Sodium Iodide I-131 Kit
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💲 Pricing
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| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sodium Iodide I-131this 69208-0000-00 | Radnostix, | 10 capsules | — | AA | FDA listed | — |
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69208-0000-00 You're viewing this | 1 KIT in 1 BOX (69208-000-00) * 3 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-35) * 2 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-25) * 1 CARTON in 1 BOX / 2 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK * 1 SOLUTION | 2020-03-16 | Active |
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| NDC identity (package / product / labeler codes) | ✓ Available |
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| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
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| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Sodium Iodide I-131 Solution is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma. Sodium Iodide I-131 is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.
⏱️ Dosage and Administration ▾
The concentrated sodium iodide I 131 solution provided must be diluted. ( 2.2 ) See Full Prescribing Information for important administration instructions and dilution and preparation instructions for sodium iodide l 131 capsules or oral solution. ( 2.2 , 2.4 ) The recommended dose is based on the thyroid gland uptake as well as the size of the gland: Treatment of Hyperthyroidism: Recommended dosage is 148 to 370 megabecquerels (MBq) [4 to 10 millicuries (mCi).
( 2.3 ) Treatment of Thyroid Carcinoma: Recommended dosage is 1,110 to 33,700 MBq (30 to 100 mCi). ( 2.3 )
2.1Radiation Safety Sodium Iodide I-131 is a radioactive drug. Handle with appropriate safety measures to minimize radiation exposure to the patient and healthcare workers [see Warnings and Precautions (5.7) ]: Use only by, or under the direction of, physicians who are qualified by specific training and experience in the safe use and handling of radioactive materials, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals. Use waterproof gloves when handling and administering the product.
Maintain adequate shielding during the life of the product. Measure patient dose with a suitable radioactivity calibration system immediately prior to administration.
2.2Important Administration Instructions Do not directly administer the concentrated Sodium Iodide I-131 solution provided to patients. The concentrated sodium iodide I 131 solution must be diluted and prepared prior to administration [see Dosage and Administration (2.4) ] . Obtain a pregnancy 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 )] .
Instruct patients to fast at least 2 hours before and 2 hours after administration to ensure absorption. Instruct patients to hydrate before and after administration of sodium iodide I-131 and to void frequently to enhance urinary elimination of the radioiodide that is not absorbed by the thyroid gland [see Warnings and Precautions (5.2) ] . Instruct patients to maintain a low-iodide diet two weeks prior to radioiodide administration and continue for several days during the uptake or imaging process [see Warnings and Precautions (5.8) and Drug Interactions (7) ] .
Instruct patients to discontinue the anti-thyroid therapy three days before administration of sodium iodide I 131 [see Warnings and Precautions (5.8) and Drug Interactions (7) ] . For patients with a history of renal impairment, evaluate renal function for therapeutic planning and consider dosimetry [see Use in Specific Populations (8.6) ] . 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 [see Warnings and Precautions (5.2) ] .
2.3Recommended Dosage and Administration Individualization of Therapy The recommended dose for orally administered sodium iodide I 131 capsules or solution is based on the thyroid gland uptake as well as the size of the gland. Thyroidal uptake and size should be determined by the physician prior to treatment and may be useful in calculating the therapeutic dose to be administered to the individual patient. Treatment of Hyperthyroidism The recommended dose is 148 to 370 MBq (4 to 10 mCi) administered orally.
Toxic nodular goiter may require a larger dose. Treatment of Thyroid Carcinoma The recommended dose is 1100 to 3700 MBq (30 to 100 mCi) administered orally. For subsequent ablation of metastases, the recommended dose is 3700 to 7400 MBq (100 to 200 mCi) administered orally.
2.4Dilution and Preparation Instructions Drug Handling Wear waterproof gloves throughout the entire handling and administration procedure. Make all transfers of radioactive solutions with an adequately shielded syringe or re…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Sodium Iodide I-131 solution componentis available in customer ordered vials available in 1, 2 and 3 mL V-Vials containing colorless, aqueous concentrated Sodium Iodide I-131 Solution at a strength of 37,000 MBq/mL (1000 mCi/mL) at time of calibration for preparation of sodium iodide I-131 capsules, therapeutic or sodium iodide I-131 solution, therapeutic. Large empty gelatin capsules and small gelatin capsules containing approximately 300 mg of dibasic sodium phosphate anhydrous as the absorbing buffer are supplied along with the Sodium Iodide I-131 solution for the preparation of sodium iodide I-131 capsules, therapeutic.
Table 2. Sodium Iodide I-131 Dispensing Concentrate Solution *At time of calibration Vial Type (Stopper) mCi I-131/mL Maximum Volume (mL) 1 mL V-Vial (13 mm) 1000 0.75 2 mL V-Vial (13 mm) 1000 1.50 3 mL V-vial (20 mm) 1000
2.25Vials: Sodium Iodide I-131 solution (with a radioconcentration of 37,000 MBq/mL (1000 mCi/mL) at the time of calibration) for the preparation of sodium iodide I-131 capsules, therapeutic or sodium iodide I-131 solution, therapeutic. ( 3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Sodium Iodide I-131 is contraindicated in: Patients with vomiting and diarrhea [see Warning and Precautions (5.7) ] . Patients with thyroid malignancies shown to have no iodide uptake, which include the majority of medullary or anaplastic carcinomas. Patients receiving concurrent anti-thyroid therapy [see Warning and Precautions (5.1) and Drug Interactions (7) ] .
Pregnancy [see Warnings and Precautions (5.4) , see Use in Specific Populations (8.1) ] . Lactation [see Warnings and Precautions (5.5) ] . Patients with vomiting and diarrhea.
( 4 ) Patients with thyroid malignancies shown to have no iodide uptake. ( 4 ) Patients receiving concurrent anti-thyroid therapy. Pregnancy.
( 4 ) Lactation. ( 4 )
⚠️ 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 )
5.1Radiation-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.
5.2Radiation-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.
5.3Hypersensitivity 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) ] .
5.4Embryo-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) ].
5.5Increased Radiation Exposure to Breast Tissue with Lactation Sodium Iodide I-131 Solution is contraindicated…
🤒 Adverse Reactions ▾
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.
6.1Postmarketing 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
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Concomitant use of bone marrow depressants may enhance the depression of the hematopoietic system caused by the use of large doses of sodium iodide I 131 [see Warnings and Precautions (5.2 )] . Many drugs and iodide-containing foods interfere with the accumulation of radioiodide by the thyroid. Review the patients history, current medications, and recent diagnostic tests prior to the administration of sodium iodide I 131 [see Warnings and Precautions (5.8) ] .
Advise patients to maintain a low-iodide diet two weeks prior to radioiodide administration and continue for several days during the uptake or imaging process and to discontinue taking the following products before they undergo the procedure as shown in Table 4. Table 4 Pharmaceuticals/OTCs/Agents Blocking Radioiodine Uptake Type of Medication Recommended time of withdrawal Thionamide medications (e.g., propylthiouracil, methimazole, carbimazole) 3 days Multivitamins containing iodide 10 days Natural or synthetic thyroid hormones triiodothyronine thyroxine 2 weeks 4 weeks Iodide-containing foods: iodized salt, dairy products, egg yolks, seafood, turkey and liver 2 weeks Kelp, agar, carrageenan, Lugol solution 3 weeks Saturated solution of potassium iodide 3 weeks Topical iodide (e.g., surgical skin preparation) 3 weeks Intravenous radiographic contrast agents Water soluble Lipophilic 2 months 6 months Amiodarone 6 months Many drugs and iodine-containing foods interfere with the accumulation of radioiodide by the thyroid.
Instruct patients to maintain a low-iodide diet (2 weeks) and discontinue anti-thyroid therapy (3 days) before administration. ( 5.8 , 7 )
👥 Use in Specific Populations ▾
Females and Males of Reproductive Potential: May impair fertility in females and males. ( 5.6 , 8.3 ) Geriatric Use: Dose selection may be necessary for geriatric patients due to possible decreased renal function. ( 8.5 ) Renal Impairment: May increase radiation exposure. ( 5.2 , 8.6 )
8.1Pregnancy Risk Summary Sodium Iodide I-131 is contraindicated in pregnancy because fetal exposure can lead to neonatal hypothyroidism, which in some cases is severe and irreversible [see Warnings and Precautions (5.4) ] . Data from the published literature describe thyroid abnormalities after fetal exposure; including agenesis of the thyroid and hypothyroidism (see Data ). No animal reproductive studies have been conducted.
Clinical Considerations . Fetal/ Neonatal Adverse Reactions A fetus exposed to sodium iodide I 131 can develop neonatal hypothyroidism. 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 bone age.
Monitor thyroid function in any infant born after in utero exposure to sodium iodide I 131. Data Human Data Sodium iodide I 131 crosses the placenta and the fetal thyroid begins to concentrate iodide during the 10-12 th week of gestation. In literature reports of maternal exposures to sodium iodide I 131 at doses of 333 – 8325 MBq (9 – 225 mCi) during 4-26 weeks gestational age, the most common adverse outcomes were hypothyroid infants and children.
8.2Lactation Risk Summary Sodium Iodide I-131 Solution is contraindicated during lactation because I-131 concentrates in the breast during lactation via the increased expression of the sodium iodide symporter in breast tissue and can lead to hypothyroidism in the infant through breastfeeding. If sodium iodide I-131 is administered postpartum, breastfeeding should not be restarted for the remainder of the postpartum period. In addition, to minimize the absorbed radiation dose to the breast tissue, breastfeeding and breast-pumping should be discontinued for at least 6 weeks before administration of sodium iodide I-131 [see Warnings and Precautions (5.5) ] .
Infants exposed to sodium iodide I-131 through breast milk are at risk for development of hypothyroidism because sodium iodide I-131 is distributed into breast milk and may reach concentrations equal to or greater than concentrations in maternal plasma(see Data ). Data Published literature describes sodium iodide I-131 transfer into breast milk and uptake by the thyroid of the breastfed infant. The amount of sodium Iodide I-131 detected in the breast milk at 36 to 48 hours after administration is 1% to 27% of the injected dose (with injected doses between
1.1MBq to 5,143 MBq).
8.3Females and Males of Reproductive Potential Sodium Iodide I-131 is contraindicated in pregnancy because of the risk of fetal hypothyroidism [see Warnings and Precautions (5.4) and [see Use in Specific Populations (8.1) ] . Pregnancy Testing Obtain a pregnancy test in females of reproductive potential and verify the absence of pregnancy before initiating treatment [see Dosage and Administration (2.2) ]. Contraception 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 of Sodium Iodide I-131 Solution.
Infertility Females Fertility may be impaired with Sodium Iodide I-131 Solution treatment. Transient amenorrhea and ovarian insufficiency have been observed after sodium iodide I-131 therapy in females. The literature describes reports of transient menstrual cycle irregularities, including amenorrhea, and ovarian failure in females treated with cumulative doses of 1,000 MBq to 59,000 MBq (27 mCi to 1,595 mCi) sodium iodide I-131.
In a published literature analysis, the effects on fertility occurred in up to 30% of women treated with sodium iodide I-131, and may resolve 12 months after treatment. Males Fertility may b…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Sodium Iodide I-131 is contraindicated in pregnancy because fetal exposure can lead to neonatal hypothyroidism, which in some cases is severe and irreversible [see Warnings and Precautions (5.4) ] . Data from the published literature describe thyroid abnormalities after fetal exposure; including agenesis of the thyroid and hypothyroidism (see Data ). No animal reproductive studies have been conducted.
Clinical Considerations . Fetal/ Neonatal Adverse Reactions A fetus exposed to sodium iodide I 131 can develop neonatal hypothyroidism. 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 bone age.
Monitor thyroid function in any infant born after in utero exposure to sodium iodide I 131. Data Human Data Sodium iodide I 131 crosses the placenta and the fetal thyroid begins to concentrate iodide during the 10-12 th week of gestation. In literature reports of maternal exposures to sodium iodide I 131 at doses of 333 – 8325 MBq (9 – 225 mCi) during 4-26 weeks gestational age, the most common adverse outcomes were hypothyroid infants and children.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of Sodium Iodide I-131 Solution have not been established in pediatric patients. Pediatric patients are at an increased lifetime risk for malignancy from radiation exposure.
🧓 Geriatric Use ▾
8.5Geriatric 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) ].
🆘 Overdosage ▾
10 OVERDOSAGE In case of exposure to a radioactive dose of sodium iodide I 131 exceeding the intended therapeutic dose, provide general supportive care, promote frequent voiding, monitor for bone marrow and thyroid suppression. Consider administering a thyroid blocking agent (e.g. potassium iodide (KI) or perchlorate) promptly within 4 to 6 hours after the exposure. Assess the benefit of administering a thyroid blocking agent against the risk of failure of sodium iodide I 131 therapy.
Appropriate replacement therapy is recommended if hypothyroidism occurs.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Iodide is actively transported by the sodium-iodide symporter (NIS) protein, in thyroid follicular cells. Iodide is concentrated in follicular cells to levels up to 50 times higher than in the plasma. Iodide is metabolically oxidized by thyroid peroxidase to iodinium (I + ) which in turn iodinates tyrosine residues of thyroglobulin (tri or tetra-iodinated tyrosine).
The beta emission of I 131 is responsible for the therapeutic effect.
12.2Pharmacodynamics The relationship between the extent of iodide I 131 exposure and pharmacologic effects has not been explored in clinical trials.
12.3Pharmacokinetics Absorption Following oral administration of sodium iodide I 131, 90% of the administered radioactivity of Iodide I 131 is systemically absorbed in the first 60 minutes. Distribution Following absorption, I 131 is distributed within the extra-cellular space. It is actively transported by the sodium-iodide symporter (NIS) protein, and binds to thyroglobulin resulting in accumulation in the thyroid.
The thyroid uptake of iodide is usually increased in hyperthyroidism and 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 thyroidal 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%.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Iodide is actively transported by the sodium-iodide symporter (NIS) protein, in thyroid follicular cells. Iodide is concentrated in follicular cells to levels up to 50 times higher than in the plasma. Iodide is metabolically oxidized by thyroid peroxidase to iodinium (I + ) which in turn iodinates tyrosine residues of thyroglobulin (tri or tetra-iodinated tyrosine).
The beta emission of I 131 is responsible for the therapeutic effect.
📦 How Supplied / Storage and Handling ▾
16.1How Supplied The Sodium Iodide I-131 Solution provides a concentrated solution of sodium iodide I-131 with a radioconcentration of 37,000 MBq/mL (1,000 mCi/mL) at the time of calibration and can be supplied in any of the following vials: 1, 2 and 3 mL clear glass V-vials. The concentrated solution is intended for use in the preparation of capsules and solutions of varying strengths for oral administration. Concentrated Sodium Iodide I-131 Solution NDC Code Size/type Container 69208-001-15 1 mL V-vial 69208-001-25 2 mL V-vial 69208-001-35 3 mL V-vial A minimum of one carton of capsules containing 2 blister packs of capsules may be provided with each shipment.
Each blister pack includes 5 empty #1 capsules and 5 filled #2 capsules containing approximately 300 mg of dibasic sodium phosphate anhydrous USP as the absorbing buffer. The capsules may be supplied along with the Sodium Iodide I-131 Solution for the preparation of sodium iodide I-131 capsules, therapeutic.
📦 Storage and Handling ▾
16.2Storage The Sodium Iodide I-131 Solution should be stored between 2 °C and 25 °C (36 °F and 77 °F). Store and dispose of Sodium Iodide I-131 Solution in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide. Use Sodium Iodide I-131 Solution per the expiry date on the lead shield label.
Use prepared capsules within 7 days of preparing. Discard unused capsules after all Sodium Iodide I-131Solution has been dispensed or expired. New blister packages of hard gelatin capsules may be provided with each new shipment of Sodium Iodide I-131 Solution.
This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.
📋 Description ▾
11 DESCRIPTION
11.1Chemical Characteristics Sodium Iodide I-131 Solution, a radioactive therapeutic agent, provides a concentrated solution of sodium iodide I-131 with a radioconcentration of 37,000 MBq/mL (1,000 mCi/mL). Each mL of the concentrated solution contains 37,000 MBq of 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. The pH of the concentrated solution is between 7.5 and 10.
The concentrated solution provided with Sodium Iodide I-131 Solution is used for the preparation of sodium iodide I-131 capsules or sodium iodide I-131 solution of varying strengths for oral administration for therapy. Sodium iodide I-131 solution is designated chemically as Na 131 I and has a molecular weight of 153.99 g/mol. Hard gelatin capsules, provided for the preparation of the sodium iodide I-131 capsules final dosage form, contain approximately 300 mg of dibasic sodium phosphate anhydrous USP as the absorbing buffer.
11.2Physical Characteristics Iodine I-131 decays by beta emission and associated gamma emission with a physical half-life of 8.02 days. The principal radiation emissions are listed in Table 5. Table 5 Principal Radiation Emission Data from Decay of Sodium Iodide I 131 Radiation Mean % per Disintegration Mean Energy (keV) Beta-1 2.1%
69.4Beta-3 7.2%
96.6Beta-4 89.4% 191.6 Gamma-7 6.1% 284.3 Gamma-14 81.2% 364.5 Gamma-18 7.1% 637.0
11.3External Radiation The specific gamma-ray constant for iodide I 131 is 4.26 × 10 -13 C·m 2 ·kg -1 ·MBq -1 ·s -1 (2.2 R·cm 2 /mCi·hr). The first half-value thickness of lead (Pb) for iodide I 131 is 0.27 cm. A range of values for the relative attenuation of the radiation emitted by iodide I 131 that results from interposition of various thicknesses of Pb is shown in Table 6.
For example, the use of 2.59 cm of Pb will decrease the external radiation exposure by a factor of about 1,000. Table 6 Radiation Attenuation of Iodine I 131 by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.27 0.5 0.56 0.25 0.99 10 -1 2.59 10 -2 4.53 10 -3 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 7. Table 7 Physical Decay Chart: Iodine I-131 Half-Life 8.02 days *Calibration time Days Fraction Remaining Days Fraction Remaining Days Fraction Remaining 0* 1.000 11 .386 22 .149 1 .917 12 .354 23 .137 2 .841 13 .325 24 .126 3 .772 14 .298 25 .115 4 .708 15 .274 26 .106 5 .649 16 .251 27 .097 6 .595 17 .230 28 .089 7 .546 18 .211 29 .082 8 .501 19 .194 30 .075 9 .459 20 .178 10 .421 21 .163
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Radiation Safety Precautions [see Warnings and Precautions (5.7) ] . Advise patients treated for hyperthyroidism to monitor for and seek medical care for signs and symptoms of thyrotoxicosis and thyroid storm arising during the post-treatment period. For mild radiation-induced thyroiditis, patients may be advised to consider symptomatic management with pain-relievers or anti-inflammatory medications [see Warnings and Precautions (5.1) ] .
Advise patients to hydrate and void frequently and to use a sialagogue after administration of radioiodide to minimize radiation dose [see Warnings and Precautions (5.2) ] . Advise patients to avoid close contact with others, especially pregnant women and children, and to take care to avoid contamination of other persons or the environment with body fluids [see Warnings and Precautions (5.7) ] . Embryo-Fetal Toxicity Advise female patients of the risk to a fetus [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1) ] .
Advise females and males of reproductive potential to use effective contraception during treatment with sodium iodide I 131 and for at least 6 months after the last dose [see Warnings and Precautions (5.4) , Use in Specific Populations (8.3) ] . Advise female patients to contact their healthcare provider with a known or suspected pregnancy. Lactation • Instruct women to stop breastfeeding and breast-pumping at least 6 weeks prior to sodium iodide I 131 administration [see Contraindications (4) , Warnings and Precautions (5.5) and Use in Specific Populations (8.2) ].
Effects on Fertility • Advise females and males of reproductive potential of the potential for impaired fertility with Sodium Iodide I-131 treatment [see Warnings and Precautions (5.6) and Use in Specific Populations (8.3) ]. Manufactured by: Idaho Falls, Idaho 83401, USA 1-208-524-5300 www.intisoid.com