SODIUM IODIDE I-131 kit

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

International Isotopes Inc

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Sodium Iodide I-131 Solution is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma. 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)] . 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. 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 1.1 MBq to 5,143 MBq). 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 be impaired with Sodium Iodide I-131 Solution treatment. Discuss sperm banking for males who are expected to receive a high cumulative dose of sodium iodide I-131. Transient dose-related impairment of testicular function after sodium iodide I-131 therapy has been reported in the published literature. The literature describes reports of males treated with sodium iodide I-131 at doses of 370 MBq to 22,000 MBq (10 mCi to 595 mCi) resulting in transiently impaired testicular function (including spermatogenesis). The risk of persistent testicular dysfunction increases after administration of repeated or high cumulative radioiodide exposure. 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. 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) ]. Sodium Iodide I 131 is primarily excreted by the kidneys. Renal function impairment decreases excretion of sodium iodide I 131 and increases the radiation exposure and risk of radiation toxicity. For patients with a history of renal impairment, evaluate renal function for therapeutic planning and consider dosimetry. Sodium Iodide I 131 is dialyzable. Hemodialysis can be used to reduce total body radiation exposure [see Clinical Pharmacology (12.3)].

Podsumowanie produktu:

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. 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. 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.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

SODIUM IODIDE I-131- SODIUM IODIDE I-131
INTERNATIONAL ISOTOPES INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM IODIDE I-131
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SODIUM
IODIDE I-131.
SODIUM IODIDE I-131 (FOR THE PREPARATION OF SODIUM IODIDE I 131
CAPSULES AND SOLUTION),
THERAPEUTIC, FOR ORAL USE.
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
Sodium Iodide I-131 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 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)
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.
Pregnancy. ( 4)
Lactation. ( 4)
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. Ve