Professional Drug Information > Indium DTPA In 111

Indium In 111 Pentetate (Systemic)

VA CLASSIFICATION
Primary: DX201

Commonly used brand name(s): Indium DTPA In 111.

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

^†Not commercially available in Canada.

Category:


Diagnostic aid, radioactive (cerebrospinal fluid flow disorders)—

Indications

Accepted

Cisternography, radionuclide—Indium In 111 pentetate ( ¹¹¹In-DTPA) is indicated as an imaging agent in cisternography to study the flow of cerebrospinal fluid (CSF) in the brain, to diagnose abnormalities in CSF circulation, to assess and help localize the site of CSF leakage, and to test the patency of or localize blocks in CSF shunts. ^{{01} {02} {03} {08} {10} {11} {12} {15} {20} {23}}
—Also, cisternography with ¹¹¹In-DTPA is used in the diagnosis and classification of hydrocephalus, especially normal pressure hydrocephalus, and in the evaluation of obstructive hydrocephalus. ^{08}
—¹¹¹In-DTPA cisternography is useful to detect, localize, and quantify CSF rhinorrhea, especially when the CSF leaks are small, intermittent, or questionable. ^{{13} {14} {18} {21}}
—In preterm infants with hydrocephalus, lumbar cisternography using ¹¹¹In-DTPA helps to evaluate CSF dynamics and the patency of the cerebral ventricular system. ^{{16} {17}}


Physical Properties

Nuclear data: ^{23}

Radionuclide (half-life)	Mode of decay	Principal photon emissions (keV)	Mean number of emissions/ disintegration
In 111 (2.83 days)	Electron capture	Gamma (171.3)	0.90
		Gamma (245.4)	0.94

Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

The use of indium In 111 pentetate ( ¹¹¹In-DTPA) in radionuclide cisternography is based on its distribution. When administered intrathecally, this agent diffuses to the basal, sylvian, and cerebral cisterns and subarachnoid space around the convexity of the brain; it is then absorbed via the subarachnoid granulations into the bloodstream. Since this transit can be followed by means of external imaging, any deviations from the normal pattern can be detected. Significant abnormalities may be manifest as delayed or non-appearance of the agent in the subarachnoid space around the convexity of the brain or as reflux of the agent into the cerebral ventricles. The site of CSF leakage may be identified by an abnormal collection of activity. When ¹¹¹ In-DTPA is used to test the patency of CSF shunts (e.g., ventriculoperitoneal), absent or markedly diminished accumulation in and transit through the shunt tubing is an indication of obstruction. ^{{01} {02} {20} {23}}

Distribution:

Diffuses to the basal, sylvian, and cerebral cisterns and subarachnoid space around the convexity of the brain, and is subsequently absorbed into the bloodstream. ^{{01} {23}}

Time to radioactivity visualization

Basal cisterns—2 to 4 hours. ^{23}

Subarachnoid space around the convexity of the brain—24 hours (in patients with no significant abnormalities). ^{{01} {23}}

Radiation dosimetry:
^{09}

Organ	Estimated absorbed radiation dose *
	Lumbar injection		Cisternal injection
	mGy/ MBq	rad/ mCi	mGy/ MBq	rad/ mCi
Spinal cord	0.95	3.51	0.57	2.10
Red marrow	0.24	0.88	0.14	0.52
Bladder wall	0.20	0.74	0.18	0.67
Adrenals	0.16	0.59	0.065	0.24
Bone surfaces	0.072	0.27	0.076	0.28
Small intestine	0.060	0.22	0.023	0.085
Large intestine (upper)	0.047	0.17	0.019	0.070
Uterus	0.044	0.16	0.029	0.11
Spleen	0.040	0.15	0.019	0.070
Stomach wall	0.040	0.15	0.027	0.10
Ovaries	0.039	0.14	0.020	0.074
Liver	0.036	0.13	0.017	0.063
Lungs	0.033	0.12	0.022	0.081
Large intestine (lower)	0.024	0.089	0.015	0.056
Thyroid	0.021	0.078	0.039	0.14
Testes	0.011	0.040	0.0085	0.031
Breast	0.010	0.037	0.0096	0.035
Other tissue	0.027	0.10	0.017	0.063

Radionuclide and impurities	Effective dose*
	Lumbar injection		Cisternal injection
	mSv/ MBq	rem/ mCi	mSv/ MBq	rem/ mCi
In 111	0.14	0.52	0.12	0.44
In 114m †	1.8	6.67	2.1	7.78

^* For adults. Data based on the International Commission on Radiological Protection (ICRP) Publication 53—Radiation dose to patients from radiopharmaceuticals.
^† Impurity. Radionuclidic purity at calibration time is at least 99.88% with less than 0.06% indium In 114m and 0.06% zinc Zn 65. The concentration of each radionuclidic contaminant changes with time. ^{{21} {23}}

Elimination:
    Renal; about 65% of the injected activity eliminated within 24 hours in normal subjects. ^{{01} {20} {21} {23}}


Precautions to Consider

Carcinogenicity/Mutagenicity

Long-term animal studies to evaluate carcinogenic or mutagenic potential of indium In 111 pentetate ( ¹¹¹In-DTPA) have not been performed. ^{23}

Pregnancy/Reproduction

Pregnancy—
Indium In 111 crosses the placenta. However, studies have not been done in humans with ¹¹¹In-DTPA. ^{23}

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. ^{07}

Studies have not been done in animals. ^{23}

FDA Pregnancy Category C. ^{{01} {23}}

Breast-feeding

It is not known whether indium In 111 is distributed into breast milk. ^{23} Because of the potential risk to the infant from radiation exposure, temporary discontinuation of nursing is recommended for a length of time that may be assessed by measuring the activity of breast milk and estimating the radiation exposure to the infant ^{{05} {21}}.

Pediatrics

Although ¹¹¹In-DTPA is used in children, there have been no specific studies evaluating safety and efficacy of ¹¹¹In-DTPA in pediatric patients. ^{23} When this radiopharmaceutical is used in children, the diagnostic benefit should be judged to outweigh the potential risk of radiation. ^{05}


Geriatrics


Appropriate studies on the relationship of age to the effects of ¹¹¹In-DTPA have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interfere with the diagnostic imaging.

Acetazolamide    (inhibition of carbonic anhydrase by acetazolamide may decrease the rate of cerebrospinal fluid [CSF] production by the choroid plexus, thus altering CSF kinetics; may result in a false-positive cisternogram ^{04})


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).


Risk-benefit should be considered when the following medical problems exist
Renal function impairment, severe    (elimination of the agent may be delayed or impaired ^{{01} {23}})


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:

Those indicating need for medical attention
Incidence rare
    
Aseptic meningitis (severe drowsiness; fever; severe headache; continuing loss of appetite; nausea; vomiting)





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: Distribution mimics that of cerebrospinal fluid ^{20}

Transit of agent may be visualized by external imaging

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—¹¹¹In-DTPA may cross 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 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


Side/adverse effects
Signs of potential side effects, especially aseptic meningitis


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 the appropriate Federal or State agency, if required, or, outside the U.S., the appropriate authority. ^{23}

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. ^{22}


Parenteral Dosage Forms

INDIUM In 111 PENTETATE INJECTION USP

Usual adult and adolescent administered activity
Cisternography
Intrathecal, 18.5 megabecquerels (500 microcuries). ^{23}


Usual pediatric administered activity
Dosage must be individualized by physician.

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

Strength(s) usually available
U.S.—


37 megabecquerels (1 millicurie) per mL (total activity, 55.5 megabecquerels [1.5 millicuries] per single-dose vial) at calibration time (Rx) [Indium DTPA In 111^{23}]

Canada—
Not commercially available.

Packaging and storage:
Store between 5 and 30 °C (41 and 86 °F), unless otherwise specified by manufacturer. ^{23}

Stability:
Do not use if contents are turbid. ^{23}

Injection should be administered within 7 days after the calibration date. ^{23}

Discard after single use. ^{23}

Note: Caution—Radioactive material.

Revised: 04/30/1996

References

1. MPI Indium DTPA In 111 package insert (Medi-Physics—US), Rev 5/83.
   

2. Indium In 111 pentetate (Medi-Physics). In: PDR Physicians' desk reference for radiology and nuclear medicine. 7th ed. 1977-78: 43.
   

3. Reviewers' responses to monograph revision of 5/2/84.
   

4. Hladik WB, Saha GB, Study KT. Essentials of nuclear medicine science. Baltimore: Williams & Wilkins, 1987: 202.
   

5. USP Radiopharmaceuticals Advisory Panel meeting, 1/88.
   

6. Schichia H, Voth E, Emrich D. Detection of occult and intermittent rhinorrhea using ¹¹¹In-DTPA. Eur J Nucl Med 1985; 11: 76-9.
   

7. USP Radiopharmaceuticals Advisory Panel meeting, 5/91.
   

8. Maisey MN, Britton KE, Gilday DL. Clinical nuclear medicine. 2nd ed. Philadelphia: J.B. Lippincott, 1991: 413.
   

9. 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: 238.
   

10. Jeffery PJ, Sostre S, Scherer LR, et al. Bowel visualization during indium-111-labelled diethylene triamine penta-acetic cisternography due to massive cerebrospinal fluid leak. Case report and review of the literature. Eur J Nucl Med 1990; 17(6-8): 365-8.
    

11. Zubi SM, Kirkwood R, Abbasy M, et al. Intestinal activity visualized on radionuclide cisternography in patients with cerebrospinal fluid leak. J Nucl Med 1991; 32(1): 151-3.
    

12. Wolbers JG, van Halderen P, van Lingen A, et al. Quantitative radioisotope cisternography for the investigation of CSF circulation in the posterior fossa and basal cisterns—a preliminary report. Neurosurgery 1986; 9(1–2): 125-8.
    

13. Glaubitt D, Haubrich J, Cordoni-Voutsas M. Detection and quantitation of intermittent CSF rhinorrhea during prolonged cisternography with ¹¹¹In-DTPA. Am J Neuroradiol 1983; 4(3): 560-3.
    

14. Bret P, Hor F, Huppert J, et al. Treatment of cerebrospinal fluid rhinorrhea by percutaneous lumboperitoneal shunting: review of 15 cases. Neurosurgery 1985; 16(1): 44-7.
    

15. Maeda T, Ishida H, Matsuda H, et al. The utility of radionuclide myelography and cisternography in the progress of cerebrospinal fluid leaks. Eur J Nucl Med 1984; 9(9): 416-8.
    

16. Keyes JW Jr, Donn SM, Roloff DW, et al. Radionuclide cisternography in the preterm neonate. Clin Nucl Med 1983; 8(10): 465-8.
    

17. Donn SM, Roloff DW, Keyes JW Jr. Lumbar cisternography in evaluation of hydrocephalus in the preterm infant. Pediatrics 1983; 72(5): 670-6.
    

18. Park JI, Strelzow VV, Friedman WH. Current management of cerebrospinal fluid rhinorrhea. Laryngoscope 1983; 93(10): 1294-1300.
    

19. Fukuyama H, Kawamura J. Radioisotope cisternography in acute viral encephalitis. A reappraisal. Arch Neurol 1982; 39(5): 293-7.
    

20. Reviewers' responses to monograph revision of 5/18/92.
    

21. Swanson DP, Chilton HM, Thrall JH, editors. Pharmaceuticals in medical imaging. New York: Macmillan Publishing Company, 1990: 331-5.
    

22. Reviewers' responses to Ballot of 5/11/94.
    

23. Indium DTPA In 111 package insert (Medi-Physics Amersham—US), Rev 7/94, Rec 11/95.
    

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