From the Guidelines
Briviact (brivaracetam) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. According to the European Respiratory Journal study 1, there is limited data on the use of Briviact during pregnancy, and its classification is not explicitly stated in the provided table. However, considering the general principles of medication use during pregnancy, it is essential to weigh the benefits and risks of using Briviact in pregnant women. Women with epilepsy who are pregnant or planning pregnancy should not stop taking their medication without consulting their healthcare provider, as uncontrolled seizures pose significant risks to both mother and baby.
Key Considerations
- Limited human data exists on Briviact use during pregnancy, though animal studies have shown some developmental concerns at doses higher than those used in humans.
- If Briviact is necessary during pregnancy, the lowest effective dose should be used.
- The patient should be enrolled in the North American Antiepileptic Drug Pregnancy Registry if possible.
- Folic acid supplementation (0.4-4 mg daily) is recommended before and during pregnancy to reduce the risk of neural tube defects associated with antiepileptic medications.
- Regular monitoring of drug levels may be needed as pregnancy can alter medication metabolism.
Mechanism of Action
Briviact works by binding to synaptic vesicle protein 2A in the brain, modifying neurotransmitter release and helping control seizure activity, which is essential for maternal and fetal health during pregnancy. The study on hypertension management during pregnancy 1 is not directly relevant to the use of Briviact in pregnancy, but it highlights the importance of careful consideration of medication use during pregnancy to minimize risks to both mother and fetus.
From the FDA Drug Label
Available data from the North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study, case reports, and a case series are insufficient to identify a risk of major birth defects, miscarriage or other maternal or fetal outcomes associated with BRIVIACT use during pregnancy In animal studies, brivaracetam produced evidence of developmental toxicity (increased embryofetal mortality and decreased fetal body weights in rabbits; decreased growth, delayed sexual maturation, and long-term neurobehavioral changes in rat offspring) at maternal plasma exposures greater than clinical exposures The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U. S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Briviact use in pregnancy is not well understood due to insufficient data.
- Key points:
- Available human data are insufficient to identify a risk of major birth defects or miscarriage.
- Animal studies show developmental toxicity at high doses.
- Background risk of major birth defects and miscarriage in the general population is 2-4% and 15-20%, respectively. Given the lack of clear evidence, caution is advised when using Briviact in pregnancy, and patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry 2.
From the Research
Briviact in Pregnancy
- There are limited studies on the use of Briviact (brivaracetam) in pregnancy, but available data suggest that it may be safe, similar to levetiracetam 3.
- A study of three cases of women with epilepsy treated with brivaracetam during pregnancy found no major congenital malformations, but minor congenital malformations were observed in two infants 3.
- Another study on newer-generation antiepileptic drugs, including levetiracetam, found no increased risk of major birth defects compared to no exposure 4.
- Levetiracetam, which is similar to brivaracetam, has been studied in pregnancy and found to have a low risk of major birth defects and spontaneous abortions, but dual therapy with levetiracetam and lamotrigine may increase the risk of spontaneous abortion and birth defects 5.
- A review of levetiracetam use in pregnancy found that the clearance of levetiracetam increases during pregnancy, leading to decreased serum concentrations, and recommended monitoring serum concentrations and adjusting the dose as needed 6.
- Brivaracetam has a favorable pharmacokinetic profile and is well tolerated, but there is limited data on its use in pregnancy, and more studies are needed to determine its safety 7.