FDA

Sodium Iodide I 131

Approved 5 Feb 2020OralSolution

The FDA lists this product in 11 strengths and forms.

Indications

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.

Contraindications

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 )

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 ) 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 )

5.1Radiation-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.

Contraindications

Warnings and precautions

Discontinue lactation 6 weeks prior to therapy. ( 5.5 , 8.2 )

5.1Radiation-induced Thyroiditis

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 Population (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 Population (8.3) ]. Radiation Exposure to Other Individuals [see Warnings and Precautions (5.7) ]. Risk of Decreased Effectiveness of Therapy [see Warnings and Precautions (5.8) ]. Common adverse reactions reported with therapeutic doses of sodium iodide I-131 include local swelling, radiation sickness, sialadenitis, salivary gland dysfunction, bone marrow depression, lacrimal gland dysfunction, hypothyroidism, hyperthyroidism, thyrotoxic crisis.( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact International Isotopes Inc. at 1-800-699-3108 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Postmarketing Experience

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

Sodium Iodide I 131

Indications

Contraindications

Warnings and precautions

5.1Radiation-induced Thyroiditis

Two medicines in one question?

Sodium Iodide I 131

Indications

Contraindications

Warnings and precautions

5.1Radiation-induced Thyroiditis

Two medicines in one question?

5.2Radiation-induced Toxicities Sodium Iodide I

5.3Hypersensitivity Reactions

5.4Embryo-Fetal Toxicity Sodium Iodide I-131

5.5Increased Radiation Exposure to Breast Tissue with Lactation Sodium Iodide I-131

5.6Transient Infertility

5.7Risk of Radiation Exposure Household Contacts

5.8Risk of Decreased Effectiveness of Therapy

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Sodium Iodide

Adverse reactions

6.1Postmarketing Experience

Composition

Strengths and forms

Official product information

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