Lacosamide UCB: Uses, Dosage & Side Effects

What Is Lacosamide UCB and What Is It Used For?

Lacosamide UCB is a prescription antiepileptic medicine used to treat partial-onset seizures (focal seizures) with or without secondary generalization in patients with epilepsy. It can be used as monotherapy in patients aged 16 years and older, or as adjunctive therapy in patients from 2 years of age.

Lacosamide belongs to a class of medicines known as antiepileptics or anticonvulsants. The active substance, lacosamide, is a functionalized amino acid that was developed by UCB Pharma specifically for the treatment of epilepsy. Unlike many older antiepileptic drugs that were discovered serendipitously, lacosamide was designed through rational drug design to target a specific aspect of neuronal sodium channel function.

Epilepsy is one of the most common neurological disorders worldwide, affecting approximately 50 million people globally according to the World Health Organization (WHO). Partial-onset seizures, also called focal seizures, are the most common seizure type in adults, originating from a specific area of the brain. These seizures may remain localized (simple or complex partial seizures) or spread to involve the entire brain (secondary generalization), leading to convulsions. Effective control of focal seizures is essential to prevent physical injury, cognitive decline, and impairment of quality of life.

Lacosamide UCB contains 50 mg of lacosamide per film-coated tablet. This is the lowest available strength and is typically used during the initial titration phase of treatment or for patients requiring a low maintenance dose. The tablet formulation is designed for oral administration and can be taken with or without food, providing flexibility for patients in their daily routines.

How does lacosamide work in the brain?

Lacosamide has a unique mechanism of action that distinguishes it from other antiepileptic drugs. While traditional sodium channel blockers such as carbamazepine, phenytoin, and lamotrigine primarily affect the fast inactivation of voltage-gated sodium channels, lacosamide selectively enhances slow inactivation of these channels. This is a fundamentally different pharmacological approach.

Voltage-gated sodium channels are essential for the generation and propagation of electrical signals in the brain. During a seizure, neurons fire rapidly and repetitively in an abnormal pattern. By enhancing slow inactivation, lacosamide preferentially reduces the ability of hyperexcitable neurons to fire repetitively without significantly affecting the normal signaling of healthy neurons. This selectivity contributes to the favorable side effect profile of lacosamide compared to some older antiepileptic drugs.

Additionally, lacosamide has been shown to bind to collapsin response mediator protein-2 (CRMP-2), a protein involved in neuronal differentiation and axonal growth. While the clinical significance of this interaction is not fully established, preclinical research suggests it may contribute to neuroprotective effects. The dual mechanism offers a theoretical advantage in the management of epilepsy, particularly in patients who have not responded adequately to conventional sodium channel blockers.

Approved indications

Lacosamide UCB is approved for the following indications by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA):

• Monotherapy: Treatment of partial-onset seizures with or without secondary generalization in adults and adolescents aged 16 years and older with newly diagnosed epilepsy
• Adjunctive therapy: Treatment of partial-onset seizures with or without secondary generalization in adults, adolescents, and children from 2 years of age with epilepsy

It is important to note that lacosamide is not indicated for the treatment of generalized-onset seizures (such as absence seizures or primary generalized tonic-clonic seizures) or for non-epileptic conditions, although off-label use in neuropathic pain has been studied in clinical trials.

What Should You Know Before Taking Lacosamide UCB?

Before starting Lacosamide UCB, inform your doctor about any heart conditions, liver or kidney problems, history of depression or suicidal thoughts, and all other medications you take. An ECG may be recommended before treatment. Women of childbearing potential should discuss contraception and pregnancy planning.

Contraindications

You should not take Lacosamide UCB if you have any of the following conditions:

• Hypersensitivity: Known allergy to lacosamide or any of the excipients (inactive ingredients) in the tablet
• Known second-degree or third-degree atrioventricular (AV) block: Lacosamide can prolong the PR interval and must not be used in patients with high-grade cardiac conduction disorders

If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before starting treatment. A thorough medical history and, in many cases, a baseline electrocardiogram (ECG) should be obtained before initiating lacosamide therapy.

Warnings and Precautions

Several important warnings apply to the use of lacosamide. Your prescribing physician should be aware of your complete medical history to ensure safe use of this medication.

Cardiac conduction effects: Lacosamide causes a dose-dependent prolongation of the PR interval on the electrocardiogram (ECG). This means it can slow the electrical conduction between the atria and ventricles of the heart. In clinical trials, first-degree AV block was observed in approximately 0.4% of patients on lacosamide versus 0% on placebo. Patients with underlying cardiac conduction problems, those taking other PR interval-prolonging medications (such as certain antiarrhythmic drugs, beta-blockers, or calcium channel blockers), and patients with severe cardiac disease (such as a history of myocardial infarction or heart failure) should be monitored closely. An ECG is recommended before starting treatment and after reaching steady-state dose.

Suicidal ideation and behavior: Antiepileptic drugs, including lacosamide, have been associated with a small increased risk of suicidal thoughts and behavior. A meta-analysis conducted by the U.S. FDA of placebo-controlled trials of antiepileptic drugs found that the risk of suicidal ideation or behavior was approximately 0.43% in patients on active drug compared to 0.24% on placebo. Patients should be monitored for signs of depression, unusual changes in mood or behavior, and emergence of suicidal thoughts, especially during the initial months of therapy or after dose changes.

Dizziness and ataxia: Lacosamide can cause dizziness, diplopia (double vision), and ataxia (coordination problems), particularly during the titration phase. These effects are dose-dependent and usually resolve with continued treatment or dose reduction. Patients should be cautioned about driving or operating heavy machinery until they know how lacosamide affects them.

Hepatic impairment: Lacosamide is partially metabolized by the liver (CYP2C19). Patients with mild to moderate hepatic impairment (Child-Pugh A or B) may require dose adjustment. Lacosamide is not recommended in patients with severe hepatic impairment (Child-Pugh C) due to limited clinical data.

Renal impairment: No dose adjustment is required for patients with mild to moderate renal impairment. However, in patients with severe renal impairment (creatinine clearance ≤ 30 mL/min) or those on hemodialysis, a maximum dose reduction may be necessary. Approximately 40% of lacosamide is eliminated unchanged by the kidneys, and a supplemental dose of up to 50% may be needed after a 4-hour hemodialysis session.

Pregnancy and Breastfeeding

The use of lacosamide during pregnancy requires careful consideration of the risks and benefits. All antiepileptic drugs carry some degree of teratogenic risk (risk of birth defects), but uncontrolled seizures during pregnancy also pose significant dangers to both mother and fetus, including physical injury, hypoxia, and, rarely, maternal death.

Pregnancy: Animal studies have shown adverse developmental effects at doses producing maternal plasma levels similar to or exceeding expected clinical levels. Human data on lacosamide use during pregnancy is limited. Data from pregnancy registries, including the European Registry of Antiepileptic Drugs and Pregnancy (EURAP) and the North American Antiepileptic Drug (NAAED) Pregnancy Registry, are still being collected. Women of childbearing potential should use effective contraception during treatment. If pregnancy is planned, the treating neurologist should be consulted well in advance to assess whether lacosamide can be continued, switched to an alternative, or gradually withdrawn.

Breastfeeding: It is not known whether lacosamide is excreted in human breast milk, although it is present in rat milk. A decision must be made whether to discontinue breastfeeding or to discontinue lacosamide, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother. If breastfeeding is continued while taking lacosamide, the infant should be monitored for sedation, poor feeding, and adequate weight gain.

How Does Lacosamide UCB Interact with Other Drugs?

Lacosamide has relatively few pharmacokinetic drug interactions compared to many older antiepileptic drugs. However, it can interact with other PR interval-prolonging medications and certain enzyme-inducing antiepileptics. Strong CYP2C19 inhibitors may increase lacosamide levels, while enzyme inducers may decrease them.

One of the clinical advantages of lacosamide is its relatively favorable drug interaction profile. Unlike carbamazepine, phenytoin, and phenobarbital, which are potent enzyme inducers affecting the metabolism of many other medications, lacosamide has minimal effects on hepatic cytochrome P450 enzymes. It does not significantly inhibit or induce CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP3A4 at therapeutic concentrations. This makes it easier to combine with other medications without unexpected changes in drug levels.

However, several clinically important interactions should be considered:

Major Interactions

Minor Interactions

Lacosamide does not have clinically significant interactions with many commonly used medications, including:

• Oral contraceptives: Lacosamide does not affect the plasma levels of ethinylestradiol or levonorgestrel, meaning it does not reduce the efficacy of hormonal contraception. This is an important advantage over enzyme-inducing antiepileptics such as carbamazepine and phenytoin.
• Metformin and omeprazole: No clinically significant pharmacokinetic interactions have been observed with these commonly used medications.
• Lamotrigine, levetiracetam, topiramate, valproate: Population pharmacokinetic analyses have shown no clinically relevant interactions between lacosamide and these commonly co-prescribed antiepileptic drugs.
• Warfarin: Co-administration of lacosamide with warfarin did not result in clinically significant changes in warfarin pharmacokinetics or INR values.

What Is the Correct Dosage of Lacosamide UCB?

The typical adult starting dose is 50 mg twice daily, increased weekly by 50 mg twice daily to a recommended maintenance dose of 150–200 mg twice daily. The maximum dose is 300 mg twice daily (600 mg/day). In children, the dose is based on body weight. Always follow your doctor's instructions.

Dosing of lacosamide must be individualized based on the patient's age, body weight, kidney and liver function, concomitant medications, and clinical response. The following dosing guidelines are based on EMA and FDA-approved labeling and international epilepsy treatment guidelines from the ILAE (International League Against Epilepsy).

Adults

The titration schedule allows the body to gradually adjust to the medication, minimizing dose-dependent side effects such as dizziness, nausea, and diplopia. In clinical practice, many physicians prefer a slower titration (e.g., every two weeks) in elderly patients or those particularly sensitive to CNS side effects.

Children

For younger children or those requiring doses not achievable with tablets, an oral solution formulation of lacosamide (Vimpat syrup 10 mg/mL) may be more appropriate. Always use a calibrated measuring device for liquid formulations.

Elderly

No dose reduction is required solely based on age in elderly patients. However, age-related decline in renal function should be considered, and the prescribing physician may choose a more conservative titration schedule. Elderly patients may be more susceptible to dizziness and falls, and the PR interval prolongation effect warrants particular attention in older adults who may have age-related cardiac conduction changes.

Missed Dose

If you miss a dose of Lacosamide UCB, take it as soon as you remember. However, if it is almost time for your next scheduled dose (less than 6 hours until the next dose), skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a missed one. If you miss multiple doses, contact your doctor for advice, as abrupt changes in antiepileptic drug levels can increase seizure risk.

Overdose

In the event of an overdose, seek immediate medical attention. Symptoms of lacosamide overdose may include severe dizziness, nausea, vomiting, seizures (paradoxically), and cardiac conduction abnormalities (including AV block and cardiac arrest at very high doses). There is no specific antidote for lacosamide overdose. Treatment is supportive, and hemodialysis can effectively remove approximately 50% of lacosamide from the plasma within a 4-hour session. In cases of suspected significant overdose, cardiac monitoring is essential.

What Are the Side Effects of Lacosamide UCB?

The most common side effects of lacosamide are dizziness, headache, nausea, and diplopia (double vision). These are usually dose-dependent, mild to moderate in severity, and often improve during continued treatment. Serious but rare side effects include cardiac conduction disorders, severe skin reactions, and suicidal ideation.

Like all medicines, Lacosamide UCB can cause side effects, although not everybody gets them. The side effects listed below are based on data from controlled clinical trials and post-marketing surveillance reports submitted to the EMA and FDA. Side effects are classified by frequency according to the internationally accepted convention:

Most side effects of lacosamide are dose-related and are most likely to occur during the initial titration period. The incidence of dizziness, for example, increases significantly at doses above 400 mg/day. Many patients report that side effects diminish or resolve entirely as their body adapts to the medication over the first few weeks of treatment.

It is important to report any suspected side effects to your doctor, even if they are not listed above. You can also report side effects directly to your national pharmacovigilance authority (e.g., the Yellow Card Scheme in the UK, MedWatch in the US, or the relevant authority in your country). By reporting side effects, you help provide more information on the safety of this medicine.

How Should You Store Lacosamide UCB?

Store Lacosamide UCB at room temperature below 30°C (86°F) in the original packaging. Keep out of reach of children. Do not use after the expiry date. Do not dispose of medicines in wastewater or household waste.

Proper storage of medication is essential to maintain its efficacy and safety throughout its shelf life. Lacosamide UCB film-coated tablets should be stored under the following conditions:

• Temperature: Store below 30°C (86°F). Do not freeze. Avoid storing in locations with extreme temperature fluctuations, such as near radiators, in direct sunlight, or in the bathroom.
• Packaging: Keep the tablets in the original blister pack until ready for use. The blister provides protection from moisture and light.
• Expiry date: Do not use this medicine after the expiry date stated on the carton and blister after “EXP.” The expiry date refers to the last day of that month.
• Children: Keep this medicine out of the sight and reach of children. Store in a secure location.
• Disposal: Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

If your tablets appear discolored, damaged, or the blister pack is torn, do not use them. Return them to your pharmacy for proper disposal and obtain a replacement. Regular inspection of your medication stock, particularly checking expiry dates, is good practice for all patients on chronic therapy.

What Does Lacosamide UCB Contain?

Each Lacosamide UCB 50 mg film-coated tablet contains 50 mg of the active substance lacosamide. The tablet also contains inactive ingredients (excipients) that help form the tablet and its film coating.

The complete composition of each Lacosamide UCB 50 mg film-coated tablet is as follows:

Active substance:

• Lacosamide 50 mg

Tablet core excipients (inactive ingredients):

• Microcrystalline cellulose — a plant-derived filler and binder
• Hydroxypropyl cellulose (low substituted) — a disintegrant that helps the tablet break down in the stomach
• Hydroxypropyl cellulose — a binder
• Crospovidone — a disintegrant
• Magnesium stearate — a lubricant used during tablet manufacturing

Film-coating excipients:

• Polyvinyl alcohol — provides the protective film coat
• Polyethylene glycol — plasticizer
• Talc — anti-adherent
• Titanium dioxide (E171) — white colorant and opacifier
• Iron oxide yellow (E172) — colorant
• Iron oxide red (E172) — colorant

Patients with known allergies or intolerances to any of these excipients should inform their doctor or pharmacist. The tablet does not contain lactose, gluten, or sucrose, making it suitable for patients with these specific intolerances. However, always verify with your pharmacist if you have concerns about specific ingredients.

Frequently Asked Questions About Lacosamide UCB