Pregnancy: There are no available human data for the use of VYZULTA during pregnancy to inform any drug associated risks.
The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies.
Studies in animal have however shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Breast-feeding: There are no data on the presence of VYZULTA in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for VYZULTA, and any potential adverse effects on the breastfed infant from VYZULTA.
Fertility: There are no available fertility data for the use of VYZULTA (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).