urated solution of potassium iodide 3 weeks topical iodine (e.g., surgical skin preparation) 3 weeks radiographic contrast agents water soluble lipophilic 2 months 6 months amiodarone 6 months the recent intake of iodine in any form or the use of thyroid or anti-thyroid drugs will affect the uptake of sodium iodide i 131. ( 5.3 , 7 )

um iodide i 131 capsules diagnostic contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. follow safe administration instructions to minimize radiation exposure to the patient and healthcare providers [see dosage and administration ( 2.1 ) ]. 5.3 risk of radioactive uptake measurement and imaging misinterpretation the recent intake of stable iodine in any form, or the use of thyroid or anti-thyroid drugs will affect the uptake of sodium iodide i 131. question the patient carefully regarding their exposure to these drugs or procedures involving radiographic contrast media [see drug interactions ( 7 ) ]. 5.4 hypersensitivity reactions hypersensitivity reactions including anaphylaxis may occur in patients who receive sodium iodide i 131. although iodine 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 ) ].

bration system immediately prior to administration. 2.2 recommended dosage and administration instructions administer sodium iodide i 131 capsules diagnostic orally prior to scanning. the recommended dose of sodium iodide i 131 capsules diagnostic for an adult patient is the following: thyroid function: 0.185 to 1.1 megabecquerels (mbq) [5 to 30 microcuries (microci)]. administer 24 hours before uptake measurement. thyroid imaging (scintigraphy): 1.85 to 3.70 mbq (50 to 100 microci). administer 16 -24 hours before imaging. consult the color-coded decay calendar that is updated in january of every year to determine which colored capsule(s) correspond to the prescribed dose: https://www.draximage.com/products/us/draximage-i-131-diagnostic-capsules/ or calculate the correct dose from the date and time of calibration provided on the container label. prior to sodium iodide i 131 capsules diagnostic administration obtain a pregnacy test in females of reproductive potential prior to administration to verify the absence of pregnancy [see contraindications ( 4 ) and use in specific populations ( 8.1, 8.3 ) ]. advise patients to maintain a low-iodine diet two weeks prior to radioiodine administration and continue for several days during the uptake or imaging process [see drug interactions ( 7 ) ]. advise patients to fast at least 2 hours before and 2 hours after administration to ensure absorption. advise patients to hydrate before and after administration of radioiodine and void frequently to ensure rapid excretion. 2.3 radiation dosimetry the biokinetic and radiation dose distributions associated with thyroid uptake of iodide i 131 depend on dietary intake of stable iodine. a range of uptake percentages in an average adult (73.7 kg) are shown in table 1. for a thyroid blocked from iodide uptake in the production of hormones, the effective half-life of iodide i 131 is approximately 1.4 hours; for "low" to "high" uptake, the effective half-life of i 131 ranges from approximately 80 to 90 hours. table 1 absorbed dose per unit activity sodium iodide i 131 administered orally (mgy/mbq) in adult (73.7-kg reference model) organ thyroid uptake of i 131 (% administered activity a 0 ) 24 h after oral administration blocked thyroid (0% a 0 ) low uptake (16% a 0 ) medium uptake (26% a 0 ) high uptake (36% a 0 ) adrenals 0.044 0.051 0.055 0.059 bone surfaces 0.030 0.089 0.12 0.16 brain 0.021 0.093 0.13 0.17 breast 0.020 0.038 0.048 0.058 gallbladder wall 0.037 0.043 0.046 0.049 gastrointestinal tract stomach wall 0.87 0.77 0.71 0.66 small intestine wall 0.035 0.033 0.032 0.032 colon wall 0.14 0.14 0.14 0.14 (upper large intestine wall) 0.12 0.12 0.12 0.12 (lower large intestine wall) 0.17 0.17 0.17 0.16 heart wall 0.062 0.089 0.10 0.12 kidneys 0.27 0.27 0.27 0.27 liver 0.050 0.093 0.12 0.14 lungs 0.053 0.10 0.13 0.15 muscles 0.026 0.084 0.12 0.15 oesophagus 0.024 0.10 0.14 0.19 ovaries 0.038 0.037 0.036 0.035 pancreas 0.060 0.064 0.066 0.068 red marrow 0.031 0.072 0.095 0.12 salivary glands 0.27 0.22 0.19 0.16 skin 0.019 0.043 0.057 0.071 spleen 0.064 0.069 0.072 0.075 testes 0.025 0.024 0.023 0.22 thymus 0.024 0.10 0.14 0.19 thyroid 2.2 280 430 580 urinary bladder wall 0.54 0.45 0.39 0.34 uterus 0.045 0.042 0.040 0.038 remaining organs 0.029 0.84 0.11 0.15 effective dose per administered activity (msv/mbq) 0.28 14 22 29

suspected adverse reactions, contact jubilant draximage inc. at 1-888-633-5343 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

urated solution of potassium iodide 3 weeks topical iodine (e.g., surgical skin preparation) 3 weeks radiographic contrast agents water soluble lipophilic 2 months 6 months amiodarone 6 months the recent intake of iodine in any form or the use of thyroid or anti-thyroid drugs will affect the uptake of sodium iodide i 131. ( 5.3 , 7 )

dism. delay in diagnosis of neonatal hypothyroidism after exposure to sodium iodide i 131 in utero can result in severe sequelae such as decreased mental capacity and delayed skeletal maturation. monitor thyroid function in any infant born after in utero exposure to sodium iodide i 131. data human data literature reports of maternal exposures to sodium iodide i 131 at doses of 330-8300 mbq during 4-26 weeks estimated gestational age. there were various adverse pregnancy outcomes; the most common was hypothyroidism in infants and children. 8.2 lactation risk summary advise women to discontinue breastfeeding after administration of sodium iodide i 131 capsules diagnostic. infant exposure to sodium iodide i 131 via breast milk is expected and may lead to hypothyroidism in the infant because sodium iodide i 131 in breast milk may reach concentrations equal to or greater than concentrations in maternal plasma (see data ). data published studies show that sodium iodide i 131 is transferred into breast milk and is taken up by the thyroid of the breastfed infant. 8.3 females and males of reproductive potential sodium iodide i 131 is contraindicated in pregnancy because it causes fetal hypothyroidism [see use in specific populations ( 8.1 ) and warnings and precautions ( 5.1 ) ]. pregnancy testing obtain a pregnancy test in females of reproductive potential and verify the absence of pregnancy before administering sodium iodide i 131 capsules diagnostic [see dosage and administration ( 2.2 ) ]. 8.4 pediatric use safety and efficacy in pediatric patients have not been established. published reports suggest that the thyroid gland of pediatric patients is more sensitive to the adverse effects of sodium iodide i 131 (e.g., increased risk of radiation absorption). 8.5 geriatric use clinical experience has not identified differences in safety or effectiveness in geriatric patients compared to younger patients. however, elderly patients are more likely to have decreased renal function and radiation exposure is greater in patients with impaired renal function [see use in specific populations ( 8.6 ) , clinical pharmacology ( 12.3 ) ]. 8.6 renal impairment radiation exposure following sodium iodide i 131 capsules diagnostic is greater in patients with impaired renal function compared to patients with normal renal function [see clinical pharmacology ( 12.3 ) ].

h as decreased mental capacity and delayed skeletal maturation. monitor thyroid function in any infant born after in utero exposure to sodium iodide i 131. data human data literature reports of maternal exposures to sodium iodide i 131 at doses of 330-8300 mbq during 4-26 weeks estimated gestational age. there were various adverse pregnancy outcomes; the most common was hypothyroidism in infants and children.

in goiter, and is decreased in hypothyroidism. sodium iodide i 131 also accumulates in the stomach, choroid plexus, salivary glands breast, liver, gall bladder, and kidneys. elimination metabolism in thyroid follicular cells, iodide is oxidized through the action of thyroid peroxidase to iodinium (i + ) which in turn iodinates tyrosine residues of thyroglobulin. excretion sodium iodide i 131 is excreted in urine and feces. the normal range of urinary excretion is 37% to 75% of the administered dose, varying with the thyroid and renal function of the patient. fecal excretion is about 10%.

is 37% to 75% of the administered dose, varying with the thyroid and renal function of the patient. fecal excretion is about 10%.

in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide. this radiopharmaceutical is approved for use by persons under license by the nuclear regulatory commission or the relevant regulatory authority of an agreement state.

tions ( 8.2 ) ].