Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation
Pregnancy
Risk related to epilepsy and antiepileptic medicinal products in general: 
It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population. In the treated population, an increase in malformations has been noted with polytherapy; however, the extent to which the treatment and/or the illness is responsible has not been elucidated.

Moreover, effective anti-epileptic therapy should not be interrupted abruptly, since the aggravation of the illness is detrimental to both the mother and the foetus. AED treatment during pregnancy should be carefully discussed with the treating physician.

Risk related to rufinamide:
Studies in animals revealed no teratogenic effect but foetotoxicity in the presence of maternal toxicity was observed (see section 5.3). The potential risk for humans is unknown.

For rufinamide, no clinical data on exposed pregnancies are available.

Taking these data into consideration, rufinamide should not be used during pregnancy, or in women of childbearing age not using contraceptive measures, unless clearly necessary.

Women of childbearing potential must use contraceptive measures during treatment with Inovelon tablets. Physicians should try to ensure that appropriate contraception is used and should use clinical judgement when assessing whether oral contraceptives, or the doses of the oral contraceptive components, are adequate based on the individual patients clinical situation (see sections 4.4 and 4.5).
If women treated with rufinamide plan to become pregnant, the continued use of this product should be carefully weighed. During pregnancy, interruption of an effective antiepileptic can be detrimental to both the mother and the foetus if it results in aggravation of the illness.

Breast-feeding
It is not known if rufinamide is excreted in human breast milk. Due to the potential harmful effects for the breast fed infant, breast-feeding should be avoided during maternal treatment with rufinamide.

Fertility
No data are available on the effects on fertility following treatment with rufinamide.