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.
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We are always looking to improve our programs and greatly appreciate your feedback! Please complete the following survey to help us evaluate the effectiveness of this program, and to prepare for future programs.

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* 1. Which program did you attend?

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* 2. On a scale of 1 to 5, how much did this program enhance your understanding of VALTOCO (1=not at all, 3=somewhat, 5=very much)?

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* 3. On a scale of 1 to 5, how informative was this program in managing seizures at school through the use of seizure action plans and seizure rescue medications (1=not at all, 3=somewhat, 5=very much)?

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* 4. On a scale of 1 to 5, how familiar were you with VALTOCO prior to this program (1=not at all familiar, 3=somewhat familiar, 5=very familiar)?

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* 5. After attending this program, do you feel comfortable recommending VALTOCO to the healthcare providers of students who experience episodes of frequent seizures and to their parents and care partners?

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* 6. Neurelis is interested in learning firsthand about your experience with VALTOCO. Do you have a success story that you would like to share?
(Please do not provide any identifiable information about the student)

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* 7. Are you familiar with any of the following seizure rescue medications (please select all that apply)?

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* 8. Are there any resources that you would like to learn more about (please select all that apply)?

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* 9. For future programs, which days/time frames would you be more likely to attend (please select all that apply)?

  Morning Noontime/early afternoon Midafternoon Evening
Monday
Tuesday
Wednesday
Thursday

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* 10. Which time zone are you in?

Please read the full Prescribing Information and Instructions for Use.

*Please scroll down and click “Done” after the Important Safety Information to submit your responses.*

IMPORTANT SAFETY INFORMATION

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTION
  • 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.

© Neurelis, Inc. 2023. All rights reserved.
NEURELIS, VALTOCO, and the NEURELIS and VALTOCO logos are trademarks or registered trademarks of Neurelis, Inc. 

US-PRC-21-00182 v2  01/2023

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