Sodium Iodide I-131 Therapeutic
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Uses
Sodium Iodide I 131 Solution Therapeutic is indicated for the treatment of hyperthyroidism and thyroid carcinomas that take up iodide. Palliative effects may be observed in patients with advanced thyroid malignancy if the metastatic lesions take up iodide.
History
There is currently no drug history available for this drug.
Other Information
Sodium Iodide I 131 (Na I-131) Solution Therapeutic is supplied for oral administration as a stabilized aqueous solution. The solution is available in vials that contain from 185 to 5550 MBq (5 to 150 mCi) iodine-131 at the time of calibration. Sodium Iodide I 131 Solution Therapeutic is packaged in shielded, screw-cap 15 mL vials.
The solution contains 0.1% sodium bisulfite and 0.2% edetate disodium as stabilizers, 0.5% sodium phosphate anhydrous as a buffer and sodium iodide I-131 at concentrations of 185 or 925 MBq (5 or 25 mCi) per milliliter. The pH has been adjusted to between 7.5 and 9. The iodine-131 utilized in the preparation of the solution contains not less than 99% iodine-131 at the time of calibration. The expiration date is not later than one month after the calibration date. The calibration date and the expiration date are stated on the label.
Iodine-131 decays by beta emission and associated gamma emission with a physical half-life of 8.02 days3. The principal beta emissions and gamma photons are listed in Table 4.
Table 4. Principal Radiation Emission Data
| Radiation |
Mean Percent Per Disintegration |
Energy (keV) |
| Beta-1 |
2.10 |
69.4 Avg. |
| Beta-3 |
7.27 |
96.6 Avg. |
| Beta-4 |
89.9 |
191.6 Avg. |
| Gamma-7 |
6.14 |
284.3 |
| Gamma-14 |
81.7 |
364.5 |
| Gamma-17 |
7.17 |
637.0 |
The specific gamma ray constant for iodine-131 is 2.20 R/hr-mCi at 1 cm. The first half-value thickness of lead (Pb) for iodine-131 is 0.27 cm. 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 5. For example, the use of 4.5 cm of Pb will decrease the external radiation exposure by a factor of about 1,000.
Table 5. Radiation Attenuation by Lead Shielding4
| Shield Thickness (Pb), cm |
Coefficient of Attenuation |
| 0.27 |
0.5 |
| 0.99 |
10-1 |
| 2.6 |
10-2 |
| 4.5 |
10-3 |
To correct for physical decay of this radionuclide, the fractions that remain at selected time intervals after the date of calibration are shown in Table 6.
Table 6. Physical Decay Chart
Iodine-131: Half-Life 8.02 Days
| Days |
Fraction |
Days |
Fraction |
Days |
Fraction |
| 0* |
1.000 |
11 |
0.387 |
22 |
0.149 |
| 1 |
0.917 |
12 |
0.355 |
23 |
0.137 |
| 2 |
0.841 |
13 |
0.325 |
24 |
0.126 |
| 3 |
0.772 |
14 |
0.298 |
25 |
0.115 |
| 4 |
0.708 |
15 |
0.274 |
26 |
0.106 |
| 5 |
0.649 |
16 |
0.251 |
27 |
0.097 |
| 6 |
0.595 |
17 |
0.230 |
28 |
0.089 |
| 7 |
0.546 |
18 |
0.211 |
29 |
0.082 |
| 8 |
0.501 |
19 |
0.194 |
30 |
0.075 |
| 9 |
0.459 |
20 |
0.178 |
||
| 10 |
0.421 |
21 |
0.163 |
*Calibration Day
Iodine-131 decays by beta emission and associated gamma emission with a physical half-life of 8.02 days3. The principal beta emissions and gamma photons are listed in Table 4.
Table 4. Principal Radiation Emission Data
| Radiation |
Mean Percent Per Disintegration |
Energy (keV) |
| Beta-1 |
2.10 |
69.4 Avg. |
| Beta-3 |
7.27 |
96.6 Avg. |
| Beta-4 |
89.9 |
191.6 Avg. |
| Gamma-7 |
6.14 |
284.3 |
| Gamma-14 |
81.7 |
364.5 |
| Gamma-17 |
7.17 |
637.0 |
The specific gamma ray constant for iodine-131 is 2.20 R/hr-mCi at 1 cm. The first half-value thickness of lead (Pb) for iodine-131 is 0.27 cm. 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 5. For example, the use of 4.5 cm of Pb will decrease the external radiation exposure by a factor of about 1,000.
Table 5. Radiation Attenuation by Lead Shielding4
| Shield Thickness (Pb), cm |
Coefficient of Attenuation |
| 0.27 |
0.5 |
| 0.99 |
10-1 |
| 2.6 |
10-2 |
| 4.5 |
10-3 |
To correct for physical decay of this radionuclide, the fractions that remain at selected time intervals after the date of calibration are shown in Table 6.
Table 6. Physical Decay Chart
Iodine-131: Half-Life 8.02 Days
| Days |
Fraction |
Days |
Fraction |
Days |
Fraction |
| 0* |
1.000 |
11 |
0.387 |
22 |
0.149 |
| 1 |
0.917 |
12 |
0.355 |
23 |
0.137 |
| 2 |
0.841 |
13 |
0.325 |
24 |
0.126 |
| 3 |
0.772 |
14 |
0.298 |
25 |
0.115 |
| 4 |
0.708 |
15 |
0.274 |
26 |
0.106 |
| 5 |
0.649 |
16 |
0.251 |
27 |
0.097 |
| 6 |
0.595 |
17 |
0.230 |
28 |
0.089 |
| 7 |
0.546 |
18 |
0.211 |
29 |
0.082 |
| 8 |
0.501 |
19 |
0.194 |
30 |
0.075 |
| 9 |
0.459 |
20 |
0.178 |
||
| 10 |
0.421 |
21 |
0.163 |
*Calibration Day
Sources
Sodium Iodide I-131 Therapeutic Manufacturers
-
Mallinckrodt Inc.
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Sodium Iodide I-131 Therapeutic | Mallinckrodt Inc.
2.1 Radiation SafetySodium iodide I-131 solution emits radiation and must be handled with safety measures to minimize inadvertent radiation exposure to clinical personnel and patients [see Warnings and Precautions (5.7)].
Radiopharmaceuticals should be used only by or under the direction of physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Wear waterproof gloves during the entire sodium iodide I-131 solution handling and administration procedure. Maintain adequate shielding during the radiation-emitting life of the product. Measure the patient dose using a suitable radioactivity calibration system immediately prior to administration. 2.2 HyperthyroidismFor hyperthyroidism, the usual sodium iodide I-131 dose range is 148 to 370 MBq (4 to 10 mCi). Higher doses may be necessary for the treatment of toxic nodular goiter and other special situations. Consider discontinuation of anti-thyroid therapy in a severely hyperthyroid patient three to four days before administration of sodium iodide I-131. Evaluate patients for risk of thyroid enlargement and obstruction of structures in the neck [see Warnings and Precautions (5.1, 5.2)].
2.3 Thyroid CarcinomaFor thyroid carcinoma, the usual sodium iodide I-131 therapeutic dose is 3700 to 5550 MBq (100 to 150 mCi). For ablation of post-operative residual thyroid tissue, the usual dose is 1850 MBq (50 mCi).
2.4 Individualization of TherapyIndividualize sodium iodide I-131 therapy, including dose selection, based upon patient-specific factors such as the nature of the underlying condition, co-morbidities, age, estimated thyroid tissue iodine uptake, thyroid size, as well as ability of the patient to comply with the therapeutic regimen and radiation safety procedures. Perform a clinical assessment, including history, physical examination and laboratory testing when preparing patients for sodium iodide I-131 therapy in order to detect conditions which may alter thyroid iodine uptake and increase the risks of the therapy or diminish its effectiveness. For example, intake of iodine in radiographic contrast may diminish thyroid iodine uptake while low serum chloride or nephrosis may increase thyroid iodine uptake. Obtain a drug history and ascertain whether any medications need to be withheld before the administration of the therapy [see Drug Interactions (7)].
2.5 Radiation DosimetryThe estimated absorbed radiation doses1 to an average (70 kg) euthyroid (normal functioning thyroid) patient from an oral dose of iodine-131 in both milligray (mGy) per megabecquerel (MBq) and rad per millicurie (mCi) are shown in Table 1.
Table 1. Absorbed Radiation Doses
Tissue
Thyroid Uptake
5%
15%
25%
mGy/
MBq
rads/
mCi
mGy/
MBq
rads/
mCi
mGy/
MBq
rads/
mCi
Thyroid
72
266
210
777
360
1300
Stomach Wall
0.45
1.7
0.46
1.7
0.46
1.7
Red Marrow
0.038
0.14
0.054
0.20
0.07
0.26
Liver
0.03
0.11
0.032
0.12
0.035
0.13
Testes
0.029
0.11
0.028
0.10
0.027
0.10
Ovaries
0.044
0.16
0.043
0.16
0.043
0.16
Urinary Bladder
0.58
2.1
0.52
1.9
0.46
1.7
Salivary Glands2
0.5
1.85
0.5
1.85
0.5
1.85
Other
0.040
0.15
0.065
0.24
0.090
0.33
2.1 Radiation SafetySodium iodide I-131 solution emits radiation and must be handled with safety measures to minimize inadvertent radiation exposure to clinical personnel and patients [see Warnings and Precautions (5.7)].
Radiopharmaceuticals should be used only by or under the direction of physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Wear waterproof gloves during the entire sodium iodide I-131 solution handling and administration procedure. Maintain adequate shielding during the radiation-emitting life of the product. Measure the patient dose using a suitable radioactivity calibration system immediately prior to administration. 2.2 HyperthyroidismFor hyperthyroidism, the usual sodium iodide I-131 dose range is 148 to 370 MBq (4 to 10 mCi). Higher doses may be necessary for the treatment of toxic nodular goiter and other special situations. Consider discontinuation of anti-thyroid therapy in a severely hyperthyroid patient three to four days before administration of sodium iodide I-131. Evaluate patients for risk of thyroid enlargement and obstruction of structures in the neck [see Warnings and Precautions (5.1, 5.2)].
2.3 Thyroid CarcinomaFor thyroid carcinoma, the usual sodium iodide I-131 therapeutic dose is 3700 to 5550 MBq (100 to 150 mCi). For ablation of post-operative residual thyroid tissue, the usual dose is 1850 MBq (50 mCi).
2.4 Individualization of TherapyIndividualize sodium iodide I-131 therapy, including dose selection, based upon patient-specific factors such as the nature of the underlying condition, co-morbidities, age, estimated thyroid tissue iodine uptake, thyroid size, as well as ability of the patient to comply with the therapeutic regimen and radiation safety procedures. Perform a clinical assessment, including history, physical examination and laboratory testing when preparing patients for sodium iodide I-131 therapy in order to detect conditions which may alter thyroid iodine uptake and increase the risks of the therapy or diminish its effectiveness. For example, intake of iodine in radiographic contrast may diminish thyroid iodine uptake while low serum chloride or nephrosis may increase thyroid iodine uptake. Obtain a drug history and ascertain whether any medications need to be withheld before the administration of the therapy [see Drug Interactions (7)].
2.5 Radiation DosimetryThe estimated absorbed radiation doses1 to an average (70 kg) euthyroid (normal functioning thyroid) patient from an oral dose of iodine-131 in both milligray (mGy) per megabecquerel (MBq) and rad per millicurie (mCi) are shown in Table 1.
Table 1. Absorbed Radiation Doses
Tissue
Thyroid Uptake
5%
15%
25%
mGy/
MBq
rads/
mCi
mGy/
MBq
rads/
mCi
mGy/
MBq
rads/
mCi
Thyroid
72
266
210
777
360
1300
Stomach Wall
0.45
1.7
0.46
1.7
0.46
1.7
Red Marrow
0.038
0.14
0.054
0.20
0.07
0.26
Liver
0.03
0.11
0.032
0.12
0.035
0.13
Testes
0.029
0.11
0.028
0.10
0.027
0.10
Ovaries
0.044
0.16
0.043
0.16
0.043
0.16
Urinary Bladder
0.58
2.1
0.52
1.9
0.46
1.7
Salivary Glands2
0.5
1.85
0.5
1.85
0.5
1.85
Other
0.040
0.15
0.065
0.24
0.090
0.33
-
Mallinckrodt Nuclear Medicine Llc
Sodium Iodide I-131 Therapeutic | Mallinckrodt Nuclear Medicine Llc
2.1 Radiation SafetySodium Iodide I 131 Solution emits radiation and must be handled with safety measures to minimize inadvertent radiation exposure to clinical personnel and patients [see Warnings and Precautions (5.7)].
Radiopharmaceuticals should be used only by or under the direction of physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Wear waterproof gloves during the entire sodium iodide I-131 solution handling and administration procedure. Maintain adequate shielding during the radiation-emitting life of the product. Measure the patient dose using a suitable radioactivity calibration system immediately prior to administration. 2.2 HyperthyroidismFor hyperthyroidism, the usual sodium iodide I-131 dose range is 148 to 370 MBq (4 to 10 mCi). Higher doses may be necessary for the treatment of toxic nodular goiter and other special situations. Consider discontinuation of anti-thyroid therapy in a severely hyperthyroid patient three to four days before administration of sodium iodide I-131. Evaluate patients for risk of thyroid enlargement and obstruction of structures in the neck [see Warnings and Precautions (5.1, 5.2)].
2.3 Thyroid CarcinomaFor thyroid carcinoma, the usual sodium iodide I-131 therapeutic dose is 3700 to 5550 MBq (100 to 150 mCi). For ablation of post-operative residual thyroid tissue, the usual dose is 1850 MBq (50 mCi).
2.4 Individualization of TherapyIndividualize sodium iodide I-131 therapy, including dose selection, based upon patient-specific factors such as the nature of the underlying condition, co-morbidities, age, estimated thyroid tissue iodine uptake, thyroid size, as well as ability of the patient to comply with the therapeutic regimen and radiation safety procedures. Perform a clinical assessment, including history, physical examination and laboratory testing when preparing patients for sodium iodide I-131 therapy in order to detect conditions which may alter thyroid iodine uptake and increase the risks of the therapy or diminish its effectiveness. For example, intake of iodine in radiographic contrast may diminish thyroid iodine uptake while low serum chloride or nephrosis may increase thyroid iodine uptake. Obtain a drug history and ascertain whether any medications need to be withheld before the administration of the therapy [see Drug Interactions (7)].
2.5 Radiation DosimetryThe estimated absorbed radiation doses1 to an average (70 kg) euthyroid (normal functioning thyroid) patient from an oral dose of iodine-131 in both milligray (mGy) per megabecquerel (MBq) and rad per millicurie (mCi) are shown in Table 1.
Table 1. Absorbed Radiation Doses
Tissue
Thyroid Uptake
5%
15%
25%
mGy/
MBqrads/
mCimGy/
MBqrads/
mCimGy/
MBqrads/
mCiThyroid
72
266
210
777
360
1300
Stomach Wall
0.45
1.7
0.46
1.7
0.46
1.7
Red Marrow
0.038
0.14
0.054
0.20
0.07
0.26
Liver
0.03
0.11
0.032
0.12
0.035
0.13
Testes
0.029
0.11
0.028
0.10
0.027
0.10
Ovaries
0.044
0.16
0.043
0.16
0.043
0.16
Urinary Bladder
0.58
2.1
0.52
1.9
0.46
1.7
Salivary Glands2
0.5
1.85
0.5
1.85
0.5
1.85
Other
0.040
0.15
0.065
0.24
0.090
0.33
2.1 Radiation SafetySodium Iodide I 131 Solution emits radiation and must be handled with safety measures to minimize inadvertent radiation exposure to clinical personnel and patients [see Warnings and Precautions (5.7)].
Radiopharmaceuticals should be used only by or under the direction of physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Wear waterproof gloves during the entire sodium iodide I-131 solution handling and administration procedure. Maintain adequate shielding during the radiation-emitting life of the product. Measure the patient dose using a suitable radioactivity calibration system immediately prior to administration. 2.2 HyperthyroidismFor hyperthyroidism, the usual sodium iodide I-131 dose range is 148 to 370 MBq (4 to 10 mCi). Higher doses may be necessary for the treatment of toxic nodular goiter and other special situations. Consider discontinuation of anti-thyroid therapy in a severely hyperthyroid patient three to four days before administration of sodium iodide I-131. Evaluate patients for risk of thyroid enlargement and obstruction of structures in the neck [see Warnings and Precautions (5.1, 5.2)].
2.3 Thyroid CarcinomaFor thyroid carcinoma, the usual sodium iodide I-131 therapeutic dose is 3700 to 5550 MBq (100 to 150 mCi). For ablation of post-operative residual thyroid tissue, the usual dose is 1850 MBq (50 mCi).
2.4 Individualization of TherapyIndividualize sodium iodide I-131 therapy, including dose selection, based upon patient-specific factors such as the nature of the underlying condition, co-morbidities, age, estimated thyroid tissue iodine uptake, thyroid size, as well as ability of the patient to comply with the therapeutic regimen and radiation safety procedures. Perform a clinical assessment, including history, physical examination and laboratory testing when preparing patients for sodium iodide I-131 therapy in order to detect conditions which may alter thyroid iodine uptake and increase the risks of the therapy or diminish its effectiveness. For example, intake of iodine in radiographic contrast may diminish thyroid iodine uptake while low serum chloride or nephrosis may increase thyroid iodine uptake. Obtain a drug history and ascertain whether any medications need to be withheld before the administration of the therapy [see Drug Interactions (7)].
2.5 Radiation DosimetryThe estimated absorbed radiation doses1 to an average (70 kg) euthyroid (normal functioning thyroid) patient from an oral dose of iodine-131 in both milligray (mGy) per megabecquerel (MBq) and rad per millicurie (mCi) are shown in Table 1.
Table 1. Absorbed Radiation Doses
Tissue
Thyroid Uptake
5%
15%
25%
mGy/
MBqrads/
mCimGy/
MBqrads/
mCimGy/
MBqrads/
mCiThyroid
72
266
210
777
360
1300
Stomach Wall
0.45
1.7
0.46
1.7
0.46
1.7
Red Marrow
0.038
0.14
0.054
0.20
0.07
0.26
Liver
0.03
0.11
0.032
0.12
0.035
0.13
Testes
0.029
0.11
0.028
0.10
0.027
0.10
Ovaries
0.044
0.16
0.043
0.16
0.043
0.16
Urinary Bladder
0.58
2.1
0.52
1.9
0.46
1.7
Salivary Glands2
0.5
1.85
0.5
1.85
0.5
1.85
Other
0.040
0.15
0.065
0.24
0.090
0.33
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