요오드화나트륨(123Ⅰ)

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

Sodium Iodide I-131 is contraindicated in: Patients with vomiting and diarrhea [see Warning and Precautions (5.7) ] . 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 [see Warning and Precautions (5.1) and Drug Interactions (7) ] . Pregnancy [see Warnings and Precautions (5.4) , see Use in Specific Populations (8.1) ] . Lactation [see Warnings and Precautions (5.5) ] . Patients with vomiting and diarrhea. ( 4 ) Patients with thyroid malignancies shown to have no iodide uptake. ( 4 ) Patients receiving concurrent anti-thyroid therapy. Pregnancy. ( 4 ) Lactation. ( 4 )

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 ) Fetal toxicity: May cause severe and irreversible hypothyroidism in the neonate. Verify absence of pregnancy before administering the product. ( 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 lactation 6 weeks prior to therapy. ( 5.5 , 8.2 ) 5.1 Radiation-induced Thyroiditis 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. 5.2 Radiation-induced Toxicities Sodium …

8.1 Pregnancy 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 …