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Prescribing Information

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.

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 and 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.
  • VALTOCO is given in the nose (nasal) only.
  • 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.
  • Make a note of the time VALTOCO was given.
  • Call for emergency help if any of the following happen:
  • Seizure cluster behavior is different than other seizure clusters 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 are the most common side effects of VALTOCO?

The most common side effects of VALTOCO include:

  • Feeling sleepy or drowsy
  • Headache
  • Nose discomfort
  • Feeling sleepy or drowsy
  • Headache
  • Nose discomfort

These are not all of the possible side effects of VALTOCO. Call your healthcare provider if you experience any side effects following administration of VALTOCO. You may report side effects to Neurelis, Inc. at 1-866-696-3873 or to FDA at
1-800-FDA-1088.

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

This site is intended for US residents only.

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Whether you’re prescribed VALTOCO or a care partner of someone who is prescribed VALTOCO, myNEURELIS is here to help you every step of the way. Learn more about the benefits and support offerings.

1-866-myNEURELIS (1-866-696-3873)

Monday-Friday 8 AM to 8 PM ET

www.myNEURELIS.com

NEURELIS, VALTOCO, MYNEURELIS, PERSONALIZED SUPPORT FOR PATIENTS AND CARE PARTNERS, GIVE SEIZURES THE SPRAYER, and the NEURELIS, VALTOCO, and MYNEURELIS logos are trademarks or registered trademarks of Neurelis, Inc.

All other trademarks are the property of their respective owners.

© Neurelis, Inc. 2023. All rights reserved. US-PRC-24-00122-v2 12/2024

Indication and Important Safety Information

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.

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 and 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.
  • VALTOCO is given in the nose (nasal) only.
  • 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.
  • Make a note of the time VALTOCO was given.
  • Call for emergency help if any of the following happen:
    • Seizure cluster behavior is different than other seizure clusters 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 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 if you experience any side effects following administration of VALTOCO. You may report side effects to Neurelis, Inc. at 1-866-696-3873 or to FDA at 1-800-FDA-1088.

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

DeJah, an outgoing traveler and full-time employee who found confidence to venture out with VALTOCO

Where DeJah’s seizure story started

I’ve always been one for the spotlight. When I was a little girl, my family and friends would regularly fall victim to playing audience members for the shows I’d put on.”

“Now fast-forward to the tradition of documenting the end of childhood and the beginning of adulthood with high school senior pictures. The next thing I knew, I felt myself bobbing up and down as if I were on a raft in the middle of a lake. I opened my eyes and saw flashing red and white lights refracting through the rain pelting the windows of the ambulance. The paramedic reassured me that my family was following close behind us and that we were on our way to the nearest hospital.

“Before I was discharged from the hospital, a neurologist officially diagnosed me with a seizure disorder.”

What DeJah learned from her diagnosis

“One thing nobody tells you about epilepsy is the paranoia that comes with the diagnosis. I was hesitant to attend events or activities on campus, and as a result, I missed out on new and different opportunities as well as friendships. I had a Seizure Action Plan that I trained those around me to use when I had a seizure, but I still didn’t feel confident in my ability to control my seizures.”

Newfound confidence with VALTOCO

“My neurologist and I never considered an immediate-use seizure medication for me because my seizures have never lasted much longer than three minutes, but I still felt like there was more I could do. I decided I needed to advocate for myself.

“We talked about VALTOCO. We decided it was worth a shot, and we worked together to make it a part of my Seizure Action Plan. In my desk, I have a neon box I keep as an emergency kit for when I have a seizure. Inside, I keep VALTOCO and a list of emergency contacts. Everyone in my office knows where it is and how to use it as part of my Seizure Action Plan.

“It feels great to be able to go out with confidence and know there is something I can do if I feel an aura coming on or experience a seizure.

“For years, I let epilepsy rob me of the spotlight. But since I’ve always had a flair for the dramatic, I’ve taken it back. My hope for the future moving forward is that people never let anything, especially epilepsy, rain on their parade. So, I encourage you—be bold. Take the stage. Your audience awaits you.”

Amy, a caring pharmacy technician and camp counselor who carries VALTOCO to stop her episodes of frequent seizures

Amy’s Story
Danielle_Circle

Danielle’s Story
Amy, a caring pharmacy technician and camp counselor who carries VALTOCO to stop her episodes of frequent seizures*

Amy’s epilepsy diagnosis

I’m a pharmacy technician and volunteer with support groups and various camps for kids from all avenues of life. I always did my best to be there for them, but I never dreamed that one day, I’d be the one that needed help when I was diagnosed with epilepsy and episodes of frequent seizures.” 

“I was working as a social worker and youth specialist at a residential rehab for troubled teenagers. [After experiencing a head injury,] I began having strange feelings I couldn’t explain, kind of like feeling spaced out. These feelings became more intense and frequent over the next couple months. 

“I was taking a group of teens from the children’s home to see a movie. That weird feeling hit me in the theater, so I got up for a drink of water and the next thing I knew I was on the floor having my first grand mal seizure. I was rushed to the ER and given anti-seizure drugs, along with a litany of tests, including an EEG, EKG, and CT scans.

“When the test results came back, they suspected I’d had a grand mal seizure, and I was formally diagnosed with epilepsy. Those strange feelings I’d been having were called auras that, for many patients, precede the actual seizure.”

Making life adjustments

“Adjusting to life with epilepsy was tough. At the time, there weren’t any immediate-use seizure medications for episodes of frequent seizures available to help in an emergency that could be promptly administered by someone nearby.

“Because my seizures were unpredictable, I never returned to work at the children’s home because it would put them at risk. Life went on and I continued having seizures: on the bus, in the grocery store, at restaurants, or just walking down the street. The worst part was that I never knew when or where my seizures would occur, if they would be small or large, or even worse, become a cluster.

“It was hard not to feel that epilepsy was trying to limit my life.”

Discovering new life with VALTOCO

“Around this same time, though, I became aware of VALTOCO. I liked that it was an easy-to-use immediate-use seizure medication. It’s also less awkward or embarrassing because I don’t have to rely on someone else to administer it rectally. I liked that I could carry it around with me in my backpack or coat pocket, and that for most people, one dose usually works.

“So I did my research to learn more and asked my nurse practitioner and neurologist what they thought about it. They agreed it would be a good option for me.


“While most of my seizures are nocturnal, I’m very aware of the things that tend to trigger them, like allergies, stress, lack of sleep, low blood sugar, or just being worn down. My nurse practitioner told me when I have those signs, I can go ahead and self-administer VALTOCO. I love that I have an immediate-use seizure medication I can use quickly, and I don’t have to plan my day around administering it. Because of that, I don’t feel like I’m missing out on life as much as I used to.”

CT = computed tomography; EEG = electroencephalogram; EKG = electrocardiogram.

Danielle_Circle

Danielle’s Story
Dejah_Circle

Dejah’s Story
Danielle, an epilepsy advocate with a love for travel who keeps VALTOCO nearby for peace of mind

Growing up with epilepsy

I am a daughter, sister, and epilepsy advocate. I grew up with my loving parents and younger brother, which created a great childhood. A childhood that would take one heck of a detour the morning of my first day of third grade.”

“My parents knew something was very wrong when, on that morning, they were unable to wake me for school. They quickly gathered me and my brother and rushed to a local children’s hospital. After a ton of tests—MRIs, CT scans, blood work, EEGs, and various other prodding and probing—the neurologist diagnosed me with epilepsy.

“As I got older, the time it would take for me to recover from my seizures gradually got longer and longer, while the frequency lessened. I couldn’t just wake up a few hours after my seizures like I used to and be okay. Instead, it took two or three days to fully recover from each seizure. And that’s how things progressed into my teen years.”

The need for something more

“Through EEGs, MRIs, and about a dozen other tests, they were able to quickly determine that my seizures were coming from my frontal lobe. If uncontrolled, my seizures would affect those functions associated with the frontal lobe, such as reasoning, planning, and long-term memory.

“This scared the life out of me. I was on a daily seizure medication, sure, but I still struggled with seizure control. My mother had diazepam rectal gel to use as an immediate-use seizure medication in case of episodes of frequent seizures, but who wants their mom using that on them? It was not ideal. I yearned to be independent and manage things on my own.”

Updating her Seizure Action Plan with VALTOCO

“I remember when I was about 19 years old, I wanted to take a trip to South Africa by myself. I was tired of epilepsy controlling where I went and who I went with. Having a Seizure Action Plan has allowed me a little peace of mind and freedom to travel solo.

“But there was still one part I had to figure out—my immediate-use seizure medication. So a few years ago, I was talking with my epileptologist, who suggested VALTOCO. The same medication, but no more rectal administration? Yes, please.

“Now I have VALTOCO on hand with me everywhere I go. It gives me peace of mind because it’s less embarrassing to use and it’s easy to train others around me how to use it. I’m really pleased at how quickly VALTOCO works to stop my seizure clusters.*

“There is something empowering about finding an immediate-use seizure medication that works for you, and I think for me, this was a sign that something could be done about epilepsy, that we didn’t have to let it rule over our lives anymore.”

*Individual results may vary.

CT = computed tomography; EEG = electroencephalogram; MRI = magnetic resonance imaging.

Dejah_Circle

Dejah’s Story
Amy, a caring pharmacy technician and camp counselor who carries VALTOCO to stop her episodes of frequent seizures

Amy’s Story

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Maurene, a career mom with episodes of frequent seizures

I thought that I was being fearless by enduring the seizure, or focal seizure, without taking medication. . . . My doctor later told me that I was actually doing damage to myself.”

Maurene

A career mom with epilepsy