Gavreto Use In Pregnancy & Lactation

Women of childbearing potential/Contraception in females and males: Women of childbearing potential should be informed that pralsetinib may cause foetal harm (see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions).
The pregnancy status of women of childbearing potential should be verified prior to initiating Gavreto treatment.
Women of childbearing potential have to use highly effective non-hormonal contraception during treatment and for at least 2 weeks following the last dose of Gavreto (see Precautions).
Males with female partners of childbearing potential have to use effective contraception during treatment with Gavreto and for at least 1 week following the last dose of Gavreto.
Patients should be advised to contact their healthcare provider immediately if they become pregnant, or if pregnancy is suspected, while taking Gavreto.
Pregnancy: There are no data from the use of pralsetinib in pregnant women. Studies in animals have shown reproductive toxicity (see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions).
Based on its mechanism of action and findings in animals, pralsetinib may cause foetal harm when administered to pregnant women.
Gavreto should not be used during pregnancy unless the clinical condition of the woman requires treatment with pralsetinib.
Breast-feeding: It is unknown whether pralsetinib or its metabolites are excreted in human milk.
A risk to the breast-fed child cannot be excluded.
Breast-feeding should be discontinued during treatment with Gavreto and for 1 week following the final dose.
Fertility: There is no clinical data on the effects of pralsetinib on fertility.
Based on non-clinical safety findings, fertility may be compromised during treatment with pralsetinib (see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions). Men and women should seek advice on effective fertility preservation before treatment.