VALTOCO® (diazepam nasal spray)
RELIABLE DELIVERY OF RESCUE THERAPY
FOR SEIZURE CLUSTERS
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Presenters
Patricia Penovich, MD
Emeritus – Minnesota Epilepsy Group
Adjunct Clinical Professor Department of Neurology
University of Minnesota Medical School Minneapolis, MN
Biography:
Dr Penovich earned her medical degree from Case Western Reserve University School of Medicine in Cleveland, Ohio. She completed a medical internship at the University of California-San Diego. Dr Penovich then attended the University of Rochester School of Medicine and Dentistry in New York, where she completed a fellowship in clinical pharmacology, a residency and chief residency in neurology and an EEG fellowship. After that, Dr Penovich completed a fellowship in electroencephalography and epilepsy at the University of Minnesota in Minneapolis. She is Board certified in neurology with added qualifications in epilepsy, in clinical neurophysiology with qualifications in electroencephalography, and in neurophysiology.
Dr Penovich is currently Adjunct Clinical Professor in the Department of Neurology at the University of Minnesota Medical School and is Emeritus at the Minnesota Epilepsy Group. She has held numerous physician leadership roles at Allina Health. She is a Fellow in the American Academy of Neurology and a Fellow in the American Epilepsy Society. Additionally, she is a member of the Professional Advisory Board for the Epilepsy Foundation and will chair the Professional Advisory Board for the Epilepsy Foundation of Minnesota in January 2021. Dr Penovich has served as a principal investigator or subinvestigator for numerous clinical trials and has published more than a hundred articles and abstracts in peer-reviewed journals.
Danielle Becker, MD, MS
Director of Epilepsy, MetroHealth System
Associate Professor, Case Western Reserve School of Medicine
Biography:
Danielle Becker, MD, MS is an associate professor at Case Western Reserve School of Medicine and the Director of Epilepsy at the MetroHealth Hospital System, where she will be continuing her research interests in women with epilepsy and the assessment and management of response to implanted neurostimulation devices in subjects with epilepsy. She is also an active member of the American Academy of Neurology and the American Epilepsy Society.
Previously, she was an Assistant Professor of Clinical Neurology at the Hospital of the University of Pennsylvania. She completed 2 years of neurophysiology/epilepsy fellowship – first at the Hospital of the University of Pennsylvania, second at the NYU Medical Center. She is boarded in both Neurology and Epilepsy subspecialty. She served as the Director of the neurostimulation program for surgical management at the University of Pennsylvania as well as head of epilepsy education. 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.
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
RISK FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
- Reserve concomitant prescribing of these drugs for use in 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
Contraindications: VALTOCO is contraindicated in patients with:
- Known 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. Advise patients and caregivers to be alert for these behavioral changes and to immediately report them to a healthcare provider.
Glaucoma
Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma.
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 see full Prescribing Information, including Boxed Warning, for additional important safety information.
© Neurelis, Inc. 2020. All rights reserved. NEURELIS, VALTOCO, and the NEURELIS logo are registered trademarks of Neurelis, Inc.
For more information about VALTOCO, visit VALTOCOHCP.COM
US-PRC-20-00370 10/2020