INDICATIONS
Therapeutic doses of Sodium Iodide I 131 Solution USP prepared with HICON™
are indicated for the treatment of hyperthyroidism and selected cases of carcinoma
of the thyroid.
DOSAGE AND ADMINISTRATION
The concentrated Sodium Iodide I 131 Solution USP provided with HICON™
must not be used for direct administration to patients. It must be diluted and
prepared as described in the Drug Handling And Dosage Form Preparation section.
The recommended dosage for orally administered Sodium Iodide I 131 Solution
USP is based on the thyroid gland uptake as well as the size of the gland. Thyroidal
uptake and size should be determined by the physician prior to treatment and
may be useful in calculating the therapeutic dose to be administered to the
individual patient. Recommended dosages of orally administered Sodium Iodide
I-131 are:
Disease Therapy
Antihyperthyroid Therapy: Oral dose of 148 to 370 megabecquerels (4
to 10 millicuries).
Toxic nodular goiters and other serious thyroid conditions may require larger
dosages.
Antineoplastic – Ablation of normal thyroid tissue: Initial oral dose
of 1.1 to 3.7 gigabecquerels (30 to 100 millicuries).
Subsequent ablation of metastases with oral dose of 3.7 to 7.4 giga-becquerels
(100 to 200 millicuries).
General Dosing Information
Patients should be adequately hydrated before and after administration of
radioiodide to assure rapid urinary elimination of the iodide that is not absorbed
by the thyroid gland.
Radiation Dosimetry
Following administration of Sodium Iodide I-131, about 40 percent of the activity
has an effective half-life of 0.34 days and 60 percent has an effective half-life
of 7.61 days. On this basis, the estimated absorbed radiation dose to an average
adult (70 kg) from an oral dose of 370 MBq (10 mCi) of Sodium Iodide I-131 is
shown in Table 4.
Table 4 : Absorbed Radiation Doses I-131
Tissue |
mGy/370 MBq |
Rads/10 mCi |
Thyroid |
350,000 |
350,000 |
Testes |
92 |
9.2 |
Ovaries |
93 |
9.3 |
Whole body |
160 |
16.0 |
Method of Calculation: A Schema for Absorbed-Dose Calculations for Biologically
Distributed Radionuclides, MIRD Pamphlet No. 1, J Nucl Med Suppl, 1:7, 1968.
Drug Handling And Final Dosage Form Preparation
Drug Handling
- The concentrated Sodium Iodide I 131 Solution USP provided with HICON™
should not be used after the expiration date stated on the container label.
- The solution should be inspected visually for particulate matter and discoloration
prior to administration whenever solution and container permit. The solution
should not be used if cloudy, discolored, or found to contain particulate
matter. However, it is well known that glass tends to darken in the presence
of high radioactivity.
- Care should be taken to minimize radiation exposure to the patient consistent
with proper patient management and to insure minimum radiation exposure to
occupational workers. Waterproof gloves should be used during the entire handling
and administration procedure. Adequate shielding should be maintained during
the life of the product.
Preparation of Dilute Sodium Iodide I 131 Solution USP
- Using the calibration date and radionuclidic concentration on the label
of the product vial, calculate the required volume to produce the necessary
dose in MBq or mCi.
- Using a shielded syringe, remove the required volume.
- Using the shielded syringe, transfer the required volume to a suitably shielded
receiving vial.
- Add diluent solution to the receiving vial to produce a final dose of the
desired volume. The recommended diluent is Purified Water USP containing 0.2
% Sodium Thiosulfate USP as a reducing agent. The use of acidic diluents may
cause the pH to drop below 7.5 and stimulate the volatilization of Iodine
I-131 hydriodic acid.
- The patient dose should be measured by a suitable radioactivity calibration
system immediately prior to administration.
- The finished preparation should not be used after the expiration date stated
on the container label.
Preparation of Sodium Iodide I 131 Capsules USP
1. The kit includes one large gelatin capsule and one small gelatin capsule
for each dose prepared. Each large capsule is empty and each small capsule contains
approximately 300 mg of Dibasic Sodium Phosphate Anhydrous USP as the absorbing
buffer.
2. Using the calibration date and radionuclidic concentration on the label
of the product vial, calculate the required volume to produce the necessary
dose in MBq or mCi.
3. Open one LARGE capsule by pulling apart the capsule into two pieces as illustrated
below:
4. Insert an unopened SMALL capsule into the bottom half of the empty
large capsule as illustrated below:
5. With an appropriate syringe, withdraw the required volume of Sodium Iodide
I 131 Solution USP (maximum 150 μL) from the vial as illustrated below:
6. Inject into the center of the SMALL capsule through the top as illustrated
below:
7. Slip the upper half of the large capsule over the bottom half to completely
cover the small capsule and push down gently until locked as illustrated below:
8. After dispensing, the patient dose should be measured in a suitable radioactivity
calibration system immediately prior to administration.
9. Store the capsule in a suitable polypropylene container and place inside
a lead pot until use. The capsule should be used within seven days.
HOW SUPPLIED
Each HICON™ kit of 9.25 GBq (250 mCi) includes:
- a blister package of ten small hard gelatin capsules each containing approximately
300 mg of Dibasic Sodium Phosphate Anhydrous USP as absorbing buffer.
- a blister package of ten empty large hard gelatin capsules.
- a 1 mL vial containing 0.25 mL of Sodium Iodide I 131 Solution USP, therapeutic
oral solution containing approximately 9.25 GBq (250 mCi) at time of calibration.
Each HICON™ kit of 18.5 GBq (500 mCi) includes:
- two blister packages of ten small hard gelatin capsules each containing
approximately 300 mg of Dibasic Sodium Phosphate Anhydrous USP as absorbing
buffer.
- two blister packages of ten empty large hard gelatin capsules.
- a 1 mL vial containing 0.5 mL of Sodium Iodide I 131 Solution USP, therapeutic
oral solution containing approximately 18.5 GBq (500 mCi) at time of calibration.
Each HICON™ kit of 37 GBq (1,000 mCi) includes:
- four blister packages of ten small hard gelatin capsules each containing
approximately 300 mg of Dibasic Sodium Phosphate Anhydrous USP as absorbing
buffer.
- four blister packages of ten empty large hard gelatin capsules.
- a 1 mL vial containing 1 mL of Sodium Iodide I 131 Solution USP, therapeutic
oral solution containing approximately 37 GBq (1,000 mCi) at time of calibration.
Each mL of the aqueous product that comes with HICON™ contains:
37 gigabecquerels of Sodium Iodide I-131
< 2.0 mg of Disodium Edetate Dihydrate USP
< 4.4 mg of Sodium Thiosulphate Pentahydrate USP
< 40 mg of Dibasic Sodium Phosphate Anhydrous USP
Complete assay data are available on the container.
Storage
The Sodium Iodide I 131 Solution USP provided with HICON™ should be stored
between 2° C and 25° C (36° F and 77° F).
NDC 65174-880-25 (for 250 mCi vial size)
NDC 65174-880-50 (for 500 mCi vial size)
NDC 65174-880-00 (for 1,000 mCi vial size)
Manufactured by: Jubilant DraxImage Inc., Kirkland, Québec,
Canada.