Julitam/Julitam I.V. Use In Pregnancy & Lactation

Julitam: Pregnancy: Tablet: There are no adequate data available from the use of Levetiracetam in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for human is unknown.
Levetiracetam is not recommended during pregnancy and in women of childbearing potential not using contraception unless clearly necessary.
As with other antiepileptic medicinal products, physiological changes during pregnancy may affect levetiracetam concentration. Decrease in levetiracetam plasma concentrations has been observed during pregnancy. This decrease is more pronounced during the third trimester. Appropriate clinical management of pregnant women treated with levetiracetam should be ensured. Discontinuation of antiepileptic treatments may result in exacerbation of the disease which could be harmful to the mother and the foetus.
Oral solution Pregnancy Category C.
In animal studies, levetiracetam produced evidence of developmental toxicity at doses similar to or greater than human therapeutic doses.
Administration to female rats throughout pregnancy and lactation was associated with increased incidences of minor fetal skeletal abnormalities and retarded offspring growth pre- and/or postnatally at doses ≥350 mg/kg/day (approximately equivalent to the maximum recommended human dose of 3000 mg [MRHD] on a mg/m² basis) and with increased pup mortality and offspring behavioral alterations at a dose of 1800 mg/kg/day (6 times the MRHD on a mg/m² basis). The developmental no effect dose was 70 mg/kg/day (0.2 times the MRHD on a mg/m² basis). There was no overt maternal toxicity at the doses used in this study.
Treatment of pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and increased incidences of minor fetal skeletal abnormalities at doses ≥600 mg/kg/day (approximately 4 times MRHD on a mg/m² basis) and in decreased fetal weights and increased incidences of fetal malformations at a dose of 1800 mg/kg/day (12 times the MRHD on a mg/m² basis). The developmental no effect dose was 200 mg/kg/day (1.3 times the MRHD on a mg/m² basis). Maternal toxicity was also observed at 1800 mg/kg/day.
When pregnant rats were treated during the period of organogenesis, fetal weights were decreased and the incidence of fetal skeletal variations was increased at a do se of 3600 mg/kg/day (12 times the MRHD). 1200 mg/kg/day (4 times the MRHD) was a developmental no effect dose. There was no evidence of maternal toxicity in this study.
Treatment of rats during the last third of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1800 mg/kg/day (6 times the MRHD on a mg/m² basis).
There are no adequate and well-controlled studies in pregnant women. Levetiracetam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Registries: To provide information regarding the effects of in utero exposure to levetiracetam, physicians are advised to recommend that pregnant patients taking levetiracetam enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry.
The effect of levetiracetam on labor and delivery in humans is unknown.
Breastfeeding: Tablet: Levetiracetam is excreted in human breast milk. Therefore, breastfeeding is not recommended. However, if levetiracetam treatment is needed during breastfeeding, the benefit/risk of the treatment should be weighed considering the importance of breastfeeding.
Oral solution: Levetiracetam is excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants from levetiracetam, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Impairment of Fertility: Tablet: No impact on fertility was detected in animal studies. No clinical data are available, potential risk for human is unknown.
Oral solution: No adverse effects on male or female fertility or reproductive performance were observed in rats at doses up to 1800 mg/kg/day (approximately 6 times the maximum recommended human dose on a mg/m² or exposure basis).
Julitam I.V.: Women with childbearing potential/Contraception: Not recommended unless clinically necessary in women with childbearing potential and who do not undergo contraception.
Women with childbearing potential should seek expert medical advice. Levetiracetam should be re-evaluated in women planning pregnancy. As with all antiepileptic drugs, sudden discontinuation of treatment with levetiracetam should be avoided because this can lead to sudden seizures that can have serious consequences for the mother and her unborn child. Where possible, monotherapy should be preferred because treatment with multiple antiepileptic drugs has been associated with a higher risk of congenital malformation than monotherapy due to concomitant antiepileptics.
Pregnancy: Category C: Should not be used in pregnancy unless clearly necessary. Studies in animals have shown reproductive toxicity. Potential risk for human is unknown.
Should not be used in pregnancy unless clearly necessary. Studies in animals have shown reproductive toxicity. Potential risk for human is unknown.
As with other antiepileptic drugs, physiological changes during pregnancy may affect levetiracetam concentration. Decrease in levetiracetam plasma concentrations has been observed during pregnancy. This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy). Appropriate clinical management of pregnant women treated with JULITAM IV should be ensured. Discontinuation of antiepileptic treatments may result in exacerbation of the disease which could be harmful to the mother and the foetus.
Lactation: Levetiracetam is excreted in human breast milk. Therefore, breast-feeding is not recommended during treatment with JULITAM IV.
However, a decision on whether to discontinue breast-feeding or to discontinue/abstain from JULITAM IV therapy should take into account the benefit of breast-feeding for the child, and the benefit of JULITAM IV therapy for the breastfeeding mother.
Fertility: No impact on fertility was detected in animal studies. No clinical data are available, potential risk for human is unknown.