Sodium Iodide I 131
Generic Name: sodium iodide i 131
Brand Names:
Hicon
11 DESCRIPTION 11.1 Chemical Characteristics 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.
Overview
11 DESCRIPTION 11.1 Chemical Characteristics 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.
Uses
1 INDICATIONS AND USAGE HICON ® is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma. HICON ® is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.
Dosage
2 DOSAGE AND ADMINISTRATION The concentrated sodium iodide I 131 solution USP provided with HICON ® must be diluted. ( 2.2 ) See Full Prescribing Information for important administration instructions and dilution and preparation instructions for sodium iodide l 131 capsules or oral solution. ( 2.2 , 2.4 ) The recommended dose is based on the thyroid gland uptake as well as the size of the gland: Treatment of Hyperthyroidism: Recommended dosage is 148 MBq to 370 MBq (4 mCi to 10 mCi). ( 2.3 ) Treatment of Thyroid Carcinoma: Recommended dosage is 1,110 MBq to 3,700 MBq (30 mCi to 100 mCi). ( 2.3 ) 2.1 Radiation Safety HICON ® is a radioactive drug.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described below and elsewhere in labeling: Radiation-induced Thyroiditis [see Warnings and Precautions ( 5.1 )] . Radiation-induced Toxicities [see Warnings and Precautions ( 5.2 )] . Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] . Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.1 )] . Increased Radiation Exposure to Breast Tissue with Lactation [see Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.2 )] . Transient Infertility [see Warnings and Precautions ( 5.6 ), Use in Specific Populations ( 8.3 )] . Radiation Exposure to Other Individuals [see Warnings and Precautions ( 5.7 )] .
Interactions
7 DRUG INTERACTIONS 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.
Warnings
5 WARNINGS AND PRECAUTIONS Radiation-induced thyroiditis may cause or worsen hyperthyroidism. Consider pre-treatment with anti-thyroid medications. ( 5.1 ) Multiple non-thyroid radiation toxicities, including hematopoietic suppression: Individualize dose and monitor for toxicity. ( 5.2 ) Embryo-Fetal toxicity: May cause severe and irreversible hypothyroidism in the neonate. Verify pregnancy status in females of reproductive potential prior to initiating treatment. Females and males of reproductive potential should use effective contraception. ( 5.4 , 8.1 , 8.3 ) Radiation exposure to breast tissue with lactation: Sodium iodide I 131 concentrates in the breast of lactating women. Discontinue breast feeding at least 6 weeks prior to therapy. 4 CONTRAINDICATIONS HICON ® is contraindicated in: 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
8.1 Pregnancy 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.
Storage
16.2 Storage and Handling 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.
Frequently Asked Questions
What is Sodium Iodide I 131 used for?▼
1 INDICATIONS AND USAGE HICON ® is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma. HICON ® is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.
What are the side effects of Sodium Iodide I 131?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described below and elsewhere in labeling: Radiation-induced Thyroiditis [see Warnings and Precautions ( 5.1 )] . Radiation-induced Toxicities [see Warnings and Precautions ( 5.2 )] . Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] . Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.1 )] . Increased Radiation Exposure to Breast Tissue with Lactation [see Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.2 )] . Transient Infertility [see Warnings and Precautions ( 5.6 ), Use in Specific Populations ( 8.3 )] . Radiation Exposure to Other Individuals [see Warnings and Precautions ( 5.7 )] .
Can I take Sodium Iodide I 131 during pregnancy?▼
8.1 Pregnancy 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.
What are the important warnings for Sodium Iodide I 131?▼
5 WARNINGS AND PRECAUTIONS Radiation-induced thyroiditis may cause or worsen hyperthyroidism. Consider pre-treatment with anti-thyroid medications. ( 5.1 ) Multiple non-thyroid radiation toxicities, including hematopoietic suppression: Individualize dose and monitor for toxicity. ( 5.2 ) Embryo-Fetal toxicity: May cause severe and irreversible hypothyroidism in the neonate. Verify pregnancy status in females of reproductive potential prior to initiating treatment. Females and males of reproductive potential should use effective contraception. ( 5.4 , 8.1 , 8.3 ) Radiation exposure to breast tissue with lactation: Sodium iodide I 131 concentrates in the breast of lactating women. Discontinue breast feeding at least 6 weeks prior to therapy. 4 CONTRAINDICATIONS HICON ® is contraindicated in: 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 )] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.