GET TO KNOW VALTOCO

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.1

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RELIABLE ON-HAND RESCUE TREATMENT FOR SEIZURE CLUSTERS1

VALTOCO is there for your patients when they need it most

diazepam icon
  • VALTOCO optimizes diazepam for nasal delivery using two key ingredients1,2:
    • Intravail®—Designed to facilitate drug delivery and absorption across the nasal mucosa by increasing permeability and loosening tight junctions between cells3,4
    • Vitamin E—Provides adequate drug concentration within a small liquid volume, while coating the nasal cavity5-7
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  • 91% of seizure episodes used a single dose within 12 hours10
VALTOCO sprayer icon

SEE HOW VALTOCO WORKS

Learn how VALTOCO's unique formulation optimizes diazepam for nasal delivery, and how it helps patients manage seizure clusters wherever, whenever.1,2

VALTOCO® mechanism of action
 

RELIABLE ABSORPTION WITH SUSTAINED PLASMA LEVELS THROUGHOUT THE DAY1,8,9

Pharmacokinetic (PK) studies were conducted in patients with epilepsy and healthy volunteers1

  • 97% absolute bioavailability relative to IV diazepam1,8,9
  • Plasma levels sustained for 24 hours1
  • Predictable PK with low interpatient and intrapatient variability1
    • Diazepam PK 2- to 4-fold less variable than diazepam rectal gel regardless of patient weight1,11

NASAL SPRAY ADMINISTRATION COUPLED WITH THE PROPRIETARY VALTOCO FORMULATION ACCOUNT FOR KEY PK DIFFERENCES VS IV DIAZEPAM1,8,9

Chart of PK differences

Seizure clusters occur over a 24-hour period.12

Data from an open-label, crossover study of the bioavailability and pharmacokinetics of diazepam after intranasal and intravenous administration to healthy volunteers (N=24) under fasted conditions (Study 01).

SPECIFIC, INDIVIDUALIZED DOSING1

VALTOCO is available in 4 treatment doses: 5 mg, 10 mg, 15 mg, 20 mg. A patient's dose is based on age and weight. It's important to note that1:

  • No more than 2 doses should be used to treat a seizure cluster1
  • A second dose may be given at least 4 hours after the initial dose, if required1
  • It is recommended that VALTOCO be used to treat no more than 1 episode every 5 days and no more than 5 episodes per month1

VALTOCO DOSING1

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

Each box of VALTOCO contains 2 blister packs1

1 blister pack = 1 complete dose with Instructions for Use1

SINGLE DOSE USED FOR VAST MAJORITY OF EPISODES10

Percentage of seizure episodes for which a single dose of VALTOCO was used over the course of 24 hours (N=3,914)10

Percentage of seizure episodes for which a single dose of VALTOCO was used

Data from a 12-month, open-label, repeat-dose safety study in epilepsy subjects (Study 05).

  • Ongoing open-label, repeat-dose safety study10
    • 177 patients with epilepsy, ages 6 to 65 years of age10
    • 3,914 seizure episodes were treated with VALTOCO10
    • Exploratory analysis. Study did not have prespecified efficacy endpoints10
  • 12-month treatment period for each patient13

WANT TO LEARN MORE ABOUT VALTOCO?

Get a free Office Starter Kit. All kits include a demo sprayer, further information about VALTOCO, such as a step-by-step guide, and other helpful tools to support you and your patients.

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RELIABLE SEIZURE CONTROL, WHEREVER, WHENEVER

VALTOCO is an on-hand rescue treatment ready to use when patients need it most1:

  • Small and portable packaging1
  • One-time use device: entire contents delivered when plunger is pressed1
  • Room temperature storage1
  • No active participation required from patient14

VALTOCO is designed for prompt administration by anyone1:

  • Can be administered in an actively seizing patient laying on either their side or back14
  • When giving VALTOCO, the person's head can be in any position at any time during the seizure cluster cycle14
  • Anyone who may need to give VALTOCO should review the full Instructions for Use before use

HOW TO ADMINISTER VALTOCO14

Remove VALTOCO from the blister pack

1. HOLD

VALTOCO® (diazepam nasal spray) instructions for use (step 1)

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

VALTOCO® (diazepam nasal spray) instructions for use (step 2)

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

VALTOCO® (diazepam nasal spray) instructions for use (step 3)

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.14

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

Please see full Instructions for Use for a complete guide to administering VALTOCO.

SIMPLY PRESCRIBE VALTOCO, AND MAXOR WILL TAKE IT FROM THERE

We've partnered with Maxor Specialty Pharmacy to make it easier on you and your patients in prescribing and receiving VALTOCO, which can be delivered straight to your patient's door with no extra cost to them.

Step 1

Once you have prescribed VALTOCO, submit the prescription to Maxor Specialty Pharmacy via fax (1-866-217-8034) or e-prescription

Step 2

A Maxor representative will reach out to you within 24 hours if any clarification or authorization is needed

Step 3

After that, Maxor will work with the insurer, you/your staff, and your patient so that their VALTOCO shipment will be ready to go

Step 4

Maxor will ship VALTOCO right to your patient's door. All they have to do is sign for it!

Through the VALTOCO copay card offering, eligible patients may pay as little as $20*

*No enrollment necessary.

For patients with commercial insurance who qualify.

WANT MORE INFORMATION ON PRESCRIBING VALTOCO?

Help ensure your patients receive the VALTOCO you've prescribed by having them follow these simple steps.

 

LOOKING FOR MORE HELPFUL TOOLS?

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IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING 

RISK FROM CONCOMITANT USE WITH OPIOIDS

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

  • Reserve concomitant prescribing of these drugs for use in 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

Contraindications: VALTOCO is contraindicated in patients with:

  • Known 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. Advise patients and caregivers to be alert for these behavioral changes and to immediately report them to a healthcare provider.

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

RISK FROM CONCOMITANT USE WITH OPIOIDS

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

  • Reserve concomitant prescribing of these drugs for use in 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

Contraindications: VALTOCO is contraindicated in patients with:

  • Known 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. Advise patients and caregivers to be alert for these behavioral changes and to immediately report them to a healthcare provider.

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. Data on file. REF-00253. Neurelis, Inc. 3. Maggio ET. Intravail: highly effective intranasal delivery of peptide and protein drugs. Expert Opin Drug Deliv. 2006;3(4):529-539. 4. Maggio ET, Pillion DJ. High efficiency intranasal drug delivery using Intravail® alkylsaccharide absorption enhancers. Drug Deliv Transl Res. 2013;3:16-25. 5. Yang C, Wu T, Qi Y, Zhang Z. Recent advances in the application of vitamin E TPGS for drug delivery. Theranostics. 2018;8(2):464-485. 6. Pieper-Fürst U, Dao V-A, Shah-Hosseini K, et al. Alpha-tocopherol acetate nasal spray in the treatment of pollen-induced allergic rhinitis. Allergo J Int. 2019;28(5):152-159. 7. Testa D, Marcuccio G, Panin G, et al. Nasal mucosa healing after endoscopic sinus surgery in chronic rhinosinusitis of elderly patients: role of topic alpha-tocopherol acetate. Aging Clin Exp Res. 2017; doi: 10.1007/s40520-016-0647-x. 8. Maglalang PD, Rautiola D, Siegel RA, et al. Rescue therapies for seizure emergencies: new modes of administration. Epilepsia. 2018;59(Suppl 2):207-215. 9. 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. 10. Data on file. REF-00643. Neurelis, Inc. 11. Tanimoto S, Koplowitz LP, Lowenthal RE, Koplowitz B, Rabinowicz AL, Carrazana E. Evaluation of pharmacokinetics and dose proportionality of diazepam after intranasal administration of NRL-1 to healthy volunteers. Clin Pharmacol Drug Dev. 2020; doi: 10.1002/cpdd.767. 12. Fisher RS, Bartfeld E, Cramer JA. Use of an online epilepsy diary to characterize repetitive seizures. Epilepsy Behav. 2015;47:66-71. 13. Data on file. REF-00208. Neurelis, Inc. 14. VALTOCO® (diazepam nasal spray) Instructions for Use. Neurelis, Inc.