CONFIDENCE IN THE CLASSROOM
VALTOCO® (diazepam nasal spray): Intranasal Seizure Cluster Rescue Therapy in Children 6 Years of Age and Older
Please register by selecting the date and time that works best for you.
Wednesday, November 4, 2020
12:00 PM EST – 1:00 PM EST
Presented by Patricia Osborne Shafer, RN MN, FAES
Thursday, November 12, 2020
3:00 PM EST – 4:00 PM EST
Presented by Patricia Osborne Shafer, RN MN, FAES
Presenters
Patricia Osborne Shafer, RN, MN, FAES
Nurse Specialist, Patient Advocate
Biography:
Patricia Osborne Shafer received her BSN in Nursing from the University of Vermont and a Masters in Physiological Nursing – Neuroscience from University of Washington in Seattle Washington. She began her career as a director of a community-based program for ALS, then focused her work in epilepsy. As a clinical nurse specialist in a comprehensive epilepsy center, she coordinated an outpatient nursing clinic and provided education to health care professionals, families and people with epilepsy for many years. She has experience with clinical drug trials and self-management research in epilepsy. Most recently she has been the associate editor and community manager of epilepsy.com, the largest public use website for epilepsy and as a senior director for programs, health education and resources at the Epilepsy Foundation. She has worked for many years developing and implementing training programs in epilepsy, most recently leading a telementoring program for school nurses and a certification program in seizure first aid.
Nancy Santilli, PNP, MN, FAAN
Nurse Specialist, Patient Advocate
Biography:
Ms. Nancy Santilli has served as the Global Managing Director of Human Care Systems, Inc., since 2014. Prior, she worked at Endo Health Solutions (Chadds Ford, PA), Elan Pharmaceuticals (Dublin, Ireland), and the University of Virginia School of Medicine (Charlottesville, VA) where she was the Associated Director of the Comprehensive Epilepsy Program and Associate Professor of Neurology, School of Medicine.
Ms. Santilli earned her MSN degree and NP certification from the University of Virginia in Charlottesville, and she received her BSN from Seton Hall University in South Orange, NJ.
Ms. Santilli has held numerous leadership positions. She is the Chair Emeritus of the Healthcare Businesswomen’s Association, Past President of the Epilepsy Foundation, and Past Treasurer of the American Epilepsy Society. She secured and led multiple clincial trials evaluating new therapies for epilepsy. She is well published, having authored 37 articles and chapters, 50 abstracts, and two books. She is a Fellow of the American Academy of Nursing and a recipient of the International League Against Epilepsy Ambassador Award.
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-20-00360 10/2020