Sodium Iodide I-131
Generic: SODIUM IODIDE I-131
Basic Information
Manufacturer
Radnostix, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
380e8e26-0625-4233-b36e-afb9f66e8a77
Indications & Usage
1 INDICATIONS AND USAGE 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 a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.
Adverse Reactions
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 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.
6.1 Postmarketing 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
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.
6.1 Postmarketing 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