Iodohippurate Sodium I 123 (Systemic)


VA CLASSIFICATION
Primary: DX201

Commonly used brand name(s): Nephropure.

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

*Not commercially available in the U.S.



Category:


Diagnostic aid, radioactive (renal disorders; urinary tract obstructions)—

Indications

Accepted

Renography—Iodohippurate sodium I 123 is indicated in renography to determine renal function, effective renal blood flow, and urinary tract obstruction. {01} {15}

Renal imaging, radionuclide—Iodohippurate sodium I 123 is indicated as a renal imaging agent to assess renal size, position, configuration, and function. {01} {06}


Physical Properties

Nuclear data:



Radionuclide
(half-life)
Mode of
decay
Principal
photon
emissions
(keV)
Mean number
of emissions/
disintegration
I 123
(13.2 hr)
Electron
capture
Gamma
(159)

0.83


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Based on its elimination by both tubular secretion and glomerular filtration, which can be monitored or observed by appropriate imaging or detection equipment. {15}

Half-life:

For iodohippurate sodium (biological)—Approximately 20 to 30 minutes.

Time to peak concentration:

Kidneys—Approximately 3 to 6 minutes. {15}

Radiation dosimetry:
{14}

Organ
Estimated absorbed radiation dose*
With normal
kidney function
With impaired
kidney function
mGy/
MBq
rad/mCi
mGy/
MBq
rad/mCi
Bladder wall
0.20
0.74
0.11
0.41
Uterus
0.17
0.63
0.013
0.048
Large intestine
(lower)
0.0075
0.028
0.0078
0.029
Ovaries
0.0073
0.027
0.0079
0.029
Kidneys
0.0064
0.024
0.027
0.099
Testes
0.0046
0.017
0.0053
0.020
Small intestine
0.0032
0.012
0.0060
0.022
Large intestine (upper)
0.0025
0.0093
0.0056
0.021
Red marrow
0.0025
0.0093
0.0064
0.024
Bone surfaces
0.0013
0.0048
0.0051
0.019
Adrenals
0.00092
0.0034
0.0053
0.020
Pancreas
0.00089
0.0033
0.0051
0.019
Spleen
0.00082
0.0030
0.0049
0.018
Stomach wall
0.00079
0.0029
0.0044
0.016
Liver
0.00072
0.0027
0.0059
0.022
Lungs
0.00048
0.0018
0.0038
0.014
Breast
0.00044
0.0016
0.0034
0.013
Thyroid
0.00037
0.0014
0.0030
0.011
Other tissue
0.0022
0.0081
0.0045
0.017
Effective dose
0.015
mSv/MBq
0.056
rem/mCi
0.013
mSv/MBq
0.048
rem/mCi
* For adults; intravenous administration.
 Data based on the International Commission on Radiological Protection (ICRP) Publication 53—Radiation Dose to Patients from Radiopharmaceuticals.

Elimination:
    Renal, 50 to 75% within 25 minutes; 90 to 95% within 8 hours; primarily by tubular cell secretion, but also by glomerular filtration.
    Iodide I 123 is excreted in breast milk, also. {01} {15}


Precautions to Consider

Carcinogenicity/Mutagenicity

Long-term animal studies to evaluate carcinogenic or mutagenic potential of iodohippurate sodium I 123 have not been performed.

Pregnancy/Reproduction

Pregnancy—
Studies have not been done in humans. Other radioiodines (e.g., iodide I 131) cross the placenta and may cause severe and irreversible hypothyroidism in the newborn and are not recommended for use during pregnancy. {15}

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. {05} {12}

Studies have not been done in animals. {01}

FDA Pregnancy Category C. {01}

Breast-feeding

Iodide I 123 is excreted in breast milk. Because of the potential risk to the infant from radiation exposure, temporary discontinuation of nursing is recommended for approximately 3 days. {05} {15} {18}

Pediatrics

Although iodohippurate sodium I 123 is used in children, there have been no specific studies evaluating its safety and efficacy in pediatric patients. When this radiopharmaceutical is used in children, the diagnostic benefit should be judged to outweigh the potential risk of radiation. {05} {12} {15}


Geriatrics


Appropriate studies on the relationship of age to the effects of iodohippurate sodium I 123 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 this test

Due to other medications
Probenecid    (concurrent use may decrease kidney uptake of iodohippurate sodium I 123 due to a direct inhibition of the enzyme transport system in the proximal tubule by probenecid {10})


Due to medical problems or conditions
Dehydration    (may prolong renal transit time of iodohippurate sodium I 123, thus increasing the time required to reach peak radioactivity level in kidney)

Due to other diagnostic tests
Retrograde pyelogram    (may alter renogram curve; renogram should be performed before or at least 24 hours after this procedure {06} {10})

With other diagnostic test results
Thyroid function determinations and
Thyroid imaging    (Lugol's solution used prior to the administration of iodohippurate sodium I 123 may cause a decrease in radioactive iodine or pertechnetate ion uptake for several weeks)


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:

Those indicating need for medical attention
Incidence rare
    
Allergic reaction (skin rash, hives, or itching{01})
    
fainting
    
nausea or vomiting{01}{15}





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: Elimination by tubular cell secretion and glomerular filtration

Appearance, concentration, and elimination of iodohippurate sodium I 123 in kidneys allows monitoring and 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—Risk to fetus from radiation exposure as opposed to benefit derived from use should be considered; possibility of hypothyroidism in newborn





Breast-feeding—Iodide I 123 excreted in 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 apply; patient should inquire in advance


Precautions after having this test:
Possible interference with future thyroid tests



Side/adverse effects
Signs of potential side effects, especially allergic reaction, fainting, nausea or vomiting


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 appropriate Federal or state agency, if required, or, outside the U.S., the appropriate authority. {16}

To help minimize thyroidal uptake of free iodide I 123, a thyroid blocking agent such as a saturated solution of potassium iodide or potassium perchlorate should be given prior to administration of iodohippurate sodium I 123 and for several days afterwards. {01} {11} {15}

To assure adequate urine flow, increased oral intake of fluids is recommended 1 hour prior to the diagnostic procedure, unless contraindicated because of the presence of edema or congestive heart failure. {07} {08}

Manufacturer's package insert or other appropriate literature should be consulted for optimal times when imaging should be performed. In general, imaging should be performed as close to time of calibration as possible since the quality of the image will degrade with time because of the increase in the proportion of radionuclidic contaminants (primarily I 124). {01} {10}

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. {19}


Parenteral Dosage Forms

IODOHIPPURATE SODIUM I 123 INJECTION USP

Usual adult and adolescent administered activity
Renography
Intravenous, 3.7 to 14.8 megabecquerels (100 to 400 microcuries).

Renal imaging, radionuclide
Intravenous, 37 megabecquerels (1 millicurie).


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.—
Not commercially available.

Canada—


37 megabecquerels (1 millicurie) of iodohippurate sodium I 123, at time of calibration, per vial (Rx) [Nephropure]


74 megabecquerels (2 millicuries) of iodohippurate sodium I 123, at time of calibration, per vial (Rx) [Nephropure]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.

Note: Caution—Radioactive material.




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. Package insert for Nephroflow.
  1. USP/NF.
  1. USP/NF Supplement 5.
  1. Report by M Stabin, Oak Ridge Assoc. University, Radiopharmaceutical Internal Dose Inf. Center, 4/84.
  1. Panel comments (1/88).
  1. Maynard CD. Clinical Nuclear Medicine. Lea & Febiger, 1971: 228.
  1. Hladik WB, Saha GB, Study KT. Essentials of Nuclear Medicine Science. Williams & Wilkins, 1987: 26, 29, 30 120, 415.
  1. Chilton HM, Witcofski RL. Nuclear Pharmacy—An introduction to the clinical application of radiopharmaceuticals. Lea & Febiger, 1986: 127.
  1. Mountford PJ, Coakley AJ. A review of the secretion of radioactivity in human breast milk: data, quantitative analysis and recommendations 1989; Nuclear Medicine Communications 10: 15-27.
  1. Panelist comment per 5/85 revision.
  1. American Hospital Formulary Service.
  1. USP Radiopharmaceuticals Advisory Panel meeting 5/91.
  1. Maisey MN, Britton KE, Gilday DL. Clinical nuclear medicine. 2nd ed. Philadelphia: J.B. Lippincott, 1991: 91, 98.
  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.
  1. Swanson DP, Chilton HM, Thrall JH, editors. Pharmaceuticals in medical imaging. New York: Macmillan Publishing Company, 1990: 515.
  1. USP Radiopharmaceuticals Advisory Panel meeting 05/04/91.
  1. Reviewers' responses to monograph revision of 05/27/92.
  1. Rose MR, et al. Excretion of iodine-123 hippuran, technetium-99m red blood cells, and technetium-99m macroaggregated albumin into breast milk. J Nucl Med 1990; 31: 978-84.
  1. Reviewers' responses to Ballot of 5/11/94.
  1. Eshima D, Fritzber AR, Taylor A Jr. Tc 99m renal tubular function agents: current status. Sem Nuc Med 1990; 20(1): 28-40.
  1. Thrall JH, Koff SA, Keyes JW. Diuretic radionuclide renography and scintigraphy in the differential diagnosis of hydroureteronephrosis. Sem Nuc Med 1981; 11(2): 89-104.
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