Rozlytrek Use In Pregnancy & Lactation

Females and Males of Reproductive Potential: Fertility: See PHARMACOLOGY: Toxicology: Preclinical safety data: Impairment of Fertility under Actions.
Pregnancy testing: Female patients of reproductive potential should have medically supervised pregnancy testing prior to initiating ROZLYTREK therapy.
Contraception: Female patients of reproductive potential, must use highly effective contraceptive methods during treatment and for 5 weeks following the last dose of ROZLYTREK.
Based on the potential for genotoxicity, male patients with female partners of child-bearing potential must use highly effective contraceptive methods during treatment and for 3 months following the last dose of ROZLYTREK (See PHARMACOLOGY: Toxicology: Preclinical safety data: Genotoxicity under Actions).
Pregnancy: Female patients of reproductive potential must be advised to avoid pregnancy while receiving ROZLYTREK (see Precautions). There is no available data on the use of ROZLYTREK in pregnant women. Based on animal studies with entrectinib (see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions) and its mechanism of action, ROZLYTREK may cause fetal harm when administered to a pregnant woman. Patients receiving ROZLYTREK should be advised of the potential harm to the fetus. Female patients should be advised to contact the doctor, should pregnancy occur.
Labor and Delivery: The safe use of ROZLYTREK during labor and delivery has not been established.
Lactation: It is not known whether entrectinib or its metabolites are excreted in human breast milk. No studies have been conducted to assess the effects of ROZLYTREK on milk production or its presence in breast milk. As the potential for harm to the nursing infant is unknown, mothers should be advised to discontinue breast-feeding during treatment with ROZLYTREK.