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 ionising radiation (if there are any) should be offered to the patient. Before the use of Lutathera, pregnancy should be excluded using an adequate/validated test.

Contraception in males and females

Lutathera can cause foetal harm when administered to a pregnant woman.
Female patients of reproductive potential should be advised to use effective contraception during treatment and for 7 months after the last dose of Lutathera.

Male patients with female partners of reproductive potential should be advised to use effective contraception during treatment and for 4 months after the last dose of Lutathera.

Pregnancy

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

Breast-feeding

It is unknown whether lutetium (177Lu) oxodotreotide is excreted in breast milk. A risk to the breast- fed child associated with ionising radiation cannot be excluded. Breast-feeding should be avoided during treatment with this medicinal product. If treatment with Lutathera during breast-feeding is necessary, the child must be weaned.

Fertility

No animal studies have been performed to determine the effects of lutetium (177Lu) oxodotreotide on male and female fertility. Ionising radiations of lutetium (177Lu) oxodotreotide 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.