Reliable Seizure Control,
Wherever, Whenever1

See what specific, individualized dosing looks like for those who need VALTOCO® (diazepam nasal spray) to treat their episodes of frequent seizure activity.

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VALTOCO Is Ready to Use1

The on-hand rescue treatment is easy to use because of the following:

VALTOCO easy to carry icon

Easy to Carry1

  • It's small and portable1
  • Store at room temperature. Do not freeze. Protect from light1
VALTOCO delivery icon

One-Time Use Device

Entire contents delivered when plunger is pressed1

VALTOCO nose administration icon

Designed for Prompt Administration by Anyone1

  • Can be administered in an actively seizing patient laying on either their side or back2
  • Can be administered with the head in any position at any time during the seizure cluster cycle2
  • Anyone who may need to give VALTOCO should review the full Instructions for Use before use

How to Administer VALTOCO2

Remove VALTOCO from the blister pack

1. HOLD

how to administer VALTOCO, step 1: hold

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

DO NOT test or prime; each device sprays only one time.

2. INSERT

how to administer VALTOCO, step 2: insert

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

For nasal use only.

3. PRESS

how to administer VALTOCO, step 3: press

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

Throw away nasal spray device(s) after use.

If giving the 15 mg or 20 mg dose, repeat the steps and use 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 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.

Instructions for Use Videos

See the specific steps on how to administer VALTOCO for 5 mg or 10 mg dose and 15 mg or 20 mg dose.

5 mg or 10 mg Dose

VALTOCO® (diazepam nasal spray) instructions for use video (5 mg and 10 mg doses)
 

15 mg or 20 mg Dose

VALTOCO® (diazepam nasal spray) instructions for use video (15 mg and 20 mg doses)
 

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

Specific, Individualized Dosing

Available in 4 treatment doses:

5 mg

VALTOCO dose, 5mg

10 mg

VALTOCO dose, 10mg

15 mg

VALTOCO dose, 15mg

20 mg

VALTOCO dose, 20mg

1 blister pack = 1 complete dose

with Instructions for Use2

 

Each box of VALTOCO contains 2 blister packs

Individualized dosing based on age and weight1

6-11 years (0.3 mg/kg | 0.66 mg/lb)
Weight
(kg)
Weight
(lb)
Dose
(mg)
Given as
10-18 22.0-39.7 5 One 5 mg nasal spray device in one nostril
19-37 41.9-81.6 10 One 10 mg nasal spray device in one nostril
38-55 83.8-121.3 15 Two 7.5 mg nasal spray devices, one in each nostril
56-74 123.5-163.1 20 Two 10 mg nasal spray devices, one in each nostril
12+ years (0.2 mg/kg | 0.44 mg/lb)
Weight
(kg)
Weight
(lb)
Dose
(mg)
Given as
14-27 30.9-59.5 5 One 5 mg nasal spray device in one nostril
28-50 61.7-110.2 10 One 10 mg nasal spray device in one nostril
51-75 112.4-165.3 15 Two 7.5 mg nasal spray devices, one in each nostril
76 and up 167.6 and up 20 Two 10 mg nasal spray devices, one in each nostril

Dosing Card

See easy-to-follow dosing information based on the age and weight of the patient.

Get the Card

more information on seizure treatment

Equip yourself, your staff, your patients, and their care partners with resources on how to get started on VALTOCO.

Here's What You Need

IMPORTANT SAFETY INFORMATION,
INCLUDING BOXED WARNING

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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 only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma.

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.

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.

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 only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma.

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.

References: 1. VALTOCO® (diazepam nasal spray) Prescribing Information. Neurelis, Inc. 2. VALTOCO® (diazepam nasal spray) Instructions for Use. Neurelis, Inc.