FDA label d6d7e659-36aa-49ec-81f7-a962878c7e3a

5.1 Radiation-induced Thyroiditis Sodium iodide I-131 may cause thyroiditis with gland enlargement and release of thyroid hormone, particularly when used to treat hyperthyroidism. The thyroiditis may cause or worsen hyperthyroidism, and may cause thyroid storm. When treating hyperthyroidism, consider pre-treatment with 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. Consider beta-blocker therapy before administration of sodium iodide I-131 to minimize the risk of hyperthyroidism and thyroid storm.

5.2 Thyroid-stimulating Hormone (TSH) and Thyroid Enlargement Enhanced TSH secretion, e.g., following discontinuation of anti-thyroid medications, or the administration of TSH to enhance sodium iodide I-131 uptake, may cause thyroid enlargement and obstructive complications of the trachea, esophagus, or blood vessels in the neck. Evaluate patients at high risk of obstructive complications before preparative treatments known to cause thyroid enlargement.

5.3 Radiation-induced Toxicities Radiation-induced toxicities, including dose-dependent fatalities, have been reported following sodium iodide I-131 therapy. Post-marketing reports have identified an increased risk for neoplasia, as well as risks for hematopoietic suppression. Salivary and lacrimal gland toxicity is relatively common and may manifest as conjunctivitis, xerophthalmia, epiphora, sialadenitis and xerostomia [see Adverse Reactions ( 6 )] .

5.4 Hypersensitivity Reactions Hypersensitivity reactions, including rash and hives have been reported following administration of sodium iodide I-131. Sodium Iodide I 131 Capsules may contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. During the pre-therapy assessment, question patients about a history of hypersensitivity to sulfite [see Adverse Reactions ( 6 )] .

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Radiation-induced Thyroiditis [see Warnings and Precautions ( 5.1 )] Thyroid-stimulating Hormone and Thyroid Enlargement [see Warnings and Precautions ( 5.2 )] Radiation-induced Toxicities [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Fetal Risk [see Warnings and Precautions ( 5.5 )] Transient Infertility [see Warnings and Precautions ( 5.6 )] Radiation Exposure to Other Individuals [see Warnings and Precautions ( 5.7 )] Radiation-related adverse reactions are a function of the dose level received by the patient. The following adverse reactions have been reported with doses of sodium iodide I-131 used in the treatment of benign disease, such as hyperthyroidism: Gastrointestinal disorders: sialadenitis Cardiac disorders: chest pain and tachycardia Skin and subcutaneous tissue disorders: iododerma, itching skin, rash, and hives Endocrine disorders: hypothyroidism, hyperthyroidism, thyrotoxic crisis, hypoparathyroidism General disorders and administration site conditions: local swelling Hepatobiliary disorders: hepatic function abnormal The following adverse reactions have been reported with doses of sodium iodide I-131 used in the treatment of malignant disease: Blood and lymphatic system disorders including fatalities: radiation sickness, bone marrow depression, anemia, leucopenia, thrombocytopenia, and blood dyscrasia Neoplasms benign, malignant and unspecified (including cysts and polyps): leukemia and solid cancers Eye disorders: lacrimal gland dysfunction, dacryostenosis acquired Gastrointestinal disorders: salivary gland dysfunction, nausea, vomiting Congenital, familial and genetic disorders: congenital hypothyroidism and chromosomal abnormalities Nervous System Disorders: *Cerebral edema Pulmonary Disorders : **Radiation pneumonitis, **Pulmonary fibrosis * In patients with iodine-avid brain metastases ** In patients with iodine-avid lung metastases Adverse reactions that occur after treatment of benign disease may also occur after treatment of malignant disease. Tenderness, pain on swallowing, sore throat, and cough have been reported, generally around the third day after sodium iodide I-131 administration. Adverse reactions that have been reported with doses of sodium iodide I-131 used in the treatment of benign disease include sialadenitis, chest pain, tachycardia, iododerma, itching skin, rash, hives, hypothyroidism, hyperthyroidism, thyrotoxic crisis, hypoparathyroidism, local swelling, and hepatic function abnormal. ( 6 ) Adverse reactions that have been reported with doses of sodium iodide I-131 used in the treatment of malignant disease include radiation sickness, bone marrow depression, anemia, leucopenia, thrombocytopenia, blood dyscrasia, leukemia, solid cancers, lacrimal gland dysfunction, dacryostenosis acquired, salivary gland dysfunction, congenital hypothyroidism, chromosomal abnormalities, cerebral edema, radiation pneumonitis, and pulmonary fibrosis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS contact Mallinckrodt Inc. at 1-888-744-1414 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch