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 any doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionizing radiation (if there are any) should be offered to the patient. Before the use of LuNET-SRY, pregnancy should be excluded using an adequate/validated test.

Contraception in males and females
LuNET-SRY can cause fetal harm when administered to a pregnant woman. During treatment with LuNET-SRY and for a minimum of 6 months after the end of the treatment, appropriate measures must be taken to avoid pregnancy; this applies to both male and female patients.


Pregnancy
No studies on animal reproductive function have been conducted with [177Lu]oxodotreotide. Radionuclide procedures carried out on pregnant women also involve a radiation dose to the fetus. The use of LuNET-SRY is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded due to the risk associated with the ionizing radiation (see section 4.3). Pregnant women should be advised of the risk to a fetus.

Breast-feeding
It is unknown whether [177Lu]DOTA-TATE is excreted in breast milk. A risk to the breast-fed child associated with ionizing radiation cannot be excluded. Breast-feeding should be avoided during treatment with this medicinal product. If treatment with LuNET-SRY during breast-feeding is necessary, the child must be weaned.

Fertility
No animal studies have been performed to determine the effects of [177Lu]DOTA-TATE on male and female fertility.
Ionizing radiation of [177Lu]DOTA-TATE may potentially have temporary toxic effects on female and male gonads.
Genetic consultation is recommended if the patient wishes to have children after treatment. Cryopreservation of sperm or eggs can be discussed as an option for patients before treatment.