Sezaby
Sezaby (phenobarbital) is an injectable medication approved in November 2022 to help treat active seizures in newborns that happen within the first 4 weeks of life. It's typically given in the neonatal intensive care unit (NICU) in the hospital by a healthcare provider. Sezaby (phenobarbital) doesn't contain harmful preservatives or inactive ingredients, making it a safe treatment option for newborns.
What is Sezaby (phenobarbital)?
What is Sezaby (phenobarbital) used for?
- Seizures in newborns (neonatal seizures)
Drug facts
Risks and warnings for Sezaby (phenobarbital)
Sezaby (phenobarbital) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Not recommended for use with opioids
When Sezaby (phenobarbital) is given with opioids (strong medications for pain or sedation), there's a risk of severe and potentially life-threatening side effects. These side effects include extreme sleepiness, slowed breathing, coma, or even death. The care team will only use this combination of medications if it's clearly needed and for the shortest amount of time possible. If your baby needs to take Sezaby (phenobarbital) and an opioid at the same time, the care team will carefully look for breathing problems and excessive sleepiness while caring for your baby. Look for these signs as well when you spend time with your baby at the bedside, and call for help right away if you do.
Slowed breathing
- Risk factors: Taking Sezaby (phenobarbital) with medications that cause slowed breathing
Sezaby (phenobarbital) can potentially cause breathing problems in your baby. Your baby's risk is higher if they're receiving Sezaby (phenobarbital) with other medications that have a slowing or calming effect on the body, such as sedatives and opioids. In some cases, slowed breathing can be life-threatening. Let the care team know if your baby's taking any other medications so they can check for potentially dangerous interactions. They'll closely monitor your baby's breathing while getting treated.
Severe allergic and skin reactions
Severe allergic reactions to Sezaby (phenobarbital) are possible, including rash, fever, and swelling. Additionally, Sezaby (phenobarbital) can cause serious skin reactions like Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and DRESS syndrome. These reactions can appear as severe rash, fever, skin reddening, blisters, skin peeling, or facial swelling. Finally, reactions like pain or swelling can happen near the area where Sezaby (phenobarbital) is infused. The care team will watch your baby for any of these severe reactions. If they occur, they'll likely stop Sezaby (phenobarbital). Let them know right away if you notice any of these symptoms in your baby.
Life-threatening abnormal heart rhythm
- Risk factors: History of heart problems, slow heart rate, or other abnormal heart rhythms (arrhythmias) | Uncontrolled hypothyroidism (low thyroid hormone) | Abnormal electrolytes | Taking other medications that cause QT prolongation
Sezaby (phenobarbital) can affect your baby's heart rhythm, which can be serious and life-threatening. One example includes affecting the time it takes for the heart to pump and then relax. This is known as QT prolongation. Your baby's risk for QT prolongation is higher if they have certain factors, including abnormal electrolyte levels and heart rhythm problems, among others. The care team will closely monitor your baby's heart rate and heart rhythm while using the medication.
Common questions about Sezaby (phenobarbital)
Sezaby (phenobarbital) is used to treat seizures that happen within the first 4 weeks (or first month) of life in both term and preterm (early) babies. The medication is given in the neonatal intensive care unit (NICU). Sezaby (phenobarbital) was granted orphan drug status by the FDA, since it's used to treat a rare condition.
Sezaby (phenobarbital) is given as an injection into the veins (intravenous or IV) by a healthcare provider. In general, it's injected every 8 or 12 hours for up to 5 days. Your baby's provider will calculate the dose based on your baby's body weight.
Sezaby (phenobarbital) can be safely used to treat seizures that your newborn baby has. Sezaby (phenobarbital) doesn't contain benzyl alcohol (a preservative) or propylene glycol (an inactive ingredient that helps medication stay in injectable form). These ingredients have both caused serious side effects, including death, in newborns. Phenobarbital is the first-choice treatment option for newborns who have seizures within the first month of life.
Sezaby (phenobarbital) is a barbiturate. It works by raising the effects of a chemical in the brain that typically slows brain activity. This is thought to help control brain activity and treat seizures.
Possible side effects of Sezaby (phenobarbital) include abnormal breathing, sleepiness, feeding problems, and low blood pressure. The care team in the NICU will keep a very close eye on your baby for any side effects. This isn't a complete list of side effects, so be sure to discuss what to expect with your baby's healthcare provider. Ask the care team in the NICU if you have any concerns about Sezaby (phenobarbital) or how your baby is doing.
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Sezaby (phenobarbital) dosage
Typical dosage for Sezaby (phenobarbital)
Sezaby (phenobarbital) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Sezaby (phenobarbital) will not be safe for you to take.
- Use in newborns with porphyria