Aprepilor Trio Use In Pregnancy & Lactation

Contraception in males and females: The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of aprepitant. Alternative non-hormonal back-up methods of contraception should be used during treatment with aprepitant and for 2 months following the last dose of aprepitant (see Precautions and Interactions).
Pregnancy: For aprepitant no clinical data on exposed pregnancies are available. The potential for reproductive toxicity of aprepitant has not been fully characterised, since exposure levels above the therapeutic exposure in humans at the 125 mg/80 mg dose could not be attained in animal studies. These studies did not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential effects on reproduction of alterations in neurokin in regulation are unknown. Aprepitant should not be used during pregnancy unless clearly necessary.
Breast-feeding: Aprepitant is excreted in the milk of lactating rats. It is not known whether aprepitant is excreted in human milk; therefore, breast-feeding is not recommended during treatment with APREPILOR TRIO.
Fertility: The potential for effects of aprepitant on fertility has not been fully characterised because exposure levels above the therapeutic exposure in humans could not be attained in animal studies. These fertility studies did not indicate direct or indirect harmful effects with respect to mating performance, fertility, embryonic/foetal development, or sperm count and motility (see Pharmacology: Toxicology: Preclinical safety data under Actions).