Professional Drug Information > TechneScan MAG3

Technetium Tc 99m Mertiatide (Systemic)

VA CLASSIFICATION
Primary: DX201

Commonly used brand name(s): TechneScan MAG3.

Other names commonly used are
technetium Tc 99m mercaptoacetyltriglycine and MAG3 . ^{{04} {05}}
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Diagnostic aid, radioactive (renal disorders)—

Indications

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

Accepted

Renal imaging, radionuclide or
Renal function studies—Technetium Tc 99m mertiatide is indicated as a renal imaging agent to assess renal perfusion, size, position, configuration, function (including differential renal function), upper urinary tract obstruction, and [active urinoma] ^{{01} {06} {08} {09} {11} {25} {26} {41}}. Technetium Tc 99m mertiatide scintigraphy provides renal images and renogram curves for the whole kidney and renal cortex ^{{29} {42}}.
—In renal transplant patients, technetium Tc 99m mertiatide scintigraphy helps in the follow-up evaluation by providing anatomical information as well as functional analysis of the kidney ^{{29} {36}}. In diuretic radionuclide renography, technetium Tc 99m mertiatide provides useful information in the evaluation of obstructive uropathy ^{{38} {39} {40}}. Also, angiotensin-converting enzyme (ACE) inhibitors–augmented renography using technetium Tc 99m mertiatide allows the detection of physiologically significant renal artery stenosis and helps in the differential diagnosis of renovascular hypertension ^{{32} {33} {34} {42}}.
—Technetium Tc 99m mertiatide is used as an indirect measurement of effective renal plasma flow ^{{11} {32} {42} {44} {45}}.

[Cystography, voiding, indirect, radionuclide] or
[Urinary bladder imaging, radionuclide]—Technetium Tc 99m mertiatide can be used following renal imaging for assessment of vesico-ureteral reflux. ^{26}


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)	0.061
			Gamma (140.5)	0.891

Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

The use of technetium Tc 99m mertiatide as a renal imaging agent is based on its clearance through the urinary tract predominantly via active tubular secretion (almost exclusively by the proximal renal tubules) ^{{30} {32}} and to a small extent by glomerular filtration ^{{01} {13} {25} {32}}. The rate of appearance and excretion and the concentration of technetium Tc 99m mertiatide in the kidney can be monitored to assess renal function ^{{29} {42}}.

Distribution:

Rapidly distributed in and cleared from plasma ^{{01} {08} {19}}. However, when compared to iodohippurate sodium I 131 (OIH ¹³¹), another renal imaging agent, technetium Tc 99m mertiatide has a significantly slower plasma clearance (50 to 65% of the clearance of OIH ¹³¹) ^{32}.

Protein binding:

High (70 to 90%), but reversible ^{{01} {06} {20} {25} {29} {32}}.

Radiation dosimetry:
^{35}

Organ	Estimated absorbed radiation dose * †
	With normal renal function		With impaired renal function
	mGy/ MBq	rad/ mCi	mGy/ MBq	rad/ mCi
Uterus	0.012	0.044	0.01	0.037
Large intestine (lower)	0.0057	0.021	0.0051	0.019
Ovaries	0.0054	0.02	0.0049	0.018
Testes	0.0037	0.014	0.0034	0.013
Kidneys	0.0034	0.013	0.014	0.052
Small intestine	0.0023	0.0085	0.0027	0.01
Large intestine (upper)	0.0017	0.0063	0.0022	0.0081
Muscles	0.0014	0.0052	0.0017	0.0063
Bone surfaces	0.0013	0.0048	0.0022	0.0081
Red marrow	0.00093	0.0034	0.0015	0.0056
Gall bladder	0.00057	0.0021	0.0016	0.0059
Skin	0.00046	0.0017	0.00078	0.0029
Pancreas	0.0004	0.0015	0.0015	0.0056
Stomach	0.00039	0.0014	0.0027	0.01
Adrenals	0.00039	0.0014	0.0016	0.0059
Spleen	0.00036	0.0013	0.0015	0.0056
Liver	0.00031	0.0011	0.0014	0.0052
Heart	0.00018	0.00067	0.00091	0.0034
Lungs	0.00015	0.00056	0.00079	0.0029
Esophagus	0.00013	0.00048	0.00074	0.0027
Thymus	0.00013	0.00048	0.00074	0.0027
Thyroid	0.00013	0.00048	0.00073	0.0027
Bladder	0.00011	0.00041	0.083	0.031
Brain	0.0001	0.00037	0.00061	0.0023
Breast	0.0001	0.00037	0.00054	0.002
Remaining organs	0.0013	0.0048	0.0017	0.0063
Effective dose	0.0073 mSv/MBq	0.027 rem/mCi	0.0063 mSv/MBq	0.023 rem/mCi

^* For adults; intravenous administration.
^† Data based on the International Commission on Radiological Protection (ICRP) Publication 53—Radiation dose to patients from radiopharmaceuticals ^{35}.

Elimination:
    Renal (70% of the administered activity in the first 30 minutes, and about 90% of the administered activity in 3 hours) ^{{01} {11} {30} {32}}. Minimal hepatobiliary elimination (approximately 3% of the administered activity) in normal patients. Hepatobiliary elimination may be increased (approximately 10% of the administered activity) in patients with severe renal function impairment ^{{04} {32} {42}}.

Note: The relatively higher extraction fraction (40 to 50%) of technetium Tc 99m mertiatide often provides superior images in patients with impaired renal function compared to technetium Tc 99m pentetate, another renal imaging agent, which has a lower extraction fraction (20%) ^{{30} {36} {37} {42}}.



Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Tc 99m (as free pertechnetate) crosses the placenta. Studies to assess transplacental transfer of technetium Tc 99m mertiatide have not been done in humans ^{{01} {43}}.

The possibility of pregnancy should be assessed in women of child-bearing potential. Clinical situations exist in which the benefit to the patient and fetus from information derived from radiopharmaceutical use outweigh the risks from radiation exposure to the fetus. In this situation, the physician should use discretion and reduce the radiopharmaceutical dose to the lowest possible amount consistent with image quality needs ^{26}.

The patient should be maximally hydrated, and encouraged to urinate frequently. ^{26}

Studies have not been done in animals. ^{01}

FDA Pregnancy Category C ^{29}.

Breast-feeding

Although it is not known whether technetium Tc 99m mertiatide is distributed into breast milk, it is known that Tc 99m as free pertechnetate is distributed into breast milk. To avoid unnecessary irradiation of the infant, discontinuation of nursing for a period of 24 hours is recommended after administration of technetium Tc 99m–labeled radiopharmaceuticals ^{{01} {24} {25} {26} {42}}.

Pediatrics

Safety and efficacy have not been established in children up to 30 days of age ^{29}. However, appropriate studies performed to date in older children have not demonstrated pediatrics-specific problems that would limit the usefulness of technetium Tc 99m mertiatide in children ^{{41} {43}}.


Geriatrics


Appropriate studies performed to date have demonstrated a significant decrease in renal clearance of technetium Tc 99m mertiatide in geriatric patients when compared to younger adults ^{31}.

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 this test

Due to medical problems or conditions
Dehydration    (decreased urinary flow may result in a pattern that mimics decreased urine production and/or obstruction ^{25})


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 should 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 ^{29}(skin rash or itching, wheezing or troubled breathing)^{01}
    
increased blood pressure^{29}
    
seizures ^{29}(convulsions)
    
tachycardia ^{29}(fast or pounding heartbeat)


Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent or rare
    
Chills^{29}
    
fever^{29}
    
nausea^{29}
    
vomiting^{29}





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: Concentration of radioactive mertiatide in kidneys

Excretion of radioactivity in urine allows visualization and evaluation of renal function

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 study 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—Safety and efficacy have not been established in children up to 30 days of age


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 bladder exposure to radiation


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 radionuclides and who are licensed by the Nuclear Regulatory Commission (NRC) or the appropriate Agreement State agency 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 ^{{01} {30}}.

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
Guidelines for the receipt, storage, handling, dispensing, and disposal of radioactive materials are available from scientific, professional, state, federal, and international bodies. Handling of this radiopharmaceutical should be limited to those individuals who are appropriately qualified and authorized ^{43}.


Parenteral Dosage Forms

TECHNETIUM Tc 99m MERTIATIDE INJECTION USP

Usual adult and adolescent administered activity
Renal imaging or
Renal function studies
Intravenous, 185 to 370 megabecquerels (5 to 10 millicuries) ^{{01} {29}}.


Usual pediatric administered activity
Renal imaging or
Renal function studies
Children up to 30 days of age: Safety and efficacy have not been established ^{29}.
Children 30 days of age and over: Intravenous, 2.6 to 5.2 megabecquerels (70 to 140 microcuries) per kilogram of body weight, with a minimum administered activity of 37 megabecquerels (1 millicurie) ^{29}.


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

Strength(s) usually available
U.S.—


1 mg betiatide (precursor to mertiatide, thiobenzoic acid, S-ester with mercaptoacetyltriglycine), 0.05 mg (minimum) stannous chloride dihydrate, and 0.2 mg (maximum) total tin expressed as stannous chloride dihydrate, 40 mg sodium tartrate dihydrate, and 20 mg lactose monohydrate in lyophilized form under argon atmosphere, per 10-mL reaction vial (Rx) [TechneScan MAG3^{01}{29}]

Canada—


1 mg betiatide (precursor to mertiatide, thiobenzoic acid, S-ester with mercaptoacetyltriglycine), 0.05 mg (minimum) stannous chloride dihydrate, and 0.2 mg (maximum) total tin expressed as stannous chloride dihydrate, 40 mg sodium tartrate dihydrate, and 20 mg lactose monohydrate in lyophilized form under argon atmosphere, per 10-mL reaction vial (Rx) [TechneScan MAG3^{42}]

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F). Protect from freezing. ^{01}

Note: Before reconstitution, protect kit from light. ^{01}


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:
Product is stable; package insert states that injection must be used within 6 hours after preparation. ^{{01} {05} {26} {29} {32}}

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.

Revised: 07/23/1996

References

1. TechneScan MAG3 package insert (Mallinckrodt—US) Rev 6/90.
   

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

3. Hladik WB, Saha GB, Study KT. Essentials of nuclear medicine science. Baltimore: Williams & Wilkins, 1987: 198, 218.
   

4. Bannister KM, Penglis S, Bellen JC, et al. Kit preparation of technetium-99-mercaptoacetyltriglycine. J Nucl Med 1990; 31(9): 1568-73.
   

5. Millar AM, Wilkinson AG, McAteer E, et al. 99Tcm-MAG3: in vitro stability and in vivo behavior at different times after preparation. Nucl Med Commun 1990; 11(6): 405-12.
   

6. Bubeck B, Brandau W, Weber E, et al. Pharmacokinetics of technetium-99m-MAG3 in humans. J Nucl Med 1990; 31(8): 1285-93.
   

7. Millar AM, O'Brien LM. An investigation of factors that might influence the radiochemical purity and stability of 99mTc-MAG3. Eur J Nucl Med 1990; 16(8-10): 615-9.
   

8. Taylor A Jr, Ziffer JA, Eshima D. Comparison of Tc-99m MAG3 and Tc-99m DTPA in renal transplant patient with impaired renal function. Clin Nucl Med 1990; 15(6): 371-8.
   

9. Fraile M, Castell J, Buxeda M, et al. Transplant renography: 99m-Tc-MAG3. A preliminary note. Eur J Nucl Med 1989; 15(12): 776-9.
   

10. Llamas-Elvira JM, Martinez-Paredes M, Jimenez-Hefferman A, et al. 99mTc-MAG3 for quantitation of differential renal function. Nucl Med Commun 1989: 10(10): 759-64.
    

11. Eshima D, Fritzberg AR, Taylor A Jr. ^99mTc renal tubular function agents: current status. Semin Nucl Med 1990; 20(1): 28-40.
    

12. Russell CD, Taylor A, Eshima D. Estimation of technetium-99m-MAG3 plasma clearance in adults from one or two blood samples. J Nucl Med 1989; 30(12): 1955-9.
    

13. Russell CD, Thorsad BL, Stutzman ME, et al. The kidney: imaging with Tc-99m mercaptoacetyltriglycine, a technetium-lableled analog of iodohippurate. Radiology 1989; 172(2): 427-30.
    

14. Abdel-Dayem HM, Sadek S, al-Bahar R, et al. Comparison of 99mTc-mercaptoacetyltriglycine and 131I-orthoiodohippurate in determination of effective renal plasma flow (ERPF). Nucl Med Commun 1989; 10(2): 99-107.
    

15. Taylor A Jr, Ziffer JA, Steves A, et al. Clinical comparison of I-131 orthoiodohippurate and the kit formulation of Tc-99m mercaptoacetyltriglycine. Radiology 1989; 170(3 Pt 1): 721-5.
    

16. Al-Nahhas AA, Jafri RA, Britton KE, et al. Clinical experience with 99mTc-MAG3, mercaptoacetyltriglycine, and a comparison with 99mTc-DTPA. Eur J Nucl Med 1988; 14(9-10): 453-62.
    

17. Russell CD, Thorsad BL, Yester MV, et al. Quantitation of renal function with technetium-99m MAG3. J Nucl Med 1988; 29(12): 1931-3.
    

18. Taylor A Jr, Eshima D. Effects of altered physiologic states on clearance and biodistribution of technetium-99m MAG3, iodine-131 OIH and iodine-125 iothalamate. J Nucl Med 1988; 29(5): 669-75.
    

19. Taylor A Jr, Eshima D, Christian PE, et al. Technetium-99m MAG3 kit formulation: preliminary results in normal volunteers and patients with renal failure. J Nucl Med 1988; 29(5): 616-22.
    

20. Bubeck B, Brandau W, Steinbacher M, et al. Technetium-99m labeled renal function and imaging agents: Clinical evaluation of 99mTc MAG3 (99mTc mercaptoacetylglycylglycine). Int J Rad Appl Instrum [B] 1988; 15(1): 109-18.
    

21. Lee HB, Blaufox MD. Technetium-99m MAG-3 clearance after captopril in experimental renovascular hypertension. J Nucl Med 1989; 30(5): 666-71.
    

22. Hvid-Jacobsen K, Thomsen HS, Nielsen SL. Diuresis renography. A simultaneous comparison between 131I-hippuran and 99mTc-MAG3. Acta Radiol 1990; 31(1): 83-6.
    

23. Romney BM, Nickoloff EL. Diagnostic nuclear medicine and the nursing mother. App Radiol May 1987.
    

24. USP Radiopharmaceuticals Advisory Panel comments.
    

25. Reviewers' responses to monograph revision of 01/91.
    

26. Radiopharmaceuticals Advisory Panel Meeting, 05/08/91.
    

27. Reviewers' responses to Ballot, 5/11/94.
    

28. The United State 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 (Third supplement, 1995): 2984.
    

29. TechneScan MAG3 package insert (Mallinckrodt—US), Rev 11/92, Rec 6/95.
    

30. Taylor A Jr. Radiopharmaceuticals, quantitation of renal function, analysis of the renogram and obstructive uropathy. Emory University School of Medicine. Presented at the Nuclear Medicine Update, Georgia, 7/95.
    

31. Klingesmith WC, Briggs DE, Smith WI. Technetium-99m-MAG3 renal studies: normal range and reproducibility of physiologic parameters as a function of age and sex. J Nucl Med 1994; 35(10): 1612-7.
    

32. Eshima D, Taylor A Jr. Technetium-99m mercaptoacetyltriglycine: update on the new Tc 99m renal tubular function agent. Semin Nucl Med 1992; 22(2): 61-73
    

33. Dondi M, Monetti N, Fanti S, et al. Use of technetium-Tc99m-MAG3 for renal scintigraphy after angiotensin-converting-enzyme inhibition. J Nucl Med 1991; 32: 424-8.
    

34. Datseris IE, Bomanji JB, Brown EA, et al. Captopril renal scintigraphy in patients with hypertension and chronic renal failure. J Nucl Med 1994; 35(2): 251-4.
    

35. Task Group of Committee 2 of the International Commission on Radiological Protection. Annals of the ICRP. ICRP Publication 53, Addendum 1—Radiation dose to patients from radiopharmaceuticals. New York: Pergamon Press, 1992: 16-8.
    

36. Schapp GH, Alferink THR, de Jong RBJ, et al. Tc-99m MAG3: dynamic studies in patients with renal disease. Eur J Nucl Med 1988; 14: 28-31.
    

37. Volkmann R, Friberg P, Jakobsson L, et al. Single-kidney Tc-99m mercaptoacetyltriglycerid extraction and clearance as compared with para-aminohippurate. In: O'Reilly P, Taylor A, Nally JV, editors. Radionuclides in Nephrourology, Vol 1. Pennsylvania: Field and Wood, 1994.
    

38. Conway JJ. Well-tempered diuresis renography: its historical development, physiological and technical pitfalls, and standarized technique protocol. Semin Nucl Med 1992; 22: 74-84.
    

39. O'Reilly PH. Diuresis renography: recent advances and recommended protocols. Br J Urol 1992; 69: 113-20.
    

40. McBiles M II, Lambert AT, Cote MG, et al. Diuretic scintirenography: past, present, and future. In: Freeman LM, editor. Nuclear Medicine Annual. New York: Raven Press, 1995.
    

41. Gordon I, Anderson PJ, Lythgoe MF, et al. Can technetium-99m-mercaptotiacetyltriglycine replace technetium-99m dimercaptosuccinic acid in the exclusion of focal renal defect? J Nucl Med 1992 Dec; 33(12): 2090-3.
    

42. Reviewers' responses to monograph revision of 10/95.
    

43. Radiopharmaceuticals Advisory Panel Meeting, 4/10/96.
    

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45. Fresco, GF, DiGiorgio F, Curti GL. Simultaneous estimation of glomerular filtration rate and renal plasma flow. J Nucl Med 1995; 36: 1701–6
    

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