SODIUM IODIDE I 131 DIAGNOSTIC- sodium iodide i 131 capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sodium Iodide I-131 (UNII: 29VCO8ACHH) (IODIDE ION I-131 - UNII:4GC1FOQ22U)

Available from:

Jubilant DraxImage Inc., dba Jubilant Radiopharma

INN (International Name):

Sodium Iodide I-131

Composition:

IODIDE ION I-131 100 mCi

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Iodide I 131 Capsules Diagnostic is indicated for use in adults for: - Assessment of thyroid function using radioactive iodine (RAI) uptake test - Imaging the thyroid (scintigraphy) Sodium Iodide I 131 Capsules Diagnostic is contraindicated in pregnancy [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1) ]. Risk Summary Sodium Iodide I 131 Capsules Diagnostic is contraindicated in pregnancy because fetal exposure can lead to neonatal hypothyroidism, which in some cases is severe and irreversible. Data from the published literature describe reports of neonatal thyroid abnormalities after fetal exposure, including agenesis of the thyroid and hypothyroidism (see Clinical Considerations, Data ). No animal reproductive studies have been conducted. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnanc

Product summary:

Each capsule contains 3.70 megabecquerels (100 microCi) at time of calibration. Half of each capsule is white, while the other half is either pink, yellow, orange, grey or green according to the manufactured lot. Store Sodium Iodide I 131 Capsules Diagnostic between 15 °C and 30 °C (59 °F and 86 °F). Store and dispose of Sodium Iodide I 131 Capsules Diagnostic 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.

Authorization status:

New Drug Application

Summary of Product characteristics

SODIUM IODIDE I 131 DIAGNOSTIC - SODIUM IODIDE I 131 CAPSULE
JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM IODIDE I 131 CAPSULES
DIAGNOSTIC SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR SODIUM IODIDE I 131 CAPSULES
DIAGNOSTIC.
SODIUM IODIDE I 131 CAPSULES, DIAGNOSTIC, FOR ORAL USE.
INITIAL U.S. APPROVAL: 1971
RECENT MAJOR CHANGES
Indications and Use. (1) 6/2016
INDICATIONS AND USAGE
Sodium Iodide I 131 Capsules Diagnostic is a radioactive diagnostic
agent indicated for the assessment of thyroid function
and for thyroid imaging. (1)
DOSAGE AND ADMINISTRATION
Use careful handling with appropriate safety measures to minimize
radiation exposure to patients and healthcare
workers. (2.1, 5.2)
Follow suitable radioactivity calibration prior to administration.
(2.1)
In an adult patient, recommended doses are (2.2):
Thyroid Function: 0.185 to 1.1 megabecquerels (MBq) [5 to 30
microcuries (microCi)]
Thyroid Imaging: 1.85 to 3.70 MBq (50 to 100 microCi)
DOSAGE FORMS AND STRENGTHS
Capsules: 3.70 MBq (100 microCi) at the time of calibration (3)
CONTRAINDICATIONS
Pregnancy (4)
WARNINGS AND PRECAUTIONS
Fetal Toxicity – I 131 can cause severe and irreversible
hypothyroidism in the neonate. Verify absence of pregnancy
before administering the product. (4, 5.1, 8.1, 8.3)
Radiation Risk – I 131 contributes to patients’s long-term
cumulative radiation exposure, which is associated with an
increased risk of cancer. Ensure safe handling to minimize radiation
exposure. (5.2)
ADVERSE REACTIONS
Common adverse reactions reported with diagnostic doses of sodium
iodide I 131 include nausea, vomiting, itching, rash
and hives. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT JUBILANT DRAXIMAGE INC.
AT 1-888-633-5343 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
The recent intake of iodine in any form or the use of thyroid or
anti-thyroid drugs will affect the uptake of sodiu