Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Women of childbearing potential/contraception in males and females
PegIntron is recommended for use in fertile women only when they are using effective contraception during the treatment.

Combination therapy with ribavirin
Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking PegIntron in combination with ribavirin. Females of childbearing potential must use an effective contraceptive during treatment and for 4 months after treatment has been concluded. Male patients or their female partners must use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin Physician's Insert).

Pregnancy
There are no adequate data from the use of interferon alfa-2b in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Interferon alfa-2b has been shown to be abortifacient in primates. PegIntron is likely to also cause this effect.
The potential risk in humans is unknown. PegIntron is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Combination therapy with ribavirin
Ribavirin causes serious birth defects when administered during pregnancy, therefore ribavirin therapy is contraindicated in women who are pregnant.

Breast-feeding
It is not known whether the components of this medicinal product are excreted in human milk. Because of the potential for adverse reactions in breast-fed infants, breast-feeding should be discontinued prior to initiation of treatment.

Fertility
There are no data available regarding potential effects of PegIntron treatment on male or female fertility.