Cobas B 123 Poc System

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.

• Use careful handling with appropriate safety measures to minimize radiation exposure to patients and healthcare workers
• Follow suitable radioactivity calibration prior to administration
• In an adult patient, recommended doses are : 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) Radiation Safety Sodium Iodide I 131 Capsules Diagnostic is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure to the patient and healthcare worker [see Warnings and Precautions ]
• Use waterproof gloves during the entire handling and administration procedure
• Maintain adequate shielding during the life of the product
• Open the capsule-containing vial in a well ventilated hood to avoid exposure to trace levels of volatile I-131 which may be present
• Measure patient dose by a suitable radioactivity calibration system immediately prior to administration
• Recommended Dosage and Administration Instructions Administer Sodium Iodide I 131 Capsules Diagnostic orally prior to scanning
• The recommended dose of Sodium Iodide I 131 Capsules Diagnostic for an adult patient is the following: Thyroid Function: 0.185 to 1.1 megabecquerels (MBq) [5 to 30 microcuries (microCi)]
• Administer 24 hours before uptake measurement
• Thyroid Imaging (Scintigraphy): 1.85 to 3.70 MBq (50 to 100 microCi)
• Administer 16 -24 hours before imaging. …

Capsules: Each capsule contains 3.70 MBq (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. …

• Safety and efficacy
• In pediatric patients have not been established
• Published reports suggest that the thyroid gland of pediatric patients is more sensitive to the adverse effects of sodium iodide I 131 (e.g., increased risk of radiation absorption)

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 ) ].

• Administration Instructions Advise patients to hydrate before and after administration of Sodium Iodide I 131 Capsules Diagnostic and void frequently to ensure rapid excretion [see Dosage and Administration ]
• Advise patients to fast at least 2 hours before and 2 hours after administration to ensure absorption [see Dosage and Administration ]
• Advise patients to maintain a low-iodine diet two weeks prior to radioiodine administration and continue for several days during the uptake or imaging process [See Dosage and Administration and Drug Interactions ]. …

• Sodium Iodide I 131 Capsules Diagnostic is contraindicated in pregnancy [see Warnings and Precautions , Use in Specific Populations ]
• Pregnancy

Certain drugs and iodine-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 Capsules Diagnostic. Advise patients to maintain a low-iodine diet two weeks prior to radioiodine administration and continue for several days during the uptake or imaging process and to discontinue the following products before they undergo the procedure as shown in Table 3: Table 3 Pharmaceuticals/OTCs/Agents Blocking Radioiodine Uptake ​Products Recommended duration of withdrawal Thionamide medications (e.g., propylthiouracil, methimazole carbimazole) 3 days …

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 ) 5.1 Fetal 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. …

The following adverse reaction has been described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 ) ] The following adverse reactions have been identified during post-approval use from Sodium Iodide I 131 Capsules Diagnostic. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. …

8.1 Pregnancy 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 ). …

In the event of an overdosage of Sodium Iodide I 131 Capsules Diagnostic, monitor for thyroid suppression and consider administering a thyroid blocking agent (e.g. potassium iodide (KI) or perchlorate). Promote frequent voiding and encourage patients to maintain hydration to minimize radiation exposure.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.