Sympazan is a thin, berry-flavored film that adheres to the tongue and dissolves to deliver clobazam.
SYMPAZAN® (clobazam): The first and only oral film formulation of clobazam
No Crushing.
No Mixing.
No Prep Work.
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SYMPAZAN (clobazam) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older.
What is SYMPAZAN?
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Requires no crushing, mixing, or measuring—which may be especially useful in patients who have difficulty in swallowing tablets
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Can support those who need clobazam in a different formulation
Support available for commercial and Medicaid patients on SYMPAZAN
For Commercially Insured Patients:
The SYMPAZAN Savings Card can help lower patients’ out-of-pocket costs. Eligible patients with commercial insurance can pay as little as $0 co-pay with the SYMPAZAN Savings Card.*
*Subject to eligibility. Restrictions apply. Maximum savings limit applies; patient out-of-pocket expense may vary. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. This is not valid for cash-paying patients. See eligibility, terms, and conditions.
For Medicaid Patients:
SYMPAZAN is available on most managed and state Medicaid plans.†
† Coverage subject to change without notice.
Important Safety Information
INDICATIONS AND USAGE
SYMPAZAN® (clobazam) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older.
IMPORTANT SAFETY INFORMATION for Sympazan
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS
- Concomitant use of benzodiazepines 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. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
- The use of benzodiazepines, including SYMPAZAN, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing SYMPAZAN and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.
- Abrupt discontinuation or rapid dosage reduction of SYMPAZAN after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue SYMPAZAN.
CONTRAINDICATIONS
SYMPAZAN is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients.
WARNINGS AND PRECAUTIONS
Risks from Concomitant Use with Opioids
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe SYMPAZAN concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use. Advise both patients and caregivers about the risks of respiratory depression and sedation when SYMPAZAN is used with opioids.
Abuse, Misuse, and Addiction
Abuse and misuse of benzodiazepines often (but not always) involves the use of doses greater than the maximum recommended dosage and commonly involves concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death.
Use of SYMPAZAN, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of SYMPAZAN along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of Central Nervous System (CNS) depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate.
Dependence and Withdrawal Reactions
Patients at an increased risk of withdrawal reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages and those who have had longer durations of use.
The continued use of benzodiazepines, including SYMPAZAN, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of SYMPAZAN after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures). In some cases, benzodiazepine users have developed protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months.
Potentiation of Sedation from Concomitant Use with Central Nervous System (CNS) Depressants
SYMPAZAN has a CNS depressant effect. Caution patients and/or caregivers against simultaneous use with other CNS depressants or alcohol as the effects of other CNS depressants or alcohol may be potentiated.
Somnolence or Sedation
SYMPAZAN causes dose-related somnolence and sedation, which generally begins within the first month of treatment and may diminish with continued treatment. Monitor patients for somnolence and sedation, particularly with concomitant use of other CNS depressants. Caution patients against engaging in hazardous activities requiring mental alertness, i.e., operating dangerous machinery or motor vehicles, until the effect of SYMPAZAN is known.
Serious Dermatological Reactions
Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults. Discontinue SYMPAZAN at the first sign of rash, unless the rash is clearly not drug-related.
Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including SYMPAZAN, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
ADVERSE REACTIONS
Adverse reactions (≥10% and more frequently than placebo) included constipation, somnolence or sedation, pyrexia, lethargy, and drooling.
DRUG INTERACTIONS
Opioids: The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression. Limit dosage and duration of concomitant use of benzodiazepines and opioids and follow patients closely for respiratory depression and sedation.
CNS Depressants and Alcohol: Concomitant use of SYMPAZAN with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence. Caution patients and/or caregivers against simultaneous use with other CNS depressants or alcohol, as effects of other CNS depressants or alcohol may be potentiated.
Hormonal Contraceptives: Hormonal contraceptives that are metabolized by CYP3A4: Effectiveness may be diminished when given with SYMPAZAN. Additional non-hormonal forms of contraception are recommended when using SYMPAZAN.
Drug Metabolized by CYP2D6: SYMPAZAN inhibits CYP2D6, therefore dose adjustment may be necessary of drugs metabolized by CYP2D6 when co-administered with SYMPAZAN.
Strong and Moderate Inhibitors of CYP2C19: Dosage adjustment of SYMPAZAN may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g., omeprazole).
Cannabidiol: Coadministration of cannabidiol and SYMPAZAN may increase the risk of SYMPAZAN-related adverse reactions. Consider dose reduction of cannabidiol or SYMPAZAN should this occur.
USE IN SPECIFIC POPULATIONS
Pregnancy: SYMPAZAN may cause fetal harm and should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have taken benzodiazepines during the later stages of pregnancy can develop dependence, withdrawal syndrome and symptoms suggestive of floppy infant syndrome. Encourage patients to call the toll-free number 1-888-233-2334 to enroll in the Pregnancy Registry or visit http://www.aedpregnancyregistry.org/
Lactation: SYMPAZAN is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from SYMPAZAN, discontinue nursing or discontinue the drug.
Please see Full Prescribing Information, including BOXED WARNING and Patient Information at https://www.sympazan.com/pdfs/pi.pdf
To report SUSPECTED ADVERSE REACTIONS, contact Assertio Therapeutics at 1-800-518-1084 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
References
1. SYMPAZAN. Package insert. Aquestive Therapeutics; 2021.