Prepare your patients with the proper dose

VALTOCO is designed for prompt administration by anyone who needs a dose of diazepam to treat episodes of frequent seizure activity.1

VALTOCO is designed for prompt administration by anyone who needs a dose of diazepam to treat episodes of frequent seizure activity.1

The right solution starts with the right dose

If a dose is too low, suboptimal seizure control may occur; if a dose is too high, patients may have a greater risk of adverse events.2

Therapeutic window

VALTOCO has individualized dosing1

VALTOCO dosing by age and weight provides the right dose for pediatric patients

Dose based on weight for patients 2-5 years (0.5 mg/kg)

Dose based on weight for patients 6-11 years (0.3 mg/kg)

5 mg

10 mg

15 mg

20 mg

2-5 years

(0.5 mg/kg)

6-11 kg

(13-24 lb)

12-22 kg

(25-49 lb)

23-33 kg

(50-73 lb)

6-11 years

(0.3 mg/kg)

10-18 kg

(22-40 lb)

19-37 kg

(41-81 lb)

38-55 kg

(82-121 lb)

56-74 kg

(122-163 lb)

VALTOCO dosing for older children and adult patients

Dose based on weight for patients 12+ years (0.2 mg/kg)

5 mg

10 mg

15 mg

20 mg

12+ years

(0.2 mg/kg)

14-27 kg

(30-60 lb)

28-50 kg

(61-111 lb)

51-75 kg

(112-166 lb)

76 kg and up

(167 lb and up)

Majority of adult doses are 15 mg and 20 mg

5 mg
2-5 years
(0.5 mg/kg)
6-11 years
(0.3 mg/kg)
6-11 kg
(13-24 lb)
10-18 kg
(22-40 lb)
5 mg
12+ years
(0.2 mg/kg)
12+ years
(0.2 mg/kg)
  • If needed, a second dose of VALTOCO may be given at least 4 hours after the initial dose
  • Patients should not use more than 2 doses of VALTOCO to treat a single episode
  • It is recommended that VALTOCO be used to treat no more than 1 episode every 5 days and no more than 5 episodes per month
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VALTOCO sprayer

VALTOCO is ready to use

Designed for prompt administration by anyone1

  • Can be administered in an actively seizing patient, regardless of their position3
  • Can be administered with the head in any position at any time during the seizure cluster cycle3
  • Anyone who may need to give VALTOCO should review the full Instructions for Use before use

VALTOCO is easy to administer3

hold

1. HOLD

VALTOCO administration visual

HOLD the nasal spray device with your thumb on the bottom of the plunger and your first and middle fingers on either side of the nozzle.

Do NOT press the plunger yet. If you press the plunger now, you will lose the medicine.

insert

2. INSERT

VALTOCO administration visual

INSERT the tip of the nozzle into 1 nostril until your fingers, on either side of the nozzle, are against the bottom of the nose.

The nasal spray device can be used with the person’s head in any position.

press

3. PRESS

VALTOCO administration visual

PRESS the bottom of the plunger firmly with your thumb to give VALTOCO.

The person does not need to breathe deeply when VALTOCO is given.

Throw away (discard) the nasal spray device and the blister pack after use.

1. HOLD

VALTOCO administration visual

HOLD the nasal spray device with your thumb on the bottom of the plunger and your first and middle fingers on either side of the nozzle.

Do NOT press the plunger yet. If you press the plunger now, you will lose the medicine.

2. INSERT

VALTOCO administration visual

INSERT the tip of the nozzle into 1 nostril until your fingers, on either side of the nozzle, are against the bottom of the nose.

The nasal spray device can be used with the person’s head in any position.

3. PRESS

VALTOCO administration visual

PRESS the bottom of the plunger firmly with your thumb to give VALTOCO.

The person does not need to breathe deeply when VALTOCO is given.

Throw away (discard) the nasal spray device and the blister pack after use.

If giving the 15 mg or 20 mg dose, repeat the steps using the second device in the other nostril to give the full dose of VALTOCO.

Remember: If needed, a second dose may be given at least 4 hours after the initial dose.1

Patients should not use more than 2 doses of VALTOCO to treat a single episode.1

These are not the full Instructions for Use. Please see the complete Instructions for Use.

100 %

of care partners said it was “extremely easy” or “very easy” to be trained to administer VALTOCO4

Instructions for Use videos

See Instructions for Use videos for the specific steps on how to administer VALTOCO for 5 mg, 10 mg, 15 mg, or 20 mg doses.

5 mg or 10 mg dose

15 mg or 20 mg dose

There are also full Instructions for Use for the 5 mg and 10 mg dose or 15 mg and 20 mg dose.

How to prescribe VALTOCO

When prescribing VALTOCO electronically, enter all the important information as shown below to save time for office staff, while ensuring the pharmacy provides exactly what you prescribed.

How to prescribe VALTOCO visual
How to prescribe VALTOCO visual

What patients can expect to receive in a box of VALTOCO

VALTOCO is available in 4 diazepam doses.

  • 1 box of VALTOCO = 5 doses
  • 1 blister pack = 1 complete dose and includes Instructions for Use
  • Ready to use; no assembly required
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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 2 years of age and older.

IMPORTANT SAFETY INFORMATION

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

  • 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 see full Prescribing Information, including Boxed Warning.

References

1. Valtoco. Prescribing Information. Neurelis Inc. https://www.valtoco.com/PI; 2. St. Louis EK. Minimizing AED adverse effects: improving quality of life in the interictal state in epilepsy care. Curr Neuropharmacol. 2009;7(2)106-114. doi:10.2174/157015909788848857; 3. Valtoco. Instructions for Use. Neurelis Inc. https://www.valtoco.com/sites/default/files/pdf/Instructions_For_Use.pdf; 4. Penovich P, Wheless JW, Hogan RE, et al. Examining the patient and caregiver experience with diazepam nasal spray for seizure clusters: results from an exit survey of a phase 3, open-label, repeat-dose safety study. Epilepsy Behav. 2021;121(pt A):108013. doi:10.1016/j.yebeh.2021.108013

1. Valtoco. Prescribing Information. Neurelis Inc; 2024; 2. Placeholder reference for the FDA approval letter; 3. Data on file. REF-01245. Neurelis Inc; 4. Data on file. REF-01288. Neurelis Inc; 5. Wheless JW, Miller I, Hogan RE, et al; DIAZ.001.05 Study Group. Final results from a Phase 3, long-term, open-label, repeat-dose safety study of diazepam nasal spray for seizure clusters in patients with epilepsy. Epilepsia. 2021;62(10):2485-2495. doi:10.1111/epi.17041; 6. Tarquinio D, Dlugos D, Wheless JW, et al. Safety of Valtoco® (diazepam nasal spray) in children and adolescents with epilepsy: final subgroup results from a phase 3, long-term, open-label, repeat-dose safety study. Poster presented at: Child Neurology Society 50th Annual Meeting; September 29 – October 2, 2021; Boston, MA; 7. Penovich P, Wheless JW, Hogan RE, et al. Examining the patient and caregiver experience with diazepam nasal spray for seizure clusters: results from an exit survey of a phase 3, open-label, repeat-dose safety study. Epilepsy Behav. 2021;121(pt A):108013. doi:10.1016/j.yebeh.2021.108013; 8. Misra SN, Sperling MR, Rao VR, et al. Significant improvements in SEIzure interVAL (time between seizure clusters) across time in patients treated with diazepam nasal spray as intermittent rescue therapy for seizure clusters. Epilepsia. 2022;63(10):2684-2693. doi:10.1111/epi.17385

MyNEURELIS® logo

If your patient was prescribed VALTOCO, myNEURELIS® is here to help them every step of the way. Learn more about the benefits and support offerings:

myNEURELIS.com

Monday through Friday, 8 AM to 8 PM ET

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

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This site is intended for US residents only.

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

Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly-owned subsidiary of Neurelis, Inc.

All other trademarks are the property of their respective owners.

© Neurelis, Inc. 2025. All rights reserved. US-PRC-23-00258-v5 06/2025

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS
  • 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.
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