Pregnancy & Lactation

Pregnancy

Elobixibat (GOOFICE®) should be used in pregnant women and women who may possibly be pregnant only if the expected therapeutic benefits outweigh the possible risks associated with treatment. [The influences of a high dose oral administration of drug in animal studies (in rats) were observed in maternal toxicity (1000 mg/kg/day) and survival, growth, and development of offspring (350 mg/kg/day and higher).]

 

Lactation

It is advised that lactating women should avoid Elobixibat (GOOFICE®). If treatment with Elobixibat (GOOFICE®) is essential, breast feeding must be discontinued during treatment.

[In an animal experiment (in rats) using 14C-elobixibat, transfer of radioactivity into milk has been reported.]