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 using an antiepileptic treatment, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population. Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects. Specialist medical advice regarding the potential risk to a foetus caused by both seizures and antiepileptic treatment should be given to all women of child-bearing potential taking antiepileptic treatment, and especially to women planning pregnancy and women who are pregnant. Sudden discontinuation of antiepileptic drug (AED) therapy should be avoided as this may lead to seizures that could have serious consequences for the woman and the unborn child.
Monotherapy is preferred for treating epilepsy in pregnancy whenever possible because therapy with multiple AEDs could be associated with a higher risk of congenital malformations than monotherapy, 
depending on the associated AEDs.
Neurodevelopmental disorders in children of mothers with epilepsy using an antiepileptic treatment has been observed. There is no data available for eslicarbazepine acetate on this risk.

Women of childbearing potential/contraception

Women of childbearing potential should use effective contraception during treatment with eslicarbazepine acetate. Eslicarbazepine acetate adversely interacts with oral contraceptives. Therefore, an alternative, effective and safe method of contraception should be used during treatment and up to the end of the current menstrual cycle after treatment has been stopped. Women of childbearing potential should be counselled regarding the use of other effective contraceptive methods. At least one effective method of contraception (such as an intra-uterine device) or two complementary forms of contraception including a barrier method should be used. Individual circumstances should be evaluated in each case, involving the patient in the discussion, when choosing the contraception method.

Risk related to eslicarbazepine acetate

There is limited amount of data from the use of eslicarbazepine acetate in pregnant women. Studies in animals have shown reproductive toxicity (see Fertility section 5.3). A risk in humans (including of major congenital malformations, neurodevelopmental disorders and other reproductive toxic effects) is unknown.
Eslicarbazepine acetate should not be used during pregnancy unless the benefit is judged to outweigh the risk following careful consideration of alternative suitable treatment options.
If women receiving eslicarbazepine acetate become pregnant or plan to become pregnant, the use of Zebinix should be carefully re-evaluated. Minimum effective doses should be given, and monotherapy whenever possible should be preferred at least during the first three months of pregnancy. Patients should be counselled regarding the possibility of an increased risk of malformations and given the opportunity to antenatal screening.

Monitoring and prevention
Antiepileptic medicinal products may contribute to folic acid deficiency, a possible contributory cause of foetal abnormality. Folic acid supplementation is recommended before and during pregnancy. As the efficacy of this supplementation is not proven, a specific antenatal diagnosis can be offered even for women with a supplementary treatment of folic acid.

In the newborn child
Bleeding disorders in the newborn caused by antiepileptic medicinal products have been reported. As a precaution, vitamin K1 should be administered as a preventive measure in the last few weeks of pregnancy and to the newborn.

Breast-feeding

It is unknown whether eslicarbazepine acetate is excreted in human milk. Animal studies have shown excretion of eslicarbazepine in breast milk. As a risk to the breast-fed child cannot be excluded breast- feeding should be discontinued during treatment with eslicarbazepine acetate.

Fertility

There are no data on the effects of eslicarbazepine acetate on human fertility. Studies in animals have shown impairment of fertility after treatment with eslicarbazepine acetate (see section 5.3).