Soolantra Use In Pregnancy & Lactation

Pregnancy: There are no or a limited amount of data from the topical use of ivermectin in pregnant women. Oral reproductive toxicity studies have shown that ivermectin is teratogenic in rats and rabbits (see Pharmacology: Toxicology: Preclinical Safetty Data under Actions), however due to the low systemic exposure following topical administration of the product at the proposed posology, there is a low safety concern for a human foetus. Soolantra is not recommended during pregnancy.
Breast-feeding: Following oral administration, ivermectin is excreted in human milk in low concentrations. Excretion in human milk following topical administration has not been evaluated. Available pharmacokinetic/toxicological data in animals have also shown excretion of ivermectin in milk. A risk to a suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Soolantra therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: No human data on the effect of ivermectin on fertility are available. In rats, there was no effect on mating or fertility with ivermectin treatment.