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Jeanatope 1-125 (Iodinated 1-125 Albumin Injection) is a sterile, nonpyrogenic, aqueous solution for intravenous use. Each milliliter provides approximately 10 mg protein (normal human serum albumin), 1.6 mg sodium phosphate, 16 mg sodium biphosphate, not more than 0.4 mg guanidine hydrochloride, sodium chloride for isotonicity, and 9 mg benzyl alcohol as a preservative. The stabilizer aceryltryptophanate and sodium caprylate have a concentration of less than 0.0089M. The pH has been adjusted to 7.2-7.8 with sodium hydroxide or hydrochloric acid.
Jeanotope I-125 was prepared from the blood that was non-reactive when tested for hepatitis B surface antigen (HBsAg) and HIV antibody.
Iodine 125 decays by electron capture with a physical half-life of 60.14 days.1
Photons that are useful for detection and imaging studies are listed in Table 1.
TABLE 1
| Principal Radiation Emission Data | ||
| Radiation | Mean % per Disintegration | Mean Energy (keV) |
| Gamma-1 | 6.7 | 35.0 |
| X-rays | 140.0 | 28.02 |
| 1 Dillman LT, Von der Lage FC, Radionuclide Decay Schemes and Nuclear Parameters for Use in Radiation-Dose Estimation. MIRD Pamphlet No. 10. pg. 71 Soc Nucl Med, 1975. 2 Weighted mean energy |
||
The specific gamma ray constant for I-125 is 1.5 R/millicurie-hour at 1 cm. The first half-value thickness of Pb for I-125 is .002 mm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of .02 min of Pb will decrease the external radiation exposure by a factor of 1,000.
TABLE 2
| Radiation Attenuation by Lead Shielding | |
| Shield Thickness (Pb) mm | Attenuation Factor |
| 0.02 | 0.5 |
| 0.06 | 10-1 |
| 0.12 | 10-2 |
| 0.20 | 10-3 |
| 0.30 | 10-4 |
| 0.40 | 10-5 |
| To correct for physical decay of this radionuclide, the fractions that remain at selected intervals before and after the time of calibration are shown in Table 3 | |
TABLE 3
| Physical Decay Chart: 1-125 half-life 60.14 days | |||||
| Days | Fraction Remaining | Days | Fraction Remaining | Days | Fraction Remaining |
| -14 | 1.175 | 1 | 0.989 | 18 | 0.813 |
| -12 | 1.148 | 2 | 0.977 | 20 | 0.794 |
| -10 | 1.122 | 3 | 0.966 | 22 | 0.776 |
| -8 | 1.096 | 4 | 0.955 | 25 | 0.750 |
| -7 | 1.084 | 5 | 0.944 | 30 | 0.708 |
| -6 | 1.072 | 6 | 0.933 | 35 | 0.668 |
| -5 | 1.060 | 7 | 0.923 | 40 | 0.631 |
| -4 | 1.047 | 8 | 0.912 | 45 | 0.596 |
| -3 | 1.035 | 10 | 0.891 | 50 | 0.562 |
| -2 | 1.023 | 12 | 0.871 | 55 | 0.531 |
| -1 | 1.012 | 14 | 0.851 | 60 | 0.501 |
| 0* | 1.000 | 16 | 0.831 | 75 | 0.422 |
| *Calibration time | |||||
JEANATOPE is indicated in adults for use in the determination of total blood and plasma volume.
Administer 10 drops of Strong Iodine Solution, USP (e.g., Lugol’s Solution) three times daily, beginning at least 24 hours before administration of JEANATOPE and continue for 1 week or 2 weeks thereafter to minimize the uptake of iodine-125.
The recommended dose of JEANATOPE for total blood or plasma volume determination in adult patients is from 0.185 MBq to 1.85 MBq (5 microCi to 50 microCi) administered intravenously.
When a procedure such as a blood volume determination is to be repeated, do not exceed 7.4 MBq (200 microCi) in any 1 week.
| Net cpm/mL reference solution Net cpm/mL patient's blood sample |
x DF* = blood volume (in mL) |
*DF: Dilution factor of reference solution
Using the formula above gives 2,725/2,500 x 4,000 = 4,360 mL
Subtract the radioactivity concentration (net cpm/mL) per aliquot of the background blood sample from the radioactivity concentration per aliquot of the blood sample obtained after the injection of JEANATOPE. The formula for calculating each blood volume determination after the first one thus becomes:
| Net cpm/mL reference solution Net cpm/mL patient's blood sample |
x DF* = blood volume (in mL) |
*DF: Dilution factor of reference solution
The procedure is essentially the same as that for blood volume determination, except that the blood sample drawn from the patient is centrifuged, the red blood cells are removed, and net cpm /mL of the plasma is determined. The formula for calculation of plasma volume, therefore is:
| Net cpm/mL reference solution Net cpm/mL patient's plasma sample |
x DF* = plasma volume (in mL) |
*DF: Dilution factor of reference solution
The estimated absorbed radiation doses to an adult patient from an intravenous injection of 1.85 MBq (50 microCi) of JEANATOPE are shown in Table 4.
Table 4: Estimated Absorbed Radiation Doses
| Tissue | Rads |
| Blood | 0.15 |
| Whole-body | 0.025 to 0.035 |
Method of Calculation: Hine GJ, Johnston RE: Absorbed Doses from Radionuclides, J. Nucl Med 11:468-469, 1970.
JEANATOPE (iodinated I 125 albumin) injection, is a colorless to very pale yellow solution available in multiple-dose vials containing the following amounts of radioactivity on the date of calibration:
| Total Radioactivity | Concentration | NDC |
| 3.7 MBq/10 mL (100 microCi/10 mL) | 0.37 MBq/mL (10 microCi/mL) | 50914-7732-9 |
| 37 MBq/mL (1,000 microCi/mL) | 37 MBq/mL (1,000 microCi/mL) | 50914-7733-5 |
Complete radioassay data for each vial are provided on the JEANATOPE vial label.
Store refrigerated at 2°C to 8°C (36°F to 46°F) in suitable lead shield.
This radiopharmaceutical is licensed for distribution to facilities and persons licensed by the U.S. Nuclear Regulatory Commission or under an equivalent license issued by an Agreement State.
Iso-Tex Diagnostics, Inc., 1511 Country Road 129 Alvin, TX 77511, U.S.A (281) 482-1231 • FAX: (281) 482-1070. Revised: Jul 2023
The following adverse reactions have been identified with the use of iodinated I 125 albumin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: Hypersensitivity
No Information provided
Aseptic meningitis and pyrogenic reactions have been reported following cisternography with JEANATOPE. The safety and effectiveness of JEANATOPE for cisternography have not been established. JEANATOPE is not approved for this use.
In the use of any radioactive material, care should be taken to minimize radiation exposure to the patient and healthcare providers consistent with proper patient management.
Radiopharmaceuticals should be used by or under control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
No long-term animal studies have been performed to evaluate carcinogenic potential or whether iodinated I 125 albumin affects fertility in males or females.
Iodine-125 crosses the placenta and can permanently impair fetal thyroid function. JEANATOPE should be administered to a pregnant woman only if clearly needed. Administration of an appropriate thyroid blocking agent is recommended before use of JEANATOPE in a pregnant woman to minimize the uptake of radioactive iodine for the woman and fetus (see DOSAGE AND ADMINISTRATION).
There are no data on iodinated I 125 albumin use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted. All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Iodine-125 is present in human milk. There are no data on the effect of iodinated I 125 albumin on the breastfed infant or milk production. Because of the potential for serious adverse reactions in the breastfed infant, including transient hypothyroidism, advise that breastfeeding be discontinued and that breastfeeding not be initiated if a woman is exposed to JEANATOPE during pregnancy.
Safety and effectiveness of JEANATOPE in pediatric patients have not been established.
Clinical studies of JEANATOPE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
No Information provided
None known.
Following intravenous injection, iodinated I 125 albumin is distributed throughout the intravascular pool within 10 minutes; extravascular distribution takes place more slowly. Iodinated I 125 albumin also can be detected in the lymph and in certain body tissues within 10 minutes after injection, but maximum distribution of radioactivity throughout the extravascular space does not occur until two to four days after administration. The time at which extravascular activity is maximal has been designated as the “equilibrium time.” When this point has been reached, the radioactivity remaining in the intravascular and extravascular spaces decreases slowly and exponentially in parallel fashion.
The administered radioactivity is eliminated almost entirely in the urine, only about 2 percent of the total dose ultimately appears in the feces.
The biologic half-life of iodinated I 125 albumin is dependent upon a number of factors, and published studies have varied considerably in their reporting of this figure. It has ranged, in the literature, from below 10 days to over 20 days. One important factor affecting the biologic half-life is the initial rate of excretion, and this depends in part on the quality of the iodinated I 125 albumin. With JEANATOPE, the biologic half-life in normal individuals has been reported to be approximately 14 days.
No information provided. Please refer to the WARNINGS AND PRECAUTIONS section.
