Pluvicto Use In Pregnancy & Lactation

Contraception in males: Because of potential effects on spermatogenesis associated with radiations of lutetium (¹⁷⁷Lu) vipivotide tetraxetan, male patients are advised not to father a child and to use a condom for intercourse during treatment with Pluvicto and for 14 weeks after the last dose (see Precautions).
Pregnancy: Pluvicto is not indicated for use in females. No animal studies using lutetium (¹⁷⁷Lu) vipivotide tetraxetan have been conducted to evaluate its effect on female reproduction and embryo-foetal development. However, all radiopharmaceuticals, including Pluvicto, have the potential to cause foetal harm when administered to a pregnant woman.
Breast-feeding: Pluvicto is not indicated for use in females. There are no data on the presence of lutetium (¹⁷⁷Lu) vipivotide tetraxetan in human milk or its effects on the breast-fed newborn/infant or on milk production.
Fertility: No studies were conducted to determine the effects of lutetium (¹⁷⁷Lu) vipivotide tetraxetan on fertility. Radiations of lutetium (¹⁷⁷Lu) vipivotide tetraxetan may potentially have toxic effects on male gonads and spermatogenesis. The recommended cumulative dose of 44400 MBq of Pluvicto results in a radiation absorbed dose to the testes within the range where Pluvicto may cause infertility. Genetic consultation is recommended if the patient wishes to have children after treatment. Cryopreservation of sperm can be discussed as an option for male patients before treatment (see Precautions).