In a peri- and postnatal developmen

In a peri- and postnatal development study in rats, oral administration of neratinib from gestation day 7 until lactation day 20 resulted in maternal toxicity including decreased body weight gains and food consumption at AUCs lower than the AUC in patients receiving 240 mg/day. Effects on long-term memory were observed in male offspring at maternal doses that were lower than the recommended dose of 240 mg/day in patients based on mg/m2. Due to the potential for serious adverse reactions in a breastfed infant, lactating women are advised in the package insert not to breast feed while taking Nerlynx and for 1 month following the last dose, since this duration exceeds 5 plasma half-lives for neratinib in patients (up to 17 hours) and is consistent with the recommendation for contraceptive use in females of reproductive potential.