Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation

Women of childbearing potential/contraception in males and females
The use of RAVICTI in women of childbearing potential must be accompanied by the use of effective contraception (see section 4.4).

Pregnancy

Studies in animals have shown reproductive toxicity (see section 5.3). There are limited data regarding the use of glycerol phenylbutyrate in pregnant women.

Glycerol phenylbutyrate should not be used during pregnancy and in women of childbearing potential not using contraception unless the clinical condition of the woman requires treatment with glycerol phenylbutyrate (see section 4.4).


Breast-feeding
It is unknown whether glycerol phenylbutyrate or its metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast- feeding or to discontinue/abstain from glycerol phenylbutyrate therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

Glycerol phenylbutyrate had no effect on fertility or reproductive function in male and female rats (see section 5.3).
There are no data for human fertility.


Ravicti-SPC-0423-V1