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Date of issue: August 2023, Version: 1.0

Perampanel is licensed as an adjunctive treatment for partial-onset seizures with or without secondarily generalised seizures, and primary generalised tonic-clonic seizures in people with idiopathic generalised epilepsy.

It is important that maternal epilepsy remains well-controlled during pregnancy.

There is limited evidence regarding the safety of perampanel use in pregnancy, with data provided by a small number of uncontrolled studies which collectively describe the outcomes of 96 exposed pregnancies, mainly exposed in early pregnancy only. As such, the available evidence regarding perampanel exposure in later pregnancy is highly limited.

Although the available data do not clearly indicate increased risks of adverse pregnancy or fetal outcomes following maternal perampanel use in early pregnancy, these data are highly limited and higher quality studies are required before a more accurate safety assessment can be provided. Additionally, no studies have investigated the risk of longer-term childhood outcomes such as neurodevelopmental impairment.

A case of presumed perampanel withdrawal and two cases of low Apgar scores have been described. Use of any centrally acting drug throughout pregnancy or near delivery may be associated with withdrawal symptoms in the neonate and/or poor neonatal adaptation syndrome (PNAS). These symptoms are likely to be more severe in infants exposed in utero to more than one CNS acting drug. Delivery should be planned in a unit with neonatal intensive care facilities.

Although not predicted from the recognised pharmacology of perampanel, it is unknown whether use prior to conception or during pregnancy may impact upon maternal folate status. UK guidelines state that women who take any anti-seizure medication should be prescribed high-dose folic acid (5mg).

More research is required to define the pregnancy safety profile of perampanel. Pregnant women and women of childbearing potential should be made aware of the limited data for most pregnancy outcomes, and highly limited data regarding exposure in late pregnancy. Perampanel should only be used during pregnancy where the benefits of treatment are considered to outweigh any potential risks. In view of the limited human pregnancy data, close monitoring of mother and fetus should be considered following perampanel use in pregnancy. Other risk factors may also be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.

This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.

If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.

If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.

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