Fintepla Use In Pregnancy & Lactation

Pregnancy: There are limited data (less than 300 pregnancy outcomes) from the use of fenfluramine in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity in the absence of paternal or maternal toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
As a precautionary measure, it is preferable to avoid the use of Fintepla during pregnancy.
Breast-feeding: It is unknown whether fenfluramine/metabolites are excreted in human milk. Available pharmacokinetic data in animals have shown excretion of fenfluramine/metabolites in milk (see Pharmacology: Toxicology: Preclinical safety data under Actions).
A risk to the suckling child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fintepla therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: No effects of fenfluramine on human fertility up to clinical doses of 104 mg/day were noted. However, animal studies suggest that Fintepla may possibly affect female fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).