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* IMPORTANT SAFETY INFORMATION
* PRESCRIBING INFORMATION
Menu
* WHY PRESERVATIVE-
FREE?
* DOSING &
RECONSTITUTION
* SAFETY &
EFFICACY
* ORDERING
INFORMATION
* CONTACT
A REP
* IMPORTANT SAFETY INFORMATION
* PRESCRIBING INFORMATION
* WHY PRESERVATIVE-
FREE?
* DOSING &
RECONSTITUTION
* SAFETY &
EFFICACY
* ORDERING
INFORMATION
* CONTACT
A REP
SEZABY® IS THE ONLY FDA-APPROVED & ONLY PRESERVATIVE-FREE PHENOBARBITAL FOR
NEONATAL SEIZURES1,2
SEZABY (phenobarbital sodium) is indicated for the treatment of neonatal
seizures in term and preterm infants.
THE ONLY FDA-APPROVED & PRESERVATIVE-FREE1,2
SEZABY® does not add to potential excipient burden on critically ill
neonates1,3–5
NO alcohol
No known safe level of exposure to ethanol in neonates6
NO propylene glycol
No safe dose established for neonates less than 14 days of age (high levels may
result in toxicity)7
NO benzyl alcohol
Exposure to high levels associated with developmental delay, cerebral palsy, and
fatal cases of “gasping” syndrome5,6,8
Polymedicated neonates may be more vulnerable to these excipients,
as all 3 are metabolized by the same enzyme, alcohol dehydrogenase (ADH).9
Respiratory Depression or Insufficiency: Abnormal respiration has been observed;
careful respiratory monitoring is needed during and after the administration of
SEZABY®.
SEZABY® is the ONLY FDA-APPROVED, PRESERVATIVE-FREE phenobarbital for neonatal
seizures1,2
Three excipients found in other, non-FDA approved, phenobarbital products are of
particular concern for neonates10-13
WHY PRESERVATIVE-FREE?
EXCIPIENT EXPOSURE
BACK TO TOP
Phenobarbital is commonly used as first-line treatment in neonatal seizures14,15
However, most phenobarbital products are not stable in solution.16 Excipients or
preservatives are added to increase stability.10–13,16
Critically ill neonates receive multiple medications and infusions
Multiple excipients
Some neonates in critical care units (NICU) can be exposed to up to 60 different
excipients5,6
Toxicity
These levels of toxic excipients can be at doses higher than those recommended
for adults5,6
Immature organ systems
Neonates have reduced capacity to metabolize and eliminate excipients3,4
Three excipients found in other, non-FDA approved phenobarbital products are of
particular concern for neonates10–13
* Alcohol (ethanol)
* Propylene glycol
* Benzyl alcohol
Alcohol dehydrogenase (ADH)
metabolizes all 3 excipients9
ADH activity
in neonates is less than 20% of adult levels9
Accumulation of harmful excipients
in vulnerable, polymedicated neonates may result9
DOSING & RECONSTITUTION
NEONATAL DOSING
BACK TO TOP
SEZABY® is the ONLY FDA-APPROVED phenobarbital with dosing specific to
neonates1,2
*If seizures persist or recur any time 15 minutes after completion of the
initial loading dose, administer a second loading dose. (Administer the second
loading dose no sooner than 15 minutes after completion of the first loading
dose.)
SEZABY® is supplied as a lyophilized powder in single-use vials. When
reconstituted, SEZABY® contains 10 mg/mL phenobarbital sodium. Administer
SEZABY® by intravenous infusion (over 15 minutes) into a large peripheral vein
to avoid local tissue toxicity. SEZABY® is for intravenous use only.
*If seizures persist or recur any time 15 minutes after completion of the
initial loading dose, administer a second loading dose. (Administer the second
loading dose no sooner than 15 minutes after completion of the first loading
dose.)
SEZABY® is supplied as a lyophilized powder in single-use vials. When
reconstituted, SEZABY® contains 10 mg/mL phenobarbital sodium. Administer
SEZABY® by intravenous infusion (over 15 minutes) into a large peripheral vein
to avoid local tissue toxicity. SEZABY® is for intravenous use only.
RECONSTITUTION
BACK TO TOP
Reconstitution and additional administration instructions1
* Determine the number of vials to be reconstituted based on the patient’s
weight and recommended dose.
* Aseptically reconstitute the lyophilized powder in the vial using 10 mL of
0.9% Sodium Chloride Injection, USP.
* Swirl the vial gently until contents are completely dissolved.
* The reconstituted solution contains 100 mg per 10 mL (10 mg/mL) of
phenobarbital sodium.
* Inspect the vial visually for particulate matter and discoloration prior to
administration (the reconstituted solution is clear, colorless, and free
from visible particulate matter).
* Discard the reconstituted solution if it is discolored or contains foreign
particles.
* Withdraw the appropriate volume from the reconstituted vial for intravenous
infusion and administer immediately.
* Discard any unused portion of the reconstituted solution left in the vial.
No other available phenobarbital product has dosing recommendations for
neonates1,10–13
SAFETY & EFFICACY
CLINICAL STUDY
BACK TO TOP
SEZABY® was demonstrated to be bioequivalent to the phenobarbital formulations
used in the NEOLEV 2 study.1
Phenobarbital demonstrated superior efficacy vs levetiracetam in neonatal
seizures1,2
Significantly more effective in seizure cessation for all 3 endpoints1
STUDY DESIGN: A multicenter, randomized, blinded, controlled phase 2b trial
(NEOLEV 2) investigated the efficacy and safety of phenobarbital compared with
levetiracetam as first-line treatment for neonatal seizures. Term infants
(corrected gestational age 36-44 weeks, weight >2.2 kg) at risk for developing
seizures or suspected of having seizures were enrolled. Overall, 106 neonates
(51 female, 55 male) were randomized to receive either phenobarbital (n=42) or
levetiracetam (n=64) as their initial treatment. Patients received up to two
15-minute infusions of initially assigned treatment (loading dose[s]) followed
by maintenance of up to 5 days. Mean durations of phenobarbital and
levetiracetam treatments were 4.3 and 4 days, respectively. Primary endpoint was
seizure-free for at least 24 hours.* Secondary endpoints were seizure-free for
more than 48 hours and seizure-free for more than 1 hour.*
*Without needing a second drug to control seizures.
Respiratory Depression or Insufficiency: Abnormal respiration has been observed;
careful respiratory monitoring is needed during and after the administration of
SEZABY®.
SAFETY PROFILE
BACK TO TOP
Adverse Reactions that occurred in at least 2% of neonates
Differences in adverse reactions to phenobarbital and levetiracetam were not
statistically significant in clinical studies.2
*55 neonates received both phenobarbital and levetiracetam, and had a similar
adverse reaction profile as those who received only phenobarbital.1
SEZABY® ORDERING INFORMATION
NDC: 62756-301-01
* Supplied: One 100 mg single dose vial (lyophilized powder)
* Reconstituted: 10 mg/mL phenobarbital sodium, for intravenous use only
SEZABY® Wholesaler Item Numbers
AmerisourceBergen: 10276604
Cardinal Health: 5823406
McKesson: 2677144
Morris & Dickson: 252676
Lessening excipient burden on critically ill neonates1,3–5
Contact a Rep
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PROVIDER TYPE* (select one)PharmacistHospital affiliation
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SPECIALTY* (select one)NeurologistPediatric
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References: 1. SEZABY [prescribing information]. Sun Pharmaceutical Industries,
Inc.; November 2022. 2. Sharpe C, Reiner GE, Davis SL, et al. Levetiracetam
versus phenobarbital for neonatal seizures: a randomized controlled trial.
Pediatrics. 2020;145:e20193182. 3. Salunke S, Brandys B, Giacoia G, Tuleu C. The
STEP (Safety and Toxicity of Excipients for Paediatrics) database: part 2 – the
pilot version. Int J Pharm. 2013;457(1):310-322.
doi:10.1016/j.ijpharm.2013.09.013 4. LeBel M, Ferron L, Masson M, et al. Benzyl
alcohol metabolism and elimination in neonates. Dev Pharmacol Ther.
1988;11:347-56. 5. Sridharan K, Hasan HM, Al Jufairi M, et al. Possible effects
of excipients used in the parenteral drugs administered in critically ill
adults, children, and neonates. Expert Opin Drug Saf. 2020;19(12):1625-1640.
doi:10.1080/14740338.2020.1805431 6. Akinmboni TO, Davis NL, Falck AJ, Bearer
CF, Mooney SM. Excipient exposure in very low birth weight preterm neonates. J
Perinatol. 2018;38:169-74. doi:10.1038/jp.2017.165 7. Food and Drug
Administration. Drug Safety Communication. Serious health problems seen in
premature babies given Kaletra (lopinavir/ritonavir) oral solution. Accessed
November 2022.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-serious-health-problems-seen-premature-babies-given-kaletra.
8. Gershanik J, Boecler B, Ensley H, McCloskey S, George W. The gasping syndrome
and benzyl alcohol poisoning. N Engl J Med. 1982;307(22):1384-1388.
doi:10.1056/NEJM198211253072206 9. Valeur KS, Hertel SA, Lundstrøm KE, Holst H.
The cumulative daily tolerance levels of potentially toxic excipients ethanol
and propylene glycol are commonly exceeded in neonates and infants. Basic Clin
Pharmacol Toxicol. 2018;122(5):523-530. doi:10.1111/bcpt.12950 10. Phenobarbital
sodium-phenobarbital sodium injection [prescribing information]. BPI Labs, LLC;
January 2022. 11. Phenobarbital sodium-phenobarbital sodium injection
[prescribing information]. Hikma Pharmaceuticals USA Inc.; January 2020. 12.
Phenobarbital sodium-phenobarbital sodium injection [prescribing information].
Cameron Pharmaceuticals, LLC; February 2020. 13. Phenobarbital
sodium-phenobarbital sodium injection [prescribing information]. Bryant Ranch
Prepack, Inc; September 2022. 14. Glass HC, Shellhaas RA, Wusthoff CJ, et al.
Contemporary profile of seizures in neonates: a prospective cohort study. J
Pediatr. 2016;174:98-103.31. doi: 10.1016/j.jpeds.2016.03.035 15. Krawiec C,
Muzio MR. Neonatal seizure. [Updated 2022 Apr 30]. In StatPearls [Internet].
Treasure Island (FL): StatPearls Publishing. Jan 2022. 16. Lyophilized
compositions of phenobarbital. Patent Grant 11406598.
https://trea.com/information/lyophilized-compositions-of-phenobarbital-sodium-salt/patentgrant/6edd4628-48d7-42a3-8f28-4756620c304c.
WARNINGS AND PRECAUTIONS
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; DEPENDENCE AND WITHDRAWAL
REACTIONS AFTER USE OF SEZABY FOR A LONGER DURATION THAN RECOMMENDED; and ABUSE,
MISUSE, ADDICTION WITH UNAPPROVED USE IN ADOLESCENTS AND ADULTS
Risks from Concomitant Use with Opioids
Concomitant use of phenobarbital products, including SEZABY, and opioids may
result in profound sedation, respiratory depression, coma, and death. Reserve
concomitant prescribing of these drugs for patients for whom alternative
treatment options are inadequate. If a decision is made for concomitant use of
these drugs, limit dosages and durations to the minimum required, and follow
patients for signs and symptoms of respiratory depression and sedation.
Dependence and Withdrawal Reactions After Use of SEZABY for a Longer Duration
than Recommended
The continued use of phenobarbital may lead to clinically significant physical
dependence. The risks of dependence and withdrawal increase with longer
treatment duration and higher daily dose. Although SEZABY is indicated only for
short-term use, if used for a longer duration than recommended, abrupt
discontinuation or rapid dosage reduction of SEZABY may precipitate acute
withdrawal reactions, which can be life-threatening. For patients receiving
SEZABY for longer duration than recommended, to reduce the risk of withdrawal
reactions, use a gradual taper to discontinue SEZABY.
Abuse, Misuse, and Addiction with Unapproved Use in Adolescents and Adults
SEZABY is not approved for use in adolescents or adults. The unapproved use of
SEZABY in adolescents and adults exposes them to risks of abuse, misuse, and
addiction, which can lead to overdose or death. Abuse and misuse of
phenobarbital commonly involve concomitant use of other drugs, alcohol, and/or
illicit substances, which is associated with an increased frequency of serious
adverse outcomes.
INDICATIONS AND USAGE
SEZABY® (phenobarbital sodium) is indicated for the treatment of neonatal
seizures in term and preterm infants.
CONTRAINDICATIONS
SEZABY is contraindicated in patients with:
• acute porphyrias
• a history of hypersensitivity reaction to phenobarbital or other barbiturates
Respiratory Depression or Insufficiency: Abnormal respiration has been observed;
careful respiratory monitoring is needed during and after the administration of
SEZABY.
Serious Dermatologic Reactions: Serious and sometimes fatal dermatologic
reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson
syndrome (SJS), have been reported with the use of phenobarbital. SEZABY should
be discontinued at the first sign of drug-related rash, unless the rash is
clearly not drug related.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan
hypersensitivity: DRESS, also known as multiorgan hypersensitivity, has been
reported in patients taking antiepileptic drugs, including phenobarbital. Some
of these events have been fatal or life-threatening.
SEZABY should be discontinued if an alternative etiology for the signs or
symptoms cannot be established.
Infusion Site Reactions: SEZABY is highly alkaline. Therefore, extreme care
should be taken to avoid perivascular extravasation or intra-arterial injection.
Extravascular injection may cause local tissue damage with subsequent necrosis;
consequences of intra-arterial injection may vary from transient pain to
gangrene of the limb. Any evidence of pain, swelling, discoloration, or
temperature change in the limb warrants stopping the injection.
QT Prolongation: SEZABY may prolong the QT interval. Avoid use of SEZABY in
patients who are at significant risk of developing torsade de pointes. If use
cannot be avoided in these patients, collect ECGs during treatment at specified
intervals as clinically indicated, and monitor serum electrolytes and correct
abnormalities.
Avoid the concomitant use of products that may increase the risk of QTc interval
prolongation that may increase concentrations of phenobarbital.
ADVERSE REACTIONS
The most common adverse reactions (incidence > 5% patients overall) are abnormal
respiration, sedation, feeding disorder, and hypotension.
DRUG INTERACTIONS
CYP2C9, 2C19, 2E1, UGT Inhibitors: Closely monitor for adverse reactions (e.g.,
over sedation, prolonged QTc interval, etc.) when used concomitantly with
inhibitors of these enzymes and reduced efficacy (e.g., breakthrough seizure);
when used with inducers of these enzymes. Consider titration of the SEZABY
maintenance dosage accordingly if concomitant use is unavoidable and decrease
SEZABY dosage, if needed.
CYP3A4, 2B6, 2C, UGT Substrates: Closely monitor neonates when SEZABY is used
concurrently with substrates of these enzymes and consider increasing the dosage
of the substrate accordingly, unless otherwise advised in its Prescribing
Information, if concomitant use is unavoidable.
CNS depressants: Closely monitor for sedation and respiratory depression with
concomitant use of SEZABY with other CNS depressants, including opioids.
Drugs that Prolong the QT Interval: Avoid concomitant use of SEZABY and these
products.
To Report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries,
Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
Please see full Prescribing Information for Boxed Warning, Contraindications,
and other important Warnings and Precautions.
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SEZABY is a registered trademark of Sun Pharma Advanced Research Company Ltd.,
used under license.
All other trademarks are property of their respective owners.
©2023 Sun Pharmaceutical Industries, Inc. All rights reserved. 09/2023
PM-US-SZB-0023
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WARNINGS AND PRECAUTIONS
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; DEPENDENCE AND WITHDRAWAL
REACTIONS AFTER USE OF SEZABY FOR A LONGER DURATION THAN RECOMMENDED; and ABUSE,
MISUSE, ADDICTION WITH UNAPPROVED USE IN ADOLESCENTS AND ADULTS
Risks from Concomitant Use with Opioids
Concomitant use of phenobarbital products, including SEZABY, and opioids may
result in profound
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