I3odine Max

Pregnancy

Risk Summary
I3odine MAXTM 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 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 10-12th 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.

Lactation

Risk Summary
I3odine MAXTM 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 [see Warnings and Precautions (5.5)]. If sodium iodide I 131 is administered in the postpartum period, the lactating mother should not breastfeed. 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 Data). Women may breast feed with the birth of another child.

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
Human Data
Limited published literature describes sodium iodide I 131 transfer into breast milk and thyroidal uptake by the breastfed infant. The amount of sodium Iodide I 131 detected in the breast milk at 36-48 hours after administration is 1-27% of the injected dose (with injected doses between 1.1 – 5143 MBq).

Female and Males of Reproductive Potential

I3odine MAXTM is contraindicated in pregnancy because of the risk of fetal hypothyroidism [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), Warnings and Precautions (5.4)].

Contraception
Advise females and males of reproductive potential to use effective contraception during treatment with Sodium Iodide I-131 and for at least six months after the last dose of Sodium Iodide I-131.

Infertility
Females
Fertility may be impaired with sodium iodide I 131 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 1000 – 59,000 MBq (27 – 1594 mCi) sodium iodide I 131.

Males
Fertility may be impaired with sodium iodide I 131 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 – 22,000 MBq (10 – 595 mCi) resulting in transiently impaired testicular function (including spermatogenesis). Permanent impairment is described with high cumulative doses ranging from 19,000 – 29,000 MBq (520 – 800 mCi).

Pediatric Use

Safety and efficacy in pediatric patients have not been established. Pediatric patients are at an increased lifetime risk for malignancy from radiation exposure

Geriatric Use

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)].

Renal Impairment

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)].

In case of exposure to a radioactive dose of sodium iodide I 131 exceeding the intended therapeutic dose, provide general supportive care, promote frequent voiding, monitor for bone marrow and thyroid suppression. Consider administering a thyroid blocking agent (e.g. potassium iodide (KI) or perchlorate) promptly within 4 to 6 hours after the exposure. Assess the benefit of administering a thyroid blocking agent against the risk of failure of sodium iodide I 131 therapy. Appropriate replacement therapy is recommended if hypothyroidism occurs.

Sodium Iodide I-131 Solution Immediate Container Label

Applies to sodium iodide-i-131: compounding powder, oral capsule, oral liquid

Cardiovascular

Cardiovascular side effects have included chest pain and tachycardia.[Ref]

Dermatologic

Dermatologic side effects have included itching skin, rash, and hives.[Ref]

Endocrine

Endocrine side effects have included acute thyroid crisis.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.[Ref]

Hematologic

Hematologic side effects have included blood dyscrasia, leukopenia, thrombocytopenia, depression of hematopoietic system, and anemia.[Ref]

Local

Local side effects have included tenderness and swelling of the neck, pain on swallowing, sore throat, and cough (usually around the third day after treatment).[Ref]

Oncologic

Oncologic side effects have included acute leukemia.[Ref]

Other

Other side effects have included temporary thinning of the hair (may occur 2 to 3 months after treatment), chromosomal abnormalities, radiation sickness, and death.[Ref]

Some side effects of i3odine Max may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.