Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 21 April 2018

Indication(s)

1 INDICATIONS AND USAGE Sodium Iodide I 131 Solution Therapeutic is indicated for the treatment of hyperthyroidism and thyroid carcinomas that take up iodide. Palliative effects may be observed in patients with advanced thyroid malignancy if the metastatic lesions take up iodide. Sodium Iodide I 131 Solution Therapeutic is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and thyroid carcinomas that take up iodine. Palliative effects may be observed in patients with advanced thyroid malignancy if the metastatic lesions take up iodine. (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS Sodium Iodide I 131 Solution Therapeutic is contraindicated in: Patients with vomiting and diarrhea [see Warnings and Precautions (5.7)]. The treatment of thyroid malignancies shown to have no iodide uptake, which include the majority of medullary and anaplastic carcinomas. Pregnancy [see Warnings and Precautions (5.5)]. Breastfeeding [see Use in Specific Populations (8.3)]. Patients with vomiting and diarrhea (4) In treatment of thyroid malignancies shown to have no iodide uptake (4) Pregnancy (4) Breastfeeding (4)
Adverse reactions
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

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Use safe handling measures to minimize inadvertent radiation exposure. (2.1) Hyperthyroidism 148 to 370 megabecquerels (MBq) (4 to 10 millicuries, mCi). Toxic nodular goiter and other situations may require larger doses. (2.2) Thyroid carcinoma For thyroid carcinoma, 3700 to 5550 MBq (100 to 150 mCi). (2.3) For post-operative ablation of normal thyroid tissue: 1850 MBq (50 mCi). (2.3) 2.1 Radiation Safety Sodium Iodide I 131 Solution emits radiation and must be handled with safety measures to minimize inadvertent radiation exposure to clinical personnel and patients [see Warnings and Precautions (5.7)]. Radiopharmaceuticals should be used only by or under the direction of phy­sicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Wear waterproof gloves during the entire sodium iodide I-131 solution handling and administration procedure. Maintain adequate shielding during the radiation-emitting life of the product. Measure the patient dose using a suitable radioactivity calibration system immediately prior to administration. 2.2 Hyperthyroidism For hyperthyroidism, the usual sodium iodide I-131 dose range is 148 to 370 MBq (4 to 10 mCi). Higher doses may be necessary for the treatment of toxic nodular goiter and other special situations. Consider discontinuation of anti-thyroid therapy in a severely hyperthyroid pa­tient three to four days before administration of sodium iodide I-131. Evaluate patients for risk of thyroid enlargement and obstruction of structures in the neck [see Warnings and Precautions (5.1, 5.2)]. 2.3 Thyroid Carcinoma For thyroid carcinoma, the usual sodium iodide I-131 therapeutic dose is 3700 to 5550 MBq (100 to 150 mCi). For ablation of post-operative residual thyroid tissue, the usual dose is 1850 MBq (50 mCi). 2.4 Individualization of Therapy Individualize sodium iodide I-131 therapy, including dose selection, based upon patient-specific factors such as the nature of the underlying condition, co-morbidities, age, estimated thyroid tissue iodine uptake, thyroid size, as well as ability of the patient to comply with the therapeutic regimen and radiation safety procedures. Perform a clinical assessment, including history, physical examination and laboratory testing when preparing patients for sodium iodide I-131 therapy in order to detect conditions which may alter thyroid iodine uptake and increase the risks of the therapy or diminish its effectiveness. For example, intake of iodine in radiographic contrast may diminish thyroid iodine uptake while low serum chloride or nephrosis may increase thyroid iodine uptake. Obtain a drug history and ascertain whether any medications need to be withheld before the administration of the therapy [see Drug Interactions (7)]. 2.5 Radiation Dosimetry The estimated absorbed radiation doses1 to an average (70 kg) euthyroid (normal functioning thy­roid) patient from an oral dose of iodine-131 in both milligray (mGy) per megabecquerel (MBq) and rad per millicurie (mCi) are shown in Table 1. Table 1. Absorbed Radiation Doses Tissue Thyroid Uptake 5% 15% 25% mGy/ MBq rads/ mCi mGy/ MBq rads/ mCi mGy/ MBq rads/ mCi Thyroid 72 266 210 777 360 1300 Stomach Wall 0.45 1.7 0.46 1.7 0.46 1.7 Red Marrow 0.038 0.14 0.054 0.20 0.07 0.26 Liver 0.03 0.11 0.032 0.12 0.035 0.13 Testes 0.029 0.11 0.028 0.10 0.027 0.10 Ovaries 0.044 0.16 0.043 0.16 0.043 0.16 Urinary Bladder 0.58 2.1 0.52 1.9 0.46 1.7 Salivary Glands2 0.5 1.85 0.5 1.85 0.5 1.85 Other 0.040 0.15 0.065 0.24 0.090 0.33
Use in special populations
8 USE IN SPECIFIC POPULATIONS Nursing Mothers: to minimize the absorbed radiation dose to breast tissue, discontinue breastfeeding at least four weeks before sodium iodide I-131 therapy. If administered in the postpartum period, the lactating mother should not breast-feed. (8.3) Pediatric Use: safety and effectiveness in pediatric patients have not been established. (8.4) Geriatric Use: enhanced evaluation, dose-selection and follow-up procedures may be necessary for geriatric patients due to underlying co-morbidities, including renal dysfunction. (8.5) Renal Impairment: may increase radiation exposure. (8.6) 8.1 Pregnancy Pregnancy Category X [see Warnings and Precautions (5.5)]. 8.3 Nursing Mothers Sodium iodide I-131 is excreted into human milk and may reach concentrations equal to or greater than concentrations in maternal plasma. To minimize the absorbed radiation dose to the breast tissue, breastfeeding and breast-pumping should be discontinued for at least four weeks before administration of sodium iodide I-131. Sodium iodide I-131 is contraindicated in pregnancy; if sodium iodide I-131 is administered in the postpartum period, the lactating mother should not breast-feed the infant. Breastfeeding may resume with the birth of another child, if the mother does not receive sodium iodide I-131 during that postpartum period. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. Published reports suggest that the thyroid gland of pediatric patients is more sensitive to the effects of sodium iodide I-131; however, it is unknown if the I-131 dose-response relationship is similar to that of adults. When considering the use of sodium iodide I-131 in pediatric patients, the risks, particularly carcinogenic risks, and benefits of sodium iodide I-131 must be carefully weighed against those of other possible treatments. 8.5 Geriatric Use Because elderly patients are more likely to have decreased renal function and co-morbid conditions, enhanced evaluation, dose-selection consideration and follow-up may be necessary for elderly patients receiving sodium iodide I-131 therapy, compared to younger patients [see Use in Specific Populations (8.6)]. When treating hyperthyroidism in geriatric patients at risk of developing cardiac complications, pre-treatment and post-treatment with anti-thyroid drugs and/or beta-blockers may help minimize the risk of excessive post-treatment hyperthyroidism due to radiation-induced thyroiditis [see Warnings and Precautions (5.1)]. 8.6 Renal Impairment Sodium iodide I-131 is eliminated predominantly through renal clearance. Patients with renal impairment are subject to decreased excretion of sodium iodide I-131 and increased radiation exposure. Evaluate renal function for therapeutic planning [see Dosage and Administration (2.4)]. Sodium iodide I-131 is dialyzable. Hemodialysis can be used to reduce total body radiation exposure.
Pregnancy and lactation
8.3 Nursing Mothers Sodium iodide I-131 is excreted into human milk and may reach concentrations equal to or greater than concentrations in maternal plasma. To minimize the absorbed radiation dose to the breast tissue, breastfeeding and breast-pumping should be discontinued for at least four weeks before administration of sodium iodide I-131. Sodium iodide I-131 is contraindicated in pregnancy; if sodium iodide I-131 is administered in the postpartum period, the lactating mother should not breast-feed the infant. Breastfeeding may resume with the birth of another child, if the mother does not receive sodium iodide I-131 during that postpartum period.

Interactions

7 DRUG INTERACTIONS Many pharmacologic agents interact with sodium iodide I-131. These agents may affect the iodide protein binding and alter the iodide pharmacokinetics and pharmacodynamics. Table 3. Drug Interactions Substance Average Duration of Effect Anti-thyroid drugs e.g., carbimazole, propylthiouracil 5 days Natural or synthetic thyroid hormone e.g., thyroxine tri-iodothyronine 4 weeks 2 weeks Iodine-containing medications e.g., amiodarone expectorants, vitamins 4 weeks 2 weeks Topical iodide 1-9 months X-ray contrast agents iodine-containing agents Up to 1 year Other drugs anticoagulants, antihistamines corticosteroids, sulfonamides tolbutamide, perchlorate phenylbutazone lithium 1 week 1 week 1 week 1-2 weeks 4 weeks Many pharmacologic agents are known to interact with radioiodide. See full prescribing information complete list. (7)

More information

Category Value
Authorisation number NDA016515
Agency product number 29VCO8ACHH
Orphan designation No
Product NDC 69945-450,69945-451
Date Last Revised 06-04-2018
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder MALLINCKRODT NUCLEAR MEDICINE LLC