{14} {31}}

Diagnostic aid (pulmonary disease)—Aerosolized droplets of technetium Tc 99m pentetate, when inhaled, distribute and accumulate in patent airways. ^{{13} {14}}

Distribution:

Rapidly distributed in and cleared from plasma following intravenous administration. ^{{01} {31}}

Protein binding:

Very low (variable, 3.7 to 10% if continuously infused). ^{35}

Radiation dosimetry:
^{16}

Organ	Estimated absorbed radiation dose* With intravenous injection
	Normal renal function		Impaired renal function
	mGy/ MBq	rad/ mCi	mGy/ MBq	rad/ mCi
Bladder wall	0.065	0.24	0.022	0.081
Uterus	0.0079	0.029	0.0063	0.023
Kidneys	0.0044	0.016	0.0079	0.029
Ovaries	0.0043	0.016	0.0049	0.018
Large intestine wall (lower)	0.0042	0.016	0.0047	0.017
Testes	0.0028	0.010	0.0033	0.012
Small intestine	0.0026	0.0096	0.0047	0.017
Red marrow	0.0025	0.0093	0.0052	0.019
Large intestine wall (upper)	0.0022	0.0081	0.0044	0.016
Bone surfaces	0.0017	0.0063	0.0044	0.016
Pancreas	0.0015	0.0056	0.0043	0.016
Spleen	0.0014	0.0052	0.0040	0.015
Adrenals	0.0014	0.0052	0.0041	0.015
Stomach wall	0.0013	0.0048	0.0038	0.019
Liver	0.0013	0.0048	0.0038	0.019
Lungs	0.0010	0.0037	0.0033	0.012
Breast	0.00094	0.0035	0.0030	0.011
Thyroid	0.00079	0.0029	0.0025	0.0093
Other tissue	0.0017	0.0063	0.0033	0.012
Radionuclide	Effective dose*
	Normal renal function		Impaired renal function
	mSv/ MBq	rem/ mCi	mSv/ MBq	rem/ mCi
Tc 99m	0.0063	0.034	0.0053	0.020

Organ	Estimated absorbed radiation dose* With intrathecal injection
	Lumbar injection		Cisternal injection
	mGy/ MBq	rad/ mCi	mGy/ MBq	rad/ mCi
Spinal cord	0.046	0.17	0.013	0.048
Red marrow	0.029	0.11	0.0085	0.031
Bladder wall	0.017	0.063	0.010	0.037
Kidneys	0.017	0.063	0.0019	0.0070
Adrenals	0.011	0.041	0.0018	0.0067
Pancreas	0.0093	0.034	0.0012	0.0044
Small intestine	0.0081	0.030	0.00088	0.0033
Bone surfaces	0.0064	0.024	0.0059	0.022
Large intestine wall (upper)	0.0062	0.023	0.00071	0.0026
Ovaries	0.0048	0.018	0.00089	0.0033
Spleen	0.0046	0.017	0.00066	0.0024
Uterus	0.0045	0.017	0.0014	0.0052
Stomach wall	0.0042	0.016	0.00076	0.0028
Liver	0.0038	0.014	0.00060	0.0022
Brain	0.0032	0.012	0.055	0.20
Large intestine wall (lower)	0.0026	0.0096	0.00075	0.0028
Lungs	0.0024	0.0089	0.00086	0.0032
Thyroid	0.0013	0.0048	0.0030	0.011
Testes	0.00089	0.0033	0.00044	0.0016
Breast	0.00065	0.0024	0.00054	0.0020
Other tissue	0.0025	0.0093	0.00086	0.0032

Radionuclide	Effective dose*
	Lumbar injection		Cisternal injection
	mSv/ MBq	rem/ mCi	mSv/ MBq	rem/ mCi
Tc 99m	0.011	0.041	0.0066	0.024

Estimated absorbed radiation dose* With aerosol administration
Organ	mGy/MBq	rad/mCi
Bladder wall	0.047	0.17
Lungs	0.017	0.063
Uterus	0.0059	0.022
Kidneys	0.0041	0.015
Ovaries	0.0033	0.012
Large intestine wall (lower)	0.0032	0.012
Red marrow	0.0027	0.010
Adrenals	0.0021	0.0078
Small intestine	0.0021	0.0078
Pancreas	0.0021	0.0078
Testes	0.0021	0.0078
Bone surfaces	0.0019	0.0070
Breast	0.0019	0.0070
Large intestine wall (upper)	0.0019	0.0070
Liver	0.0019	0.0070
Spleen	0.0019	0.0070
Stomach wall	0.0017	0.0063
Thyroid	0.00099	0.0037
Other tissue	0.0018	0.0067
Effective dose: 0.0070 mSv/MBq (0.026 rem/mCi) *

^* In adults. Data based on the International Commission on Radiological Protection (ICRP) Publication 53—Radiation dose to patients from radiopharmaceuticals. ^{16}

Elimination:
    Renal; about 50% of the intravenously administered activity eliminated in 2 hours and about 95% of the administered activity eliminated within 24 hours. ^{{01} {31}}


Precautions to Consider

Carcinogenicity/Mutagenicity

Long-term animal studies to evaluate carcinogenic or mutagenic potential of technetium Tc 99m pentetate have not been performed. ^{{01} {35} {36}}

Pregnancy/Reproduction

Pregnancy—
Tc 99m (as free pertechnetate) crosses the placenta. However, studies have not been done with technetium Tc 99m pentetate in humans.

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. ^{15}

Studies have not been done in animals.

FDA Pregnancy Category C. ^{{01} {20} {21} {22} {23} {35} {36}}

Breast-feeding

Although it is not known whether technetium Tc 99m pentetate is distributed into breast milk, it is known that Tc 99m as free pertechnetate is distributed into breast milk. ^{{35} {36}} Based on the assumption that the Tc 99m in breast milk is in the form of pertechnetate and based on the effective half-life of the radionuclide in breast milk, the daily volume of milk, a dose factor relating the radionuclide to its critical organ (thyroid) in the nursing infant, and the maximum permissible dose to that organ, a guideline has been proposed. According to this guideline, it has been calculated that nursing can be safely resumed when the concentration in breast milk reaches 30.3 × 10 ^-4 megabecquerels (8.2 × 10 ^-2 microcuries) per mL. This level of activity is probably reached, in the majority of patients, within 24 hours after administration of 740 megabecquerels (20 millicuries) of technetium Tc 99m–labeled radiopharmaceuticals. ^{18}

Pediatrics

Renal studies performed in children from 1 week to 18 years of age have not demonstrated pediatrics-specific problems that would limit the usefulness of technetium Tc 99m pentetate in children. However, there have been no specific studies evaluating the safety and efficacy of technetium Tc 99m pentetate in pediatric patients. When this radiopharmaceutical is used in children, the diagnostic benefit should be judged to outweigh the potential risk of radiation. ^{{05} {15} {31} {32} {33}}


Geriatrics


Appropriate studies on the relationship of age to the effects of technetium Tc 99m pentetate have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Drug interactions and/or related problems
See Diagnostic interference.

Diagnostic interference
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With results of brain imaging

Due to other medications
Corticosteroids, glucocorticoid    (uptake of technetium Tc 99m pentetate in cerebral tumors may be decreased because of reduced peritumor edema caused by the corticosteroids ^{03})

With results of renal imaging

Due to other medications
Captopril or
Enalapril or
Lisinopril    (in patients with renal artery stenosis, use of angiotensin-converting enzyme inhibitors may result in decreased uptake of technetium Tc 99m pentetate by the affected kidney because of a loss of effective trans-membrane filtration pressure; in the diagnosis of renal artery stenosis, this effect has been used to improve the diagnostic accuracy of renal scintigraphy by exaggerating the asymmetry of function between the ischemic and the contralateral kidneys ^{{03} {06} {25}})


Due to medical problems or conditions
Dehydration    (decreased urinary flow may result in poor renal images and/or decreased glomerular filtration rate [GFR])


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).

See also Diagnostic interference.

Risk-benefit must be considered when the following medical problem exists
Sensitivity to the radiopharmaceutical preparation


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

Incidence less frequent or rare
    
Allergic reaction (skin rash, hives, or itching^{01}{35}{36})




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



• Accumulation of radioactive pentetate in intracranial lesions, cerebrospinal fluid (CSF), and in airways (with aerosolized administration)


• Elimination by kidneys via glomerular filtration


Retention of radioactivity in intracranial lesions, CSF, and lungs (when inhaled) and excretion through kidneys allows visualization

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

Before having this test
»   Conditions affecting use, especially:
Sensitivity 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 technetium Tc 99m pentetate is distributed into breast milk, but Tc 99m as free pertechnetate is 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
Adequate intake of fluids and voiding as often as possible for 4 to 6 hours after examination to minimize radiation exposure to bladder


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


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.

Adequate hydration of the patient is recommended before and after examination to promote urinary flow. Also, urination is recommended as often as possible for 4 to 6 hours after the examination to reduce bladder exposure to radiation. ^{{35} {36}}

Manufacturer's package insert or other appropriate literature should be consulted for optimal times when imaging should be performed.

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. ^{34}


Parenteral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

TECHNETIUM Tc 99m PENTETATE INJECTION USP

Usual adult and adolescent administered activity
Renal imaging or
Glomerular filtration rate determination
Intravenous, 111 to 185 megabecquerels (3 to 5 millicuries). ^{{01} {20} {21} {22} {23} {35} {36}}

Brain imaging or
Renal perfusion studies
Intravenous, 370 to 740 megabecquerels (10 to 20 millicuries). ^{{01} {20} {21} {22} {23} {35} {36}}

[Cisternography—CSF imaging, ventriculoperitoneal shunt]¹
Intraventricular, 37 megabecquerels (1 millicurie) injected into the reservoir of the shunt system. ^{26}

[Lung imaging]¹
Inhalation, 18.5 to 37 megabecquerels (0.5 to 1 millicurie). ^{{14} {31}}


Usual pediatric administered activity
Renal imaging or
Glomerular filtration rate determination
Intravenous, 37 to 185 megabecquerels (1 to 5 millicuries). ^{27}

[Cisternography]¹
[CFS imaging, ventriculoperitoneal shunt]¹: Intraventricular, 7.4 to 37 megabecquerels (0.2 to 1 millicurie) injected into the reservoir of the shunt system. ^{{27} {28}}
[CSF imaging, shunt]¹—Lumbar subarachnoid injection, 11.1 to 37 megabecquerels (0.3 to 1 millicurie). ^{{28} {31}}


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

Strength(s) usually available
U.S.—


5 mg pentetate pentasodium and 0.17 mg (minimum) stannous chloride (in a lyophilized form and under a nitrogen atmosphere), per 10-mL multidose reaction vial (Rx) [DTPA (Chelate) Multidose] [Techneplex^{35}{36}]


20.6 mg pentetate calcium trisodium, 0.15 mg minimum stannous tin as stannous chloride dihydrate, and 0.30 mg maximum total tin as stannous chloride dihydrate (in a lyophilized form and under a nitrogen atmosphere), per 10-mL multidose reaction vial (Rx) [AN-DTPA^{20}]


25 mg pentetate calcium trisodium, 0.25 mg minimum stannous tin as stannous chloride dihydrate, and 0.385 mg maximum total tin as stannous chloride dihydrate (in a lyophilized form and under a nitrogen atmosphere), per 10-mL multidose reaction vial (Rx) [TechneScan DTPA^{23}]

Canada—


25 mg pentetate calcium trisodium, 0.25 mg minimum stannous tin as stannous chloride dihydrate, and 0.385 mg maximum total tin as stannous chloride dihydrate (in a lyophilized form and under a nitrogen atmosphere), per 10-mL multidose reaction vial (Rx) [Frosstimage DTPA]

Packaging and storage:
Store between 2 and 8 °C (36 and 46 °F). Protect from freezing. ^{30}

Note: Before reconstitution, kit may be stored at room temperature. ^{{35} {36}}


Preparation of dosage form:
To prepare injection, an oxidant-free sodium pertechnetate Tc 99m solution is used. ^{{35} {36}} See manufacturer's package insert for instructions.

Stability:
For brain and renal imaging—Injection should be administered within 6 hours after preparation. ^{{35} {36}}

For glomerular filtration rate determination—Injection should be administered within 1 hour after preparation. ^{{35} {36}}

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. ^{{35} {36}}

Note: Caution—Radioactive material.

Revised: 04/30/1996

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. MPI DTPA kit package insert (Medi-Physics—US), Rev 5/87.
   

2. Thomas SR, Atkins HL, McAfee JG, et al. MIRD Dose Estimate Report No. 12: radiation absorbed dose from Tc-99m Diethylenetriaminepentaacetic acid (DTPA). J Nucl Med 1984; 25: 503-5.
   

3. Hladik WB, Saha GB, Study KT. Essentials of nuclear medicine science. Baltimore: Williams & Wilkins, 1987: 198.
   

4. Chilton HM, Witcofski RL. Nuclear pharmacy—an introduction to the clinical application of radiopharmaceuticals. Philadelphia: Lea & Febiger, 1986.
   

5. Shore RM, Koff SA, Menster M, et al. Glomerular filtration rate in children: determination from the Tc 99m-DTPA renogram. Radiology 1984; 151: 627-33.
   

6. Geyskes GG, Oei HY, Puylaert CB, et al. Renography with captopril. Changes in a patient with hypertension and unilateral renal artery stenosis. Arch Intern Med 1986 Sept; 146: 1705-8.
   

7. MPI DTPA package insert (Medi-Physics—US), Rev 09/88.
   

8. Technetium 99m DTPA package insert (MSD—US), Rev 10/88.
   

9. Techneplex package insert (Bristol-Myers Squibb—US), Rev 10/88.
   

10. Mountford 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: 1108-10.
    

11. Smith T, Zanelli GD, Veall N. Radiation absorbed dose from technetium-99m DTPA. J Nucl Med 1987; 28: 240-3.
    

12. Waller DG, Keast CM, Fleming JS, et al. Measurement of glomerular filtration rate with technetium-99m DTPA: comparison of plasma clearance techniques. J Nucl Med 1987; 28(3): 372-7.
    

13. Reviewer's responses to monograph revision of 3/87.
    

14. Reviewer's responses to monograph revision of 10/88.
    

15. Radiopharmaceuticals Advisory Panel Meeting, 5/8/91.
    

16. 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: 188, 190, 218.
    

17. Swanson DP, Chilton HM, Thrall JH, editors. Pharmaceuticals in medical imaging. New York: Macmillan Publishing Company, 1990: 448-9.
    

18. Radiopharmaceuticals Advisory Panel Meeting, 1/88.
    

19. Radiopharmaceuticals Advisory Panel Meeting, 8/4/92.
    

20. AN-DTPA package insert (CIS-US—US), Rev 10/88.
    

21. Frosstimage DTPA package insert (Frosst—Canada), Rev 4/90.
    

22. MPI DTPA package insert (Medi-Physics—US), Rev 2/91.
    

23. TechneScan DTPA package insert (Mallinckrodt—US), Rev 9/89.
    

24. Lewis DH, Graham MM. Benefit of tomography in the scintigraphic localization of cerebrospinal fluid leak. J Nucl Med 1991; 32: 2149-51.
    

25. Mann SJ, Pickering TG, Sos TA, et al. Captopril renography in the diagnosis of renal artery stenosis: accuracy and limitations. Am J Med 1991; 90: 30-40.
    

26. Bergstrand G, Larsson S, Bergström M, et al. Cerebrospinal fluid circulation: evaluation by single-photon and positron emission tomography. Am J Neuroradiol 1983; 4(3): 557-9.
    

27. Pediatric dosages submitted by the Radiopharmaceuticals Advisory Panel, 8/92.
    

28. Sty JR, Starshak RJ, Miller JH. Pediatric nuclear medicine. Connecticut: Appleton-Century-Crofts, 1983: 83-120.
    

29. Treves ST. Pediatric nuclear medicine. New York: Springer-Verlag, 1985: 223-31.
    

30. The United States pharmacopeia. The national formulary. USP 23rd revision (January 1, 1995). NF 18th ed (January 1, 1995). Rockville, MD: The United States Pharmacopeial Convention, Inc., 1995.
    

31. Reviewers' responses to monograph revision of 11/20/92.
    

32. Stakianakis GN. Nuclear medicine in pediatric urology and nephrology. J Nucl Med 1988; 29: 1287-300.
    

33. Ash JM, Antico VF, Gilday DL, et al. Special considerations in the pediatric use of radionuclide for kidney studies. Semin Nucl Med 1982; 12(4): 345-69.
    

34. Reviewers' responses to Radiopharmaceuticals panel ballot of 5/11/94.
    

35. DTPA(Chelate) Multidose package insert (Medi-Physics Amersham—US), Rev 4/95, Rec 11/95.
    

36. Techneplex package insert (Bracco—US), Rev 6/95, Rec 11/95.
    

37. Blaufox MD. Procedures of choice in renal nuclear medicine. J Nucl Med 1991; 32: 1301-9.
    

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