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PEOPLE WITH EPILEPSY NEED OPTIONS FOR ON-HAND RESCUE TREATMENT2

Many people with epilepsy continue to experience seizures despite the use of daily medications (anti-epileptic drugs).3-5 Some patients experience bouts/periods of increased seizure activity when two or more seizures may occur within 24 hours, also known as seizure clusters.2 These seizures may occur one right after the other or hours apart.6 Once a seizure cluster has started, it's important to stop it quickly.7 However, seizures are unpredictable and can strike anytime, anywhere.8-11 This is why a seizure action plan along with an on-hand rescue medication allows for prompt treatment when it's needed most.

 
VALTOCO® (diazepam nasal spray)

VALTOCO® (diazepam nasal spray) PLACES RELIABLE SEIZURE CLUSTER RESCUE IN THEIR HANDS1,10

  • VALTOCO is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 6 years of age and older1

  • Provides 97% bioavailability with sustained blood levels throughout the day1,12-13

  • Available in four different treatment doses1

    • Specific, individualized dosing based on age and weight1

  • Heritage and Innovation come together in a reliable nasal spray. VALTOCO combines the established history of diazepam with Intravail®, a novel formulation technology, to address the principal limitations of nasal delivery1,14-16

  • VALTOCO is proven to be generally safe and well-tolerated in patients 6 years and older1

Learn about the many advantages our proprietary technology offers patients. Find out more.

To learn how VALTOCO is administered, see Instructions for Use for 5 mg and 10 mg doses and 15 mg and 20 mg doses.

 

NEURELIS PROVIDES INDIVIDUALIZED SUPPORT FOR PATIENTS WHO ARE PRESCRIBED VALTOCO

SEE OUR PROGRAM

What is VALTOCO® (diazepam nasal spray)?

  • VALTOCO is a prescription medicine used for the short-term treatment of seizure clusters (also known as “acute repetitive seizures”) in patients 6 years of age and older.
  • VALTOCO is a federal 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

Important Safety Information you should know about VALTOCO® (diazepam nasal spray), CIV

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 depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.
  • VALTOCO can make you sleepy or dizzy and can slow your thinking and your motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how VALTOCO affects you.
  • 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 of these symptoms, especially if they are new, worse, or worry you:
    • Thoughts about suicide or dying
    • Feeling agitated or restless
    • Acting aggressive, being angry, or violent
    • Attempts to commit suicide
    • Panic attacks
    • Acting on dangerous impulses
    • Trouble sleeping (insomnia)
    • An extreme increase in activity and talking (mania)
    • New or worse anxiety
    • New or worse irritability
    • Other unusual changes in behavior or mood
    • New or worse depression

How can I watch for early symptoms of suicidal thoughts or actions?

  • Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Do not use VALTOCO if you:

  • Are allergic to diazepam.
  • Have an eye problem called acute narrow-angle glaucoma.

What should I tell my doctor before taking VALTOCO?

Before using VALTOCO, tell your healthcare provider about all of your medical conditions, including if you:

  • Have asthma, emphysema, bronchitis, chronic obstructive pulmonary disease, or other breathing problems.
  • Have a history of alcohol or drug abuse.
  • Have a history of depression, mood problems, or suicidal thoughts or behavior.
  • Have liver or kidney problems.
  • Are pregnant or plan to become pregnant. VALTOCO may harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. VALTOCO passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you use VALTOCO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use VALTOCO?

  • Read the Instructions for Use for detailed information about the right way to use VALTOCO.
  • Use VALTOCO exactly as prescribed by the healthcare provider.
  • Your healthcare provider will tell you:
    • What seizure clusters are
    • Exactly how much VALTOCO to give
    • When to give VALTOCO
    • How to give VALTOCO
    • What to do after you give VALTOCO if the seizures do not stop or there is a change in breathing, behavior, or condition that worries you
  • You should carry VALTOCO with you in case you need to control your seizure clusters.
  • Family members, care providers, and other people who may have to give VALTOCO should know where you keep your VALTOCO and how to give VALTOCO before a seizure cluster happens.
  • VALTOCO is given in the nose (nasal) only.
  • VALTOCO comes ready to use.
  • Each VALTOCO only sprays 1 time and cannot be reused. Do not test or prime the nasal spray before use.
  • Each dose of VALTOCO is provided in an individual pack. Use all of the medicine in 1 pack for a complete dose.

What should I do after I give VALTOCO?

  • Stay with the person after you give VALTOCO and watch them closely.
  • Keep or move the person onto their side.
  • Make a note of the time VALTOCO was given.
  • Call for emergency help if any of the following happen:
    • Seizure behavior is different than other seizures the person has had.
    • You are alarmed by how often the seizures happen, by how severe the seizure is, by how long the seizure lasts, or by the color or breathing of the person.
  • Throw away (discard) the used VALTOCO.

If needed, a second dose may be given at least 4 hours after the first dose, using a new pack of VALTOCO. Do not give more than 2 doses of VALTOCO to treat a seizure cluster.

A second dose should not be given if there is concern about the person's breathing, they need help with their breathing, or have extreme drowsiness.

Do not use VALTOCO for more than 1 seizure cluster episode every 5 days. Do not use VALTOCO for more than 5 seizure cluster episodes in 1 month.

What should I avoid while using VALTOCO?

  • 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.

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.

 

 

References: 1. VALTOCO® (diazepam nasal spray) Prescribing Information. Neurelis, Inc. 2. Jafarpour S, Hirsch LJ, Gainza-Lein M, Kellinghaus C, Detyniecki K. Seizure cluster: definition, prevalence, consequences, and management. Seizure. 2019;68:9-15. 3. Tian N, Boring M, Kobau R, Zack MM, Croft JB. Active epilepsy and seizure control in adults—United States, 2013 and 2015. MMWR Morb Mortal Wkly Rep. 2018;67(15):437-442. 4. National Institute of Neurological Disorders and Stroke. The epilepsies and seizures: hope through research. NIH publication 15-156. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Epilepsies-and-Seizures-Hope-Through. Published April 2015. Updated August 8, 2018. Accessed January 24, 2019. 5. Manford M. Recent advances in epilepsy. J Neurol. 2017;264:1811-1824. 6. Epilepsy Foundation Greater Chicago. Status Epilepticus. https://www.epilepsychicago.org/epilepsy/seizure-types/status-epilepticus/. Accessed July 9, 2019. 7. Manno EM. Status epilepticus: current treatment strategies. Neurohospitalist. 2011;1(1):23-31. 8. Epilepsy Innovation Institute. Epilepsy Innovation Institute (Ei2): 2016 Community Survey [online] 2017;1–6. http://www.epilepsy.com/sites/core/files/atoms/files/community-survey-report-2016%20V2.pdf. Accessed July 3, 2019. 9. Schulze-Bonhage A, Kuhn A. Unpredictability of seizures and the burden of epilepsy. In: Schelter B, Timmer J, Schulze-Bonhage A, eds. Seizure Prediction in Epilepsy. Wiley-VCH Verlag GmbH & Co. KGaA; 2008. 10. Sander JW. Ultimate success in epilepsy—the patient’s perspective. Eur J Neurol. 2005;12(Suppl 4):3-11. 11. Bonnett LJ, Powell GA, Smith CT, Marson AG. Breakthrough seizures—further analysis of the standard versus new antiepileptic drugs (SANAD) study. PLoS One. 2017;12(12):e0190035. 12. Maglalang PD, Rautiola D, Siegel RA, et al. Rescue therapies for seizure emergencies: new modes of administration. Epilepsia. 2018;59(Suppl 2):207–215. 13. Agarwal SK, Kriel RK, Brundage RC, Ivaturi VD, Cloyd JC. A pilot study assessing the bioavailability and pharmacokinetics of diazepam after intranasal and intravenous administration in healthy volunteers. Epilepsy Res. 2013;105:362-367. 14. Parsonage MJ, Norris JW. Use of diazepam in treatment of severe status epilepticus. Br Med J. 1967;3:85-88. 15. Maggio ET. Intravail: highly effective intranasal delivery of peptide and protein drugs. Expert Opin Drug Deliv. 2006;3(4):529-539. 16. Data on file: VALTOCO Clinical Study Report DIAZ.001.05-CSR. Neurelis, Inc.

 

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING 

Important Safety Information you should know about VALTOCO® (diazepam nasal spray), CIV

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 depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.
  • VALTOCO can make you sleepy or dizzy and can slow your thinking and your motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how VALTOCO affects you.
  • 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 of these symptoms, especially if they are new, worse, or worry you:
    • Thoughts about suicide or dying
    • Feeling agitated or restless
    • Acting aggressive, being angry, or violent
    • Attempts to commit suicide
    • Panic attacks
    • Acting on dangerous impulses
    • Trouble sleeping (insomnia)
    • An extreme increase in activity and talking (mania)
    • New or worse anxiety
    • New or worse irritability
    • Other unusual changes in behavior or mood
    • New or worse depression

How can I watch for early symptoms of suicidal thoughts or actions?

  • Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Do not use VALTOCO if you:

  • Are allergic to diazepam.
  • Have an eye problem called acute narrow-angle glaucoma.

What should I tell my doctor before taking VALTOCO?

Before using VALTOCO, tell your healthcare provider about all of your medical conditions, including if you:

  • Have asthma, emphysema, bronchitis, chronic obstructive pulmonary disease, or other breathing problems.
  • Have a history of alcohol or drug abuse.
  • Have a history of depression, mood problems, or suicidal thoughts or behavior.
  • Have liver or kidney problems.
  • Are pregnant or plan to become pregnant. VALTOCO may harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. VALTOCO passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you use VALTOCO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use VALTOCO?

  • Read the Instructions for Use for detailed information about the right way to use VALTOCO.
  • Use VALTOCO exactly as prescribed by the healthcare provider.
  • Your healthcare provider will tell you:
    • What seizure clusters are
    • Exactly how much VALTOCO to give
    • When to give VALTOCO
    • How to give VALTOCO
    • What to do after you give VALTOCO if the seizures do not stop or there is a change in breathing, behavior, or condition that worries you
  • You should carry VALTOCO with you in case you need to control your seizure clusters.
  • Family members, care providers, and other people who may have to give VALTOCO should know where you keep your VALTOCO and how to give VALTOCO before a seizure cluster happens.
  • VALTOCO is given in the nose (nasal) only.
  • VALTOCO comes ready to use.
  • Each VALTOCO only sprays 1 time and cannot be reused. Do not test or prime the nasal spray before use.
  • Each dose of VALTOCO is provided in an individual pack. Use all of the medicine in 1 pack for a complete dose.

What should I do after I give VALTOCO?

  • Stay with the person after you give VALTOCO and watch them closely.
  • Keep or move the person onto their side.
  • Make a note of the time VALTOCO was given.
  • Call for emergency help if any of the following happen:
    • Seizure behavior is different than other seizures the person has had.
    • You are alarmed by how often the seizures happen, by how severe the seizure is, by how long the seizure lasts, or by the color or breathing of the person.
  • Throw away (discard) the used VALTOCO.

If needed, a second dose may be given at least 4 hours after the first dose, using a new pack of VALTOCO. Do not give more than 2 doses of VALTOCO to treat a seizure cluster.

A second dose should not be given if there is concern about the person's breathing, they need help with their breathing, or have extreme drowsiness.

Do not use VALTOCO for more than 1 seizure cluster episode every 5 days. Do not use VALTOCO for more than 5 seizure cluster episodes in 1 month.

What should I avoid while using VALTOCO?

  • 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.

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.