Inovelon Use In Pregnancy & Lactation

Fertility: No clinical data are available on the effects on fertility following treatment with rufinamide.
Pregnancy: 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 are responsible has not been elucidated. Moreover, discontinuation of effective anti-epileptic therapy may result in disease worsening, which can be harmful to the mother and the fetus.
Risk Related to Rufinamide: Studies in animals revealed no teratogenic effect but fetotoxicity occurred in the presence of maternal toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown.
For rufinamide, no clinical data on pregnancies during exposure to rufinamide are available.
Taking these data into consideration, rufinamide should not be used during pregnancy unless clearly necessary or in women of childbearing age not using adequate contraceptive measures.
If women treated with rufinamide plan to become pregnant, the indication of this product should be carefully weighed. Discontinuation of anti-epileptic treatments may result in disease worsening, which can be harmful to the mother and the fetus.
Lactation: Nonclinical data suggests that rufinamide or its metabolites may be excreted with the milk during lactation. Animal studies have shown an uptake of radioactivity in mammary glands in both rats and rabbits. Because of the potential for serious adverse reactions in nursing infants from rufinamide, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.