Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation
Women of childbearing potential
When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient. Women receiving sodium iodide (131I) should be advised not to become pregnant within 6-12 months of administration.

Contraception in males and females
Contraception for a period of 6 months (for patients with benign thyroid conditions) or 12 months (for patients with thyroid cancer) is recommended for both sexes after therapeutic administration of sodium iodide (131I).
Men should not father a child for a time period of 6 months after radioiodine treatment to allow the replacement of irradiated by non-irradiated spermatozoa. Sperm banking should be considered for men who have extensive disease and therefore may need high sodium iodide (131I) therapeutic doses.
Pregnancy
The use of sodium iodide (131I) is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded because transplacental passage of sodium iodine (131I) can cause severe and possibly irreversible hypothyroidism in neonates (the absorbed dose to the uterus for this medicinal product is likely to be in the range 11-511 mGy, and the foetal thyroid gland avidly concentrates iodine during the second and third trimesters (see section 4.3).

If a differentiated thyroid carcinoma is diagnosed during pregnancy, sodium iodide (131I) treatment should be postponed until after the childbirth.

Breastfeeding
Before administering radiopharmaceuticals to a mother who is breast-feeding, consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breast-feeding, and what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.

If the administration is considered necessary, breast-feeding must be discontinued at least 8 weeks before sodium iodide (131I) administration and should not be resumed (see section 4.3).

For radioprotection reasons following therapeutic doses, it is recommended to avoid close contact between mother and infants for at least one week.

Fertility
After radioiodine therapy of thyroid carcinoma, a dose dependent impairment of fertility may occur in men and women. Depending on the activity dose, a reversible impairment of the spermatogenesis could occur in doses above 1,850 MBq. Clinical relevant effects including oligospermia and azoospermia and elevated serum FSH serum levels have been described after administration greater than 3,700 MBq.