Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Men and women receiving Roferon-A should practise effective contraception. There are no adequate data on the use of Roferon-A in pregnant women. When doses greatly in excess of the recommended clinical dose were administered to pregnant rhesus monkeys in the early to mid-foetal period, an abortifacient effect was observed (see section 5.3). Although animal tests do not indicate that Roferon-A is a teratogen, harm to the foetus from use during pregnancy cannot be excluded. In pregnancy, Roferon-A should be administered only if the benefit to the woman justifies the potential risk to the foetus.

It is not known whether this drug is excreted in human milk. A decision must be taken whether to suspend breast feeding or to discontinue the drug, taking into account the importance of the drug to the mother.

Use with ribavirin in patients with chronic hepatitis C
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Ribavirin therapy is contraindicated in women who are pregnant. Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking Roferon-A in combination with ribavirin. Female patients of childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.

Male patients and their female partners must each use an effective contraceptive during treatment and for 7 months after treatment has been concluded. Please refer to the ribavirin prescribing information.