Valtoco

Seizure Clusters

Valtoco is used to treat episodes of frequent seizure activity, often referred to as seizure clusters or acute repetitive seizures. These episodes are typically distinct from a person's usual seizure pattern and involve multiple seizures occurring over a short period of time.

Rescue Treatment

This medication is intended as a rescue treatment, meaning it is used only as needed rather than on a daily schedule. It is typically prescribed for patients who are already taking other daily medications to control their epilepsy but still experience occasional bouts of increased seizure activity.

Approved Age Groups

Valtoco is approved for use in the following populations:

• Adults
• Children 6 years of age and older

The medication is designed to be administered by a caregiver or the patient during or immediately after a seizure episode to help stop the cluster and prevent further seizures from occurring during that episode.

Mechanism of Action

Valtoco contains diazepam, a medication in the benzodiazepine family. It works by increasing the activity of gamma-aminobutyric acid (GABA), a chemical messenger in the brain that helps regulate nerve signals.

GABA is an inhibitory neurotransmitter, which means it acts as a natural brake for the central nervous system. During a seizure, nerve cells in the brain experience a sudden surge of excessive electrical activity. By making GABA more effective, Valtoco helps to:

• Slow down overactive nerve signals.
• Calm the electrical bursts that cause seizures.
• Prevent the spread of seizure activity throughout the brain.

The nasal spray format allows the medication to be absorbed through the thin lining of the nasal passages. This delivery method helps the drug reach the bloodstream and the brain quickly, which is necessary for treating acute seizure clusters that are different from a person's usual seizure pattern.

Common Side Effects

The most frequently reported side effects of Valtoco include:

• Drowsiness or sleepiness
• Headache
• Nasal discomfort or congestion
• Changes in taste
• Runny nose
• Throat irritation

Serious Side Effects

Contact a healthcare provider immediately or seek emergency care if any of these serious side effects occur:

• Slowed, shallow, or stopped breathing
• Extreme dizziness or fainting
• Severe confusion or hallucinations
• New or worsening mood changes, such as agitation, aggression, or suicidal thoughts
• Significant muscle weakness or loss of coordination
• Signs of a severe allergic reaction, including rash, itching, or swelling of the face, tongue, or throat

Valtoco may cause physical dependence. Stopping the medication suddenly after frequent use can lead to withdrawal symptoms such as tremors, sweating, or seizures.

Boxed Warnings

Valtoco has several boxed warnings, which are the most serious warnings from the FDA:

• Risks from use with opioids: Using diazepam with opioid medications can lead to severe drowsiness, breathing problems (respiratory depression), coma, and death.
• Abuse, misuse, and addiction: Diazepam is a controlled substance that carries a risk for abuse and addiction, which can lead to overdose or death.
• Physical dependence and withdrawal: Long-term use can lead to physical dependence. Stopping the medication suddenly can cause life-threatening withdrawal symptoms, such as seizures.

Central Nervous System Depression

This medication causes central nervous system (CNS) depression, which can impair physical and mental abilities. It is important to avoid driving, operating heavy machinery, or participating in dangerous activities until the effects of the medication have completely worn off.

Suicidal Thoughts and Behavior

Like other seizure medications, Valtoco may increase the risk of suicidal thoughts or actions. Caregivers should monitor for any sudden changes in mood, behaviors, thoughts, or feelings, such as new or worsening depression or anxiety.

Respiratory Depression

Valtoco can cause serious breathing problems, especially in people with pre-existing respiratory conditions. Monitoring for slow or shallow breathing is necessary after the medication is administered.

Glaucoma

This medication should not be used by individuals with acute narrow-angle glaucoma. It may be used in people with open-angle glaucoma if they are receiving appropriate treatment for that condition.

Pregnancy and Newborn Risks

Using diazepam during pregnancy may cause sedation or withdrawal symptoms in the newborn baby. Healthcare providers should be informed if a patient is pregnant or planning to become pregnant.

Pregnancy

Valtoco contains diazepam, which can cause harm to an unborn baby. Using this medication during pregnancy, especially during the first trimester, may increase the risk of birth defects. If used during the later stages of pregnancy, the infant may experience withdrawal symptoms or other complications after birth.

Newborns exposed to diazepam shortly before birth may show signs of:

• Respiratory depression (slowed breathing)
• Feeding difficulties
• Low muscle tone, often called floppy infant syndrome
• Excessive sedation or sleepiness

Breastfeeding

Diazepam passes into breast milk and can be transferred to a nursing infant. This may cause the baby to become unusually sleepy or have trouble feeding. Because of these potential side effects, breastfeeding is generally not recommended while using Valtoco. Patients should consult with their healthcare provider to discuss the best way to feed their baby while managing their condition.

Dosage Forms

Valtoco is available as a nasal spray. It is provided as a liquid solution for administration into the nose.

• Nasal Spray: A single-use, disposable device designed to deliver the medication.

The medication is supplied in blister packs containing the spray devices. Each device is intended to be used once and then thrown away.

FDA Approval and Indications

Valtoco (diazepam nasal spray) was approved by the FDA in January 2020. It is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity, such as seizure clusters or acute repetitive seizures, in patients with epilepsy. These episodes must be distinct from the patient's usual seizure pattern. It is approved for use in adults and pediatric patients 6 years of age and older.

Boxed Warning

The FDA requires a boxed warning for Valtoco and other benzodiazepines due to several serious safety risks:

• Risks from Concomitant Use with Opioids: Using benzodiazepines with opioid medications may result in profound sedation, respiratory depression (slowed breathing), coma, and death.
• Abuse, Misuse, and Addiction: The use of benzodiazepines exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death.
• Physical Dependence and Withdrawal Reactions: Continued use of benzodiazepines can lead to physical dependence. Stopping the medication suddenly or reducing the dose too quickly can cause life-threatening withdrawal reactions, including seizures.

Regulatory Classification

Valtoco is classified as a Schedule IV controlled substance because it has a potential for abuse and may lead to physical or psychological dependence. Healthcare providers are advised to monitor patients for signs of misuse or addiction during treatment.

Insurance and Pharmacy Factors

The amount you pay for Valtoco is primarily determined by your health insurance plan. Different insurance providers have varying copayments, deductibles, and coinsurance rates. Some plans may also require prior authorization, meaning your doctor must get approval from the insurance company before the medication is covered.

Prices can also vary between different pharmacies. It may be helpful to compare costs at local retail pharmacies or check if your insurance offers a lower-cost mail-order pharmacy option.

Brand-Name Status

Valtoco is a brand-name medication, and there is currently no generic version available. Brand-name drugs are typically more expensive than generic versions. The lack of a generic alternative means the price is set by the manufacturer without competition from other versions of the same drug.

Financial Assistance

The manufacturer of Valtoco may offer a savings card or patient assistance program to help reduce out-of-pocket costs for eligible patients. These programs are often available to individuals with commercial insurance or those who meet certain financial criteria. You can speak with your healthcare provider or pharmacist to find out if you qualify for these programs or other cost-saving options.