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**A “seizure cluster,” also known as episodes of frequent seizure activity, is when a person has two or more seizures within a period of 24 hours.

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What is VALTOCO® (diazepam nasal spray)?

  • VALTOCO is a prescription medicine used for the short-term treatment of seizure clusters (also known as “episodes of frequent seizure activity” or “acute repetitive seizures”) in patients 6 years of age and older.
  • VALTOCO is a federally controlled substance (CIV) because it can be abused or lead to dependence. Keep VALTOCO in a safe place to prevent misuse and abuse. Selling or giving away VALTOCO may harm others and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription drugs, or street drugs.
  • It is not known if VALTOCO is safe and effective in children under 6 years of age.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about VALTOCO?

  • VALTOCO is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens:
    • Shallow or slowed breathing
    • Breathing stops (which may lead to the heart stopping)
    • Excessive sleepiness (sedation)
  • Risk of abuse, misuse, and addiction. There is a risk for abuse, misuse, and addiction with benzodiazepines, including VALTOCO, which can lead to overdose and serious side effects including coma and death.
    • Serious side effects have happened in people who have abused or misused benzodiazepines, including diazepam (the active ingredient in VALTOCO). These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
    • Use VALTOCO exactly as your healthcare provider prescribed.
  • Physical dependence and withdrawal reactions. Benzodiazepines, including VALTOCO, can cause physical dependence and withdrawal reactions, especially if you use VALTOCO daily. VALTOCO is not intended for daily use.
  • VALTOCO can make you sleepy or dizzy and can slow your thinking and motor skills.
    • Do not drive, operate heavy machinery, or do other dangerous activities until you know how VALTOCO affects you.
    • Do not drink alcohol or take opioid medicines that make you sleepy or dizzy while taking VALTOCO until you talk to your healthcare provider. When taken with alcohol or medicines that can cause sleepiness or dizziness, VALTOCO may make your sleepiness or dizziness worse.
  • Like other antiepileptic drugs, VALTOCO may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any new or worsening suicidal thoughts or related symptoms, especially unusual changes in mood, behaviors, thoughts or feelings.

What are the most common side effects of VALTOCO?

The most common side effects of VALTOCO include:

  • Feeling sleepy or drowsy
  • Headache
  • Nose discomfort

These are not all of the possible side effects of VALTOCO. Call your healthcare provider for medical advice about side effects. You may report side effects to Neurelis, Inc. at 1-866-696-3873 or to FDA at 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide for additional important safety information.