VALTOCO Date Designated: 11/16/2015 Orphan Designation: Management of acute repetitive seizures Orphan Designation Status: Designated/Approved Sponsor: Neurelis Pharmaceuticals, Inc. 11682 El Camino Reall Suite 255 San Diego, California 92130 United States The sponsor address listed is the last reported by the sponsor to …Many across the world use debit cards to access their money for payments and withdrawals easily. These cards have been in existence since the 1970s. They eliminate the need to carr...Eligible patients may pay as little as $20 with the VALTOCO copay card. To find out more about the program and how to get a copay card, patients can call 1-866-629-6779. Subject to eligibility. For private insurance programs only. 9. How can I get more information about VALTOCO? To learn more about VALTOCO, or to request a visit from your localSAN DIEGO, CA – January 13, 2020 – Neurelis, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved VALTOCO® (diazepam nasal spray) as an 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 …The shelf life of a box of VALTOCO is 27 months. 9. Is there a copay savings program? Eligible commercial patients may pay as little as $20 with the VALTOCO copay card. It may even help lower their deductible. To find out more about the program and how to get a copay card, patients and care partners can call 1-866-629-6779. 10.Save with a VALTOCO copay card. Eligible patients may pay as little as $20 with the VALTOCO copay card. Find out more by calling 1-866-myNEURELIS (1-866-696-3873). 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. Download the Card. Simple Savings. Galderma CARE Connect has easy-to-understand pricing, with most products starting at $0 for many patients with commercial insurance coverage. Nationwide Access. Galderma CARE Connect is accepted at any participating pharmacies* in the U.S. that accepts manufacturer copay cards.Diazepam nasal spray (NRL‐1; VALTOCO) is a unique intranasal preparation of diazepam in that it is formulated with Intravail A3 (n‐dodecyl beta‐D‐maltoside [DDM]) and vitamin E to enhance solubility and absorption. Three concentrations of diazepam, 5, 7.5, and 10 mg in 0.1 mL solution, facilitate weight‐based …Patients prescribed VALTOCO may pay as little as $20 * with the VALTOCO Copay Card Get Your Copay Card. Talk to Your Healthcare Provider About VALTOCO.Jan 29, 2023 · Diazepam, the active ingredient of VALTOCO nasal spray, is a benzodiazepine anticonvulsant with the chemical name 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. The structural formula is as follows: The inactive ingredients in VALTOCO nasal spray include benzyl alcohol (10.5 mg per 0.1 mL), dehydrated alcohol, n-dodecyl beta ... VALTOCO is a prescription nasal spray rescue medication for seizure clusters. Learn how to get a VALTOCO Copay Card and pay as little as $20 for eligible patients.The U.S. Food and Drug Administration (FDA) has approved Valtoco ® (diazepam nasal spray). This is a new seizure medicine designed to treat periods of frequent seizures or cluster seizures that …The recommended dose of VALTOCO nasal spray is 0.2 mg/kg or 0.3 mg/kg, depending on the patient's age and weight. See Table 1 for specific recommendations. The following table provides the acceptable weight ranges for each dose and age category, such that patients will receive between 90% and 180% of the … The healthcare provider may prescribe another dose of VALTOCO to be given at least 4 hours after the first dose. If a second dose is needed, repeat Steps 1 through 4 with a new blister pack of VALTOCO. For more information about VALTOCO, visit www.valtoco.com or call 1-866-696-3873. Report side effects of prescription drugs to the FDA by 7 Apr 2020 ... Prior Authorization: Valtoco. Products Affected: Valtoco (diazepam) nasal spray. Medication Description: The exact mechanism of action for ...Valtoco is a prescription drug approved by the U.S. Food and Drug Administration (FDA) to treat acutely adults and children 6 years of age and older for intermittent, stereotypic episodes of frequent seizure activity that are different from a person’s usual seizure pattern. Valtoco is also referred to by its drug name, diazepam nasal spray.Valtoco (Diazepam Nasal Spray) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including ...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 ...of VALTOCO. For 15 mg or 20 mg, each blister pack contains 2 nasal spray devices. Both devices must be used for 1 dose. 7. Is there a copay savings program? Eligible patients may pay as little as $20 with the VALTOCO copay card. To find out more about the program and how to get a copay card, patients can call 1-866-629-6779. Subject to eligibility.1 interaction. Contraindicated. diazepam + bupropion. contraindicated if seizure disorder use; otherwise, consider lower bupropion doses: combo may alter seizure control (antagonistic effects, bupropion may decr. seizure threshold) dalfampridine. Valtoco (diazepam nasal) +. dalfampridine. 1 interaction. VALTOCO is a prescription medicine used for short-term treatment of seizure clusters (also known as "acute repetitive seizures") in people 6 years of age and older. VALTOCO is a federally controlled substance (C-IV) because it contains diazepam that can be abused or lead to dependence. VALTOCO is a nasal spray for acute seizures in epilepsy patients. Learn how to get a copay card for eligible patients with commercial insurance, or access other …Neurelis, Inc., a neuroscience-based company dedicated to enhancing therapeutic benefits and addressing significant unmet needs in managing central nervous system (CNS) disorders, announced that it has secured the issuance of United States Patent No. 11,241,414 (the ‘414 Patent) for VALTOCO (diazepam nasal spray) CIV for …of VALTOCO. For 15 mg or 20 mg, each blister pack contains 2 nasal spray devices. Both devices must be used for 1 dose. 7. Is there a copay savings program? Eligible patients may pay as little as $20 with the VALTOCO copay card. To find out more about the program and how to get a copay card, patients can call 1-866-629-6779. Subject to …VALTOCO is a prescription nasal spray rescue medication used for the short-term treatment of seizure clusters (also known as "episodes of frequent seizure activity" or "acute repetitive seizures") in adults and children 6 years of age and older. VALTOCO is not a replacement for daily anti-seizure medications. Discover VALTOCOIf you need financial support to pay for Valtoco, or if you need help understanding your insurance coverage, help is available. For example: A program called myNEURELIS is available for Valtoco ...While experienced borrowers may wonder how many credit cards to have, those who are newer to credit cards or prefer to focus on just one card might have other credit questions on t...VALTOCO is a federally controlled substance (C-IV) because it contains diazepam that 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 ...Valtoco only comes as a brand-name drug. It’s not currently available in a generic version. A generic contains an exact copy of the active drug in a brand-name medication but tends to cost less.At Novartis Pharmaceuticals Corporation, we know that access to your medication is important. That's why we created a prescription co-pay savings program that's simple to use and can help eligible patients with out-of-pocket costs. It's easy to find out if you're eligible and to activate your co-pay card. Select your medication below to get ...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 older. 2. Valtoco Dosage and Administration.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 older. 2. Valtoco Dosage and Administration.Show this card at a participating pharmacy to receive your discount. ID # MSC56049801. Group # 8602. RxBin 006053. RxPCN MSC. Customer Care. (800) 407-8156. Pharmacy Help Desk. (800) 404-1031.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.Show this card at a participating pharmacy to receive your discount. ID # MSC56049801. Group # 8602. RxBin 006053. RxPCN MSC. Customer Care. (800) 407-8156. Pharmacy Help Desk. (800) 404-1031.Are you interested in the art of card making but worried about the cost? Look no further. In this ultimate guide, we will explore the world of free card making and provide you with...You pay your copay of $0 for drugs on Tier 1 ... VALTOCO .............................. 66 ... assistance services, free of charge, are available to you. Call ... * I agree to the terms and conditions of the VALTOCO Copay Savings Program. * By completing this form and enrolling, you certify that you are 18+ years of age or a care partner or guardian of the hub seeking copay assistance and give permission to use and disclose your personal information to Neurelis, Inc., its affiliates and service providers ... 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 older. 2. Valtoco Dosage and Administration.Many across the world use debit cards to access their money for payments and withdrawals easily. These cards have been in existence since the 1970s. They eliminate the need to carr...In today’s competitive business landscape, it is essential to make a strong first impression. One of the most effective ways to do this is by having a professionally designed busin... Available in four different treatment doses 1. Specific, individualized dosing based on age and weight 1. 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 delivery 1,15-17. Do you want to make your own personalized Christmas cards this year, but don’t know where to start? Well, worry no more! This article will show you how to customize your cards in s...Compare prices and print coupons for Valtoco and other drugs at CVS, Walgreens, and other pharmacies. Prices start at $712.09. Drug savings; ... Currently, there is no generic for Valtoco. However, GoodRx coupons, manufacturer copay cards, and patient assistance programs can help offset your cost. How can I save on Valtoco? expand_more. GoodRx ...In this video, we will be demonstrating how-to administer a commonly prescribed Benzodiazepine called VALTOCO (Diazepam Intranasal) to help control break thr...• 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.NDA 211635 Valtoco (Diazepam nasal spray) CDER Clinical Review Template 9 Version date: September 6, 2017 for all NDAs and BLAs Valtoco (diazepam nasal spray) is therapeutically acceptable. The LD, Diazepam rectal gel, has been marketed in the United States for intermittent use to control bouts of increased seizureNeurelis Celebrates Success of Valtoco. By staff-author. March 15, 2022. 1097. Over the first week of March, San Diego-based Neurelis held its annual national sales meeting – its first in-person meeting since the outbreak of the pandemic. The event at the Estancia La Jolla Hotel & Spa also served as a de facto celebration of the launch of ...Each VALTOCO nasal spray device contains 10 mg diazepam in 0.1 mL solution. Use both nasal spray devices for a full 20 mg dose. The entire carton is to be dispensed as a unit. 1 / 2. 3.457” x 2.552” x 4.214” / 0.163 lb. Store at room temperature between 68°F and 77°F (20°C to 25°C). Do not freeze. Valtoco 20 Mg/2 Spray (10Mg/0.1Ml X2) Nasal Benzodiazepines-Non-Injectable Formulations (Oral Etc.) - Uses, Side Effects, and More Generic Name: diazepam. The safety of VALTOCO is also supported by double-blind, placebo-controlled trials with diazepam rectal gel, using the same age- and weight-based dosing. 3,4. The most frequent adverse reactions from the diazepam rectal gel studies ( >_ 4%) were somnolence, headache, and diarrhea. Adverse events were usually mild or moderate in intensity 3. VALTOCO is a prescription medicine used for short-term treatment of seizure clusters (also known as "acute repetitive seizures") in people 6 years of age and older. VALTOCO is a federally controlled substance (C-IV) because it contains diazepam that can be abused or lead to dependence. Valtoco is the brand name for diazepam, a medication taken as nasal spray to. control increased seizure activity in people with epilepsy. Caregivers give the. medication to the patient during repetitive seizures. It is important to give the. medication as directed by the healthcare provider who prescribed it.Neurelis' VALTOCO® (diazepam nasal spray) CIV, a nasal spray for seizure clusters, has transformed from the newest entrant to the clear leader among all approved seizure rescue medications, with ...Enroll in the VALTOCO Co-Pay Savings Program to get help with the cost of this prescription medicine for seizure clusters. Learn about the eligibility criteria, application …Learn how to give the 5 mg or 10 mg dose of VALTOCO nasal spray seizure rescue. Check the packaging to see which dose has been prescribed. Before using VALTO... Available in four different treatment doses 1. Specific, individualized dosing based on age and weight 1. 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 delivery 1,15-17. Serious side effects of Valtoco. Along with its needed effects, diazepam (the active ingredient contained in Valtoco) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur while taking ...Specify the dose. 5 mg, 10 mg, 15 mg, or 20 mg. Indicate the number of boxes. Each box contains 2 doses. Always write “boxes” when prescribing VALTOCOso your patients get the quantity you intend. 1 box is equivalent to 1 unit. Identify the number of refills Include where each box of VALTOCO prescribed will be needed.Diazepam nasal spray (NRL‐1; VALTOCO) is a unique intranasal preparation of diazepam in that it is formulated with Intravail A3 (n‐dodecyl beta‐D‐maltoside [DDM]) and vitamin E to enhance solubility and absorption. Three concentrations of diazepam, 5, 7.5, and 10 mg in 0.1 mL solution, facilitate weight‐based …Enroll today to get individualized support for VALTOCO, a prescription medicine for seizure clusters. VALTOCO is a benzodiazepine that can cause serious side effects and should …The healthcare provider may prescribe another dose of VALTOCO to be given at least 4 hours after the first dose. If a second dose is needed, repeat Steps 1 through 5 with a new blister pack of VALTOCO. For more information about VALTOCO, visit www.valtoco.com or call 1-866-696-3873. Report side effects of prescription drugs to the FDA byIn today’s competitive business landscape, it is essential to make a strong first impression. One of the most effective ways to do this is by having a professionally designed busin...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 older. 2. Valtoco Dosage and Administration. Valtoco is a prescription drug approved by the U.S. Food and Drug Administration (FDA) to treat acutely adults and children 6 years of age and older for intermittent, stereotypic episodes of frequent seizure activity that are different from a person’s usual seizure pattern. Valtoco is also referred to by its drug name, diazepam nasal spray. Valtoco 20 Mg/2 Spray (10Mg/0.1Ml X2) Nasal Benzodiazepines-Non-Injectable Formulations (Oral Etc.) - Uses, Side Effects, and More Generic Name: diazepam. Each VALTOCO nasal spray device contains 10 mg diazepam in 0.1 mL solution. Use both nasal spray devices for a full 20 mg dose. The entire carton is to be dispensed as a unit. 1 / 2. 3.457” x 2.552” x 4.214” / 0.163 lb. Store at room temperature between 68°F and 77°F (20°C to 25°C). Do not freeze. The healthcare provider may prescribe another dose of VALTOCO to be given at least 4 hours after the first dose. If a second dose is needed, repeat Steps 1 through 4 with a new blister pack of VALTOCO. For more information about VALTOCO, visit www.valtoco.com or call 1-866-696-3873. Report side effects of prescription drugs to the FDA by The healthcare provider may prescribe another dose of VALTOCO to be given at least 4 hours after the first dose. If a second dose is needed, repeat Steps 1 through 4 with a new blister pack of VALTOCO. For more information about VALTOCO, visit www.valtoco.com or call 1-866-696-3873. Report side effects of prescription drugs to the FDA by The healthcare provider may prescribe another dose of VALTOCO to be given at least 4 hours after the first dose. If a second dose is needed, repeat Steps 1 through 4 with a new blister pack of VALTOCO. For more information about VALTOCO, visit www.valtoco.com or call 1-866-696-3873. Report side effects of prescription drugs to the FDA byThe results of this study indicated that, when Valtoco is administered after a high fat meal, the maximum drug concentration (Cmax) was reduced by 48% compared to Valtoco administered to subjects in a fasted state. The study also showed that the time to maximum drug concentration (Tmax) of Valtoco doubled from 2 hours to 4 hours when ...5. How is VALTOCO dosed? VALTOCO has specific, individualized dosing based on age and weight.1 If needed, a second dose may be given at least 4 hours after the initial dose.1 Students should not use more than 2 doses of VALTOCO to treat a single episode. 6. Can my students carry VALTOCO with them? Yes, it is important for students to have …Company to provide an overview of studies and publications for VALTOCO® in treating episodes of frequent seizure activity (seizure clusters) SAN DIEGO, CA ̶ May 31, 2022— Neurelis, Inc., today announced it will provide highlights of its clinical development program for VALTOCO ® (diazepam nasal spray), an acute therapy for …If you need financial support to pay for Valtoco, or if you need help understanding your insurance coverage, help is available. For example: A program …SAN DIEGO, CA – January 13, 2020 – Neurelis, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved VALTOCO® (diazepam nasal spray) as an 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 …Both diazepam nasal spray (Valtoco) and midazolam nasal spray (Nayzilam) are FDA approved for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity. Nayzilam was approved by the FDA in 2019 while Valtoco received approval only a year later in 2020. Both drugs act on GABA receptors, increasing inhibitory effects ...Learn how to give the 15 mg or 20 mg dose of VALTOCO nasal spray seizure rescue. Check the packaging to see which dose has been prescribed. Before using VALT...Show this card at a participating pharmacy to receive your discount. ID # MSC56049801. Group # 8602. RxBin 006053. RxPCN MSC. Customer Care. (800) 407-8156. Pharmacy Help Desk. (800) 404-1031.Company to provide an overview of studies and publications for VALTOCO® in treating episodes of frequent seizure activity (seizure clusters) SAN DIEGO, CA ̶ May 31, 2022— Neurelis, Inc., today announced it will provide highlights of its clinical development program for VALTOCO ® (diazepam nasal spray), an acute therapy for …Valtoco only comes as a brand-name drug. It’s not currently available in a generic version. A generic contains an exact copy of the active drug in a brand-name medication but tends to cost less.Valtoco only comes as a brand-name drug. It’s not currently available in a generic version. A generic contains an exact copy of the active drug in a brand-name medication but tends to cost less.Sep 28, 2023 · The typical dosage for seizures is 0.2 mg Valtoco per kg (0.2 mg/kg) of body weight. The table below shows the manufacturer’s recommended dosages for Valtoco by body weight: If the seizure ... Valtoco 5 Mg Dose Kit is used for the management of anxiety disorders or for the shortterm relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Valtoco 5 Mg Dose Kit may be useful in the symptomatic relief of acute …
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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 6 years of age and older.Please refer to your supplemental new drug application (sNDA) dated and received October 23, 2020, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Valtoco (diazepam nasal spray). We also refer to our letter dated September 23, 2020, notifying you, under Section 505(o)(4) of the FDCA, of ...Sep 28, 2023 · The typical dosage for seizures is 0.2 mg Valtoco per kg (0.2 mg/kg) of body weight. The table below shows the manufacturer’s recommended dosages for Valtoco by body weight: If the seizure ... RN. VALTOCO nasal spray. Intranasal Diazepam is an emergency medication used to treat occasional increased seizures in people with epilepsy. Initial & Date. A. States purpose of procedure and location of student’s medication in the school. Medication dosage should be verified by delegated personnel, locked and secured at room temperature. VALTOCO is a prescription medicine used for short-term treatment of seizure clusters (also known as "acute repetitive seizures") in people 6 years of age and older. VALTOCO is a federally controlled substance (C-IV) because it contains diazepam that can be abused or lead to dependence. There is currently no generic alternative to Valtoco. It is covered by most Medicare and insurance plans, but some pharmacy coupons or cash prices may be lower. Get Valtoco for as low as $712.09, which is 13% off the average retail price of $819.37 for the most common version, by using a GoodRx coupon.While experienced borrowers may wonder how many credit cards to have, those who are newer to credit cards or prefer to focus on just one card might have other credit questions on t...51 to 75 kg (about 112.4 to 165.3 lb) 15 mg. two 7.5-mg nasal spray devices, one into each nostril. 76 kg and up (about 167.6 lb and up) 20 mg. two 10-mg nasal spray devices, one into each nostril ... Valtoco is a prescription drug approved by the U.S. Food and Drug Administration (FDA) to treat acutely adults and children 6 years of age and older for intermittent, stereotypic episodes of frequent seizure activity that are different from a person’s usual seizure pattern. Valtoco is also referred to by its drug name, diazepam nasal spray. 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.51 to 75 kg (about 112.4 to 165.3 lb) 15 mg. two 7.5-mg nasal spray devices, one into each nostril. 76 kg and up (about 167.6 lb and up) 20 mg. two 10-mg nasal spray devices, one into each nostril ...Members may have the option to sign up for automated mail-order delivery. Drug tier copay levels. This 2023 comprehensive formulary is a listing of brand-name ...Valtoco ® is a new FDA-approved nasal spray version of diazepam indicated for the treatment of acute, intermittent, and stereotypic episodes of frequent seizure activity in epilepsy patients six years of age and older. Although IV and rectal diazepam are already used to treat seizure clusters, Valtoco ® has less variability in ….