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I-131 - Pharmaceutical

I-131 Kit for the preparation of Sodium Iodide I-131 Capsules and Solution USP Therapeutic – Oral

Radnostix offers FDA-approved Sodium Iodide I-131, a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid. Manufactured under GMP standards, our Sodium Iodide I-131 is designed to support reliable clinical use with consistent quality and availability.

All options are supplied at a fixed concentration of 1000 mCi/mL and are available in three vial sizes, depending on activity level. Our team is committed to responsive customer service, and we work with you to accommodate order needs and delivery schedules.

Production and Shipping Schedule

Sodium Iodide I-131 solutions are produced and shipped daily Monday through Thursday. When ordering, please indicate your prefered day of receipt. Orders are calibrated for the day of receipt at 12:00 noon MST.

Manufacturing and Distribution Information

All facets of the Sodium Iodide I-131 solution manufacturing and distribution are conducted in accordance with  FDA 21 CFR 211, current good manufacturing practice (cGMP) for finished pharmaceuticals. You can rest assured that the International Isotopes Sodium Iodide I-131 solution’s quality, efficacy, and safety has been evaluated by the FDA.

Our dedication to quality at Radnostix doesn’t stop at compliance to FDA regulations. We are also certified to ISO 9001 for quality management systems. Compliance to the ISO standard provides a framework for managing quality that is acknowledged internationally.

All orders of sodium Iodide I-131 solution are packaged and shipped in compliance with all US Department of Transportation (DOT) and Nuclear Regulatory Commission (NRC) requirements.

Contact Radnostix

Use the link below to contact us or call 1.208.524.5300

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Vial Size Minimum mCi Maximum mCi Cartons of Capsules (Optional)
1 mL 250 mCi 750 mCi 1 (400 mCi – 750 mCi)
2 mL 400 mCi 1500 mCi 2 (750 mCi – 1500 mCi)
3 mL 400 mCi 2250 mCi 3 (1500 mCi – 2250 mCi)
  • Customers wishing to place a new order or make changes to an existing order must complete this change before 10:00 AM Mountain Time (MT) Thursday two weeks prior to need date.
  • Spot orders are accepted daily; however, if the order is for next day delivery, it must be received by 10:00 AM MT. All spot orders are subject to product availability.
  • Any increase to a standing order must be made before 10:00 AM MT on Mondays, the fill date, and is subject to availability.
  • If after the deadline a customer needs to delay the delivery date the customer will still be charged for the original amount of material on the standing order.
  • If a customer accelerates delivery of an order they will be charged for the actual amount of material received.
  • Delays in product delivery to the customer caused by delays with FedEx shipments, or the originating shipment from Radnostix supplier are beyond the control of Radnostix.
  • Radnostix reserves the right to update its shipping, cancellation and return policies at its sole discretion.

Download Ordering Guidelines

 

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SODIUM IODIDE I-131
Kit for the preparation of Sodium Iodide I-131 Capsules and Solution Therapeutic – Oral

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use SODIUM IODIDE I-131 SOLUTION safely and effectively. See full prescribing information for SODIUM IODIDE I-131 SOLUTION.

SODIUM IODIDE I-131 Solution (for the preparation of sodium iodide I-131 solution or sodium iodide I-131 capsules), therapeutic, for oral use. Initial U.S. Approval: 1971

————-RECENT MAJOR CHANGES————-

Dosage and Administration (2) 10/2021
Contraindications (4) 10/2021
Warnings and Precautions (5) 10/2021

————INDICATIONS AND USAGE————

Sodium Iodide I-131 Solution is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid. (1)

——-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 MBq to 370 MBq (4 mCi to 10 mCi). (2.3)
    • Treatment of Thyroid Carcinoma:
      Recommended dosage is 1,110 MBq to 3,700 MBq (30 mCi to 100 mCi). (2.3)

——–DOSAGE FORMS AND STRENGTHS———

Vials: 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——————

  • Patients with vomiting and diarrhea. (4)
  • Patients with thyroid malignancies shown to have no iodide uptake. (4)
  • Patients receiving concurrent anti-thyroid therapy. (4)
  • Pregnancy. (4)
  • Lactation. (4)

———WARNINGS AND PRECAUTIONS———

  • Radiation-induced thyroiditis may cause or worsen hyperthyroidism. Consider pretreatment with anti-thyroid medications. (5.1)
  • Multiple non-thyroid radiation toxicities, including hematopoietic suppression: Individualize dose and monitor for toxicity. (5.2)
  • Embryo-Fetal toxicity: May cause severe and irreversible hypothyroidism in the neonate. Verify pregnancy status in females of reproductive potential prior to initiating treatment. Females and males of reproductive potential should use effective contraception. (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 breast feeding 6 weeks prior to therapy. (5.5, 8.2)

————ADVERSE REACTIONS———–

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 Radnostix at 1-800-699-3108 or FDA at 1-888-INFO-FDA (1-888-463-6332) or https://www.accessdata.fda.gov/scripts/medwatch/

————DRUG INTERACTIONS————

Many pharmacologic agents are known to interact with radioiodide. See Full Prescribing Information complete list. (5.8, 7)

——-USE IN SPECIFIC POPULATIONS——-

  • Pregnancy. (4)
  • Lactation. (4)
  • Females and Males of Reproductive Potential: May impair fertility in females and males. (5.6, 8.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 09/2021

Download Product Insert / Prescribing Information