Sodium Iodide I-131 Solution is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma.

{ "type": "p", "children": [], "text": "\nSodium Iodide I-131 Solution is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma.\n" }

Individualization of Therapy The recommended dose for orally administered sodium iodide I 131 capsules or solution 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.

Treatment of Hyperthyroidism The recommended dose is 148 to 370 MBq (4 to 10 mCi) administered orally. Toxic nodular goiter may require a larger dose.

Treatment of Thyroid Carcinoma The recommended dose is 1100 to 3700 MBq (30 to 100 mCi) administered orally. For subsequent ablation of metastases, the recommended dose is 3700 to 7400 MBq (100 to 200 mCi) administered orally.

Drug Handling

Preparation of Dilute Sodium Iodide I 131 Solution

1. 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.

2. Using a shielded syringe, remove the required volume.

3. Using the shielded syringe, transfer the required volume to a suitably shielded receiving vial.

4. Add diluent to the receiving vial to produce a final dose of the desired volume.

5. The recommended diluent is Purified Water USP containing 0.2 % sodium thiosulfate USP as a reducing agent. Acidic diluents should not be used as they may cause the pH to drop below 7.5 and stimulate the volatilization of Iodine I-131 hydriodic acid.

6. Present the dose in a shielded container for administration to the patient with a straw.

Preparation of Sodium Iodide I 131 Capsules

1. Use one large gelatin capsule and one small gelatin capsule for each dose to be prepared. Each large capsule is empty and each small capsule contains approximately 300 mg of dibasic sodium phosphate anhydrous as the absorbing buffer.

2. Using the calibration date and radionuclidic concentration on the label of the sodium iodide I-131 lead shield, 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 (maximum 150 microliters) 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. Measure the patient dose in a suitable radioactivity calibration system immediately prior to administration.

9. Prepared capsules may be stored in a suitable polypropylene container and place inside a lead pot until use, within seven days.

<div class="scrollingtable"><table width="80%"> <caption> <span>Table 1 <a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a></span> </caption> <colgroup> <col width="24%"/> <col width="19%"/> <col width="19%"/> <col width="19%"/> <col width="19%"/> </colgroup> <tfoot> <tr> <td align="left" colspan="5"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>Table 1 is not intended for treatment planning.</dd> <dt> <a href="#footnote-reference-2" name="footnote-2">†</a> </dt> <dd>These columns are not applicable to estimate organ or effective doses in patients following thyroidectomy. In patients with thyroid cancer following thyroidectomy, organ and effective doses can be estimated from the "blocked"-thyroid-uptake values.</dd> <dt> <a href="#footnote-reference-3" name="footnote-3">‡</a> </dt> <dd>These values presume unimpeded production of thyroid hormone and may not be applicable to estimate thyroid dose and effective dose in patients who have had previous treatment with I 131 for hyperthyroidism</dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="Botrule First First"> <td align="center" colspan="5">Absorbed dose per unit activity sodium iodide I 131 administered orally (mGy/MBq) in adult (73.7-kg reference model)</td> </tr> <tr class="Botrule Toprule"> <td align="center" rowspan="2">Organ</td><td align="center" class="Bold Botrule Lrule Rrule" colspan="4">Thyroid uptake of I 131 (% administered activity A <span class="Sub">0</span>) <br/> <br/> 24 h after oral administration </td> </tr> <tr align="center" class="Botrule"> <td class="Lrule Rrule"> <p class="First">Blocked thyroid <br/> <br/> (0% A <span class="Sub">0</span>) </p> </td><td class="Lrule Rrule"> <p class="First">Low uptake <a class="Sup" href="#footnote-2" name="footnote-reference-2">†</a> <br/> <br/> (16% A <span class="Sub">0</span>) </p> </td><td class="Lrule Rrule"> <p class="First">Medium uptake <a class="Sup" href="#footnote-2">†</a> <br/> <br/> (26% A <span class="Sub">0</span>) </p> </td><td class="Lrule Rrule"> <p class="First">High uptake <a class="Sup" href="#footnote-2">†</a> <br/> <br/> (36% A <span class="Sub">0</span>) </p> </td> </tr> <tr align="center"> <td class="Lrule Rrule">Adrenals</td><td class="Lrule Rrule">0.044</td><td class="Lrule Rrule">0.051</td><td class="Lrule Rrule">0.055</td><td class="Lrule Rrule">0.059</td> </tr> <tr align="center"> <td class="Lrule Rrule">Bone surfaces</td><td class="Lrule Rrule"> <p class="First">0.030</p> </td><td class="Lrule Rrule">0.089</td><td class="Lrule Rrule">0.12</td><td class="Lrule Rrule">0.16</td> </tr> <tr align="center"> <td class="Lrule Rrule">Brain</td><td class="Lrule Rrule">0.021</td><td class="Lrule Rrule">0.093</td><td class="Lrule Rrule">0.13</td><td class="Lrule Rrule">0.17</td> </tr> <tr align="center"> <td class="Lrule Rrule">Breast</td><td class="Lrule Rrule">0.020</td><td class="Lrule Rrule">0.038</td><td class="Lrule Rrule">0.048</td><td class="Lrule Rrule">0.058</td> </tr> <tr align="center"> <td class="Lrule Rrule">Gallbladder wall</td><td class="Lrule Rrule">0.037</td><td class="Lrule Rrule">0.043</td><td class="Lrule Rrule">0.046</td><td class="Lrule Rrule">0.049</td> </tr> <tr align="center"> <td class="Lrule Rrule">Gastrointestinal tract</td><td class="Lrule Rrule"></td><td class="Lrule Rrule"></td><td class="Lrule Rrule"></td><td class="Lrule Rrule"></td> </tr> <tr align="center"> <td class="Lrule Rrule">Esophagus</td><td class="Lrule Rrule">0.024</td><td class="Lrule Rrule">0.10</td><td class="Lrule Rrule">0.14</td><td class="Lrule Rrule">0.19</td> </tr> <tr align="center"> <td class="Lrule Rrule">Stomach wall</td><td class="Lrule Rrule">0.87</td><td class="Lrule Rrule">0.77</td><td class="Lrule Rrule">0.71</td><td class="Lrule Rrule">0.66</td> </tr> <tr align="center"> <td class="Lrule Rrule">Small intestine wall</td><td class="Lrule Rrule">0.035</td><td class="Lrule Rrule">0.033</td><td class="Lrule Rrule">0.032</td><td class="Lrule Rrule">0.032</td> </tr> <tr align="center"> <td class="Lrule Rrule">Colon wall</td><td class="Lrule Rrule">0.14</td><td class="Lrule Rrule">0.14</td><td class="Lrule Rrule">0.14</td><td class="Lrule Rrule">0.14</td> </tr> <tr align="center"> <td class="Lrule Rrule">(Upper large intestine wall)</td><td class="Lrule Rrule">0.12</td><td class="Lrule Rrule">0.12</td><td class="Lrule Rrule">0.12</td><td class="Lrule Rrule">0.12</td> </tr> <tr align="center"> <td class="Lrule Rrule">(Lower large intestine wall)</td><td class="Lrule Rrule">0.17</td><td class="Lrule Rrule">0.17</td><td class="Lrule Rrule">0.17</td><td class="Lrule Rrule">0.16</td> </tr> <tr align="center"> <td class="Lrule Rrule">Heart wall</td><td class="Lrule Rrule">0.062</td><td class="Lrule Rrule">0.089</td><td class="Lrule Rrule">0.10</td><td class="Lrule Rrule">0.12</td> </tr> <tr align="center"> <td class="Lrule Rrule">Kidneys</td><td class="Lrule Rrule">0.27</td><td class="Lrule Rrule">0.27</td><td class="Lrule Rrule">0.27</td><td class="Lrule Rrule">0.27</td> </tr> <tr align="center"> <td class="Lrule Rrule">Liver</td><td class="Lrule Rrule">0.050</td><td class="Lrule Rrule">0.093</td><td class="Lrule Rrule">0.12</td><td class="Lrule Rrule">0.14</td> </tr> <tr align="center"> <td class="Lrule Rrule">Lungs</td><td class="Lrule Rrule">0.053</td><td class="Lrule Rrule">0.10</td><td class="Lrule Rrule">0.13</td><td class="Lrule Rrule">0.15</td> </tr> <tr align="center"> <td class="Lrule Rrule">Muscles</td><td class="Lrule Rrule">0.026</td><td class="Lrule Rrule">0.084</td><td class="Lrule Rrule">0.12</td><td class="Lrule Rrule">0.15</td> </tr> <tr align="center"> <td class="Lrule Rrule">Ovaries</td><td class="Lrule Rrule">0.038</td><td class="Lrule Rrule">0.037</td><td class="Lrule Rrule">0.036</td><td class="Lrule Rrule">0.035</td> </tr> <tr align="center"> <td class="Lrule Rrule">Pancreas</td><td class="Lrule Rrule">0.060</td><td class="Lrule Rrule">0.064</td><td class="Lrule Rrule">0.066</td><td class="Lrule Rrule">0.068</td> </tr> <tr align="center"> <td class="Lrule Rrule">Red marrow</td><td class="Lrule Rrule">0.031</td><td class="Lrule Rrule">0.072</td><td class="Lrule Rrule">0.095</td><td class="Lrule Rrule">0.12</td> </tr> <tr align="center"> <td class="Lrule Rrule">Salivary glands</td><td class="Lrule Rrule">0.27</td><td class="Lrule Rrule">0.22</td><td class="Lrule Rrule">0.19</td><td class="Lrule Rrule">0.16</td> </tr> <tr align="center"> <td class="Lrule Rrule">Skin</td><td class="Lrule Rrule">0.019</td><td class="Lrule Rrule">0.043</td><td class="Lrule Rrule">0.057</td><td class="Lrule Rrule">0.071</td> </tr> <tr align="center"> <td class="Lrule Rrule">Spleen</td><td class="Lrule Rrule">0.064</td><td class="Lrule Rrule">0.069</td><td class="Lrule Rrule">0.072</td><td class="Lrule Rrule">0.075</td> </tr> <tr align="center"> <td class="Lrule Rrule">Testes</td><td class="Lrule Rrule">0.025</td><td class="Lrule Rrule">0.024</td><td class="Lrule Rrule">0.023</td><td class="Lrule Rrule">0.22</td> </tr> <tr align="center"> <td class="Lrule Rrule">Thymus</td><td class="Lrule Rrule">0.024</td><td class="Lrule Rrule">0.10</td><td class="Lrule Rrule">0.14</td><td class="Lrule Rrule">0.19</td> </tr> <tr align="center"> <td class="Lrule Rrule">Thyroid</td><td class="Lrule Rrule">2.2</td><td class="Lrule Rrule">280 <a class="Sup" href="#footnote-3" name="footnote-reference-3">‡</a></td><td class="Lrule Rrule">430 <a class="Sup" href="#footnote-3">‡</a></td><td class="Lrule Rrule">580 <a class="Sup" href="#footnote-3">‡</a></td> </tr> <tr align="center"> <td class="Lrule Rrule">Urinary bladder wall</td><td class="Lrule Rrule">0.54</td><td class="Lrule Rrule">0.45</td><td class="Lrule Rrule">0.39</td><td class="Lrule Rrule">0.34</td> </tr> <tr align="center"> <td class="Lrule Rrule">Uterus</td><td class="Lrule Rrule">0.045</td><td class="Lrule Rrule">0.042</td><td class="Lrule Rrule">0.040</td><td class="Lrule Rrule">0.038</td> </tr> <tr align="center" class="Botrule"> <td class="Lrule Rrule">Remaining organs</td><td class="Lrule Rrule">0.029</td><td class="Lrule Rrule">0.084</td><td class="Lrule Rrule">0.11</td><td class="Lrule Rrule">0.15</td> </tr> <tr align="center" class="Last Last Toprule"> <td class="Lrule Rrule">Effective dose per administered activity (mSv/MBq)</td><td class="Lrule Rrule">0.28</td><td class="Lrule Rrule">14 <a class="Sup" href="#footnote-3">‡</a></td><td class="Lrule Rrule">22 <a class="Sup" href="#footnote-3">‡</a></td><td class="Lrule Rrule">29 <a class="Sup" href="#footnote-3">‡</a></td> </tr> </tbody> </table></div>

Sodium Iodide I-131 solution componentis available in customer ordered vials available in 1, 2 and 3 mL V-Vials containing colorless, aqueous concentrated Sodium Iodide I-131 Solution at a strength of 37,000 MBq/mL (1000 mCi/mL) at time of calibration for preparation of sodium iodide I-131 capsules, therapeutic or sodium iodide I-131 solution, therapeutic. Large empty gelatin capsules and small gelatin capsules containing approximately 300 mg of dibasic sodium phosphate anhydrous as the absorbing buffer are supplied along with the Sodium Iodide I-131 solution for the preparation of sodium iodide I-131 capsules, therapeutic.

{ "type": "p", "children": [], "text": "Sodium Iodide I-131 solution componentis available in customer ordered vials available in 1, 2 and 3 mL V-Vials containing colorless, aqueous concentrated Sodium Iodide I-131 Solution at a strength of 37,000 MBq/mL (1000 mCi/mL) at time of calibration for preparation of sodium iodide I-131 capsules, therapeutic or sodium iodide I-131 solution, therapeutic. \n Large empty gelatin capsules and \n small gelatin capsules containing approximately 300 mg of dibasic sodium phosphate anhydrous as the absorbing buffer are supplied along with the Sodium Iodide I-131 solution for the preparation of sodium iodide I-131 capsules, therapeutic.\n " }

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 2. Sodium Iodide I-131 Dispensing Concentrate Solution *At time of calibration</span> </caption> <tbody class="Headless"> <tr class="First"> <td> Vial Type (Stopper)</td><td> mCi I-131/mL</td><td> Maximum Volume (mL)</td> </tr> <tr> <td> 1 mL V-Vial (13 mm)</td><td> 1000</td><td> 0.75</td> </tr> <tr> <td> 2 mL V-Vial (13 mm)</td><td> 1000</td><td> 1.50</td> </tr> <tr> <td> 3 mL V-vial (20 mm) </td><td> 1000</td><td> 2.25</td> </tr> <tr class="Last"> <td></td><td></td><td></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span>Table 2. Sodium Iodide I-131 Dispensing Concentrate Solution *At time of calibration</span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td> Vial Type (Stopper)</td><td> mCi I-131/mL</td><td> Maximum Volume (mL)</td>\n</tr>\n<tr>\n<td> 1 mL V-Vial (13 mm)</td><td> 1000</td><td> 0.75</td>\n</tr>\n<tr>\n<td> 2 mL V-Vial (13 mm)</td><td> 1000</td><td> 1.50</td>\n</tr>\n<tr>\n<td> 3 mL V-vial (20 mm) </td><td> 1000</td><td> 2.25</td>\n</tr>\n<tr class=\"Last\">\n<td></td><td></td><td></td>\n</tr>\n</tbody>\n</table></div>" }

Sodium Iodide I-131 is contraindicated in:

{ "type": "p", "children": [], "text": "Sodium Iodide I-131 is contraindicated in:" }

{ "type": "ul", "children": [ "Patients with vomiting and diarrhea \n [see \n Warning and Precautions (5.7)] \n .\n ", "Patients with thyroid malignancies shown to have no iodide uptake, which include the majority of medullary or anaplastic carcinomas.", "Patients receiving concurrent anti-thyroid therapy \n [see \n Warning and Precautions (5.1) and \n Drug Interactions (7)] \n .\n ", "Pregnancy \n [see \n Warnings and Precautions (5.4), see \n Use in Specific Populations (8.1)] \n .\n ", "Lactation \n [see \n Warnings and Precautions (5.5)] \n .\n " ], "text": "" }

Sodium iodide I 131 may cause thyroiditis with release of thyroid hormone, which may aggravate hyperthyroidism and thyrotoxic cardiac disease [see Adverse Reactions (6)] . When treating hyperthyroidism, consider pre-treatment anti-thyroid medication to help deplete the thyroid hormone. Discontinue the anti-thyroid therapy three days before administration of sodium iodide I 131 [see Drug Interactions (7)] . Consider a beta-blocker pre or post-treatment to minimize the risk of hyperthyroidism and thyroid storm.

The thyroiditis may cause gland enlargement resulting in tenderness and swelling of the neck, pain on swallowing, sore throat, and cough; which may occur approximately the third day after sodium iodide I 131 administration. Consider management with pain-reliever or anti-inflammatory medications.

Sodium Iodide I 131 may cause radiation induced toxicities [see Adverse Reactions (6)] :

Obtain a complete blood count within one month of therapy. If patients show leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity, while delivering less than 2 Gy to the bone marrow.

Advise good hydration for one week following sodium iodide I 131 administration and stimulate salivary flow via a sialagogue (e.g. sugar-free candy or gum, pilocarpine, and ascorbic acid) to reduce radiation exposure to the salivary glands.

Advise patients to void frequently after administration of radioiodide to enhance excretion.

Hypersensitivity reactions including anaphylaxis may occur in patients who receive sodium iodide I 131. Although iodide is not considered an allergen, hypersensitivity reactions may occur in relation with excipients or chemical component of the capsule, such as sodium thiosulfate. Obtain and document an allergy history, particularly a sulfite allergy. Emergency resuscitation equipment and personnel should be immediately available [see Adverse Reactions (6)] .

Sodium Iodide I-131 Solution is contraindicated in pregnancy because sodium iodide I-131 crosses the placenta and fetal exposure can lead to neonatal hypothyroidism. Multiple reports in the published literature describe hypothyroidism in the neonates following in utero exposure to sodium iodide I-131. Some cases of neonatal hypothyroidism were severe and irreversible. Verify pregnancy status of females of reproductive potential prior to initiating Sodium Iodide I-131 Solution treatment. Advise females and males of reproductive potential to use effective contraception during treatment with Sodium Iodide I-131 Solution and for at least six months after the last dose [see Use in Specific Populations (8.1, 8.3)].

Sodium Iodide I-131 Solution is contraindicated in lactating women because sodium iodide I-131 concentrates in the breast via the increased expression of the sodium iodide symporter in breast tissue with lactation. The literature describes moderate to marked radioiodine uptake in the breast tissue for 5 to 32 weeks post cessation of breast feeding. Advise lactating women to discontinue breast feeding at least 6 weeks prior to administration of sodium iodide I-131 to allow sufficient time for involution to occur and to avoid excess concentration of sodium iodide I-131 in breast tissue. Consider administration of drugs to suppress lactation. Consider diagnostic scintigraphy before administration of sodium iodide I-131 to assess the persistence of uptake by breast tissue. If sodium iodide I-131 is administered in the postpartum period, the lactating mother should not breastfeed the infant [see Use in Specific Populations (8.2)] .

Transient dose-related impairment of testicular function in men and transient ovarian insufficiency in women has been reported after sodium iodide I-131 therapy. Sperm banking for men may be considered prior to administration of Sodium Iodide I-131 Solution for thyroid carcinoma [see Use in Specific Populations (8.3)] .

Household Contacts Instruct patients to follow radiation safety precautions after receiving Sodium Iodide I-131 to minimize the radiation contamination of other persons or the environment. Patients should avoid close contact with others, especially pregnant women and children, and take care to avoid contamination of other persons or the environment with body fluids.

Patients and Healthcare Providers Sodium Iodide I-131 contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Follow safe handling and administration to minimize radiation exposure to the patient and healthcare providers.

Certain food or drugs may alter the thyroid uptake of sodium iodide I 131 and diminish its effectiveness. Recent intake of stable iodide in any form, or the use of thyroid or anti-thyroid drugs may diminish thyroid uptake of sodium iodide I 131 [see Drug Interactions (7)] .

The following adverse reactions have been reported during post-approval use of sodium iodide I-131 (Table 3). 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.

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="99.04%"> <tbody class="Headless"> <tr class="First"> <td colspan="2"> <p class="First">Table 3 Postmarket Adverse Reactions by System Organ Class</p> </td> </tr> <tr> <td> <p class="First">System Organ Class*</p> </td><td> <p class="First">Symptoms*</p> </td> </tr> <tr> <td> <p class="First">Cardiac disorders</p> </td><td> <p class="First">Chest pain, tachycardia</p> </td> </tr> <tr> <td> <p class="First">Congenital, familial and genetic disorders</p> </td><td> <p class="First">Chromosomal abnormalities, congenital hypothyroidism</p> </td> </tr> <tr> <td> <p class="First">Endocrine disorders</p> </td><td> <p class="First">Hyperthyroidism, hypoparathyroidism, hypothyroidism, thyrotoxic crisis</p> </td> </tr> <tr> <td> <p class="First">Eye disorders</p> </td><td> <p class="First">Lacrimal gland dysfunction</p> </td> </tr> <tr> <td> <p class="First">Gastrointestinal disorders</p> </td><td> <p class="First">Gastritis, nausea, salivary gland dysfunction, sialadenitis, vomiting</p> </td> </tr> <tr> <td> <p class="First">General disorders and administration site conditions</p> </td><td> <p class="First">Local swelling of thyroid or sites of iodide avid tumor</p> </td> </tr> <tr> <td> <p class="First">Hematologic and lymphatic disorders including fatalities</p> </td><td> <p class="First">Anemia, blood dyscrasia, bone marrow depression, leukopenia, thrombocytopenia</p> </td> </tr> <tr> <td> <p class="First">Immune system disorders</p> </td><td> <p class="First">Bronchospasm</p> </td> </tr> <tr> <td> <p class="First">Neoplasms benign, malignant and unspecified (including cysts and polyps)</p> </td><td> <p class="First">Acute leukemia, solid cancer</p> </td> </tr> <tr> <td> <p class="First">Nervous system disorders</p> </td><td> <p class="First">+Cerebral edema, headache</p> </td> </tr> <tr> <td> <p class="First">Respiratory, thoracic and mediastinal disorders</p> </td><td> <p class="First">♦Pulmonary fibrosis, ♦radiation pneumonitis</p> </td> </tr> <tr> <td> <p class="First">Skin and subcutaneous tissue disorders</p> </td><td> <p class="First">Hives, itching, rash</p> </td> </tr> <tr> <td> <p class="First">* In alphabetical order</p> <p>+ In patients with iodide-avid brain metastases</p> <p>♦ In patients with iodide-avid lung metastases</p> </td><td></td> </tr> <tr class="Last"> <td colspan="2"> <p class="First"></p> </td> </tr> </tbody> </table></div>

{ "type": "ul", "children": [ "Concomitant use of bone marrow depressants may enhance the depression of the hematopoietic system caused by the use of large doses of sodium iodide I 131 \n [see \n Warnings and Precautions (5.2)] \n .\n ", "Many drugs and iodide-containing foods interfere with the accumulation of radioiodide by the thyroid. Review the patients history, current medications, and recent diagnostic tests prior to the administration of sodium iodide I 131 \n [see \n Warnings and Precautions (5.8)] \n .\n ", "Advise patients to maintain a low-iodide diet two weeks prior to radioiodide administration and continue for several days during the uptake or imaging process and to discontinue taking the following products before they undergo the procedure as shown in Table 4." ], "text": "" }

<div class="scrollingtable"><table width="80%"> <caption> <span>Table 4 Pharmaceuticals/OTCs/Agents Blocking Radioiodine Uptake</span> </caption> <colgroup> <col width="60%"/> <col width="40%"/> </colgroup> <tbody class="Headless"> <tr align="center" class="Bold Botrule First First"> <td class="Lrule Rrule">Type of Medication</td><td align="center" class="Lrule Rrule">Recommended time of withdrawal</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule">Thionamide medications <br/> <br/> (e.g., propylthiouracil, methimazole, carbimazole) </td><td class="Lrule Rrule">3 days</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule">Multivitamins containing iodide</td><td class="Lrule Rrule">10 days</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule"><span class="Underline">Natural or synthetic thyroid hormones</span> <br/> <br/> triiodothyronine <br/> <br/> thyroxine </td><td class="Lrule Rrule" valign="bottom"> <p class="First">2 weeks</p> <p>4 weeks</p> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule">Iodide-containing foods: iodized salt, dairy products, egg yolks, seafood, turkey and liver</td><td class="Lrule Rrule">2 weeks</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule">Kelp, agar, carrageenan, Lugol solution</td><td class="Lrule Rrule">3 weeks</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule">Saturated solution of potassium iodide</td><td class="Lrule Rrule">3 weeks</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule">Topical iodide <br/> <br/> (e.g., surgical skin preparation) </td><td class="Lrule Rrule">3 weeks</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule"><span class="Underline">Intravenous radiographic contrast agents</span> <br/> <br/> Water soluble <br/> <br/> Lipophilic </td><td class="Lrule Rrule" valign="bottom"> <p class="First">2 months</p> <p>6 months</p> </td> </tr> <tr class="Last"> <td class="Lrule Rrule">Amiodarone</td><td class="Lrule Rrule">6 months</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"80%\">\n<caption>\n<span>Table 4 Pharmaceuticals/OTCs/Agents Blocking Radioiodine Uptake</span>\n</caption>\n<colgroup>\n<col width=\"60%\"/>\n<col width=\"40%\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr align=\"center\" class=\"Bold Botrule First First\">\n<td class=\"Lrule Rrule\">Type of Medication</td><td align=\"center\" class=\"Lrule Rrule\">Recommended time of withdrawal</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\">Thionamide medications\n <br/>\n<br/>\n\t\t\t(e.g., propylthiouracil, methimazole, carbimazole)\n </td><td class=\"Lrule Rrule\">3 days</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\">Multivitamins containing iodide</td><td class=\"Lrule Rrule\">10 days</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\"><span class=\"Underline\">Natural or synthetic thyroid hormones</span>\n<br/>\n<br/>\n\t\t\ttriiodothyronine\n <br/>\n<br/>\n\t\t\tthyroxine\n </td><td class=\"Lrule Rrule\" valign=\"bottom\">\n<p class=\"First\">2 weeks</p>\n<p>4 weeks</p>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\">Iodide-containing foods: iodized salt, dairy products, egg yolks, seafood, turkey and liver</td><td class=\"Lrule Rrule\">2 weeks</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\">Kelp, agar, carrageenan, Lugol solution</td><td class=\"Lrule Rrule\">3 weeks</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\">Saturated solution of potassium iodide</td><td class=\"Lrule Rrule\">3 weeks</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\">Topical iodide\n <br/>\n<br/>\n\t\t\t(e.g., surgical skin preparation)\n </td><td class=\"Lrule Rrule\">3 weeks</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\"><span class=\"Underline\">Intravenous radiographic contrast agents</span>\n<br/>\n<br/>\n\t\t\tWater soluble\n <br/>\n<br/>\n\t\t\tLipophilic\n </td><td class=\"Lrule Rrule\" valign=\"bottom\">\n<p class=\"First\">2 months</p>\n<p>6 months</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Lrule Rrule\">Amiodarone</td><td class=\"Lrule Rrule\">6 months</td>\n</tr>\n</tbody>\n</table></div>" }

Risk Summary Sodium Iodide I-131 is contraindicated in pregnancy because fetal exposure can lead to neonatal hypothyroidism, which in some cases is severe and irreversible [see Warnings and Precautions (5.4)] . Data from the published literature describe thyroid abnormalities after fetal exposure; including agenesis of the thyroid and hypothyroidism (see Data). No animal reproductive studies have been conducted.

Clinical Considerations. Fetal/ Neonatal Adverse Reactions A fetus exposed to sodium iodide I 131 can develop neonatal hypothyroidism. Delay in diagnosis of neonatal hypothyroidism after exposure to sodium iodide I 131 in utero can result in severe sequelae such as decreased mental capacity and delayed bone age. Monitor thyroid function in any infant born after in utero exposure to sodium iodide I 131.

Data Human Data Sodium iodide I 131 crosses the placenta and the fetal thyroid begins to concentrate iodide during the 10-12 th week of gestation. In literature reports of maternal exposures to sodium iodide I 131 at doses of 333 – 8325 MBq (9 – 225 mCi) during 4-26 weeks gestational age, the most common adverse outcomes were hypothyroid infants and children.

Risk Summary Sodium Iodide I-131 Solution is contraindicated during lactation because I-131 concentrates in the breast during lactation via the increased expression of the sodium iodide symporter in breast tissue and can lead to hypothyroidism in the infant through breastfeeding. If sodium iodide I-131 is administered postpartum, breastfeeding should not be restarted for the remainder of the postpartum period. In addition, to minimize the absorbed radiation dose to the breast tissue, breastfeeding and breast-pumping should be discontinued for at least 6 weeks before administration of sodium iodide I-131 [see Warnings and Precautions (5.5)] . Infants exposed to sodium iodide I-131 through breast milk are at risk for development of hypothyroidism because sodium iodide I-131 is distributed into breast milk and may reach concentrations equal to or greater than concentrations in maternal plasma(see Data).

Data Published literature describes sodium iodide I-131 transfer into breast milk and uptake by the thyroid of the breastfed infant. The amount of sodium Iodide I-131 detected in the breast milk at 36 to 48 hours after administration is 1% to 27% of the injected dose (with injected doses between 1.1 MBq to 5,143 MBq).

Sodium Iodide I-131 is contraindicated in pregnancy because of the risk of fetal hypothyroidism [see Warnings and Precautions (5.4) and [see Use in Specific Populations (8.1)] .

Pregnancy Testing Obtain a pregnancy test in females of reproductive potential and verify the absence of pregnancy before initiating treatment [see Dosage and Administration (2.2)].

Contraception Advise females and males of reproductive potential to use effective contraception during treatment with Sodium Iodide I-131 Solution and for at least six months after the last dose of Sodium Iodide I-131 Solution.

Infertility Females Fertility may be impaired with Sodium Iodide I-131 Solution treatment. Transient amenorrhea and ovarian insufficiency have been observed after sodium iodide I-131 therapy in females. The literature describes reports of transient menstrual cycle irregularities, including amenorrhea, and ovarian failure in females treated with cumulative doses of 1,000 MBq to 59,000 MBq (27 mCi to 1,595 mCi) sodium iodide I-131. In a published literature analysis, the effects on fertility occurred in up to 30% of women treated with sodium iodide I-131, and may resolve 12 months after treatment.

Males Fertility may be impaired with Sodium Iodide I-131 Solution treatment. Discuss sperm banking for males who are expected to receive a high cumulative dose of sodium iodide I-131. Transient dose-related impairment of testicular function after sodium iodide I-131 therapy has been reported in the published literature. The literature describes reports of males treated with sodium iodide I-131 at doses of 370 MBq to 22,000 MBq (10 mCi to 595 mCi) resulting in transiently impaired testicular function (including spermatogenesis). The risk of persistent testicular dysfunction increases after administration of repeated or high cumulative radioiodide exposure.

The safety and effectiveness of Sodium Iodide I-131 Solution have not been established in pediatric patients. Pediatric patients are at an increased lifetime risk for malignancy from radiation exposure.

Clinical experience has not identified differences in safety or effectiveness in geriatric patients compared to younger patients. However, elderly patients are more likely to have decreased renal function and radiation exposure is greater in patients with impaired renal function [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Sodium Iodide I 131 is primarily excreted by the kidneys. Renal function impairment decreases excretion of sodium iodide I 131 and increases the radiation exposure and risk of radiation toxicity. For patients with a history of renal impairment, evaluate renal function for therapeutic planning and consider dosimetry. Sodium Iodide I 131 is dialyzable. Hemodialysis can be used to reduce total body radiation exposure [see Clinical Pharmacology (12.3)].

In case of exposure to a radioactive dose of sodium iodide I 131 exceeding the intended therapeutic dose, provide general supportive care, promote frequent voiding, monitor for bone marrow and thyroid suppression. Consider administering a thyroid blocking agent (e.g. potassium iodide (KI) or perchlorate) promptly within 4 to 6 hours after the exposure. Assess the benefit of administering a thyroid blocking agent against the risk of failure of sodium iodide I 131 therapy. Appropriate replacement therapy is recommended if hypothyroidism occurs.

{ "type": "p", "children": [], "text": "In case of exposure to a radioactive dose of sodium iodide I 131 exceeding the intended therapeutic dose, provide general supportive care, promote frequent voiding, monitor for bone marrow and thyroid suppression. Consider administering a thyroid blocking agent (e.g. potassium iodide (KI) or perchlorate) promptly within 4 to 6 hours after the exposure. Assess the benefit of administering a thyroid blocking agent against the risk of failure of sodium iodide I 131 therapy. Appropriate replacement therapy is recommended if hypothyroidism occurs." }

Sodium Iodide I-131 Solution, a radioactive therapeutic agent, provides a concentrated solution of sodium iodide I-131 with a radioconcentration of 37,000 MBq/mL (1,000 mCi/mL). Each mL of the concentrated solution contains 37,000 MBq of no-carrier-added sodium iodide I-131, disodium edetate dihydrate USP as a stabilizer, sodium thiosulfate pentahydrate USP as a reducing agent, and dibasic sodium phosphate anhydrous USP. The pH of the concentrated solution is between 7.5 and 10.

The concentrated solution provided with Sodium Iodide I-131 Solution is used for the preparation of sodium iodide I-131 capsules or sodium iodide I-131 solution of varying strengths for oral administration for therapy.

Sodium iodide I-131 solution is designated chemically as Na 131I and has a molecular weight of 153.99 g/mol. Hard gelatin capsules, provided for the preparation of the sodium iodide I-131 capsules final dosage form, contain approximately 300 mg of dibasic sodium phosphate anhydrous USP as the absorbing buffer.

Iodine I-131 decays by beta emission and associated gamma emission with a physical half-life of 8.02 days. The principal radiation emissions are listed in Table 5.

<div class="scrollingtable"><table width="50%"> <caption> <span>Table 5 Principal Radiation Emission Data from Decay of Sodium Iodide I 131</span> </caption> <colgroup> <col width="33%"/> <col align="center" width="34%"/> <col align="center" width="33%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First First"> <td align="center" class="Lrule Rrule">Radiation</td><td align="center" class="Lrule Rrule">Mean % per <br/> <br/> Disintegration </td><td align="center" class="Lrule Rrule">Mean Energy <br/> <br/> (keV) </td> </tr> <tr> <td class="Lrule Rrule">Beta-1</td><td align="center" class="Lrule Rrule">2.1%</td><td align="center" class="Lrule Rrule">69.4</td> </tr> <tr> <td class="Lrule Rrule">Beta-3</td><td align="center" class="Lrule Rrule">7.2%</td><td align="center" class="Lrule Rrule">96.6</td> </tr> <tr> <td class="Lrule Rrule">Beta-4</td><td align="center" class="Lrule Rrule">89.4%</td><td align="center" class="Lrule Rrule">191.6</td> </tr> <tr> <td class="Lrule Rrule">Gamma-7</td><td align="center" class="Lrule Rrule">6.1%</td><td align="center" class="Lrule Rrule">284.3</td> </tr> <tr> <td class="Lrule Rrule">Gamma-14</td><td align="center" class="Lrule Rrule">81.2%</td><td align="center" class="Lrule Rrule">364.5</td> </tr> <tr class="Last"> <td class="Lrule Rrule">Gamma-18</td><td align="center" class="Lrule Rrule">7.1%</td><td align="center" class="Lrule Rrule">637.0</td> </tr> </tbody> </table></div>

The specific gamma-ray constant for iodide I 131 is 4.26 × 10 -13 C·m 2·kg -1·MBq -1·s -1 (2.2 R·cm 2/mCi·hr). The first half-value thickness of lead (Pb) for iodide I 131 is 0.27 cm. A range of values for the relative attenuation of the radiation emitted by iodide I 131 that results from interposition of various thicknesses of Pb is shown in Table 6. For example, the use of 2.59 cm of Pb will decrease the external radiation exposure by a factor of about 1,000.

<div class="scrollingtable"><table width="50%"> <caption> <span>Table 6 Radiation Attenuation of Iodine I 131 by Lead Shielding</span> </caption> <colgroup> <col align="center" width="50%"/> <col align="center" width="50%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First First"> <td align="center" class="Lrule Rrule"> <p class="First">Shield Thickness <br/> <br/> (Pb) cm </p> </td><td align="center" class="Lrule Rrule">Coefficient of Attenuation</td> </tr> <tr> <td align="center" class="Lrule Rrule">0.27</td><td align="center" class="Lrule Rrule">0.5</td> </tr> <tr> <td align="center" class="Lrule Rrule">0.56</td><td align="center" class="Lrule Rrule">0.25</td> </tr> <tr> <td align="center" class="Lrule Rrule">0.99</td><td align="center" class="Lrule Rrule">10 <span class="Sup">-1</span></td> </tr> <tr> <td align="center" class="Lrule Rrule">2.59</td><td align="center" class="Lrule Rrule">10 <span class="Sup">-2</span></td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule">4.53</td><td align="center" class="Lrule Rrule">10 <span class="Sup">-3</span></td> </tr> </tbody> </table></div>

To correct for physical decay of iodine I 131, the fractions that remain at selected intervals after the time of calibration are shown in Table 7.

<div class="scrollingtable"><table width="80%"> <caption> <span>Table 7 Physical Decay Chart: Iodine I-131 Half-Life 8.02 days</span> </caption> <colgroup> <col width="16%"/> <col align="center" width="17%"/> <col align="center" width="16%"/> <col align="center" width="17%"/> <col align="center" width="16%"/> <col align="center" width="18%"/> </colgroup> <tfoot> <tr class="First First Last Last"> <td colspan="6">*Calibration time</td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Toprule">Days</td><td align="center" class="Botrule Toprule">Fraction Remaining</td><td align="center" class="Botrule Toprule">Days</td><td align="center" class="Botrule Toprule">Fraction Remaining</td><td align="center" class="Botrule Toprule">Days</td><td align="center" class="Botrule Rrule Toprule">Fraction Remaining</td> </tr> <tr> <td align="center" class="Lrule">0*</td><td align="center">1.000</td><td align="center">11</td><td align="center">.386</td><td align="center">22</td><td align="center" class="Rrule">.149</td> </tr> <tr> <td align="center" class="Lrule">1</td><td align="center">.917</td><td align="center">12</td><td align="center">.354</td><td align="center">23</td><td align="center" class="Rrule">.137</td> </tr> <tr> <td align="center" class="Lrule">2</td><td align="center">.841</td><td align="center">13</td><td align="center">.325</td><td align="center">24</td><td align="center" class="Rrule">.126</td> </tr> <tr> <td align="center" class="Lrule">3</td><td align="center">.772</td><td align="center">14</td><td align="center">.298</td><td align="center">25</td><td align="center" class="Rrule">.115</td> </tr> <tr> <td align="center" class="Lrule">4</td><td align="center">.708</td><td align="center">15</td><td align="center">.274</td><td align="center">26</td><td align="center" class="Rrule">.106</td> </tr> <tr> <td align="center" class="Lrule">5</td><td align="center">.649</td><td align="center">16</td><td align="center">.251</td><td align="center">27</td><td align="center" class="Rrule">.097</td> </tr> <tr> <td align="center" class="Lrule">6</td><td align="center">.595</td><td align="center">17</td><td align="center">.230</td><td align="center">28</td><td align="center" class="Rrule">.089</td> </tr> <tr> <td align="center" class="Lrule">7</td><td align="center">.546</td><td align="center">18</td><td align="center">.211</td><td align="center">29</td><td align="center" class="Rrule">.082</td> </tr> <tr> <td align="center" class="Lrule">8</td><td align="center">.501</td><td align="center">19</td><td align="center">.194</td><td align="center">30</td><td align="center" class="Rrule">.075</td> </tr> <tr> <td align="center" class="Lrule">9</td><td align="center">.459</td><td align="center">20</td><td align="center">.178</td><td align="center"></td><td align="center" class="Rrule"></td> </tr> <tr class="Last"> <td align="center" class="Lrule">10</td><td align="center">.421</td><td align="center">21</td><td align="center">.163</td><td align="center"></td><td align="center" class="Rrule"></td> </tr> </tbody> </table></div>

Iodide is actively transported by the sodium-iodide symporter (NIS) protein, in thyroid follicular cells. Iodide is concentrated in follicular cells to levels up to 50 times higher than in the plasma. Iodide is metabolically oxidized by thyroid peroxidase to iodinium (I +) which in turn iodinates tyrosine residues of thyroglobulin (tri or tetra-iodinated tyrosine). The beta emission of I 131 is responsible for the therapeutic effect.

The relationship between the extent of iodide I 131 exposure and pharmacologic effects has not been explored in clinical trials.

Absorption Following oral administration of sodium iodide I 131, 90% of the administered radioactivity of Iodide I 131 is systemically absorbed in the first 60 minutes.

Distribution Following absorption, I 131 is distributed within the extra-cellular space. It is actively transported by the sodium-iodide symporter (NIS) protein, and binds to thyroglobulin resulting in accumulation in the thyroid. The thyroid uptake of iodide is usually increased in hyperthyroidism and in goiter, and is decreased in hypothyroidism. Sodium Iodide I 131 also accumulates in the stomach, choroid plexus, salivary glands, breast, liver, gall bladder, and kidneys.

Elimination Metabolism In thyroidal follicular cells iodide is oxidized through the action of thyroid peroxidase to iodinium (I +) which in turn iodinates tyrosine residues of thyroglobulin.

Excretion Sodium iodide I 131 is excreted in urine and feces. The normal range of urinary excretion is 37% to 75% of the administered dose, varying with the thyroid and renal function of the patient. Fecal excretion is about 10%.

The Sodium Iodide I-131 Solution provides a concentrated solution of sodium iodide I-131 with a radioconcentration of 37,000 MBq/mL (1,000 mCi/mL) at the time of calibration and can be supplied in any of the following vials: 1, 2 and 3 mL clear glass V-vials.

The concentrated solution is intended for use in the preparation of capsules and solutions of varying strengths for oral administration.

<div class="scrollingtable"><table width="584"> <caption> <span>Concentrated Sodium Iodide I-131 Solution</span> </caption> <tbody class="Headless"> <tr class="First"> <td>NDC Code</td><td>Size/type Container</td> </tr> <tr> <td>69208-001-15</td><td>1 mL V-vial</td> </tr> <tr> <td>69208-001-25</td><td>2 mL V-vial</td> </tr> <tr class="Last"> <td>69208-001-35</td><td>3 mL V-vial</td> </tr> </tbody> </table></div>

A minimum of one carton of capsules containing 2 blister packs of capsules may be provided with each shipment. Each blister pack includes 5 empty #1 capsules and 5 filled #2 capsules containing approximately 300 mg of dibasic sodium phosphate anhydrous USP as the absorbing buffer. The capsules may be supplied along with the Sodium Iodide I-131 Solution for the preparation of sodium iodide I-131 capsules, therapeutic.

The Sodium Iodide I-131 Solution should be stored between 2 °C and 25 °C (36 °F and 77 °F). Store and dispose of Sodium Iodide I-131 Solution in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide. Use Sodium Iodide I-131 Solution per the expiry date on the lead shield label. Use prepared capsules within 7 days of preparing.

Discard unused capsules after all Sodium Iodide I-131Solution has been dispensed or expired. New blister packages of hard gelatin capsules may be provided with each new shipment of Sodium Iodide I-131 Solution.

This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

Radiation Safety Precautions [see Warnings and Precautions (5.7)] .

{ "type": "p", "children": [], "text": "\nRadiation Safety Precautions [see \n Warnings and Precautions (5.7)] \n .\n " }

{ "type": "ul", "children": [ "Advise patients treated for hyperthyroidism to monitor for and seek medical care for signs and symptoms of thyrotoxicosis and thyroid storm arising during the post-treatment period. For mild radiation-induced thyroiditis, patients may be advised to consider symptomatic management with pain-relievers or anti-inflammatory medications \n [see \n Warnings and Precautions (5.1)] \n .\n ", "Advise patients to hydrate and void frequently and to use a sialagogue after administration of radioiodide to minimize radiation dose \n [see \n Warnings and Precautions (5.2)] \n .\n ", "Advise patients to avoid close contact with others, especially pregnant women and children, and to take care to avoid contamination of other persons or the environment with body fluids \n [see \n Warnings and Precautions (5.7)] \n .\n " ], "text": "" }

Embryo-Fetal Toxicity

{ "type": "p", "children": [], "text": "\nEmbryo-Fetal Toxicity\n" }

{ "type": "ul", "children": [ "Advise female patients of the risk to a fetus \n [see \n Warnings and Precautions (5.4) , \n Use in Specific Populations (8.1)] \n .\n ", "Advise females and males of reproductive potential to use effective contraception during treatment with sodium iodide I 131 and for at least 6 months after the last dose \n [see \n Warnings and Precautions (5.4) , \n Use in Specific Populations (8.3)] \n .\n ", "Advise female patients to contact their healthcare provider with a known or suspected pregnancy." ], "text": "" }

Lactation • Instruct women to stop breastfeeding and breast-pumping at least 6 weeks prior to sodium iodide I 131 administration [see Contraindications (4), Warnings and Precautions (5.5) and Use in Specific Populations (8.2)].

{ "type": "p", "children": [], "text": "\nLactation\n\n\n• Instruct women to stop breastfeeding and breast-pumping at least 6 weeks prior to sodium iodide I 131 administration \n [see \n Contraindications (4), \n Warnings and Precautions (5.5) and \n Use in Specific Populations (8.2)]. \n \n" }

Effects on Fertility • Advise females and males of reproductive potential of the potential for impaired fertility with Sodium Iodide I-131 treatment [see Warnings and Precautions (5.6) and Use in Specific Populations (8.3)].

{ "type": "p", "children": [], "text": "\nEffects on Fertility\n\n\n• Advise females and males of reproductive potential of the potential for impaired fertility with Sodium Iodide I-131 treatment \n [see \n Warnings and Precautions (5.6) and \n Use in Specific Populations (8.3)]. \n \n" }

Manufactured by:

{ "type": "p", "children": [], "text": "Manufactured by:" }

Idaho Falls, Idaho 83401, USA

{ "type": "p", "children": [], "text": "Idaho Falls, Idaho 83401, USA" }

1-208-524-5300

{ "type": "p", "children": [], "text": "1-208-524-5300" }

www.intisoid.com

{ "type": "p", "children": [], "text": "www.intisoid.com" }

Sodium Iodide I-131 Solution Immediate Container Label

{ "type": "p", "children": [], "text": "\nSodium Iodide I-131 Solution Immediate Container Label\n" }

Sodium Iodide I-131 Solution - Lead Shield Label

{ "type": "p", "children": [], "text": "\nSodium Iodide I-131 Solution - Lead Shield Label\n" }

Capsule Blister Pack Label

{ "type": "p", "children": [], "text": "\nCapsule Blister Pack Label\n" }

Capsule Carton Label

{ "type": "p", "children": [], "text": "\nCapsule Carton Label\n" }

Sodium Iodide I 131 Capsules Diagnostic is indicated for use in adults for:

{ "type": "p", "children": [], "text": "Sodium Iodide I 131 Capsules Diagnostic is indicated for use in adults for:" }

{ "type": "ul", "children": [ "Assessment of thyroid function using radioactive iodine (RAI) uptake test", "Imaging the thyroid (scintigraphy)" ], "text": "" }

Sodium Iodide I 131 Capsules Diagnostic is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure to the patient and healthcare worker [see Warnings and Precautions (5.2)].

Administer Sodium Iodide I 131 Capsules Diagnostic orally prior to scanning. The recommended dose of Sodium Iodide I 131 Capsules Diagnostic for an adult patient is the following:

Consult the color-coded decay calendar that is updated in January of every year to determine which colored capsule(s) correspond to the prescribed dose: https://www.draximage.com/products/us/draximage-i-131-diagnostic-capsules/ or calculate the correct dose from the date and time of calibration provided on the container label.

Prior to Sodium Iodide I 131 Capsules Diagnostic Administration

The biokinetic and radiation dose distributions associated with thyroid uptake of iodide I 131 depend on dietary intake of stable iodine. A range of uptake percentages in an average adult (73.7 kg) are shown in Table 1. For a thyroid blocked from iodide uptake in the production of hormones, the effective half-life of iodide I 131 is approximately 1.4 hours; for "low" to "high" uptake, the effective half-life of I 131 ranges from approximately 80 to 90 hours.

<div class="scrollingtable"><table width="80%"> <caption> <span>Table 1 Absorbed dose per unit activity sodium iodide I 131 administered orally (mGy/MBq) in adult (73.7-kg reference model)</span> </caption> <colgroup> <col align="center"/> <col align="center"/> <col align="center"/> <col align="center"/> <col align="center"/> </colgroup> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" rowspan="2"><span class="Bold">Organ</span></td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="4"><span class="Bold">Thyroid uptake of I 131 (% administered activity <span class="Italics">A<span class="Sub">0</span></span>) 24 h after oral administration</span></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Blocked thyroid</span> <br/> <span class="Bold">(0% <span class="Italics">A<span class="Sub">0</span></span>)</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Low uptake</span> <br/> <span class="Bold">(16% <span class="Italics">A<span class="Sub">0</span></span>) </span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Medium uptake</span> <br/> <span class="Bold">(26% <span class="Italics">A<span class="Sub">0</span></span>)</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">High uptake</span> <br/> <span class="Bold">(36% <span class="Italics">A<span class="Sub">0</span></span>)</span></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Adrenals</td><td align="center" class="Botrule Lrule Rrule Toprule">0.044</td><td align="center" class="Botrule Lrule Rrule Toprule">0.051</td><td align="center" class="Botrule Lrule Rrule Toprule">0.055</td><td align="center" class="Botrule Lrule Rrule Toprule">0.059</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Bone surfaces</td><td align="center" class="Botrule Lrule Rrule Toprule">0.030</td><td align="center" class="Botrule Lrule Rrule Toprule">0.089</td><td align="center" class="Botrule Lrule Rrule Toprule">0.12</td><td align="center" class="Botrule Lrule Rrule Toprule">0.16</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Brain</td><td align="center" class="Botrule Lrule Rrule Toprule">0.021</td><td align="center" class="Botrule Lrule Rrule Toprule">0.093</td><td align="center" class="Botrule Lrule Rrule Toprule">0.13</td><td align="center" class="Botrule Lrule Rrule Toprule">0.17</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Breast</td><td align="center" class="Botrule Lrule Rrule Toprule">0.020</td><td align="center" class="Botrule Lrule Rrule Toprule">0.038</td><td align="center" class="Botrule Lrule Rrule Toprule">0.048</td><td align="center" class="Botrule Lrule Rrule Toprule">0.058</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Gallbladder wall</td><td align="center" class="Botrule Lrule Rrule Toprule">0.037</td><td align="center" class="Botrule Lrule Rrule Toprule">0.043</td><td align="center" class="Botrule Lrule Rrule Toprule">0.046</td><td align="center" class="Botrule Lrule Rrule Toprule">0.049</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Gastrointestinal tract</td><td align="center" class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Stomach wall</td><td align="center" class="Botrule Lrule Rrule Toprule">0.87</td><td align="center" class="Botrule Lrule Rrule Toprule">0.77</td><td align="center" class="Botrule Lrule Rrule Toprule">0.71</td><td align="center" class="Botrule Lrule Rrule Toprule">0.66</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Small intestine wall</td><td align="center" class="Botrule Lrule Rrule Toprule">0.035</td><td align="center" class="Botrule Lrule Rrule Toprule">0.033</td><td align="center" class="Botrule Lrule Rrule Toprule">0.032</td><td align="center" class="Botrule Lrule Rrule Toprule">0.032</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Colon wall</td><td align="center" class="Botrule Lrule Rrule Toprule">0.14</td><td align="center" class="Botrule Lrule Rrule Toprule">0.14</td><td align="center" class="Botrule Lrule Rrule Toprule">0.14</td><td align="center" class="Botrule Lrule Rrule Toprule">0.14</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">(Upper large intestine wall)</td><td align="center" class="Botrule Lrule Rrule Toprule">0.12</td><td align="center" class="Botrule Lrule Rrule Toprule">0.12</td><td align="center" class="Botrule Lrule Rrule Toprule">0.12</td><td align="center" class="Botrule Lrule Rrule Toprule">0.12</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">(Lower large intestine wall)</td><td align="center" class="Botrule Lrule Rrule Toprule">0.17</td><td align="center" class="Botrule Lrule Rrule Toprule">0.17</td><td align="center" class="Botrule Lrule Rrule Toprule">0.17</td><td align="center" class="Botrule Lrule Rrule Toprule">0.16</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Heart wall</td><td align="center" class="Botrule Lrule Rrule Toprule">0.062</td><td align="center" class="Botrule Lrule Rrule Toprule">0.089</td><td align="center" class="Botrule Lrule Rrule Toprule">0.10</td><td align="center" class="Botrule Lrule Rrule Toprule">0.12</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Kidneys</td><td align="center" class="Botrule Lrule Rrule Toprule">0.27</td><td align="center" class="Botrule Lrule Rrule Toprule">0.27</td><td align="center" class="Botrule Lrule Rrule Toprule">0.27</td><td align="center" class="Botrule Lrule Rrule Toprule">0.27</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Liver</td><td align="center" class="Botrule Lrule Rrule Toprule">0.050</td><td align="center" class="Botrule Lrule Rrule Toprule">0.093</td><td align="center" class="Botrule Lrule Rrule Toprule">0.12</td><td align="center" class="Botrule Lrule Rrule Toprule">0.14</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Lungs</td><td align="center" class="Botrule Lrule Rrule Toprule">0.053</td><td align="center" class="Botrule Lrule Rrule Toprule">0.10</td><td align="center" class="Botrule Lrule Rrule Toprule">0.13</td><td align="center" class="Botrule Lrule Rrule Toprule">0.15</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Muscles</td><td align="center" class="Botrule Lrule Rrule Toprule">0.026</td><td align="center" class="Botrule Lrule Rrule Toprule">0.084</td><td align="center" class="Botrule Lrule Rrule Toprule">0.12</td><td align="center" class="Botrule Lrule Rrule Toprule">0.15</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Oesophagus</td><td align="center" class="Botrule Lrule Rrule Toprule">0.024</td><td align="center" class="Botrule Lrule Rrule Toprule">0.10</td><td align="center" class="Botrule Lrule Rrule Toprule">0.14</td><td align="center" class="Botrule Lrule Rrule Toprule">0.19</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Ovaries</td><td align="center" class="Botrule Lrule Rrule Toprule">0.038</td><td align="center" class="Botrule Lrule Rrule Toprule">0.037</td><td align="center" class="Botrule Lrule Rrule Toprule">0.036</td><td align="center" class="Botrule Lrule Rrule Toprule">0.035</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Pancreas</td><td align="center" class="Botrule Lrule Rrule Toprule">0.060</td><td align="center" class="Botrule Lrule Rrule Toprule">0.064</td><td align="center" class="Botrule Lrule Rrule Toprule">0.066</td><td align="center" class="Botrule Lrule Rrule Toprule">0.068</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Red marrow</td><td align="center" class="Botrule Lrule Rrule Toprule">0.031</td><td align="center" class="Botrule Lrule Rrule Toprule">0.072</td><td align="center" class="Botrule Lrule Rrule Toprule">0.095</td><td align="center" class="Botrule Lrule Rrule Toprule">0.12</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Salivary glands</td><td align="center" class="Botrule Lrule Rrule Toprule">0.27</td><td align="center" class="Botrule Lrule Rrule Toprule">0.22</td><td align="center" class="Botrule Lrule Rrule Toprule">0.19</td><td align="center" class="Botrule Lrule Rrule Toprule">0.16</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Skin</td><td align="center" class="Botrule Lrule Rrule Toprule">0.019</td><td align="center" class="Botrule Lrule Rrule Toprule">0.043</td><td align="center" class="Botrule Lrule Rrule Toprule">0.057</td><td align="center" class="Botrule Lrule Rrule Toprule">0.071</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Spleen</td><td align="center" class="Botrule Lrule Rrule Toprule">0.064</td><td align="center" class="Botrule Lrule Rrule Toprule">0.069</td><td align="center" class="Botrule Lrule Rrule Toprule">0.072</td><td align="center" class="Botrule Lrule Rrule Toprule">0.075</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Testes</td><td align="center" class="Botrule Lrule Rrule Toprule">0.025</td><td align="center" class="Botrule Lrule Rrule Toprule">0.024</td><td align="center" class="Botrule Lrule Rrule Toprule">0.023</td><td align="center" class="Botrule Lrule Rrule Toprule">0.22</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Thymus</td><td align="center" class="Botrule Lrule Rrule Toprule">0.024</td><td align="center" class="Botrule Lrule Rrule Toprule">0.10</td><td align="center" class="Botrule Lrule Rrule Toprule">0.14</td><td align="center" class="Botrule Lrule Rrule Toprule">0.19</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Thyroid</td><td align="center" class="Botrule Lrule Rrule Toprule">2.2</td><td align="center" class="Botrule Lrule Rrule Toprule">280</td><td align="center" class="Botrule Lrule Rrule Toprule">430</td><td align="center" class="Botrule Lrule Rrule Toprule">580</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Urinary bladder wall</td><td align="center" class="Botrule Lrule Rrule Toprule">0.54</td><td align="center" class="Botrule Lrule Rrule Toprule">0.45</td><td align="center" class="Botrule Lrule Rrule Toprule">0.39</td><td align="center" class="Botrule Lrule Rrule Toprule">0.34</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Uterus</td><td align="center" class="Botrule Lrule Rrule Toprule">0.045</td><td align="center" class="Botrule Lrule Rrule Toprule">0.042</td><td align="center" class="Botrule Lrule Rrule Toprule">0.040</td><td align="center" class="Botrule Lrule Rrule Toprule">0.038</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">Remaining organs</td><td align="center" class="Botrule Lrule Rrule Toprule">0.029</td><td align="center" class="Botrule Lrule Rrule Toprule">0.84</td><td align="center" class="Botrule Lrule Rrule Toprule">0.11</td><td align="center" class="Botrule Lrule Rrule Toprule">0.15</td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule Toprule">Effective dose per administered activity (mSv/MBq)</td><td align="center" class="Botrule Lrule Rrule Toprule">0.28</td><td align="center" class="Botrule Lrule Rrule Toprule">14</td><td align="center" class="Botrule Lrule Rrule Toprule">22</td><td align="center" class="Botrule Lrule Rrule Toprule">29</td> </tr> </tbody> </table></div>

Capsules: Each capsule contains 3.70 MBq (100 microCi) at time of calibration. Half of each capsule is white, while the other half is either pink, yellow, orange, grey or green according to the manufactured lot. The capsule will yield 2.03, 1.11, 0.61, or 0.33 MBq (55, 30, 16.5, or 9 microCi) according to the color-coded decay calendar which assigns a color and capsule activity for each week of the year. https://www.draximage.com/products/us/draximage-i-131-diagnostic-capsules/

{ "type": "p", "children": [], "text": "Capsules: Each capsule contains 3.70 MBq (100 microCi) at time of calibration. Half of each capsule is white, while the other half is either pink, yellow, orange, grey or green according to the manufactured lot. The capsule will yield 2.03, 1.11, 0.61, or 0.33 MBq (55, 30, 16.5, or 9 microCi) according to the color-coded decay calendar which assigns a color and capsule activity for each week of the year. https://www.draximage.com/products/us/draximage-i-131-diagnostic-capsules/" }

Table 2 below displays the (5) weeks activity of the capsule starting from the calibration day.

{ "type": "p", "children": [], "text": "Table 2 below displays the (5) weeks activity of the capsule starting from the calibration day." }

<div class="scrollingtable"><table width="60%"> <caption> <span>Table 2 Weekly Activity (MBq and microCi) of Each Capsule Starting from the Calibration Day</span> </caption> <colgroup> <col align="center"/> <col align="center"/> <col align="center"/> </colgroup> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Week</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Activity (MBq)</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Activity (microCi)</span></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">1</td><td align="center" class="Botrule Lrule Rrule Toprule">3.70</td><td align="center" class="Botrule Lrule Rrule Toprule">100.0</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">2</td><td align="center" class="Botrule Lrule Rrule Toprule">2.03</td><td align="center" class="Botrule Lrule Rrule Toprule">54.9</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">3</td><td align="center" class="Botrule Lrule Rrule Toprule">1.11</td><td align="center" class="Botrule Lrule Rrule Toprule">30.0</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">4</td><td align="center" class="Botrule Lrule Rrule Toprule">0.61</td><td align="center" class="Botrule Lrule Rrule Toprule">16.5</td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule Toprule">5</td><td align="center" class="Botrule Lrule Rrule Toprule">0.33</td><td align="center" class="Botrule Lrule Rrule Toprule">8.9</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"60%\">\n<caption>\n<span>Table 2 Weekly Activity (MBq and microCi) of Each Capsule Starting from the Calibration Day</span>\n</caption>\n<colgroup>\n<col align=\"center\"/>\n<col align=\"center\"/>\n<col align=\"center\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Week</span></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Activity (MBq)</span></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Activity (microCi)</span></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">1</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">3.70</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">100.0</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">2</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">2.03</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">54.9</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">3</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">1.11</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">30.0</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">4</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0.61</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">16.5</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">5</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">0.33</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">8.9</td>\n</tr>\n</tbody>\n</table></div>" }

Sodium Iodide I 131 Capsules Diagnostic is contraindicated in pregnancy [see Warnings and Precautions (5.1), Use in Specific Populations (8.1)].

{ "type": "p", "children": [], "text": "Sodium Iodide I 131 Capsules Diagnostic is contraindicated in pregnancy [see Warnings and Precautions (5.1), Use in Specific Populations (8.1)]." }

Sodium Iodide I 131 Capsules Diagnostic is contraindicated in pregnancy because sodium iodide I 131 crosses the placenta and can cause severe and irreversible hypothyroidism in the neonate. Multiple reports in the literature describe neonatal hypothryroidism following in utero exposure to sodium iodide I 131. Some of these cases were severe and irreversible. Verify pregnancy status of females of reproductive potential prior to administering Sodium Iodide I 131 Capsules Diagnostic [see Use in Specific Populations (8.1, 8.3)].

Sodium Iodide I 131 Capsules Diagnostic contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Follow safe administration instructions to minimize radiation exposure to the patient and healthcare providers [see Dosage and Administration (2.1)].

The recent intake of stable iodine in any form, or the use of thyroid or anti-thyroid drugs will affect the uptake of sodium iodide I 131. Question the patient carefully regarding their exposure to these drugs or procedures involving radiographic contrast media [see Drug Interactions (7)].

Hypersensitivity reactions including anaphylaxis may occur in patients who receive sodium iodide I 131. Although iodine is not considered an allergen, hypersensitivity reactions may occur in relation with excipients or chemical component of the capsule, such as sodium thiosulfate. Obtain and document an allergy history, particularly a sulfite allergy. Emergency resuscitation equipment and personnel should be immediately available [see Adverse Reactions (6)].

The following adverse reaction has been described elsewhere in the labeling:

{ "type": "p", "children": [], "text": "The following adverse reaction has been described elsewhere in the labeling:" }

{ "type": "ul", "children": [ "Hypersensitivity Reactions [see Warnings and Precautions (5.4)]" ], "text": "" }

The following adverse reactions have been identified during post-approval use from Sodium Iodide I 131 Capsules Diagnostic. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

{ "type": "p", "children": [], "text": "The following adverse reactions have been identified during post-approval use from Sodium Iodide I 131 Capsules Diagnostic. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure." }

Adverse reactions associated with the administration of Sodium Iodide I 131 Capsules Diagnostic are:

{ "type": "p", "children": [], "text": "Adverse reactions associated with the administration of Sodium Iodide I 131 Capsules Diagnostic are:" }

{ "type": "ul", "children": [ "Gastrointestinal disorders: vomiting, nausea, and diarrhea", "General disorders and administration site conditions: local thyroid swelling", "Immune system disorders: hypersensitivity reactions", "Skin and subcutaneous tissue disorders: itching, rash, hives, and erythema" ], "text": "" }

Certain drugs and iodine-containing foods interfere with the accumulation of radioiodide by the thyroid. Review the patients history, current medications, and recent diagnostic tests prior to the administration of Sodium Iodide I-131 Capsules Diagnostic. Advise patients to maintain a low-iodine diet two weeks prior to radioiodine administration and continue for several days during the uptake or imaging process and to discontinue the following products before they undergo the procedure as shown in Table 3:

{ "type": "p", "children": [], "text": "Certain drugs and iodine-containing foods interfere with the accumulation of radioiodide by the thyroid. Review the patients history, current medications, and recent diagnostic tests prior to the administration of Sodium Iodide I-131 Capsules Diagnostic. Advise patients to maintain a low-iodine diet two weeks prior to radioiodine administration and continue for several days during the uptake or imaging process and to discontinue the following products before they undergo the procedure as shown in Table 3:" }

<div class="scrollingtable"><table width="80%"> <caption> <span>Table 3 Pharmaceuticals/OTCs/Agents Blocking Radioiodine Uptake</span> </caption> <col align="left" width="70%"/> <col align="center" width="30%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule"><span><span class="Bold">​Products</span></span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Recommended duration of withdrawal</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Thionamide medications<br/>(e.g., propylthiouracil, methimazole carbimazole)</td><td align="center" class="Botrule Lrule Rrule Toprule">3 days</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Multivitamins containing iodide</td><td align="center" class="Botrule Lrule Rrule Toprule">10 days</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Underline">Natural or synthetic thyroid hormones</span> <br/>triiodothyronine<br/>thyroxine</td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">2 weeks</p> <p>4 weeks</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Iodine containing foods: iodinized salt, dairy products, egg yolks, seafood, turkey, and liver</td><td align="center" class="Botrule Lrule Rrule Toprule">2 weeks</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Kelp, agar, carrageenan, Lugol solution</td><td align="center" class="Botrule Lrule Rrule Toprule">3 weeks</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Saturated solution of potassium iodide</td><td align="center" class="Botrule Lrule Rrule Toprule">3 weeks </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Topical iodine<br/>(e.g., surgical skin preparation)</td><td align="center" class="Botrule Lrule Rrule Toprule">3 weeks</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Underline">Radiographic contrast agents</span> <br/>   Water soluble<br/>   Lipophilic</td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">2 months</p> <p>6 months</p> </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule Toprule">Amiodarone</td><td align="center" class="Botrule Lrule Rrule Toprule">6 months</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"80%\">\n<caption>\n<span>Table 3 Pharmaceuticals/OTCs/Agents Blocking Radioiodine Uptake</span>\n</caption>\n<col align=\"left\" width=\"70%\"/>\n<col align=\"center\" width=\"30%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span><span class=\"Bold\">​Products</span></span></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Recommended duration of withdrawal</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\">Thionamide medications<br/>(e.g., propylthiouracil, methimazole carbimazole)</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">3 days</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\">Multivitamins containing iodide</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">10 days</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Underline\">Natural or synthetic thyroid hormones</span>\n<br/>triiodothyronine<br/>thyroxine</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">2 weeks</p>\n<p>4 weeks</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\">Iodine containing foods: iodinized salt, dairy products, egg yolks, seafood, turkey, and liver</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">2 weeks</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\">Kelp, agar, carrageenan, Lugol solution</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">3 weeks</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\">Saturated solution of potassium iodide</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">3 weeks </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\">Topical iodine<br/>(e.g., surgical skin preparation)</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">3 weeks</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Underline\">Radiographic contrast agents</span>\n<br/>   Water soluble<br/>   Lipophilic</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">2 months</p>\n<p>6 months</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\">Amiodarone</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">6 months</td>\n</tr>\n</tbody>\n</table></div>" }

Risk Summary

Sodium Iodide I 131 Capsules Diagnostic is contraindicated in pregnancy because fetal exposure can lead to neonatal hypothyroidism, which in some cases is severe and irreversible. Data from the published literature describe reports of neonatal thyroid abnormalities after fetal exposure, including agenesis of the thyroid and hypothyroidism (see Clinical Considerations, Data). No animal reproductive studies have been conducted.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

A fetus exposed to sodium iodide I 131 can develop neonatal hypothyroidism. Delay in diagnosis of neonatal hypothyroidism after exposure to sodium iodide I 131 in utero can result in severe sequelae such as decreased mental capacity and delayed skeletal maturation. Monitor thyroid function in any infant born after in utero exposure to sodium iodide I 131.

Data

Human Data

Literature reports of maternal exposures to sodium iodide I 131 at doses of 330-8300 MBq during 4-26 weeks estimated gestational age. There were various adverse pregnancy outcomes; the most common was hypothyroidism in infants and children.

Risk Summary Advise women to discontinue breastfeeding after administration of Sodium Iodide I 131 Capsules Diagnostic. Infant exposure to sodium iodide I 131 via breast milk is expected and may lead to hypothyroidism in the infant because sodium iodide I 131 in breast milk may reach concentrations equal to or greater than concentrations in maternal plasma (see Data).

Data Published studies show that sodium iodide I 131 is transferred into breast milk and is taken up by the thyroid of the breastfed infant.

Sodium Iodide I 131 is contraindicated in pregnancy because it causes fetal hypothyroidism [see Use in Specific Populations (8.1) and Warnings and Precautions (5.1)].

Pregnancy Testing Obtain a pregnancy test in females of reproductive potential and verify the absence of pregnancy before administering Sodium Iodide I 131 Capsules Diagnostic [see Dosage and Administration (2.2)].

Safety and efficacy in pediatric patients have not been established. Published reports suggest that the thyroid gland of pediatric patients is more sensitive to the adverse effects of sodium iodide I 131 (e.g., increased risk of radiation absorption).

Clinical experience has not identified differences in safety or effectiveness in geriatric patients compared to younger patients. However, elderly patients are more likely to have decreased renal function and radiation exposure is greater in patients with impaired renal function [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Radiation exposure following Sodium Iodide I 131 Capsules Diagnostic is greater in patients with impaired renal function compared to patients with normal renal function [see Clinical Pharmacology (12.3)].

In the event of an overdosage of Sodium Iodide I 131 Capsules Diagnostic, monitor for thyroid suppression and consider administering a thyroid blocking agent (e.g. potassium iodide (KI) or perchlorate). Promote frequent voiding and encourage patients to maintain hydration to minimize radiation exposure.

{ "type": "p", "children": [], "text": "In the event of an overdosage of Sodium Iodide I 131 Capsules Diagnostic, monitor for thyroid suppression and consider administering a thyroid blocking agent (e.g. potassium iodide (KI) or perchlorate). Promote frequent voiding and encourage patients to maintain hydration to minimize radiation exposure." }

Sodium Iodide I 131 Capsules Diagnostic is a radiodioactive diagnostic agent containing sodium iodide I 131 and supplied for oral administration in a gelatin capsule. Each capsule contains no-carrier-added sodium iodide I 131, disodium edetate dihydrate USP as a stabilizer, sodium thiosulfate pentahydrate USP as a reducing agent, and dibasic sodium phosphate anhydrous USP.

Sodium Iodide I 131 is designated chemically as Na131I and has a molecular weight of 153.99.

Iodine I 131 decays by beta emission and associated gamma emission with a physical half-life of 8.04 days. The principal radiation emissions are listed in Table 4.

<div class="scrollingtable"><table width="60%"> <caption> <span>Table 4 Principal Radiation Emission Data from Decay of Sodium Iodide I 131</span> </caption> <colgroup> <col align="left" width="33%"/> <col align="center" width="33%"/> <col align="center" width="33%"/> </colgroup> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">Radiation</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Mean % per Disintegration</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Mean Energy (keV) </span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Beta-1</td><td align="center" class="Botrule Lrule Rrule Toprule">2.13%</td><td align="center" class="Botrule Lrule Rrule Toprule">69.4</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Beta-3</td><td align="center" class="Botrule Lrule Rrule Toprule">7.20%</td><td align="center" class="Botrule Lrule Rrule Toprule">96.6</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Beta-4</td><td align="center" class="Botrule Lrule Rrule Toprule">89.4%</td><td align="center" class="Botrule Lrule Rrule Toprule">191.6</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Gamma-7</td><td align="center" class="Botrule Lrule Rrule Toprule">6.14%</td><td align="center" class="Botrule Lrule Rrule Toprule">284.3</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Gamma-14</td><td align="center" class="Botrule Lrule Rrule Toprule">81.2%</td><td align="center" class="Botrule Lrule Rrule Toprule">364.5</td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule Toprule">Gamma-18</td><td align="center" class="Botrule Lrule Rrule Toprule">7.12%</td><td align="center" class="Botrule Lrule Rrule Toprule">637.0</td> </tr> </tbody> </table></div>

The specific gamma-ray constant for iodine I 131 is 4.26 x 10-13 C•m2•kg-1•MBq-1•s-1 (2.2 R•cm2/mCi•hr). The first half-value thickness of lead (Pb) for iodine I 131 is 0.27 cm. A range of values for the relative attenuation of the radiation emitted by iodine I 131 that results from interposition of various thicknesses of Pb is shown in Table 5. For example, the use of 2.59 cm of Pb will decrease the external radiation exposure by a factor of about 100.

<div class="scrollingtable"><table width="60%"> <caption> <span>Table 5 Radiation Attenuation of Iodine I 131 by Lead Shielding</span> </caption> <colgroup> <col align="center" width="50%"/> <col align="center" width="50%"/> </colgroup> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Shield Thickness (Pb) cm</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Coefficient of Attenuation</span></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">0.27</td><td align="center" class="Botrule Lrule Rrule Toprule">0.5</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">0.56</td><td align="center" class="Botrule Lrule Rrule Toprule">0.25</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">0.99</td><td align="center" class="Botrule Lrule Rrule Toprule">10<span class="Sup">-1</span></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">2.59</td><td align="center" class="Botrule Lrule Rrule Toprule">10<span class="Sup">-2</span></td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule Toprule">4.53</td><td align="center" class="Botrule Lrule Rrule Toprule">10<span class="Sup">-3</span></td> </tr> </tbody> </table></div>

To correct for physical decay of iodine I 131, the fractions that remain at selected intervals after the time of calibration are shown in Table 6.

<div class="scrollingtable"><table width="80%"> <caption> <span>Table 6 Physical Decay Chart: Iodine I 131, Half-Life 8.04 days</span> </caption> <colgroup> <col align="center" width="16%"/> <col align="center" width="17%"/> <col align="center" width="16%"/> <col align="center" width="17%"/> <col align="center" width="16%"/> <col align="center" width="17%"/> </colgroup> <tfoot> <tr> <td align="left" colspan="6"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>Calibration Time</dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Days</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Fraction Remaining</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Days</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Fraction Remaining</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Days</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Fraction Remaining</span></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">0<a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a></td><td align="center" class="Botrule Lrule Rrule Toprule">1.000</td><td align="center" class="Botrule Lrule Rrule Toprule">11</td><td align="center" class="Botrule Lrule Rrule Toprule">0.388</td><td align="center" class="Botrule Lrule Rrule Toprule">22</td><td align="center" class="Botrule Lrule Rrule Toprule">0.151</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">1</td><td align="center" class="Botrule Lrule Rrule Toprule">0.918</td><td align="center" class="Botrule Lrule Rrule Toprule">12</td><td align="center" class="Botrule Lrule Rrule Toprule">0.356</td><td align="center" class="Botrule Lrule Rrule Toprule">23</td><td align="center" class="Botrule Lrule Rrule Toprule">0.138</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">2</td><td align="center" class="Botrule Lrule Rrule Toprule">0.842</td><td align="center" class="Botrule Lrule Rrule Toprule">13</td><td align="center" class="Botrule Lrule Rrule Toprule">0.327</td><td align="center" class="Botrule Lrule Rrule Toprule">24</td><td align="center" class="Botrule Lrule Rrule Toprule">0.127</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">3</td><td align="center" class="Botrule Lrule Rrule Toprule">0.773</td><td align="center" class="Botrule Lrule Rrule Toprule">14</td><td align="center" class="Botrule Lrule Rrule Toprule">0.300</td><td align="center" class="Botrule Lrule Rrule Toprule">25</td><td align="center" class="Botrule Lrule Rrule Toprule">0.116</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">4</td><td align="center" class="Botrule Lrule Rrule Toprule">0.709</td><td align="center" class="Botrule Lrule Rrule Toprule">15</td><td align="center" class="Botrule Lrule Rrule Toprule">0.275</td><td align="center" class="Botrule Lrule Rrule Toprule">26</td><td align="center" class="Botrule Lrule Rrule Toprule">0.107</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">5</td><td align="center" class="Botrule Lrule Rrule Toprule">0.651</td><td align="center" class="Botrule Lrule Rrule Toprule">16</td><td align="center" class="Botrule Lrule Rrule Toprule">0.253</td><td align="center" class="Botrule Lrule Rrule Toprule">27</td><td align="center" class="Botrule Lrule Rrule Toprule">0.098</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">6</td><td align="center" class="Botrule Lrule Rrule Toprule">0.597</td><td align="center" class="Botrule Lrule Rrule Toprule">17</td><td align="center" class="Botrule Lrule Rrule Toprule">0.232</td><td align="center" class="Botrule Lrule Rrule Toprule">28</td><td align="center" class="Botrule Lrule Rrule Toprule">0.090</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">7</td><td align="center" class="Botrule Lrule Rrule Toprule">0.548</td><td align="center" class="Botrule Lrule Rrule Toprule">18</td><td align="center" class="Botrule Lrule Rrule Toprule">0.213</td><td align="center" class="Botrule Lrule Rrule Toprule">29</td><td align="center" class="Botrule Lrule Rrule Toprule">0.083</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">8</td><td align="center" class="Botrule Lrule Rrule Toprule">0.503</td><td align="center" class="Botrule Lrule Rrule Toprule">19</td><td align="center" class="Botrule Lrule Rrule Toprule">0.195</td><td align="center" class="Botrule Lrule Rrule Toprule">30</td><td align="center" class="Botrule Lrule Rrule Toprule">0.076</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule">9</td><td align="center" class="Botrule Lrule Rrule Toprule">0.461</td><td align="center" class="Botrule Lrule Rrule Toprule">20</td><td align="center" class="Botrule Lrule Rrule Toprule">0.179</td><td align="center" class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"></td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule Toprule">10</td><td align="center" class="Botrule Lrule Rrule Toprule">0.423</td><td align="center" class="Botrule Lrule Rrule Toprule">21</td><td align="center" class="Botrule Lrule Rrule Toprule">0.164</td><td align="center" class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"></td> </tr> </tbody> </table></div>

Iodine is actively transported by the sodium-iodide symporter (NIS) protein, in thyroid follicular cells. Iodide is concentrated in follicular cells up to 50 times higher than in the plasma. Iodide is metabolically oxidized by thyroid peroxidase to iodinium (I+) which in turn iodinates tyrosine residues of thyroglobulin (tri or tetra-iodinated tyrosine). The gamma emission of Iodine I 131 is imaged or counted.

Absorption Following oral administration of Sodium Iodide I 131 Capsules Diagnostic, 90% of the administered radioactivity of sodium iodide I 131 is systemically absorbed in the first 60 minutes.

Distribution Following absorption, sodium iodide I 131 is distributed within the extra-cellular space. It is actively transported by the sodium-iodide symporter (NIS) protein and binds to thyroglobulin resulting in accumulation in the thyroid. The thyroid uptake of iodide is usually increased in hyperthyroidism and in goiter, and is decreased in hypothyroidism. Sodium iodide I 131 also accumulates in the stomach, choroid plexus, salivary glands breast, liver, gall bladder, and kidneys.

Elimination Metabolism In thyroid follicular cells, iodide is oxidized through the action of thyroid peroxidase to iodinium (I+) which in turn iodinates tyrosine residues of thyroglobulin.

Excretion Sodium iodide I 131 is excreted in urine and feces. The normal range of urinary excretion is 37% to 75% of the administered dose, varying with the thyroid and renal function of the patient. Fecal excretion is about 10%.

Each capsule contains 3.70 megabecquerels (100 microCi) at time of calibration. Half of each capsule is white, while the other half is either pink, yellow, orange, grey or green according to the manufactured lot.

Store Sodium Iodide I 131 Capsules Diagnostic between 15 °C and 30 °C (59 °F and 86 °F).

Store and dispose of Sodium Iodide I 131 Capsules Diagnostic in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.

This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

Administration Instructions

{ "type": "p", "children": [], "text": "\nAdministration Instructions\n" }

{ "type": "ul", "children": [ "Advise patients to hydrate before and after administration of Sodium Iodide I 131 Capsules Diagnostic and void frequently to ensure rapid excretion [see Dosage and Administration (2.2)].", "Advise patients to fast at least 2 hours before and 2 hours after administration to ensure absorption [see Dosage and Administration (2.2)].", "Advise patients to maintain a low-iodine diet two weeks prior to radioiodine administration and continue for several days during the uptake or imaging process [See Dosage and Administration (2.2) and Drug Interactions (7)]." ], "text": "" }

Fetal Toxicity Advise female patients of reproductive potential of the risk of neonatal hypothyroidism with fetal exposure [see Contraindications (4), Warnings and Precautions (5.1) and Use in Specific Populations (8.1, 8.3)].

{ "type": "p", "children": [], "text": "\nFetal Toxicity\nAdvise female patients of reproductive potential of the risk of neonatal hypothyroidism with fetal exposure [see Contraindications (4), Warnings and Precautions (5.1) and Use in Specific Populations (8.1, 8.3)]." }

Lactation Advise women to discontinue breastfeeding after Sodium Iodide I 131 Capsules Diagnostic administration [see Use in Specific Populations (8.2)].

{ "type": "p", "children": [], "text": "\nLactation\nAdvise women to discontinue breastfeeding after Sodium Iodide I 131 Capsules Diagnostic administration [see Use in Specific Populations (8.2)]." }

Manufactured by:Jubilant DraxImage Inc., Kirkland, Québec, Canada, H9H 4J4.

{ "type": "p", "children": [], "text": "Manufactured by:Jubilant DraxImage Inc., Kirkland, Québec, Canada, H9H 4J4." }

Art Rev.: 2.1Revised: February 2020

{ "type": "p", "children": [], "text": "Art Rev.: 2.1Revised: February 2020" }

HICON® is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma.

{ "type": "p", "children": [], "text": "HICON® is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma." }

Individualization of Therapy The recommended dose for orally administered sodium iodide I 131 capsules or solution 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.

Treatment of Hyperthyroidism The recommended dose is 148 MBq to 370 MBq (4 mCi to 10 mCi) administered orally. Toxic nodular goiter may require a larger dose.

Treatment of Thyroid Carcinoma The recommended dose is 1,100 MBq to 3,700 MBq (30 mCi to 100 mCi) administered orally. For subsequent ablation of metastases, the recommended dose is 3,700 MBq to 7,400 MBq (100 mCi to 200 mCi) administered orally.

Drug Handling

Preparation of Dilute Sodium Iodide I 131 Solution

Preparation of Sodium Iodide I 131 Capsules

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="80%"> <caption> <span>Table 1<a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a>- Absorbed dose per unit activity sodium iodide I 131 administered orally (mGy/MBq) in adult (73.7 kg reference model) </span> </caption> <colgroup></colgroup> <tfoot> <tr> <td align="left" colspan="0"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>Table 1 is not intended for treatment planning.</dd> <dt> <a href="#footnote-reference-2" name="footnote-2">†</a> </dt> <dd>These columns are not applicable to estimate organ or effective doses in patients following thyroidectomy. In patients with thyroid cancer following thyroidectomy, organ and effective doses can be estimated from the "blocked"-thyroid-uptake values.</dd> <dt> <a href="#footnote-reference-3" name="footnote-3">‡</a> </dt> <dd>These values presume unimpeded production of thyroid hormone and may not be applicable to estimate thyroid dose and effective dose in patients who have had previous treatment with I 131 for hyperthyroidism.</dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" rowspan="2" valign="middle"> <span class="Bold">Organ</span> <br/> </td><td align="center" class="Rrule" colspan="4" valign="middle"><span class="Bold">Thyroid uptake of I 131 (% administered activity A<span class="Sub">0</span>)<br/> 24 h after oral administration</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle"><span class="Bold"> Blocked thyroid<br/> (0% A<span class="Sub">0</span>)</span> <br/> <br/> </td><td class="Rrule" valign="middle"><span class="Bold"> Low uptake<a class="Sup" href="#footnote-2" name="footnote-reference-2">†</a> <br/> (16% A<span class="Sub">0</span>)</span> <br/> </td><td class="Rrule" valign="middle"><span class="Bold"> Medium uptake<a class="Sup" href="#footnote-2">†</a> <br/> (26% A<span class="Sub">0</span>)</span> <br/> </td><td class="Rrule" valign="middle"><span class="Bold"> High uptake<a class="Sup" href="#footnote-2">†</a> <br/> (36% A<span class="Sub">0</span>)</span> <br/> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Adrenals<br/> </td><td class="Rrule" valign="middle"> 0.044</td><td class="Rrule" valign="middle"> 0.051</td><td class="Rrule" valign="middle"> 0.055</td><td class="Rrule" valign="middle"> 0.059</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Bone surfaces<br/> </td><td class="Rrule" valign="middle"> 0.03<br/> </td><td class="Rrule" valign="middle"> 0.089</td><td class="Rrule" valign="middle"> 0.12</td><td class="Rrule" valign="middle"> 0.16</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Brain<br/> </td><td class="Rrule" valign="middle"> 0.021</td><td class="Rrule" valign="middle"> 0.093</td><td class="Rrule" valign="middle"> 0.13</td><td class="Rrule" valign="middle"> 0.17</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Breast<br/> </td><td class="Rrule" valign="middle">0.02</td><td class="Rrule" valign="middle"> 0.038</td><td class="Rrule" valign="middle"> 0.048</td><td class="Rrule" valign="middle"> 0.058</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Gallbladder wall<br/> </td><td class="Rrule" valign="middle">0.037</td><td class="Rrule" valign="middle"> 0.043</td><td class="Rrule" valign="middle"> 0.046</td><td class="Rrule" valign="middle"> 0.049</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Gastrointestinal tract<br/> </td><td class="Rrule" valign="middle"></td><td class="Rrule" valign="middle"></td><td class="Rrule" valign="middle"></td><td class="Rrule" valign="middle"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">      Esophagus<br/> </td><td class="Rrule" valign="middle">0.024</td><td class="Rrule" valign="middle">0.1</td><td class="Rrule" valign="middle">0.14</td><td class="Rrule" valign="middle">0.19</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">      Stomach wall<br/> </td><td class="Rrule" valign="middle">0.87</td><td class="Rrule" valign="middle"> 0.77</td><td class="Rrule" valign="middle"> 0.71</td><td class="Rrule" valign="middle"> 0.66</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">      Small intestine wall<br/> </td><td class="Rrule" valign="middle">0.035</td><td class="Rrule" valign="middle"> 0.033</td><td class="Rrule" valign="middle"> 0.032</td><td class="Rrule" valign="middle"> 0.032</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">      Colon wall<br/> </td><td class="Rrule" valign="middle">0.14</td><td class="Rrule" valign="middle"> 0.14</td><td class="Rrule" valign="middle"> 0.14</td><td class="Rrule" valign="middle"> 0.14</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">      (Upper large intestine wall)<br/> </td><td class="Rrule" valign="middle">0.12</td><td class="Rrule" valign="middle"> 0.12</td><td class="Rrule" valign="middle"> 0.12</td><td class="Rrule" valign="middle"> 0.12</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">      (Lower large intestine wall)<br/> </td><td class="Rrule" valign="middle"> 0.17</td><td class="Rrule" valign="middle"> 0.17</td><td class="Rrule" valign="middle"> 0.17</td><td class="Rrule" valign="middle"> 0.16</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Heart wall<br/> </td><td class="Rrule" valign="middle"> 0.062</td><td class="Rrule" valign="middle"> 0.089</td><td class="Rrule" valign="middle"> 0.1</td><td class="Rrule" valign="middle"> 0.12</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Kidneys<br/> </td><td class="Rrule" valign="middle"> 0.27</td><td class="Rrule" valign="middle"> 0.27</td><td class="Rrule" valign="middle"> 0.27</td><td class="Rrule" valign="middle"> 0.27</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Liver<br/> </td><td class="Rrule" valign="middle"> 0.05</td><td class="Rrule" valign="middle"> 0.093</td><td class="Rrule" valign="middle"> 0.12</td><td class="Rrule" valign="middle"> 0.14</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Lungs<br/> </td><td class="Rrule" valign="middle"> 0.053</td><td class="Rrule" valign="middle"> 0.1</td><td class="Rrule" valign="middle"> 0.13</td><td class="Rrule" valign="middle"> 0.15</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Muscles<br/> </td><td class="Rrule" valign="middle"> 0.026</td><td class="Rrule" valign="middle"> 0.084</td><td class="Rrule" valign="middle"> 0.12</td><td class="Rrule" valign="middle"> 0.15</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Ovaries<br/> </td><td class="Rrule" valign="middle"> 0.038</td><td class="Rrule" valign="middle"> 0.037</td><td class="Rrule" valign="middle"> 0.036</td><td class="Rrule" valign="middle"> 0.035</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Pancreas<br/> </td><td class="Rrule" valign="middle"> 0.06</td><td class="Rrule" valign="middle"> 0.064</td><td class="Rrule" valign="middle"> 0.066</td><td class="Rrule" valign="middle"> 0.068</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Red marrow<br/> </td><td class="Rrule" valign="middle"> 0.031</td><td class="Rrule" valign="middle"> 0.072</td><td class="Rrule" valign="middle"> 0.095</td><td class="Rrule" valign="middle"> 0.12</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Salivary glands<br/> </td><td class="Rrule" valign="middle"> 0.27</td><td class="Rrule" valign="middle"> 0.22</td><td class="Rrule" valign="middle"> 0.19</td><td class="Rrule" valign="middle"> 0.16</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Skin<br/> </td><td class="Rrule" valign="middle"> 0.019</td><td class="Rrule" valign="middle"> 0.043</td><td class="Rrule" valign="middle"> 0.057</td><td class="Rrule" valign="middle"> 0.071</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Spleen<br/> </td><td class="Rrule" valign="middle"> 0.064</td><td class="Rrule" valign="middle"> 0.069</td><td class="Rrule" valign="middle"> 0.072</td><td class="Rrule" valign="middle"> 0.075</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Testes<br/> </td><td class="Rrule" valign="middle"> 0.025</td><td class="Rrule" valign="middle"> 0.024</td><td class="Rrule" valign="middle"> 0.023</td><td class="Rrule" valign="middle"> 0.22</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Thymus<br/> </td><td class="Rrule" valign="middle"> 0.024</td><td class="Rrule" valign="middle"> 0.1</td><td class="Rrule" valign="middle"> 0.14</td><td class="Rrule" valign="middle"> 0.19</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Thyroid<br/> </td><td class="Rrule" valign="middle"> 2.2</td><td class="Rrule" valign="middle"> 280<a class="Sup" href="#footnote-3" name="footnote-reference-3">‡</a></td><td class="Rrule" valign="middle"> 430<a class="Sup" href="#footnote-3">‡</a></td><td class="Rrule" valign="middle"> 580<a class="Sup" href="#footnote-3">‡</a></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Urinary bladder wall<br/> </td><td class="Rrule" valign="middle"> 0.54</td><td class="Rrule" valign="middle"> 0.45</td><td class="Rrule" valign="middle"> 0.39</td><td class="Rrule" valign="middle"> 0.34</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Uterus<br/> </td><td class="Rrule" valign="middle"> 0.045</td><td class="Rrule" valign="middle"> 0.042</td><td class="Rrule" valign="middle"> 0.04</td><td class="Rrule" valign="middle"> 0.038</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Remaining organs<br/> </td><td class="Rrule" valign="middle"> 0.029</td><td class="Rrule" valign="middle"> 0.084</td><td class="Rrule" valign="middle"> 0.11</td><td class="Rrule" valign="middle"> 0.15</td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule" valign="middle"> <br/> <span class="Bold"> Effective dose per administered activity (mSv/MBq)</span></td><td class="Rrule" valign="middle"> 0.28</td><td class="Rrule" valign="middle"> 14<a class="Sup" href="#footnote-3">‡</a></td><td class="Rrule" valign="middle"> 22<a class="Sup" href="#footnote-3">‡</a></td><td class="Rrule" valign="middle"> 29<a class="Sup" href="#footnote-3">‡</a></td> </tr> </tbody> </table></div>

HICON® is available in 1 mL size, clear vials containing a colorless, aqueous, concentrated Sodium Iodide I 131 Solution USP [9,250 MBq (250 mCi), 18,500 MBq (500 mCi), and 37,000 MBq (1,000 mCi) at time of calibration] for the preparation of sodium iodide I 131 capsules, therapeutic or sodium iodide I 131 solution, therapeutic. Refer to Table 2 for the radioactivity and volume in each vial. Large gelatin capsules (empty) and small gelatin capsules containing approximately 300 mg of dibasic sodium phosphate anhydrous as the absorbing buffer are supplied along with HICON® for the preparation of sodium iodide I 131 capsules, therapeutic.

{ "type": "p", "children": [], "text": "HICON® is available in 1 mL size, clear vials containing a colorless, aqueous, concentrated Sodium Iodide I 131 Solution USP [9,250 MBq (250 mCi), 18,500 MBq (500 mCi), and 37,000 MBq (1,000 mCi) at time of calibration] for the preparation of sodium iodide I 131 capsules, therapeutic or sodium iodide I 131 solution, therapeutic. Refer to Table 2 for the radioactivity and volume in each vial. Large gelatin capsules (empty) and small gelatin capsules containing approximately 300 mg of dibasic sodium phosphate anhydrous as the absorbing buffer are supplied along with HICON® for the preparation of sodium iodide I 131 capsules, therapeutic." }

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="80%"> <caption> <span>Table 2 HICON<span class="Sup">®</span> Concentrated Sodium Iodide I 131 Solution USP </span> </caption> <colgroup></colgroup> <tfoot> <tr> <td align="left" colspan="0"> <dl class="Footnote"> <dt> <a href="#footnote-reference-4" name="footnote-4">*</a> </dt> <dd>At time of calibration</dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="Botrule First"> <td class="Lrule Rrule" valign="middle"> <span class="Bold">Total Radioactivity</span><a class="Sup" href="#footnote-4" name="footnote-reference-4">*</a><span class="Bold">/ Via</span>l<br/> </td><td align="center" class="Rrule" valign="middle"> <br/> <span class="Bold">Solution Volume (mL) / Vial</span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> 9,250 MBq (250 mCi)</td><td align="center" class="Rrule" valign="middle"> <br/> 0.25</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> 18,500 MBq (500 mCi)</td><td align="center" class="Rrule" valign="middle"> <br/> 0.5</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule" valign="middle"> <br/> 37,000 MBq (1,000 mCi)</td><td align="center" class="Rrule" valign="middle"> 1<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"80%\">\n<caption>\n<span>Table 2 HICON<span class=\"Sup\">®</span> Concentrated Sodium Iodide I 131 Solution USP \n\t\t\t</span>\n</caption>\n<colgroup></colgroup>\n<tfoot>\n<tr>\n<td align=\"left\" colspan=\"0\">\n<dl class=\"Footnote\">\n<dt>\n<a href=\"#footnote-reference-4\" name=\"footnote-4\">*</a>\n</dt>\n<dd>At time of calibration</dd>\n</dl>\n</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td class=\"Lrule Rrule\" valign=\"middle\"> <span class=\"Bold\">Total Radioactivity</span><a class=\"Sup\" href=\"#footnote-4\" name=\"footnote-reference-4\">*</a><span class=\"Bold\">/ Via</span>l<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">\n<br/> <span class=\"Bold\">Solution Volume (mL) / Vial</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"> 9,250 MBq (250 mCi)</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">\n<br/> 0.25</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"> 18,500 MBq (500 mCi)</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">\n<br/> 0.5</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Lrule Rrule\" valign=\"middle\">\n<br/> 37,000 MBq (1,000 mCi)</td><td align=\"center\" class=\"Rrule\" valign=\"middle\"> 1<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

HICON® is contraindicated in:

{ "type": "p", "children": [], "text": "HICON® is contraindicated in:" }

{ "type": "ul", "children": [ "Patients with vomiting and diarrhea [see Warnings and Precautions (5.7)].", "Patients with thyroid malignancies shown to have no iodide update, which include the majority of medullary or anaplastic carcinomas.", "Patients receiving concurrent anti-thyroid therapy [see Warnings and Precautions (5.1) and Drug Interactions (7)].", "Pregnancy [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)].", "Lactation [see Warnings and Precautions (5.5), Use in Specific Populations (8.2)]." ], "text": "" }

Sodium iodide I 131 may cause thyroiditis with gland enlargement and release of thyroid hormone, which may cause or aggravate hyperthyroidism, thyroid storm and thyrotoxic cardiac disease [see Adverse Reactions (6)]. When treating hyperthyroidism, consider pre-treatment anti-thyroid medication to help deplete the thyroid hormone content within the gland. Discontinue the anti-thyroid medication at least three days before administration of sodium iodide I 131 [see Drug Interactions (7)]. Consider a beta-blocker pre or post-treatment to minimize the risk of hyperthyroidism and thyroid storm.

Thyroiditis may cause gland enlargement resulting in tenderness and swelling of the neck, pain on swallowing, sore throat, and cough; which may occur approximately the third day after sodium iodide I 131 administration. Consider management with pain-reliever or anti-inflammatory medications.

Sodium Iodide I 131 may cause radiation induced toxicities [see Adverse Reactions (6)]:

Obtain a complete blood count within one month of therapy. If patients show leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity, while delivering less than 2 Gy to the bone marrow.

Advise good hydration for one week following sodium iodide I 131 administration and stimulate salivary flow via a sialagogue (e.g. sugar-free candy or gum, pilocarpine, and ascorbic acid) to reduce radiation exposure to the salivary glands.

Advise patients to void frequently after administration of radioiodide to enhance excretion.

Hypersensitivity reactions including anaphylaxis may occur in patients who receive sodium iodide I 131. Although iodide is not considered an allergen, hypersensitivity reactions may occur in relation with excipients or chemical component of the capsule, such as sodium thiosulfate. Obtain and document an allergy history, particularly a sulfite allergy. Emergency resuscitation equipment and personnel should be immediately available [see Adverse Reactions (6)].

HICON® is contraindicated in pregnancy because sodium iodide I 131 crosses the placenta and fetal exposure can lead to neonatal hypothyroidism. Multiple reports in the published literature describe hypothyroidism in the neonates following in utero exposure to sodium iodide I 131. Some cases of neonatal hypothyroidism were severe and irreversible. Verify pregnancy status of females of reproductive potential prior to initiating HICON® treatment. Advise females and males of reproductive potential to use effective contraception during treatment with HICON® and for at least 6 months after the last dose [see Use in Specific Populations (8.1, 8.3)].

HICON® is contraindicated in lactating women because sodium iodide I 131 concentrates in the breast via the increased expression of the sodium iodide symporter in breast tissue with lactation. The literature describes moderate to marked radioiodine uptake in the breast tissue for 5 to 32 weeks post cessation of breast feeding. Advise lactating women to discontinue breast feeding at least 6 weeks prior to administration of sodium iodide I 131 to allow sufficient time for involution to occur and to avoid excess concentration of sodium iodide I 131 in breast tissue. Consider administration of drugs to suppress lactation. Consider diagnostic scintigraphy before administration of sodium iodide I 131 to assess the persistence of uptake by breast tissue. If sodium iodide I 131 is administered in the postpartum period, the lactating mother should not breastfeed the infant [see Use in Specific Populations (8.2)].

Transient dose-related impairment of testicular function in men and transient ovarian insufficiency in women has been reported after sodium iodide I 131 therapy. Sperm banking for men may be considered prior to administration of HICON® for thyroid carcinoma [see Use in Specific Populations (8.3)].

Household Contacts Instruct patients to follow radiation safety precautions after receiving HICON® to minimize the radiation contamination of other persons or the environment. Patients should avoid close contact with others, especially pregnant women and children, and take care to avoid contamination of other persons or the environment with body fluids.

Patients and Healthcare Providers HICON® contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Follow safe handling and administration to minimize radiation exposure to the patient and healthcare providers.

Certain food or drugs may alter the thyroid uptake of sodium iodide I 131 and diminish its effectiveness. Recent intake of stable iodide in any form, or the use of thyroid or anti-thyroid drugs may diminish thyroid uptake of sodium iodide I 131 [see Drug Interactions (7)].

The following adverse reactions have been reported during post-approval use of sodium iodide I 131 (Table 3). 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.

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="80%"> <caption> <span> Table 3 Postmarket Adverse Reactions by System Organ Class </span> </caption> <tfoot> <tr> <td align="left" colspan="0"> <dl class="Footnote"> <dt> <a href="#footnote-reference-5" name="footnote-5">*</a> </dt> <dd>In alphabetical order</dd> <dt> <a href="#footnote-reference-6" name="footnote-6">†</a> </dt> <dd>In patients with iodide-avid brain metastases</dd> <dt> <a href="#footnote-reference-7" name="footnote-7">‡</a> </dt> <dd>In patients with iodide-avid lung metastases</dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="Botrule First"> <td class="Lrule Rrule" valign="top"><span class="Bold">System Organ Class<a class="Sup" href="#footnote-5" name="footnote-reference-5">*</a></span> <br/> </td><td class="Rrule" valign="top"><span class="Bold">Symptoms<a class="Sup" href="#footnote-5">*</a></span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">Cardiac disorders <br/> </td><td class="Rrule" valign="top">Chest pain, tachycardia<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"> Congenital, familial and genetic disorders <br/> </td><td class="Rrule" valign="top">Chromosomal abnormalities, congenital hypothyroidism<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">Endocrine disorders <br/> </td><td class="Rrule" valign="top">Hyperthyroidism, hypoparathyroidism,  hypothyroidism, thyrotoxic crisis<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">Eye disorders<br/> </td><td class="Rrule" valign="top">Lacrimal gland dysfunction<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">Gastrointestinal disorders <br/> </td><td class="Rrule" valign="top">Gastritis, nausea, salivary gland dysfunction, sialadenitis, vomiting<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">General disorders and administration site conditions <br/> </td><td class="Rrule" valign="top">Local swelling of thyroid or sites of iodide avid tumor<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">Hematologic and lymphatic disorders including fatalities <br/> </td><td class="Rrule" valign="top">Anemia, blood dyscrasia, bone marrow depression, leukopenia, thrombocytopenia<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">Immune system disorders <br/> </td><td class="Rrule" valign="top">Bronchospasm<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">Neoplasms benign, malignant and unspecified (including cysts and polyps) <br/> </td><td class="Rrule" valign="top">Acute leukemia, solid cancer<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">Nervous system disorders <br/> </td><td class="Rrule" valign="top"><a class="Sup" href="#footnote-6" name="footnote-reference-6">†</a>Cerebral edema, headache<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">Respiratory, thoracic and mediastinal disorders <br/> </td><td class="Rrule" valign="top"><a class="Sup" href="#footnote-7" name="footnote-reference-7">‡</a>Pulmonary fibrosis, <a class="Sup" href="#footnote-7">‡</a>radiation pneumonitis<br/> </td> </tr> <tr class="Last"> <td class="Lrule Rrule" valign="top">Skin and subcutaneous tissue disorders <br/> </td><td class="Rrule" valign="top">Hives, itching, rash<br/> </td> </tr> </tbody> </table></div>

{ "type": "ul", "children": [ "Concomitant use of bone marrow depressants may enhance the depression of the hematopoietic system caused by the use of large doses of sodium iodide I 131 [see Warnings and Precautions (5.2)].", "Many drugs and iodide-containing foods interfere with the accumulation of radioiodide by the thyroid. Review the patient’s history, current medications, and recent diagnostic tests prior to the administration of sodium iodide I 131 [see Warnings and Precautions (5.8)].", "Advise patients to maintain a low-iodide diet two weeks prior to radioiodide administration and continue for several days during the uptake or imaging process and to discontinue taking the following products before they undergo the procedure as shown in Table 4." ], "text": "" }

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="80%"> <caption> <span>Table 4 Pharmaceuticals / OTCs / Agents Blocking Radioiodine Uptake </span> </caption> <colgroup></colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Type of Medication</span></td><td align="center" class="Rrule" valign="middle"><span class="Bold"> Recommended time of withdrawal</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> Thionamide medications<br/>  (e.g., propylthiouracil, methimazole, carbimazole)</td><td class="Rrule" valign="middle">  3 days</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> Multivitamins containing iodide</td><td class="Rrule" valign="middle">  10 days</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Underline">Natural or synthetic thyroid hormones</span> <br/>  triiodothyronine<br/>  thyroxine</td><td class="Rrule" valign="bottom">  2 weeks<br/>  4 weeks<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> Iodide-containing foods: iodized salt, dairy products, egg yolks, seafood, turkey and liver</td><td class="Rrule" valign="middle">  2 weeks</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> Kelp, agar, carrageenan, Lugol solution</td><td class="Rrule" valign="middle">  3 weeks</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> Saturated solution of potassium iodide</td><td class="Rrule" valign="middle">  3 weeks</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> Topical iodide<br/>  (e.g., surgical skin preparation)</td><td class="Rrule" valign="middle">  3 weeks</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Underline">Intravenous radiographic contrast agents</span> <br/>    Water soluble<br/>    Lipophilic</td><td class="Rrule" valign="bottom">  2 months<br/>  6 months<br/> </td> </tr> <tr class="Last"> <td class="Lrule Rrule" valign="middle"> Amiodarone</td><td class="Rrule" valign="middle">  6 months</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"80%\">\n<caption>\n<span>Table 4 Pharmaceuticals / OTCs / Agents Blocking Radioiodine Uptake \n\t\t\t</span>\n</caption>\n<colgroup></colgroup>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td class=\"Lrule Rrule\" valign=\"middle\"><span class=\"Bold\"> Type of Medication</span></td><td align=\"center\" class=\"Rrule\" valign=\"middle\"><span class=\"Bold\"> Recommended time of withdrawal</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"> Thionamide medications<br/>  (e.g., propylthiouracil, methimazole, carbimazole)</td><td class=\"Rrule\" valign=\"middle\">  3 days</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"> Multivitamins containing iodide</td><td class=\"Rrule\" valign=\"middle\">  10 days</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"><span class=\"Underline\">Natural or synthetic thyroid hormones</span>\n<br/>  triiodothyronine<br/>  thyroxine</td><td class=\"Rrule\" valign=\"bottom\">  2 weeks<br/>  4 weeks<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"> Iodide-containing foods: iodized salt, dairy products, egg yolks, seafood, turkey and liver</td><td class=\"Rrule\" valign=\"middle\">  2 weeks</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"> Kelp, agar, carrageenan, Lugol solution</td><td class=\"Rrule\" valign=\"middle\">  3 weeks</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"> Saturated solution of potassium iodide</td><td class=\"Rrule\" valign=\"middle\">  3 weeks</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"> Topical iodide<br/>  (e.g., surgical skin preparation)</td><td class=\"Rrule\" valign=\"middle\">  3 weeks</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"><span class=\"Underline\">Intravenous radiographic contrast agents</span>\n<br/>    Water soluble<br/>    Lipophilic</td><td class=\"Rrule\" valign=\"bottom\">  2 months<br/>  6 months<br/>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Lrule Rrule\" valign=\"middle\"> Amiodarone</td><td class=\"Rrule\" valign=\"middle\">  6 months</td>\n</tr>\n</tbody>\n</table></div>" }

Risk Summary HICON® is contraindicated in pregnancy because fetal exposure can lead to neonatal hypothyroidism, which in some cases is severe and irreversible [See Warnings and Precautions (5.4)]. Data from the published literature describe reports of neonatal thyroid abnormalities after fetal exposure; including agenesis of the thyroid and hypothyroidism (see Clinical Considerations, Data). No animal reproductive studies have been conducted.

Clinical Considerations Fetal/ Neonatal Adverse Reactions A fetus exposed to sodium iodide I 131 can develop neonatal hypothyroidism. Delay in diagnosis of neonatal hypothyroidism after exposure to sodium iodide I 131 in utero can result in severe sequelae such as cognitive impairment and delayed bone age. Monitor thyroid function in any infant born after in utero exposure to sodium iodide I 131.

Data Human Data Sodium iodide I 131 crosses the placenta and the fetal thyroid begins to concentrate iodide during the 10th to 12th week of gestation. In literature reports of maternal exposures to sodium iodide I 131 at doses of 333 MBq to 8,325 MBq (9 mCi to 225 mCi) during 4 to 26 weeks gestational age, the most common adverse outcomes were hypothyroid infants and children.

Risk Summary HICON® is contraindicated during lactation because I 131 concentrates in the breast during lactation via the increased expression of the sodium iodide symporter in breast tissue and can lead to hypothyroidism in the infant through breastfeeding. If sodium iodide I 131 is administered postpartum, breastfeeding should not be restarted for the remainder of the postpartum period. In addition, to minimize the absorbed radiation dose to the breast tissue, breastfeeding and breast-pumping should be discontinued for at least 6 weeks before administration of sodium iodide I 131  [see Data and Warnings and Precautions (5.5)].

Infants exposed to sodium iodide I 131 through breast milk are at risk for development of hypothyroidism because sodium iodide I 131 is distributed into breast milk and may reach concentrations equal to or greater than concentrations in maternal plasma (see Data).

Data Published literature describes sodium iodide I 131 transfer into breast milk and uptake by the thyroid of the breastfed infant. The amount of sodium Iodide I 131 detected in the breast milk at 36 to 48 hours after administration is 1% to 27% of the injected dose (with injected doses between 1.1 MBq (0,0297 mCi) to 5,143 MBq (139 mCi)).

HICON® is contraindicated in pregnancy because of the risk of fetal hypothyroidism [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1)].

Pregnancy Testing Obtain a pregnancy test in females of reproductive potential and verify the absence of pregnancy within 24 hours prior to administration of treatment [see Dosage and Administration (2.2)].

Contraception Advise females and males of reproductive potential to use effective contraception during treatment with HICON® and for at least six months after the last dose of HICON®.

Infertility Females Fertility may be impaired with HICON® treatment. Transient amenorrhea and ovarian insufficiency have been observed after sodium iodide I 131 therapy in females. The literature describes reports of transient menstrual cycle irregularities, including amenorrhea, and ovarian failure in females treated with cumulative doses of 1,000 MBq to 59,000 MBq (27 mCi to 1,595 mCi) sodium iodide I 131. In a published literature analysis, the effects on fertility occurred in up to 30% of women treated with sodium iodide I 131, and may resolve 12 months after treatment.

Males Fertility may be impaired with HICON® treatment. Discuss sperm banking for males who are expected to receive a high cumulative dose of sodium iodide I 131. Transient dose-related impairment of testicular function after sodium iodide I 131 therapy has been reported in the published literature. The literature describes reports of males treated with sodium iodide I 131 at doses of 370 MBq to 22,000 MBq (10 mCi to 595 mCi) resulting in transiently impaired testicular function (including spermatogenesis). The risk of persistent testicular dysfunction increases after administration of repeated or high cumulative radioiodide exposure.

The safety and effectiveness of HICON® have not been established in pediatric patients. Pediatric patients are at an increased lifetime risk for malignancy from radiation exposure.

Clinical experience has not identified differences in safety or effectiveness in geriatric patients compared to younger patients. However, elderly patients are more likely to have decreased renal function and radiation exposure is greater in patients with impaired renal function [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

HICON® is primarily excreted by the kidneys. Renal function impairment decreases excretion of sodium iodide I 131 and increases the radiation exposure and risk of radiation toxicity. For patients with a history of renal impairment, evaluate renal function for therapeutic planning and consider dosimetry. Sodium Iodide I 131 is dialyzable. Hemodialysis can be used to reduce total body radiation exposure [see Clinical Pharmacology (12.3)].

In case of exposure to a radioactive dose of sodium iodide I 131 exceeding the intended therapeutic dose, provide general supportive care, promote frequent voiding, monitor for bone marrow and thyroid suppression. Consider administering a thyroid blocking agent (e.g. potassium iodide (KI) or perchlorate) promptly within 4 to 6 hours after the exposure. Assess the benefit of administering a thyroid blocking agent against the risk of failure of sodium iodide I 131 therapy. Appropriate replacement therapy is recommended if hypothyroidism occurs.

{ "type": "p", "children": [], "text": "In case of exposure to a radioactive dose of sodium iodide I 131 exceeding the intended therapeutic dose, provide general supportive care, promote frequent voiding, monitor for bone marrow and thyroid suppression. Consider administering a thyroid blocking agent (e.g. potassium iodide (KI) or perchlorate) promptly within 4 to 6 hours after the exposure. Assess the benefit of administering a thyroid blocking agent against the risk of failure of sodium iodide I 131 therapy. Appropriate replacement therapy is recommended if hypothyroidism occurs." }

HICON®, a radioactive therapeutic agent, provides a concentrated solution of sodium iodide I 131 with a radioconcentration of 37,000 MBq/mL (1,000 mCi/mL). Each mL of the concentrated solution contains 37,000 MBq (1,000 mCi) of no-carrier-added sodium iodide I 131, disodium edetate dihydrate USP as a stabilizer, sodium thiosulfate pentahydrate USP as a reducing agent, and dibasic sodium phosphate anhydrous USP. The pH of the concentrated solution is between 7.5 and 10.

The concentrated solution provided with HICON® is used for the preparation of sodium iodide I 131 capsules or sodium iodide I 131 solution of varying strengths for oral administration for therapy.

Sodium iodide I 131 solution is designated chemically as Na 131I and has a molecular weight of 153.99 g/mol. Hard gelatin capsules, provided for the preparation of the sodium iodide I 131 capsules final dosage form, contain approximately 300 mg of dibasic sodium phosphate anhydrous USP as the absorbing buffer.

Iodide I 131 decays by beta emission and associated gamma emission with a physical half-life of 8.02 days. The principal radiation emissions are listed in Table 5.

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="50%"> <caption> <span>Table 5 Principal Radiation Emission Data from Decay of Sodium Iodide I 131 </span> </caption> <colgroup></colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="middle"> <span class="Bold">Radiation</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Mean % per <br/> Disintegration</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Mean Energy<br/> (keV)</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> Beta-1</td><td align="center" class="Rrule" valign="middle"> 2.1%<br/> </td><td align="center" class="Rrule" valign="middle"> 69.4<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> Beta-3</td><td align="center" class="Rrule" valign="middle"> 7.2%<br/> </td><td align="center" class="Rrule" valign="middle"> 96.6<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> Beta-4</td><td align="center" class="Rrule" valign="middle"> 89.4%<br/> </td><td align="center" class="Rrule" valign="middle"> 191.6<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> Gamma-7</td><td align="center" class="Rrule" valign="middle"> 6.1%<br/> </td><td align="center" class="Rrule" valign="middle"> 284.3<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> Gamma-14</td><td align="center" class="Rrule" valign="middle"> 81.2%<br/> </td><td align="center" class="Rrule" valign="middle"> 364.5<br/> </td> </tr> <tr class="Last"> <td class="Lrule Rrule" valign="middle"> Gamma-18</td><td align="center" class="Rrule" valign="middle"> 7.1%<br/> </td><td align="center" class="Rrule" valign="middle"> 637.0<br/> </td> </tr> </tbody> </table></div>

The specific gamma-ray constant for iodide I 131 is 4.26 × 10-13 C•m2•kg-1•MBq-1•s-1 (2.2 R•cm2/mCi•hr). The first half-value thickness of lead (Pb) for iodide I 131 is 0.27 cm. A range of values for the relative attenuation of the radiation emitted by iodide I 131 that results from interposition of various thicknesses of Pb is shown in Table 6. For example, the use of 2.59 cm of Pb will decrease the external radiation exposure by a factor of about 100.

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="50%"> <caption> <span>Table 6 Radiation Attenuation of Iodine I 131 by Lead Shielding </span> </caption> <colgroup></colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="middle"> <span class="Bold">Shield Thickness<br/> (Pb) cm</span> <br/> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold"> Coefficient of Attenuation</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle"> 0.27<br/> </td><td align="center" class="Rrule" valign="middle">0.5<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle"> 0.56<br/> </td><td align="center" class="Rrule" valign="middle"> 0.25<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle"> 0.99<br/> </td><td align="center" class="Rrule" valign="middle"> 10<span class="Sup">-1</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle"> 2.59<br/> </td><td align="center" class="Rrule" valign="middle"> 10<span class="Sup">-2</span> <br/> </td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule" valign="middle"> 4.53<br/> </td><td align="center" class="Rrule" valign="middle"> 10<span class="Sup">-3</span> <br/> </td> </tr> </tbody> </table></div>

To correct for physical decay of iodine I 131, the fractions that remain at selected intervals after the time of calibration are shown in Table 7.

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="80%"> <caption> <span>Table 7 Physical Decay Chart: Iodine I-131 Half-Life 8.02 Days </span> </caption> <colgroup></colgroup> <tfoot> <tr> <td align="left" colspan="0"> <dl class="Footnote"> <dt> <a href="#footnote-reference-8" name="footnote-8">*</a> </dt> <dd>Calibration time</dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="middle"><span class="Bold">Days</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Fraction Remaining</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Days</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Fraction Remaining</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Days</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Fraction Remaining</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">0<a class="Sup" href="#footnote-8" name="footnote-reference-8">*</a> <br/> </td><td align="center" class="Rrule" valign="middle">1.000<br/> </td><td align="center" class="Rrule" valign="middle">11<br/> </td><td align="center" class="Rrule" valign="middle">0.388<br/> </td><td align="center" class="Rrule" valign="middle">22<br/> </td><td align="center" class="Rrule" valign="middle">0.151<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">1<br/> </td><td align="center" class="Rrule" valign="middle">0.918<br/> </td><td align="center" class="Rrule" valign="middle">12<br/> </td><td align="center" class="Rrule" valign="middle">0.356<br/> </td><td align="center" class="Rrule" valign="middle">23<br/> </td><td align="center" class="Rrule" valign="middle">0.138<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">2<br/> </td><td align="center" class="Rrule" valign="middle">0.842<br/> </td><td align="center" class="Rrule" valign="middle">13<br/> </td><td align="center" class="Rrule" valign="middle">0.327<br/> </td><td align="center" class="Rrule" valign="middle">24<br/> </td><td align="center" class="Rrule" valign="middle">0.127<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">3<br/> </td><td align="center" class="Rrule" valign="middle">0.773<br/> </td><td align="center" class="Rrule" valign="middle">14<br/> </td><td align="center" class="Rrule" valign="middle">0.300<br/> </td><td align="center" class="Rrule" valign="middle">25<br/> </td><td align="center" class="Rrule" valign="middle">0.116<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">4<br/> </td><td align="center" class="Rrule" valign="middle">0.709<br/> </td><td align="center" class="Rrule" valign="middle">15<br/> </td><td align="center" class="Rrule" valign="middle">0.275<br/> </td><td align="center" class="Rrule" valign="middle">26<br/> </td><td align="center" class="Rrule" valign="middle">0.107<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">5<br/> </td><td align="center" class="Rrule" valign="middle">0.651<br/> </td><td align="center" class="Rrule" valign="middle">16<br/> </td><td align="center" class="Rrule" valign="middle">0.253<br/> </td><td align="center" class="Rrule" valign="middle">27<br/> </td><td align="center" class="Rrule" valign="middle">0.098<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">6<br/> </td><td align="center" class="Rrule" valign="middle">0.597<br/> </td><td align="center" class="Rrule" valign="middle">17<br/> </td><td align="center" class="Rrule" valign="middle">0.232<br/> </td><td align="center" class="Rrule" valign="middle">28<br/> </td><td align="center" class="Rrule" valign="middle">0.090<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">7<br/> </td><td align="center" class="Rrule" valign="middle">0.548<br/> </td><td align="center" class="Rrule" valign="middle">18<br/> </td><td align="center" class="Rrule" valign="middle">0.213<br/> </td><td align="center" class="Rrule" valign="middle">29<br/> </td><td align="center" class="Rrule" valign="middle">0.083<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">8<br/> </td><td align="center" class="Rrule" valign="middle">0.503<br/> </td><td align="center" class="Rrule" valign="middle">19<br/> </td><td align="center" class="Rrule" valign="middle">0.195<br/> </td><td align="center" class="Rrule" valign="middle">30<br/> </td><td align="center" class="Rrule" valign="middle">0.076<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">9<br/> </td><td align="center" class="Rrule" valign="middle">0.461<br/> </td><td align="center" class="Rrule" valign="middle">20<br/> </td><td align="center" class="Rrule" valign="middle">0.179<br/> </td><td align="center" class="Rrule" valign="middle"></td><td align="center" class="Rrule" valign="middle"></td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule" valign="middle">10<br/> </td><td align="center" class="Rrule" valign="middle">0.423<br/> </td><td align="center" class="Rrule" valign="middle">21<br/> </td><td align="center" class="Rrule" valign="middle">0.164<br/> </td><td align="center" class="Rrule" valign="middle"></td><td align="center" class="Rrule" valign="middle"></td> </tr> </tbody> </table></div>

Iodide is actively transported by the sodium-iodide symporter (NIS) protein, in thyroid follicular cells. Iodide is concentrated in follicular cells to levels up to 50 times higher than in the plasma. Iodide is metabolically oxidized by thyroid peroxidase to iodinium (I+) which in turn iodinates tyrosine residues of thyroglobulin (tri or tetra-iodinated tyrosine). The beta emission of I 131 is responsible for the therapeutic effect.

The relationship between the extent of iodide I 131 exposure and pharmacologic effects has not been explored in clinical trials.

Absorption Following oral administration of HICON®, 90% of the administered radioactivity of sodium iodide I 131 is systemically absorbed in the first 60 minutes.

Distribution Following absorption, sodium iodide I 131 is distributed within the extra-cellular space. It is actively transported by the sodium-iodide symporter (NIS) protein, and binds to thyroglobulin resulting in accumulation in the thyroid. The thyroid uptake of iodide is usually increased in hyperthyroidism and in goiter, and is decreased in hypothyroidism. Sodium iodide I 131 also accumulates in the stomach, choroid plexus, salivary glands, breast, liver, gall bladder, and kidneys.

Elimination Metabolism In thyroidal follicular cells iodide is oxidized through the action of thyroid peroxidase to iodinium (I+) which in turn iodinates tyrosine residues of thyroglobulin.

Excretion Sodium iodide I 131 is excreted in urine and feces. The normal range of urinary excretion is 37% to 75% of the administered dose, varying with the thyroid and renal function of the patient. Fecal excretion is about 10%.

HICON® provides a concentrated solution of sodium iodide I 131 with a radioconcentration of 37,000 MBq/mL (1,000 mCi/mL). It is supplied in 1 mL clear vials that contain approximately 9,250 MBq (250 mCi), 18,500 MBq (500 mCi), and 37,000 MBq (1,000 mCi) at the time of calibration.

The concentrated solution is intended for use in the preparation of capsules and solutions of varying strengths for oral administration.

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="80%"> <caption> <span>HICON<span class="Sup">®</span></span> </caption> <colgroup></colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="middle"><span class="Bold"> NDC</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Volume of Concentrated Solution</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Total Radioactivity per Vial</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle"> 65174-880-25<br/> </td><td align="center" class="Rrule" valign="middle"> 0.25 mL<br/> </td><td align="center" class="Rrule" valign="middle">9,250 MBq (250 mCi)<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle"> 65174-880-50<br/> </td><td align="center" class="Rrule" valign="middle"> 0.50 mL<br/> </td><td align="center" class="Rrule" valign="middle">18,500 MBq (500 mCi)<br/> </td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule" valign="middle"> 65174-880-00<br/> </td><td align="center" class="Rrule" valign="middle"> 1 mL<br/> </td><td align="center" class="Rrule" valign="middle">37,000 MBq (1,000 mCi)<br/> </td> </tr> </tbody> </table></div>

A minimum of one blister package of 10 empty large hard gelatin capsules and a minimum of one blister package of 10 small hard gelatin capsules containing approximately 300 mg of dibasic sodium phosphate anhydrous as the absorbing buffer are supplied along with HICON® for the preparation of sodium iodide I 131 capsules, therapeutic.

HICON® should be stored between 2 °C and 25 °C (36 °F and 77 °F). Store and dispose of HICON® in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide. Use HICON® solution per the expiry date on the lead pot label. Use prepared capsules within 7 days of preparing.

Discard unused capsules after all HICON® solution has been dispensed or expired. New blister packages of hard gelatin capsules are provided with each new shipment of HICON®.

This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

Radiation Safety Precautions

{ "type": "p", "children": [], "text": "\nRadiation Safety Precautions\n" }

{ "type": "ul", "children": [ "Advise patients treated for hyperthyroidism to monitor for and seek medical care for signs and symptoms ofthyrotoxicosis and thyroid storm arising during the post-treatment period. For mild radiation-induced thyroiditis, patients may be advised to consider symptomatic management with pain-relievers or anti-inflammatory medications [see Warnings and Precautions (5.1)].", "Advise patients to hydrate and void frequently and to use a sialagogue after administration of radioiodide to minimize radiation dose [see Warnings and Precautions (5.2)].", "Advise patients to avoid close contact with others, especially pregnant women and children, and to take care to avoid contamination of other persons or the environment with body fluids [see Warnings and Precautions (5.7)]." ], "text": "" }

Embryo-Fetal Toxicity

{ "type": "p", "children": [], "text": "\nEmbryo-Fetal Toxicity\n" }

{ "type": "ul", "children": [ "Advise female patients of the risk to a fetus [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)].", "Advise females and males of reproductive potential to use effective contraception during treatment with HICON® and for at least 6 months after the last dose [see Warnings and Precautions (5.4), Use in Specific Populations (8.3)].", "Advise female patients to contact their healthcare provider with a known or suspected pregnancy." ], "text": "" }

Lactation

{ "type": "p", "children": [], "text": "\nLactation\n" }

{ "type": "ul", "children": [ "Instruct women to stop breastfeeding and breast-pumping for the remainder of the postpartum period after and for at least 6 weeks prior to HICON® administration [see Contraindications (4), Warnings and Precautions (5.5), Use in Specific Populations (8.2)]." ], "text": "" }

Effects on Fertility

{ "type": "p", "children": [], "text": "\nEffects on Fertility\n" }

{ "type": "ul", "children": [ "Advise females and males of reproductive potential of the potential for impaired fertility with HICON® treatment and possible use of sperm banking for males of reproductive potential [see Warnings and Precautions (5.6), Use in Specific Populations (8.3)]\n" ], "text": "" }

Manufactured by:

{ "type": "p", "children": [], "text": "Manufactured by:" }

Jubilant DraxImage Inc., dba Jubilant RadiopharmaTM 16 751 TransCanada HighwayKirkland, Quebec H9H 4J4 Canada1-888-633-5343www.jubilantradiopharma.com

{ "type": "p", "children": [], "text": "Jubilant DraxImage Inc., dba Jubilant RadiopharmaTM\n16 751 TransCanada HighwayKirkland, Quebec H9H 4J4 Canada1-888-633-5343www.jubilantradiopharma.com" }

Revised: November 2021

{ "type": "p", "children": [], "text": "Revised: November 2021" }

Art Rev.: 2.1

{ "type": "p", "children": [], "text": "Art Rev.: 2.1" }

50000000796

{ "type": "p", "children": [], "text": "50000000796" }

HICON® is a registered trademark of Jubilant DraxImage Inc.

{ "type": "p", "children": [], "text": "\nHICON® is a registered trademark of Jubilant DraxImage Inc.\n" }

Jubilant RadiopharmaTM is a trademark used under license by Jubilant DraxImage Inc.

{ "type": "p", "children": [], "text": "\nJubilant RadiopharmaTM is a trademark used under license by Jubilant DraxImage Inc.\n" }