Sodium Iodide I 131

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 a radioactive diagnostic agent indicated for the assessment of thyroid function and for thyroid imaging.

Sodium Iodide I 131 Capsules Diagnostic is contraindicated in pregnancy [see Warnings and Precautions ( 5.1 ) , Use in Specific Populations ( 8.1 ) ]. Pregnancy

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 )

5.1Fetal Toxicity Sodium Iodide I 131 Capsules

Diagnostic is contraindicated in pregnancy because sodium iodide I 131 crosses the placenta and can cause severe and irreversible hypothyroidism in the neonate. Multiple reports in the literature describe neonatal hypothryroidism following in utero exposure to sodium iodide I 131. Some of these cases were severe and irreversible. Verify pregnancy status of females of reproductive potential prior to administering Sodium Iodide I 131 Capsules Diagnostic [see Use in Specific Populations ( 8.1, 8.3 ) ].

5.2Radiation Exposure Sodium 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 ) ].