Xcopri

Indications for Use

Xcopri is an antiepileptic drug specifically approved to treat partial-onset seizures in adults. These types of seizures, also called focal seizures, start in one specific part of the brain rather than affecting the entire brain at once.

How It Is Prescribed

This medication is used for patients 18 years of age and older. Depending on the patient's needs, a healthcare provider may prescribe Xcopri as:

• Monotherapy: The only medication taken to manage seizure activity.
• Adjunctive therapy: An additional treatment taken alongside other seizure medications when those drugs alone do not provide enough control.

The primary goal of using Xcopri is to reduce the frequency of seizures. In some cases, it may help patients achieve a seizure-free state.

Mechanism of Action

While the exact way Xcopri works is not fully understood, researchers believe it helps control seizures by affecting how nerve cells in the brain communicate. It appears to work through two primary methods to prevent the brain from becoming overexcited.

Enhancing Inhibitory Signals

The medication is thought to increase the activity of gamma-aminobutyric acid (GABA). GABA is a chemical messenger in the brain that acts as a natural calming agent. By boosting the effects of GABA, Xcopri helps strengthen the brain's ability to suppress excessive electrical activity.

Blocking Excitatory Signals

Xcopri also targets specific sodium channels on the surface of nerve cells. These channels act like gates that allow electrical impulses to travel through the nervous system. By blocking these channels, the drug helps prevent the rapid, repetitive electrical firing that typically leads to a seizure.

Stabilizing Brain Activity

By addressing both the inhibitory and excitatory pathways in the brain, Xcopri helps maintain a more stable electrical balance. This dual action makes it harder for a seizure to start and helps prevent electrical disturbances from spreading to other parts of the brain.

Common Side Effects

Many people taking Xcopri experience mild side effects as their bodies adjust to the medication. These may include:

• Drowsiness, sleepiness, or extreme tiredness
• Dizziness
• Double vision or blurred vision
• Headache
• Nausea, constipation, or diarrhea
• Dry mouth

Serious Side Effects

Some side effects can be severe and require immediate medical attention. Contact a healthcare provider right away if you experience any of the following:

• Mood or behavior changes: New or worsening depression, anxiety, panic attacks, irritability, or thoughts of self-harm.
• Severe allergic reactions: A serious condition called DRESS can occur, causing fever, rash, swollen lymph nodes, or inflammation of organs like the liver or kidneys.
• Heart rhythm changes: Xcopri can shorten the QT interval, which may cause the heart to beat irregularly.
• Neurological issues: Significant problems with balance, walking, coordination, or slurred speech.
• Liver problems: Symptoms such as yellowing of the skin or eyes (jaundice), dark urine, or pain in the upper right side of the stomach.

Do not stop taking Xcopri suddenly, as this can cause more frequent or severe seizures. Always consult a healthcare professional before making changes to your medication schedule.

Suicidal Thoughts and Behaviors

Antiepileptic medications, including Xcopri, may increase the risk of suicidal thoughts or actions in a small number of people. It is important to monitor for any new or worsening depression, anxiety, or unusual changes in mood or behavior.

Serious Allergic Reactions

Xcopri can cause a rare but serious condition called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), which can be life-threatening. This reaction may involve a skin rash, fever, and damage to internal organs like the liver or kidneys.

Heart Rhythm Changes

This medication can cause a shortening of the QT interval, which affects the heart's electrical activity. Xcopri should not be used by individuals with a genetic condition called Familial Short QT syndrome. Caution is advised when taking other medications that also shorten the QT interval.

Neurological Effects

Xcopri commonly causes central nervous system depression, leading to symptoms such as:

• Extreme sleepiness or fatigue
• Dizziness
• Difficulty with coordination or balance
• Trouble walking

These effects may impair the ability to drive or operate machinery, especially when starting the medication or increasing the dose.

Withdrawal Seizures

Discontinuing Xcopri suddenly can cause an increase in seizure frequency or status epilepticus, a life-threatening condition of continuous seizures. Any changes to the dosage should be managed gradually by a healthcare professional.

Pregnancy

There is currently not enough research to determine if Xcopri is safe for use during human pregnancy. Animal studies have shown that the drug may cause harm to a developing fetus. Because of these potential risks, it is important to discuss the benefits and risks of treatment with a healthcare provider.

Stopping seizure medication suddenly during pregnancy can lead to breakthrough seizures, which may be dangerous for both the parent and the baby. If you become pregnant while taking Xcopri, do not stop the medication unless directed by a doctor.

Patients are often encouraged to join the North American Antiepileptic Drug (NAAED) Pregnancy Registry to help track the safety of the medication during pregnancy.

Contraception

Xcopri can reduce the effectiveness of hormonal birth control methods, including pills, patches, rings, and implants. Individuals who can become pregnant should talk to their doctor about using effective non-hormonal backup contraception while taking this medication.

Breastfeeding

It is unknown whether Xcopri passes into breast milk or how it might affect a breastfeeding infant. Decisions regarding breastfeeding while taking this medication should be made in consultation with a healthcare provider, weighing the benefits of breastfeeding against the potential risks to the infant.

Dosage Forms

Xcopri is available as a tablet for oral administration. The tablets are typically swallowed whole with water.

Packaging Options

This medication is provided in several types of packaging to support different stages of treatment:

• Titration Packs: These packs are used when first starting the medication or when increasing the dose. They contain a specific sequence of tablets to help the body adjust to the medicine.
• Maintenance Packs: These are used once a stable daily dose has been established.
• Individual Bottles: Tablets may also be dispensed in standard prescription bottles.

FDA Approval and Indication

Xcopri was approved by the U.S. Food and Drug Administration (FDA) in November 2019. It is indicated for the treatment of partial-onset seizures in adult patients.

Controlled Substance Status

The FDA and the Drug Enforcement Administration (DEA) have classified Xcopri as a Schedule V controlled substance. This classification is based on the potential for the medication to be habit-forming or lead to physical or psychological dependence. Patients are advised to follow their healthcare provider's instructions for use and disposal to prevent misuse.

Safety and Regulatory Warnings

The FDA-approved labeling for Xcopri includes warnings regarding several serious risks:

• DRESS Syndrome: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is a serious, life-threatening reaction that can affect the skin and internal organs. To reduce this risk, the medication must be started at a low dose and increased slowly.
• QT Shortening: Xcopri can cause a change in the electrical activity of the heart known as QT shortening. It should be used with caution in patients with a history of heart rhythm problems.
• Suicidal Thoughts: Like other antiepileptic drugs, Xcopri may increase the risk of suicidal thoughts or behavior. Regulatory guidance suggests monitoring patients for changes in mood or behavior.

Factors Affecting Cost

The price of Xcopri can vary significantly based on individual circumstances. Because it is a brand-name drug without a generic alternative, the cost is generally higher than older epilepsy medications. Factors that influence the price include:

• Insurance Coverage: Your out-of-pocket cost will depend on whether your insurance plan includes Xcopri on its formulary and which tier it is assigned to.
• Dosage and Quantity: Xcopri is available in several strengths and titration packs, which may affect the total price.
• Pharmacy Choice: Prices can differ between retail pharmacies and mail-order services.

Financial Assistance

The manufacturer of Xcopri offers programs to help eligible patients manage the cost of the medication:

• Savings Card: Patients with commercial insurance may be eligible for a savings card to reduce their co-pay.
• Patient Assistance Program: For individuals without insurance or those who meet certain financial criteria, the manufacturer may provide the medication at no cost or a reduced rate through a dedicated assistance program.

Patients are encouraged to speak with their healthcare provider or pharmacist to explore these options and confirm their specific costs.