Vitrakvi Use In Pregnancy & Lactation

Pregnant Women: There are no clinical data on the use of VITRAKVI in pregnant women. In embryo-fetal development studies where pregnant rats and rabbits were dosed with larotrectinib during the period of organogenesis, malformations were observed at maternal exposures that were approximately 9- and 0.6-times, respectively, those observed at the clinical dose of 100 mg twice daily (see Pharmacology: Toxicology: Non-Clinical Toxicology under Actions). Larotrectinib crosses the placenta in animals.
Based on its mechanism of action and non-clinical data, there may be risk of fetal harm when larotrectinib is administered to a pregnant woman (see Pharmacology: Mechanism of Action under Actions). Advise pregnant women of the potential risk to a fetus.
Breast-feeding: There are no data on the presence of larotrectinib in human milk, the effects of larotrectinib on the breastfed child, or the effects of larotrectinib on milk production. Because of the unknown risk of larotrectinib in nursing infants, advise a nursing woman to discontinue breastfeeding during treatment with VITRAKVI and for 1 week following the final dose.