image 1

Sodium Iodide I 131 Diagnostic Capsules USP Diagnostic - Oral

DESCRIPTION Sodium Iodide I 131 Capsule USP for diagnostic use is a radiopharmaceutical containing Sodium Iodide I-131 and supplied for oral administration in a gelatin capsule. Each capsule contains no-carrier-added Sodium Iodide I-131, Disodium Edetate Dihydrate USP as a stabilizer, Sodium Thiosulfate Pentahydrate USP as a reducing agent, and Dibasic Sodium Phosphate Anhydrous USP. Sodium Iodide I 131 Capsule USP (Diagnostic - Oral) is available in 3.70 megabecquerels (100 microcuries) at time of calibration. Other activities of 2.03, 1.11, 0.61, and 0.33 megabecquerels (55, 30, 16.5, and 9 microcuries/capsule) are available by using the color-coded decay calendar provided or by calculation using the date and time of calibration. Sodium Iodide I-131 is designated chemically as Na131I (MW 153.99, CAS 7681-72-5).

PHYSICAL CHARACTERISTICS

Iodine I-131 decays by beta emission and associated gamma emission with a physical half-life of 8.04 days.1 Photons that are useful for detection and imaging are listed in Table 1. Table 1Principal Radiation Emission Data

EXTERNAL RADIATION The specific gamma-ray constant for iodine I-131 is 15.8 uC *kg-1 *MBq-1 *hr-1 (2.27 R/mCi-hr) at 1 cm. The first half-value thickness of lead (Pb) for iodine I-131 is 0.24 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 2.55 cm of Pb will decrease the external radiation exposure by a factor of about 1,000. Table 2Radiation Attenuation by Lead Shielding

To correct for physical decay of iodine I-131, the fractions that remain at selected intervals after the time of calibration are shown in Table 3. Table 3Physical Decay Chart: Iodine I-131, Half-Life 8.04 days

CLINICAL PHARMACOLOGY

Pharmacokinetics Absorption: Following oral administration, Sodium Iodide I-131 is readily absorbed from the gastrointestinal tract. Distribution: Following absorption, the iodide is primarily distributed within the extra-cellular fluid of the body. It is trapped by the thyroid. The thyroid uptake of iodide is usually increased in hyperthyroidism and in goiter with impaired hormone synthesis, decreased in hypothyroidism, and normal to decreased in hypothyroidism receiving iodine. It should be noted that the uptake of radioactive iodide is a function of stable iodide concentration in the serum and the functional state of the thyroid. The iodine concentrating mechanism of the thyroid, termed the iodide trap or pump, accounts for an iodide concentration of some 25 times plasma levels, but may increase as much as 500 times under certain conditions. It is also concentrated by the stomach, choroid plexus, and salivary glands, but is not protein-bound. Metabolism: Trapped iodide is oxidized to iodine and organically incorporated so rapidly that the iodide trap of the thyroid contains less than 0.2 % free iodide in comparison to the organically bound iodine. This process results in further concentration of iodine in the thyroid gland to about 500 times that in the blood. The iodinated organic compounds chiefly consist of thyroxine (T4) and triiodothyronine (T3), which are bound by thyroglobulin in the follicular colloid. T4 and T3 are released by enzymatic proteolysis of thyroglobulin into the blood where they are specifically bound and transported by plasma thyroid binding proteins. These reactions are primarily under the control of anterior pituitary gland release of thyroid stimulating hormone (TSH) and hypothalamic thyroid release factor (TRF). Excretion: Sodium Iodide I-131 is excreted by the kidneys. The normal range of urinary excretion is 37 to 75 % of the administered dose, varying with the thyroid and renal function of the patient.

CONTRAINDICATIONS

Sodium Iodide I-131 is contraindicated for use in women who are or may become pregnant. Iodine-131 may cause harm to the fetal thyroid gland when administered to pregnant women. Review of the literature has shown that transplacental passage of radioiodide may cause severe, and possibly irreversible, hypothyrodism in neonates. Use of Sodium Iodide I-131 in women of childbearing age should be deferred until the possibility of pregnancy has been ruled out. If this drug is administered to a woman with reproductive potential, the patient should be apprised of the potential hazard to a fetus.

WARNINGS

None.

PRECAUTIONS General The recent intake of stable iodine in any form, or the use of thyroid or anti-thyroid drugs will affect the uptake of radioiodide. Accordingly, the patient should be questioned carefully regarding previous medication and procedures involving radiographic contrast media. The calibration date and expiration date are indicated on the container label. Radiopharmaceuticals should be used only by nuclear physicians and/or radiopharmacists 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. (See Drug Handling section.) As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to assure minimum radiation exposure to occupational workers. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or whether this drug affects fertility in males or females. Pregnancy Category X See CONTRAINDICATIONS section. Nursing Mothers Radioiodine is excreted in human milk during lactation. Therefore, formula feedings should be substituted for breast feedings. Pediatric Use Safety and efficacy in pediatric patients have not been established. Geriatric Use Adequate and well controlled studies on the relationship of age to the effect of radioiodide have not been performed in geriatric population. This drug is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.

INFORMATION FOR PATIENTS

Patients should inform their healthcare practitioner if they have one or more of the following: * Inform your physician if you are pregnant. * Inform your physician if you are allergic to any drugs or food, or if you have immune, autoimmune, or immune deficiency disorders. Also, inform your physician if you had any reactions to previous injections of dyes used for x-ray procedures. * Inform your physician of all medications you are currently taking, including non-prescription drugs (over-the-counter), before you have this procedure.

DRUG ABUSE AND DEPENDENCE

Patients administered Sodium Iodide I 131 Capsule USP are not at risk for developing chemical dependency.

OVERDOSAGE

The clinical consequences of overdosing with Sodium Iodide I 131 Capsule USP are not known. Treatment of an overdose should be directed toward the support of all vital functions and prompt institution of symptomatic therapy.

DOSAGE AND ADMINISTRATION

The suggested oral dosage ranges employed in the average patient (70 kg) for diagnostic procedures for thyroid function are as follows: Thyroid Uptake:0.185 to 0.555 megabecquerels (5 to 15 microcuries) Scintiscanning:1.85 to 3.70 megabecquerels (50 to 100 microcuries) Localization of Extra-Thyroidal Metastases: 37 megabecquerels (1,000 microcuries). General Dosing Information Patients should be adequately hydrated before and after administration of radioiodide to assure rapid urinary elimination of the iodide that is not absorbed by the thyroid gland. Radition Dosimetry The estimated absorbed radiation doses to an average (70 kg) euthyroid (normal functioning thyroid) patient from an oral dose of 3.70 megabecquerels (100 microcuries) of iodine I-131 are shown in Table 4.

Table 4Estimated Absorbed Radiation Doses froman Oral Dose of 3.70 megabecquerels (100 microcuries)

DRUG HANDLING

1. Sodium Iodide I 131 Capsule USP should not be used after the expiration date stated on the container label. 2. Care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to insure minimum radiation exposure to occupational workers. Waterproof gloves should be used during the entire handling and administration procedure. Adequate shielding should be maintained during the life of the product. 3. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

HOW SUPPLIED Each capsule contains 3.70 megabecquerels (100 microcuries) at time of calibration. The capsules will yield 2.03, 1.11, 0.61, or 0.33 megabecquerels (55, 30, 16.5, or 9 microcuries) according to the color-coded decay calendar, which assigns a color and capsule activity for each week of the year. The capsules are composed of one opaque white half, while the other half is an opaque pink, yellow, orange, grey or green. The capsules are packaged in plastic vials containing 5 capsules of the same strength. The vials also contain one desiccant packet . Please consult the color-coded decay calendar provided to help you establish which colored capsules are required for your prescribed dose, or calculate correct dosage from date and time of calibration provided on the container label. STORAGE Sodium Iodide I 131 Capsule USP should be stored between 15 degC and 30 degC (59 degF and 86 degF). Storage and disposal of Sodium Iodide I 131 Capsule USP should be controlled in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide. The U.S. Nuclear Regulatory Commission has allowed distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in Section 35.100, and to persons who hold an equivalent license by an Agreement State. NDC 65174-461-05 (Vial) Jubilant DraxImage Inc.,Kirkland, Quebec Canada. Revised: October, 2011Printed in Canada.

PRINCIPAL DISPLAY PANEL