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VALTOCO^® (diazepam nasal spray)

Rapid, Reliable, and Ready Seizure Rescue for Episodes of Frequent Seizures

Register Below

Presenters

Danielle Becker, MD, MS, FAES, is an adult epileptologist and the Division Director of Epilepsy and an Associate Professor of Neurology at The Ohio State University Wexner Medical Center. She has managed a wide variety of patients with epilepsy, on both the inpatient and outpatient level. She is well versed in anti-seizure medication management, as well as surgical and neuromodulation management. She has an additional interest in epilepsy and women and has created specialty pregnancy clinics for patients who are pregnant with epilepsy. She also continues her research interest in the assessment and management of response to implanted neurostimulation devices in subjects with epilepsy and is the Director of Neuromodulation at The Ohio State University Wexner Medical Center.
Dr Becker completed 2 years of neurophysiology/epilepsy fellowship—first at the Hospital of the University of Pennsylvania, second at the NYU Medical Center. She then served as an Assistant Professor of Clinical Neurology at the Hospital of the University of Pennsylvania from 2014 to 2020. She was the Director of the Responsive Neurostimulation System Program for Surgical Management as well as Head of Epilepsy Education at the University of Pennsylvania. She was also the Associate Program Director of both the neurology residency and neurology medical student clerkship and Assistant Director of the Epilepsy Fellowship Program. She then moved to become the Medical Director of Epilepsy at MetroHealth in Cleveland, Ohio, where she started an epilepsy program for the underserved community from 2020 to 2023.
Dr Becker is board certified in both neurology and epilepsy by the American Board of Psychiatry and Neurology and is a member of the American Academy of Neurology and the American Epilepsy Society.

Dr Wheless is an experienced neurologist and researcher, whose research is focused on pediatric antiepileptic drug development, the ketogenic diet, epilepsy surgery, and noninvasive brain mapping.
Dr Wheless is a Professor and the Chief of Pediatric Neurology and the Le Bonheur Chair in Pediatric Neurology at the University of Tennessee Health Science Center in Memphis. He also serves as the Director of the Neuroscience Institute and the Le Bonheur Comprehensive Epilepsy Program and is the Tom Horton & Donna Wiener Endowed Chair in Neurosciences for Le Bonheur Children’s Hospital. Dr Wheless is also an Adjunct Clinical Faculty Member in the Department of Pediatric Medicine at St. Jude Children’s Research Hospital. He is a diplomate of the American Board of Pediatrics and the American Board of Psychiatry and Neurology, with special qualifications in child neurology, clinical neurophysiology, and epilepsy.
Dr Wheless earned his medical degree and completed an internship and residency in pediatrics at the University of Oklahoma in Oklahoma City. He subsequently completed fellowships in child neurology at Children’s Memorial Hospital at Northwestern University in Chicago and in EEG/epilepsy at the Medical College of Georgia in Augusta. Dr Wheless is a fellow of the American Academy of Pediatrics, American Academy of Neurology, and American Epilepsy Society. He is a member of the Editorial Board of the Journal of Child Neurology and serves as a reviewer for a number of journals, including Neurology, Epilepsia, Pediatrics, and Epilepsy & Behavior. His primary interests include childhood convulsive disorders. He has authored more than 950 chapters, articles, and abstracts on these subjects and is the editor of four textbooks on epilepsy. Dr Wheless lectures widely on pediatric epilepsy. He oversees an interdisciplinary team of pediatric specialists who treat epilepsy patients with the most effective medical treatments available.

VALTOCO^® (diazepam nasal spray)

Rapid, Reliable, and Ready Seizure Rescue for Episodes of Frequent Seizures

Indication

VALTOCO^® (diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 6 years of age and older.

IMPORTANT SAFETY INFORMATION

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 VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALTOCO and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.
The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO.

Contraindications: VALTOCO is contraindicated in patients with:

Hypersensitivity to diazepam
Acute narrow-angle glaucoma

Central Nervous System (CNS) Depression

Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits.

The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner.

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior.

Glaucoma

Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma.

Neonatal Sedation and Withdrawal Syndrome

Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly.

Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative

VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including “gasping syndrome,” can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known.

Adverse Reactions

The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort.

Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance.

To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Please read full Prescribing Information, including Boxed Warning, for additional important safety information.

VALTOCO® (diazepam nasal spray)

Rapid, Reliable, and Ready Seizure Rescue for Episodes of Frequent Seizures

Register Below

Thur, October 10 • 1:00 PM - 2:00 PM ET

Wed, October 30 • 1:00 PM - 2:00 PM ET

Thur, November 14 • 3:00 PM - 4:00 PM ET

Thur, November 21 • 12:00 PM - 1:00 PM ET

Presenters

Danielle Becker, MD, MS, FAES

James W Wheless, BScPharm, MD, FAAP, FACP, FAAN, FAES

VALTOCO® (diazepam nasal spray)

Rapid, Reliable, and Ready Seizure Rescue for Episodes of Frequent Seizures

VALTOCO^® (diazepam nasal spray)

VALTOCO^® (diazepam nasal spray)