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warnings and cautions
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 ) 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 Iodide I 131 may cause radiation induced toxicities [see Adverse Reactions (6) ] : Dose-dependent fatalities (bone marrow suppression, malignancy). Dose-dependent hematopoietic suppression which manifests as a transient thrombocytopenia or neutropenia 3-5 weeks following sodium iodide I 131 administrations, may lead to increased susceptibility to infections or bleeding. Salivary gland toxicity: sialadenitis, xerostomia. Lacrimal gland toxicity: conjunctivitis, xerophthalmia, and epiphora. Increased risk of developing new solid tumors and leukemias. Obtain a complete blood count within one month of therapy. If patients show leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity, while delivering less than 2 Gy to the bone marrow. Advise good hydration for one week following sodium iodide I 131 administration and stimulate salivary flow via a sialagogue (e.g. sugar-free candy or gum, pilocarpine, and ascorbic acid) to reduce radiation exposure to the salivary glands. Advise patients to void frequently after administration of radioiodide to enhance excretion. 5.3 Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis may occur in patients who receive sodium iodide I 131. Although iodide is not considered an allergen, hypersensitivity reactions may occur in relation with excipients or chemical component of the capsule, such as sodium thiosulfate. Obtain and document an allergy history, particularly a sulfite allergy. Emergency resuscitation equipment and personnel should be immediately available [see Adverse Reactions (6) ] . 5.4 Embryo-Fetal Toxicity Sodium Iodide I-131 Solution is contraindicated in pregnancy because sodium iodide I-131 crosses the placenta and fetal exposure can lead to neonatal hypothyroidism. Multiple reports in the published literature describe hypothyroidism in the neonates following in utero exposure to sodium iodide I-131. Some cases of neonatal hypothyroidism were severe and irreversible. Verify pregnancy status of females of reproductive potential prior to initiating Sodium Iodide I-131 Solution treatment. Advise females and males of reproductive potential to use effective contraception during treatment with Sodium Iodide I-131 Solution and for at least six months after the last dose [see Use in Specific Populations (8.1 , 8.3) ]. 5.5 Increased Radiation Exposure to Breast Tissue with Lactation Sodium Iodide I-131 Solution is contraindicated in lactating women because sodium iodide I-131 concentrates in the breast via the increased expression of the sodium iodide symporter in breast tissue with lactation. The literature describes moderate to marked radioiodine uptake in the breast tissue for 5 to 32 weeks post cessation of breast feeding. Advise lactating women to discontinue breast feeding at least 6 weeks prior to administration of sodium iodide I-131 to allow sufficient time for involution to occur and to avoid excess concentration of sodium iodide I-131 in breast tissue. Consider administration of drugs to suppress lactation. Consider diagnostic scintigraphy before administration of sodium iodide I-131 to assess the persistence of uptake by breast tissue. If sodium iodide I-131 is administered in the postpartum period, the lactating mother should not breastfeed the infant [see Use in Specific Populations (8.2) ] . 5.6 Transient Infertility Transient dose-related impairment of testicular function in men and transient ovarian insufficiency in women has been reported after sodium iodide I-131 therapy. Sperm banking for men may be considered prior to administration of Sodium Iodide I-131 Solution for thyroid carcinoma [see Use in Specific Populations (8.3) ] . 5.7 Risk of Radiation Exposure Household Contacts Instruct patients to follow radiation safety precautions after receiving Sodium Iodide I-131 to minimize the radiation contamination of other persons or the environment. Patients should avoid close contact with others, especially pregnant women and children, and take care to avoid contamination of other persons or the environment with body fluids. Patients and Healthcare Providers Sodium Iodide I-131 contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Follow safe handling and administration to minimize radiation exposure to the patient and healthcare providers. 5.8 Risk of Decreased Effectiveness of Therapy Certain food or drugs may alter the thyroid uptake of sodium iodide I 131 and diminish its effectiveness. Recent intake of stable iodide in any form, or the use of thyroid or anti-thyroid drugs may diminish thyroid uptake of sodium iodide I 131 [see Drug Interactions (7) ] .
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
adverse reactions table
<table border="0" cellpadding="0" cellspacing="0" width="99.04%"><tbody><tr><td colspan="2"><paragraph>Table 3 Postmarket Adverse Reactions by System Organ Class</paragraph></td></tr><tr><td><paragraph>System Organ Class*</paragraph></td><td><paragraph>Symptoms*</paragraph></td></tr><tr><td><paragraph>Cardiac disorders</paragraph></td><td><paragraph>Chest pain, tachycardia</paragraph></td></tr><tr><td><paragraph>Congenital, familial and genetic disorders</paragraph></td><td><paragraph>Chromosomal abnormalities, congenital hypothyroidism</paragraph></td></tr><tr><td><paragraph>Endocrine disorders</paragraph></td><td><paragraph>Hyperthyroidism, hypoparathyroidism, hypothyroidism, thyrotoxic crisis</paragraph></td></tr><tr><td><paragraph>Eye disorders</paragraph></td><td><paragraph>Lacrimal gland dysfunction</paragraph></td></tr><tr><td><paragraph>Gastrointestinal disorders</paragraph></td><td><paragraph>Gastritis, nausea, salivary gland dysfunction, sialadenitis, vomiting</paragraph></td></tr><tr><td><paragraph>General disorders and administration site conditions</paragraph></td><td><paragraph>Local swelling of thyroid or sites of iodide avid tumor</paragraph></td></tr><tr><td><paragraph>Hematologic and lymphatic disorders including fatalities</paragraph></td><td><paragraph>Anemia, blood dyscrasia, bone marrow depression, leukopenia, thrombocytopenia</paragraph></td></tr><tr><td><paragraph>Immune system disorders</paragraph></td><td><paragraph>Bronchospasm</paragraph></td></tr><tr><td><paragraph>Neoplasms benign, malignant and unspecified (including cysts and polyps)</paragraph></td><td><paragraph>Acute leukemia, solid cancer</paragraph></td></tr><tr><td><paragraph>Nervous system disorders</paragraph></td><td><paragraph>+Cerebral edema, headache</paragraph></td></tr><tr><td><paragraph>Respiratory, thoracic and mediastinal disorders</paragraph></td><td><paragraph>♦Pulmonary fibrosis, ♦radiation pneumonitis</paragraph></td></tr><tr><td><paragraph>Skin and subcutaneous tissue disorders</paragraph></td><td><paragraph>Hives, itching, rash</paragraph></td></tr><tr><td><paragraph>* In alphabetical order</paragraph><paragraph>+ In patients with iodide-avid brain metastases</paragraph><paragraph>♦ In patients with iodide-avid lung metastases</paragraph></td><td/></tr><tr><td colspan="2"><paragraph/></td></tr></tbody></table>