Neonatal seizures, affecting 1 to 4 per 1000 newborns in their first 28 days of life, have found a new standard of care with the FDA approval of Sezaby, a preservative-free phenobarbital formulation developed by Sun Pharmaceutical Industries. This breakthrough treatment addresses a critical need in neonatal care, where seizures can lead to severe complications including cerebral palsy and global developmental delay in 40% to 60% of affected infants.
Clinical Trial Demonstrates Superior Efficacy
The NEOLEV 2 trial, a multicenter, randomized, blinded, controlled phase 2b study, provided compelling evidence for Sezaby's efficacy. The trial enrolled 106 term infants with gestational ages between 36-44 weeks, comparing phenobarbital against levetiracetam as first-line treatment. The results were striking: approximately 80% of patients receiving phenobarbital remained seizure-free for 24 hours, compared to only 28% in the levetiracetam group (P < .001; relative risk 0.35 [95% CI: 0.22-0.56]).
Dosing Protocol and Administration
Sezaby's treatment protocol involves a sophisticated dosing regimen:
- Initial loading dose: 20 mg/kg for all eligible infants
- Second loading dose (if needed): 10-20 mg/kg for preterm infants; 20 mg/kg for term infants
- Maximum total loading dose: 40 mg/kg
- Maintenance dosing: 4.5 mg/kg per day for up to 5 days, starting 8-12 hours after the first loading dose
The medication is supplied in single-use vials for intravenous administration, ensuring precise dosing and sterility.
Safety Profile and Adverse Events
While demonstrating superior efficacy, healthcare providers should be aware of potential adverse events, which were more frequent in the phenobarbital group compared to the levetiracetam group. Common adverse events included:
- Abnormal respiration
- Sedation
- Feeding disorder
- Hypotension
- Bradycardia
- Hyponatremia
- Sepsis
Role of Pharmacists in Patient Care
Pharmacists play a crucial role in optimizing treatment outcomes for neonatal seizure patients. Their responsibilities include:
- Collaborating with healthcare teams to determine appropriate treatment protocols
- Ensuring accurate dosing calculations and administration instructions
- Monitoring patient responses to treatment
- Assisting in adverse event management
- Providing guidance to caregivers on seizure monitoring and documentation
The unique formulation of Sezaby, being preservative-free, represents a significant advancement in neonatal care by reducing the excipient burden on critically ill newborns. This characteristic sets it apart from other phenobarbital products that require stabilizing additives.
