Inovelon Use In Pregnancy & Lactation

Use in Pregnancy: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. INOVELON should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Rufinamide produced developmental toxicity when administered orally to pregnant animals at clinically relevant doses.
Rufinamide was administered orally to rats at doses of 20, 100, and 300 mg/kg per day and to rabbits at doses of 30, 200, and 1000 mg/kg/day during the period of organogenesis (implantation to closure of the hard palate); the high doses are associated with plasma AUCs ≈2 times the human plasma AUC at the maximum recommended human dose (MRHD, 3200 mg per day). Decreased fetal weights and increased incidences of fetal skeletal abnormalities were observed in rats at doses associated with maternal toxicity. In rabbits, embryo-fetal death, decreased fetal body weights, and increased incidences of fetal visceral and skeletal abnormalities occurred at all but the low dose. The highest dose tested in rabbits was associated with abortion. The no-effect doses for adverse effects on rat and rabbit embryo-fetal development (20 and 30 mg/kg per day, respectively) were associated with plasma AUCs ≈ 0.2 times that in humans at the MRHD.
In a rat pre- and post-natal development study (dosing from implantation through weaning) conducted at oral doses of 5, 30, and 150 mg/kg per day (associated with plasma AUCs up to ≈1.5 times that in humans at the MRHD), decreased offspring growth and survival were observed at all doses tested. A no-effect dose for adverse effects on pre- and post-natal development was not established. The lowest dose tested was associated with plasma AUC < 0.1 times that in humans at the MRHD.
Use in Lactation: Rufinamide is likely to be excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from INOVELON, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.