Valtoco diazepam 10 mg/.1mL Spray — NDC 72252-510-05 (Billing 72252-0510-05)

1 INDICATIONS AND USAGE 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 2 years of age and older. VALTOCO is a benzodiazepine 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 2 years of age and older.

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2 DOSAGE AND ADMINISTRATION Administer VALTOCO by the nasal route only. ( 2.3 ) Dosage is dependent on the patient's age and weight. ( 2.2 ) Initial Dose: VALTOCO 5 mg and 10 mg doses are administered as a single spray intranasally into one nostril.

Administration of 15 mg and 20 mg doses requires two nasal spray devices, one spray into each nostril. ( 2.2 ) Second Dose: A second dose, when required, may be administered at least 4 hours after the initial dose. If administered, use a new blister pack.

( 2.2 ) Maximum Dosage and Treatment Frequency: Do not use more than 2 doses to treat a single episode. It is recommended that VALTOCO be used to treat no more than one episode every five days and no more than five episodes per month. ( 2.2 )

2.1Instructions Prior to Dosing Prior to treatment, healthcare professionals should instruct the individual administering VALTOCO on how to identify seizure clusters and use the product appropriately [see Dosage and Administration (2.3) and Patient Counseling Information (17) ].

2.2Dosing Information The recommended dose of VALTOCO nasal spray is 0.2 mg/kg to 0.5 mg/kg, depending on the patient's age and weight. See Table 1 and Table 2 for specific recommendations. Table 1: Recommended Dose Based on Age Age (Years) Recommended Dose 2 through 5 0.5 mg/kg 6 through 11 0.3 mg/kg 12 and older 0.2 mg/kg Table 2: Recommended Dosage and Administration for Adults and Pediatric Patients 2 Years of Age and Older Dose Based on Age and Weight Administration 2 to 5 Years of Age (0.5 mg/kg) 6 to 11 Years of Age (0.3 mg/kg) 12 Years of Age and Older (0.2 mg/kg) Dose (mg) Number of Nasal Spray Devices Number of Sprays Weight (kg) 6 to 11 10 to 18 14 to 27 5 One 5 mg device One spray in one nostril 12 to 22 19 to 37 28 to 50 10 One 10 mg device One spray in one nostril 23 to 33 38 to 55 51 to 75 15 Two 7.5 mg devices One spray in each nostril 56 to 74 76 and up 20 Two 10 mg devices One spray in each nostril Second Dose (if needed): A second dose, when required, may be administered after at least 4 hours after the initial dose.

If the second dose is to be administered, use a new blister pack of VALTOCO. Maximum Dosage and Treatment Frequency : Do not use more than 2 doses of VALTOCO to treat a single episode. Do not use VALTOCO to treat more than one episode every five days or more than five episodes per month.

2.3Important Administration Instructions VALTOCO is for intranasal use only. No device assembly is required. VALTOCO nasal spray delivers its entire contents upon activation. Do not prime or attempt to use for more than one administration per device. Patients and caregivers should be counseled to read carefully the "Instructions for Use" for complete directions on how to properly administer VALTOCO.

3 DOSAGE FORMS AND STRENGTHS VALTOCO is available in 5 mg, 7.5 mg, and 10 mg strengths. Each VALTOCO nasal spray device contains 0.1 mL solution. Nasal spray: 5 mg, 7.5 mg, or 10 mg of diazepam in 0.1 mL. ( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) . Concomitant use with Opioids Concomitant use of benzodiazepines, including VALTOCO, and opioids may result in profound sedation, respiratory depression, coma, and death. Do not use such drugs concomitantly unless supervised by a health care provider [see Warnings and Precautions (5.1) ] .

Abuse, Misuse, and Addiction Inform patients that the use of VALTOCO more frequently than recommended, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug [see Warnings and Precautions (5.2) and Drug Abuse and Dependence (9.2) ].

Withdrawal Reactions Inform patients that use of VALTOCO more frequently than recommended may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months [see Warnings and Precautions (5.3) and Drug Abuse and Dependence (9.3) ].

Important Treatment Instructions Instruct patients and caregivers on what is and is not an intermittent and stereotypic episode of increased seizure activity (i.e., seizure cluster) that is appropriate for treatment, and the timing of administration in relation to the onset of the episode. Instruct patients and caregivers on what to observe following administration, and what would constitute an outcome requiring immediate medical attention. Instruct patients and caregivers not to administer a second dose of VALTOCO if they are concerned by the patient's breathing, the patient requires emergency rescue treatment with assisted breathing or intubation, or there is excessive sedation [see Use in Specific Populations (8.6) ].

Advise patients and caregivers on how frequently they can treat successive seizure cluster episodes over time. Pregnancy Advise pregnant females that the 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 newborns [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1) ] . Instruct patients to inform their healthcare provider if they are pregnant.

Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant while taking VALTOCO. The registry is collecting information about the safety of antiepileptic drugs during pregnancy [see Use in Specific Populations (8.1) ] . Lactation Counsel patients that diazepam, the active ingredient in VALTOCO, is excreted in breast milk.

Instruct patients to inform their healthcare provider if they are breastfeeding or intend to breastfeed. Instruct breastfeeding patients who take VALTOCO to monitor their infants for excessive sedation, poor feeding and poor weight gain, and to seek medical attention if they notice these signs [see Use in Specific Populations (8.2) ].

MEDICATION GUIDE VALTOCO ® (val-toe-koe) (diazepam nasal spray), CIV This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 04/2025 US-PRC-25-00100-v1 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 medical 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) Do not drive or operate heavy machinery until you know how taking VALTOCO with opioids affects you.

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 including coma and death 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. You can develop an addiction even if you use VALTOCO as prescribed by your healthcare provider.

Use VALTOCO exactly as your healthcare provider prescribed. Do not share your VALTOCO with other people. Keep VALTOCO in a safe place and away from children.

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.

Do not suddenly stop using VALTOCO without talking to your healthcare provider. Stopping VALTOCO suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.

Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months , including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears. Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.

Do not use more VALTOCO than prescribed or use VALTOCO more often than prescribed. 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 other drugs that may make you sleepy or dizzy while using VALTOCO without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, VALTOCO may make your sleepiness or dizziness worse. Like other antiepileptic medicines, VALTOCO may cause suicidal thoughts or actions in a small number of people, about 1 in 500.

Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you : thoughts about suicide or dying feeling agitated or restless acting aggressive, being angry, or violent attempts to commit suicide panic attacks acting on dange… [Excerpted — this section continues on DailyMed.]

INSTRUCTIONS FOR USE For 5 mg and 10 mg Doses VALTOCO ® (diazepam nasal spray) CIV You, your family members, caregivers, and others who may need to give VALTOCO should read these Instructions for Use before using it. Talk to your healthcare provider if you, your caregiver, or others who may need to give VALTOCO have any questions about the use of VALTOCO. Important: For Nasal Use Only.

Do not test or prime the nasal spray device. Each device sprays one time only. Do not use past the expiration date printed on box and blister pack.

Do not open blister pack until ready to use. Each blister pack contains 1 nasal spray device. 1 dose = 1 nasal spray device.

To give VALTOCO nasal spray: Step 1: Open the blister pack by peeling back the corner tab with the arrow. Remove the nasal spray device from the blister pack. Step 2: 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. Step 3: 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.

Step 4: 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. Remove the nasal spray device from the nose after giving VALTOCO.

After giving VALTOCO nasal spray: Throw away (discard) the nasal spray device and the blister pack after use. Call for emergency help if any of the following happen: Seizure behavior in the person is different from that of other episodes. 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.

Make a note of the time VALTOCO was given and continue to watch the person closely. Time of first VALTOCO dose:______________ Time of second VALTOCO dose (if given): ______________________ 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 visiting www.fda.gov/medwatch or by calling 1-800-FDA-1088. These Instructions for Use have been approved by the U.S.

Food and Drug Administration. Issued: 02/2022 © Neurelis, Inc. 2022.

NEURELIS, VALTOCO, and the NEURELIS and VALTOCO logos are trademarks or registered trademarks of Neurelis, Inc. US-PRC-22-00029 02/2022 Image Step 1 Step 2 Step 3 Step 4

INSTRUCTIONS FOR USE For 15 mg and 20 mg Doses VALTOCO ® (diazepam nasal spray) CIV You, your family members, caregivers, and others who may need to give VALTOCO should read these Instructions for Use before using it. Talk to your healthcare provider if you, your caregiver, or others who may need to give VALTOCO have any questions about the use of VALTOCO. Important: For Nasal Use Only.

Do not test or prime the nasal spray devices. Each device sprays one time only. Do not use past the expiration date printed on box and blister pack.

Do not open blister pack until ready to use. Each blister pack contains 2 nasal spray devices. 1 dose = 2 nasal spray devices.

To give VALTOCO nasal spray: Step 1: Open the blister pack by peeling back the corner tab with the arrow. Remove the first nasal spray device from the blister pack. Step 2: 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. Step 3: 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.

Step 4: Press the bottom of the plunger firmly with your thumb to give VALTOCO. The person does not need to brea… [Excerpted — this section continues on DailyMed.]