Oxtella XR

Seizure Control

Oxtellar XR is an antiepileptic drug (AED) used to manage partial-onset seizures. These seizures occur when there is a burst of abnormal electrical activity in one specific area of the brain. The medication is intended to help reduce the frequency of these episodes.

Approved Patient Groups

This medication is approved for use in the following populations:

• Adults: It can be used as a standalone treatment (monotherapy) or in combination with other seizure medications (adjunctive therapy).
• Children: It is used for children aged 6 years and older, either alone or with other medications, to control partial-onset seizures.

Oxtellar XR is an extended-release formulation, which means the active ingredient is released slowly into the bloodstream over time. This allows for once-daily dosing. It is not used for the immediate treatment of a seizure that is already happening.

Mechanism of Action

The exact way Oxtellar XR works to prevent seizures is not fully understood, but it is believed to target the electrical signaling system in the brain. It primarily works by blocking voltage-sensitive sodium channels on the surface of nerve cells.

By interacting with these channels, the medication helps to:

• Stabilize nerve cell membranes that have become overexcited.
• Inhibit the rapid, repetitive firing of electrical signals.
• Reduce the spread of abnormal electrical activity that causes seizures.

Research also suggests the medication may influence other electrical pathways, such as potassium and calcium channels, which further helps regulate nerve cell activity.

Extended-Release Delivery

Oxtellar XR uses a specialized delivery system to release the medication gradually. This extended-release formulation allows the active ingredient to enter the bloodstream slowly over a 24-hour period. This helps maintain a more consistent level of the drug in the body throughout the day compared to immediate-release versions of the medication.

Common Side Effects

The most frequently reported side effects of Oxtellar XR include:

• Dizziness or drowsiness
• Nausea and vomiting
• Double vision or vision changes
• Feeling tired or weak
• Problems with coordination or walking
• Tremors
• Headache
• Stomach pain

Serious Side Effects

Seek medical attention immediately if you experience any of the following serious symptoms:

• Low blood sodium (hyponatremia): Symptoms include nausea, lack of energy, confusion, muscle spasms, or an increase in the frequency of seizures.
• Severe skin reactions: Rashes that blister, peel, or cause sores in the mouth or around the eyes. These reactions can be life-threatening.
• Mental health changes: New or worsening depression, anxiety, or suicidal thoughts and behaviors.
• Liver problems: Yellowing of the skin or eyes (jaundice), dark urine, or pain in the upper right side of the stomach.
• Blood disorders: Unusual bruising or bleeding, fever, or a sore throat that does not go away.
• Allergic reactions: Swelling of the face, lips, tongue, or throat, or difficulty breathing.

Serious Skin Reactions

Oxtellar XR can cause rare but life-threatening skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These reactions can lead to permanent damage or death. Risk may be higher in patients of Asian ancestry who carry the HLA-B*1502 genetic allele.

Low Blood Sodium (Hyponatremia)

Significant decreases in serum sodium levels can occur during treatment. This is more common in patients also taking other medications that lower sodium, such as diuretics. Symptoms of low sodium include nausea, malaise, headache, confusion, and increased seizure frequency.

Suicidal Behavior and Ideation

Antiepileptic drugs, including Oxtellar XR, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Healthcare providers typically monitor for the emergence or worsening of depression, suicidal thoughts, or any unusual changes in mood or behavior.

Multi-organ Hypersensitivity

Serious and potentially fatal multi-organ hypersensitivity reactions, also known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. These reactions can affect the liver, kidneys, or blood cells. Symptoms often include fever and rash associated with other organ system involvement.

Withdrawal Seizures

Abruptly discontinuing Oxtellar XR may increase seizure frequency or lead to status epilepticus. If the medication needs to be stopped, it is generally done through a gradual dose reduction under medical supervision.

Cognitive and Motor Effects

Treatment may cause dizziness, somnolence, and difficulties with coordination or gait. These side effects can impair the ability to perform tasks requiring mental alertness, such as driving or operating machinery.

Blood Disorders

Rare cases of significant decreases in white blood cell counts (leukopenia), platelet counts (thrombocytopenia), or all blood cell types (pancytopenia) have been reported. Discontinuation of the drug may be necessary if these conditions develop.

Pregnancy

Oxtellar XR may cause fetal harm when taken during pregnancy. Research suggests an increased risk of birth defects, including cleft lip, cleft palate, and heart malformations. It is important to balance these risks against the risks of untreated seizures, which can also be harmful to both the pregnant person and the fetus.

Blood levels of oxcarbazepine may decrease during pregnancy, which could increase the frequency of seizures. Healthcare providers typically monitor drug levels closely and adjust dosages as needed. Patients who become pregnant are encouraged to join the North American Antiepileptic Drug (NAAED) Pregnancy Registry to help track the safety of the medication.

This medication can also interfere with hormonal contraceptives, such as birth control pills, injections, or implants, making them less effective. Discussion with a clinician regarding non-hormonal or supplemental birth control methods is recommended.

Breastfeeding

Oxcarbazepine and its active metabolites are known to pass into breast milk. The potential effects on a nursing infant are not fully understood. Healthcare providers generally recommend weighing the benefits of breastfeeding against the potential risks to the infant when deciding whether to continue the medication while nursing.

Dosage Forms

Oxtellar XR is available as a film-coated, extended-release tablet. This formulation is designed to release the active ingredient gradually after it is swallowed.

The tablets are produced in several different appearances, including variations in color and shape, to distinguish between the available options. These tablets are intended for oral use and must be swallowed whole to maintain the extended-release properties of the medication.

FDA Approval and Indications

Oxtellar XR was approved by the U.S. Food and Drug Administration (FDA) as an adjunctive (add-on) therapy for the treatment of partial-onset seizures. It is specifically indicated for use in adults and pediatric patients between the ages of 6 and 17 years. As an extended-release formulation, it is designed to be taken once daily.

Safety Warnings and Regulatory Notifications

The FDA requires several warnings in the labeling for Oxtellar XR to address potential serious risks associated with its active ingredient, oxcarbazepine:

• Serious Skin Reactions: The FDA warns of rare but life-threatening skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These are more common in patients with the HLA-B*1502 genetic allele, frequently found in people of Asian descent. Testing for this marker may be recommended before starting treatment.
• DRESS Syndrome: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported. This is a serious, potentially fatal reaction that can affect the liver, kidneys, or heart.
• Suicidal Thoughts and Behavior: Like other antiepileptic drugs, Oxtellar XR carries a general regulatory warning regarding an increased risk of suicidal thoughts or behavior. Patients should be monitored for new or worsening depression or unusual changes in mood.
• Hyponatremia: Significant decreases in blood sodium levels (hyponatremia) have been observed in patients taking this medication, which may require clinical monitoring.

Generic Availability

Generic versions of oxcarbazepine extended-release tablets are FDA-approved and available. These generic alternatives must meet the same rigorous standards for bioequivalence, safety, and quality as the brand-name medication.

Factors Influencing Price

The cost of Oxtellar XR can vary significantly based on several factors:

• Generic Availability: Generic versions of oxcarbazepine extended-release are available. Generic medications typically cost less than brand-name versions.
• Insurance Coverage: Your out-of-pocket expenses will depend on your insurance plan's formulary, deductible, and copayment or coinsurance levels.
• Pharmacy Choice: Prices may differ between retail pharmacies, and some mail-order pharmacies may offer lower costs for a 90-day supply.

Financial Assistance Programs

There are options that may help reduce the cost of this medication:

• Manufacturer Savings Cards: Eligible patients with commercial insurance may be able to use a savings card from the manufacturer to lower their copay.
• Patient Assistance Programs: Some organizations offer programs to help individuals who are uninsured or have limited income afford their prescriptions.

To find the most accurate price, it is best to contact your insurance provider or local pharmacy.