Lacosamide

Pronunciation

Class: Anticonvulsants, Miscellaneous
VA Class: CN400
Chemical Name: (R)-2-acetamido-N-benzyl-3-methoxypropionamide
Molecular Formula: C13H18N2O3
CAS Number: 175481-36-4
Brands: Vimpat

Introduction

Anticonvulsant; a functionalized amino acid.1 4 5 6 22 23 34

Uses for Lacosamide

Seizure Disorders

Management (in combination with other anticonvulsants) of partial-onset seizures in patients ≥17 years of age with epilepsy.1 2 3 4 20 24 36

Slideshow: Flashback: FDA Drug Approvals 2013

IV lacosamide is used as a short-term alternative to oral therapy in patients in whom oral administration of the drug is temporarily not feasible (e.g., patients undergoing surgical procedures, those experiencing difficulty swallowing, those with acute GI disorders).1 20 24 36

Neuropathic Pain

Oral lacosamide has been studied in the treatment of pain associated with diabetic peripheral neuropathy (DPN) in several short- and long-term clinical trials; additional controlled trials needed to confirm efficacy and safety.14 15 16 17 18 38 43

Lacosamide Dosage and Administration

General

  • Do not discontinue lacosamide abruptly; withdraw gradually (e.g., gradually discontinue therapy over ≥1 week and/or taper the daily dosage by 200 mg each week) to minimize the potential for increased seizure frequency in patients with seizure disorders.1 37

  • Closely monitor for notable changes in behavior that could indicate emergence or worsening of suicidal thoughts or behavior or depression.1 9 10 11 12 (See Suicidality Risk under Cautions.)

Administration

Administer orally or by IV infusion.1 The 30- and 60-minute IV infusions are bioequivalent to the oral tablets.1

Oral Administration

Administer twice daily without regard to food.1

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.1

Discard any unused portion of the injection.1

Dilution

Lacosamide injection may be administered without further dilution or may be diluted with 5% dextrose, lactated Ringer’s, or 0.9% sodium chloride injection.1

Rate of Administration

Administer over 30–60 minutes.1

Shorter IV infusion times (e.g., over 10 and 15 minutes) have been used safely in a limited number of patients in clinical trials; further clinical experience is needed to confirm safety.24 36 40 41

Dosage

Adults

Seizure Disorders
Partial Seizures
Oral or IV

Initiate treatment with either oral or IV therapy.1 Use IV lacosamide if oral administration is temporarily not feasible.1 20 24 36

Patients ≥17 years of age: Initially, 100 mg daily (given as 50 mg twice daily).1 Based on clinical response and tolerability, may increase dosage in increments of 100 mg daily (given in 2 divided doses) at weekly intervals until the recommended maintenance dosage of 200–400 mg daily is achieved.1

In clinical trials, an oral dosage of 600 mg daily was not more effective than 400 mg daily and was associated with a substantially higher incidence of adverse effects.1

Conversion from Oral to IV Therapy

Initial IV dosage should be equivalent to the total daily dosage and frequency of oral lacosamide.1 There is experience with twice-daily IV infusions for up to 5 days.1 24 36

Conversion from IV to Oral Therapy

At the end of the IV treatment period, may switch to oral administration at the equivalent daily dosage and frequency of the IV administration.1

Neuropathic Pain
Pain Associated with Diabetic Peripheral Neuropathy
Oral

Initial dosage of 100 mg daily (given as 50 mg twice daily) usually has been used in clinical trials, with subsequent weekly increases to reach maintenance dosages of 400–600 mg daily (given as 200–300 mg twice daily) based on individual patient response and tolerability.14 15 16 17 18 38

Prescribing Limits

Adults

Seizure Disorders
Partial Seizures
Oral

Dosages of 600 mg daily were not more effective than 400 mg daily and were associated with a substantially higher incidence of adverse effects.1

Special Populations

Hepatic Impairment

Mild or moderate hepatic impairment: Titrate dosage with caution; maximum dosage of 300 mg daily is recommended.1 During dosage titration, closely monitor patients with coexisting hepatic and renal impairment.1 (See Special Populations under Pharmacokinetics.)

Severe hepatic impairment: Use is not recommended.1 (See Special Populations under Pharmacokinetics.)

Renal Impairment

Mild to moderate renal impairment: Dosage adjustment is not necessary.1 (See Special Populations under Pharmacokinetics.)

Severe renal impairment (ClCr ≤30 mL/minute) or end-stage renal disease: Manufacturer recommends a maximum dosage of 300 mg daily.1 In patients undergoing hemodialysis, consider dosage supplementation of up to 50% following hemodialysis.1 (See Special Populations under Pharmacokinetics.)

Titrate dosage with caution in patients with any degree of renal impairment.1 During dosage titration, closely monitor patients with coexisting hepatic and renal impairment.1

Geriatric Patients

Dosage adjustment not necessary; however, manufacturer recommends cautious dosage titration.1 (See Special Populations under Pharmacokinetics.)

Cautions for Lacosamide

Contraindications

  • No known contraindications in the US.1 In the European Union, contraindicated in patients with hypersensitivity to lacosamide or any ingredient in the formulation and in patients with known second- or third-degree AV block.37

Warnings/Precautions

Sensitivity Reactions

Multiorgan Hypersensitivity Reactions

One case of symptomatic hepatitis and nephritis, consistent with a delayed multiorgan hypersensitivity reaction, reported in a healthy individual 10 days after discontinuing lacosamide;1 full recovery occurred within 1 month without specific treatment.1 Additional cases of possible multiorgan hypersensitivity reaction include 2 cases with rash and elevated hepatic enzyme concentrations and 1 case with myocarditis and hepatitis of uncertain etiology.1

Multiorgan hypersensitivity reactions (also known as drug reaction with eosinophilia and systemic symptoms or DRESS) also reported with other anticonvulsants; clinical presentation is variable but typically includes fever and rash associated with other organ system involvement (e.g., eosinophilia, hepatitis, nephritis, lymphadenopathy, myocarditis).1

If a multiorgan hypersensitivity reaction is suspected, discontinue lacosamide and initiate alternative therapy.1

Suicidality Risk

Increased risk of suicidality (suicidal ideation or behavior) observed in an analysis of studies using various anticonvulsants in patients with epilepsy, psychiatric disorders (e.g., bipolar disorder, depression, anxiety), and other conditions (e.g., migraine, neuropathic pain); risk in patients receiving anticonvulsants (0.43%) was approximately twice that in patients receiving placebo (0.24%).1 9 10 11 12 Increased suicidality risk was observed ≥1 week after initiation of anticonvulsant therapy and continued through 24 weeks.9 10 11 Risk was higher for patients with epilepsy compared with those receiving anticonvulsants for other conditions.1 9 10 11

Closely monitor all patients currently receiving or beginning anticonvulsant therapy for changes in behavior that may indicate emergence or worsening of suicidal thoughts or behavior or depression.1 9 10 11 12 Anxiety, agitation, hostility, hypomania, and mania may be precursors to emerging suicidality.10

Balance risk of suicidality with the risk of untreated illness.1 10 Epilepsy and other illnesses treated with anticonvulsants are themselves associated with morbidity and mortality and an increased risk of suicidality.1 12 If suicidal thoughts or behavior emerge during anticonvulsant therapy, consider whether these symptoms may be related to the illness itself.1 12 (See Advice to Patients.)

Dizziness and Ataxia

Dizziness and ataxia reported in 25 and 6%, respectively, of patients with partial-onset seizures receiving lacosamide 200–400 mg daily and 1–3 concomitant anticonvulsants compared with 8 and 2%, respectively, of placebo recipients; dizziness was the adverse effect most frequently leading to drug discontinuance (3%).1

The onset of dizziness and ataxia was most commonly observed during dosage titration.1 Incidence was substantially increased at dosages >400 mg daily.1 (See Advice to Patients.)

PR-Interval Prolongation

Dose-dependent increases in PR interval observed in patients and healthy individuals receiving lacosamide.1 2 4 5 13 19 20 24 43 At steady state, the timing of the maximum observed mean PR interval coincided with peak plasma lacosamide concentrations.1

Asymptomatic, first-degree AV block observed in 0.4 or 0.5% of lacosamide-treated patients with partial-onset epilepsy or diabetic neuropathy, respectively, compared with none of the placebo recipients.1 2 20

When lacosamide is given with other drugs that prolong the PR interval, further PR prolongation is possible.1 23 37 (See Drugs that Prolong PR Interval under Interactions.)

Use lacosamide with caution in patients with known cardiac conduction abnormalities (e.g., marked first-degree AV block, second- or third-degree AV block, sick sinus syndrome without a pacemaker) or severe cardiovascular disease (e.g., myocardial ischemia, heart failure).1 23 The manufacturer recommends obtaining an ECG before initiating lacosamide and after titration to steady state in such patients.1

Atrial Fibrillation and Atrial Flutter

Lacosamide may predispose patients, particularly those with diabetic neuropathy and/or cardiovascular disease, to develop atrial arrhythmias (i.e., atrial fibrillation or flutter).1 Atrial fibrillation or flutter reported in 0.5 or 0% of patients receiving lacosamide or placebo, respectively, in diabetic neuropathy studies; no cases of atrial fibrillation or flutter reported in epilepsy studies.1 (See Advice to Patients.)

Syncope

Syncope or loss of consciousness reported in 1.2 or 0% of patients receiving lacosamide or placebo, respectively, in short-term diabetic neuropathy trials.1 No increase in syncope observed in short-term, controlled trials in epilepsy patients without significant systemic illness.1

Most cases of syncope occurred with dosages >400 mg daily.1 The cause was not determined in most cases; however, several cases were associated with orthostatic changes in BP, atrial fibrillation/flutter (and associated tachycardia), or bradycardia.1 (See Advice to Patients.)

Discontinuance of Anticonvulsants

Abrupt withdrawal of anticonvulsants may result in increased seizure frequency in patients with seizure disorders.1 Withdraw lacosamide gradually (e.g., over ≥1 week).1 (See General under Dosage and Administration.)

Specific Populations

Pregnancy

Category C.1

UCB AED Pregnancy Registry (for clinicians and patients) at 888-537-7734.1 North American Antiepileptic Drug (NAAED) Pregnancy Registry (for patients) at 888-233-2334 or .1

Effect on labor and delivery is unknown.1

Lacosamide produced developmental toxicity (i.e., increased embryofetal and perinatal mortality, growth deficit) when given to pregnant animals.1 Developmental neurotoxicity was observed in animals given lacosamide during a period of postnatal development corresponding to the third trimester of human pregnancy.1 Effects were observed at dosages associated with clinically relevant plasma exposures.1

Lactation

Lacosamide and/or its metabolites are distributed into milk in rats.1 Unknown if lacosamide is distributed into human milk.1 Discontinue nursing or the drug.1

Pediatric Use

The manufacturer in the US states that safety and efficacy of oral and IV lacosamide have not been established in pediatric patients <17 years of age.1 However, the drug has been used in pediatric patients ≥16 years of age in some clinical studies4 and is approved for such use in the European Union.29 37

Lacosamide interfered with activity of collapsin response mediator protein-2 (CRMP-2), a protein involved in neuronal differentiation and control of axonal outgrowth, in some in vitro studies; potential adverse effects on CNS development cannot be ruled out.1 (See Actions.)

Decreased brain weights and long-term neurobehavioral changes (e.g., altered open field performance, deficits in learning and memory) reported in rats given lacosamide during neonatal and juvenile periods of postnatal development.1

Geriatric Use

Insufficient experience in geriatric patients to adequately assess the drug’s efficacy in this population.1 (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Use is not recommended in patients with severe hepatic impairment.1 21 In patients with mild or moderate hepatic impairment, titrate dosage with caution.1 During dosage titration, closely monitor patients with coexisting hepatic and renal impairment.1 (See Hepatic Impairment under Dosage and Administration and see also Special Populations under Pharmacokinetics.)

Renal Impairment

Titrate dosage with caution.1 During dosage titration, closely monitor patients with coexisting hepatic and renal impairment.1 (See Renal Impairment under Dosage and Administration and see also Special Populations under Pharmacokinetics.)

Common Adverse Effects

With oral lacosamide for partial-onset seizures: Dizziness,1 2 3 4 13 14 15 16 headache,1 4 13 14 15 16 diplopia,1 3 4 13 nausea,1 2 3 4 14 16 vomiting,1 2 3 4 13 fatigue,1 4 13 15 16 blurred vision,1 3 13 ataxia,1 2 somnolence,1 tremor,1 3 15 16 nystagmus,1 2 3 memory impairment,1 balance disorder,1 vertigo,1 4 diarrhea.1 14

With short-term IV lacosamide therapy for partial-onset seizures: Systemic adverse effects similar to those observed with oral therapy, local adverse effects (injection site pain or discomfort, irritation, and erythema).1 8 24 36

Interactions for Lacosamide

Metabolized by CYP2C19.1 Relative contribution of other CYP isoenzymes or non-CYP enzymes in the metabolism of lacosamide is unclear.1

Does not substantially induce CYP isoenzymes 1A2, 2B6, 2C9, 2C19, or 3A4 in vitro.1 19 37

Does not substantially inhibit CYP isoenzymes 1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 2E1, 3A4, or 3A5 at plasma concentrations observed in clinical studies.1 19 37 In vitro data suggest that lacosamide may inhibit CYP2C19 at therapeutic concentrations; however, in vivo data (with omeprazole) suggested minimal or no inhibition (see Specific Drugs under Interactions).1 19

Does not inhibit and is not a substrate of the P-glycoprotein transport system.1 37

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Potential for pharmacokinetic drug interactions generally appears to be low.1 4 19 26 37

In vitro data suggest that lacosamide may inhibit CYP2C19 at therapeutic concentrations; however, an in vivo study with omeprazole did not show an inhibitory effect (see Specific Drugs under Interactions).1 19

Drugs Affecting or Affected by P-glycoprotein Transport

Pharmacokinetic interactions unlikely.1 37

Drugs that Prolong PR Interval

Potential pharmacodynamic interaction (additive effect on PR-interval prolongation).1 23 37 39 42 (See PR-Interval Prolongation under Cautions and see also Specific Drugs under Interactions.)

Protein-bound Drugs

Clinically relevant pharmacokinetic interactions unlikely.1 16 37

Specific Drugs

Drug

Interaction

Comments

Alcohol

No data currently available37 41

β-adrenergic blocking agents

Potential additive effect on PR-interval prolongation1 13 23

Calcium-channel blocking agents

Potential additive effect on PR-interval prolongation1 23

Carbamazepine

No change in pharmacokinetics of either drug in healthy individuals1

In patients with partial-onset seizures, no change in steady-state plasma concentrations of carbamazepine and its epoxide metabolite1

Small (15–20%) reductions in plasma lacosamide concentrations observed during concurrent administration of carbamazepine, phenobarbital, or phenytoin in population pharmacokinetic studies in patients with partial-onset seizures1 19 20 37

Potential additive effect on PR-interval prolongation; however, subgroup analysis did not reveal an increased magnitude of PR prolongation during concurrent administration1 23 37

Clonazepam

No change in steady-state plasma clonazepam concentrations1 22

Digoxin

Lacosamide did not alter digoxin pharmacokinetics in healthy individuals1 22 37

Potential additive effect on PR-interval prolongation1 23 42

Gabapentin

No change in steady-state gabapentin concentrations1 22

Lamotrigine

No change in steady-state lamotrigine concentrations1 22

Potential additive effect on PR-interval prolongation; however, subgroup analysis did not reveal an increased magnitude of PR prolongation during concurrent administration1 23 37

Levetiracetam

No change in steady-state levetiracetam concentrations1 22

Metformin

No clinically important changes in metformin concentrations1 22

Metformin did not alter lacosamide pharmacokinetics1

Omeprazole

Lacosamide did not alter pharmacokinetics of single-dose omeprazole in healthy individuals1

Omeprazole reduced plasma concentrations of lacosamide’s inactive O-desmethyl metabolite by about 60%1

Oral contraceptives

Ethinyl estradiol/levonorgestrel: No substantial change in pharmacodynamics and pharmacokinetics of the oral contraceptive; small (20%) increase in peak plasma ethinyl estradiol concentrations1 22 37

Oxcarbazepine

No change in steady-state concentrations of oxcarbazepine’s active monohydroxy metabolite (MHD)1 22

Phenobarbital

No change in steady-state plasma phenobarbital concentrations1 22

Small (15–20%) reductions in plasma lacosamide concentrations observed during concurrent administration of carbamazepine, phenobarbital, or phenytoin in population pharmacokinetic studies in patients with partial-onset seizures1 19 20 37

Phenytoin

No change in steady-state plasma phenytoin concentrations1

Small (15–20%) reductions in plasma lacosamide concentrations observed during concurrent administration of carbamazepine, phenobarbital, or phenytoin in population pharmacokinetic studies in patients with partial-onset seizures1 19 20 37

Pregabalin

Potential additive effect on PR-interval prolongation1 37 39

Topiramate

No change in steady-state plasma topiramate concentrations1

Valproic Acid

No change in pharmacokinetics of either drug in healthy individuals1

In patients with partial-onset seizures, no change in steady-state plasma concentrations of valproic acid1

Zonisamide

No change in steady-state plasma zonisamide concentrations1

Lacosamide Pharmacokinetics

Absorption

Pharmacokinetics of oral and IV lacosamide are generally dose-proportional over a range of 100–800 mg.1 19

Bioavailability

Oral bioavailability is approximately 100%.1 Peak plasma lacosamide concentrations attained within 0.5–4 hours after oral administration.1 8 22 Peak plasma concentrations of inactive O-desmethyl metabolite attained within 0.5–12 hours after oral administration.1

Lacosamide 30- and 60-minute IV infusions are bioequivalent to the oral tablet.1 Peak plasma concentrations reached at end of infusion.1

Food

Food does not affect rate or extent of absorption.1

Distribution

Extent

Lacosamide and/or metabolites distribute into milk in rats; unknown if distributed into human milk.1

Plasma Protein Binding

<15%.1

Elimination

Metabolism

Metabolized by CYP2C19; effect of other CYP isoenzymes or non-CYP enzymes in the metabolism of lacosamide is unclear.1

Elimination Route

Eliminated primarily by renal excretion and biotransformation.1 19 Following oral and IV administration of a 100-mg radiolabeled dose, approximately 95% of the dose was recovered in urine and <0.5% was recovered in feces; the principal compounds excreted were unchanged lacosamide (approximately 40%), O-desmethyl-lacosamide (approximately 30%; inactive metabolite), and a structurally unknown polar fraction (approximately 20%; possibly serine derivatives).1 37

Half-life

Lacosamide: Approximately 12–13 hours.1 19 22

O-desmethyl metabolite: 15–23 hours.1

Special Populations

In individuals with mild or moderate renal impairment, AUC is increased by approximately 25%.1 41 In individuals with severe renal impairment, AUC is increased by approximately 60%.1 41 However, peak plasma concentrations were unaffected.1 41 A 4-hour hemodialysis session reduces the AUC by approximately 50%.1

Individuals with moderate hepatic impairment (Child-Pugh class B) had higher plasma concentrations of lacosamide (approximately 50–60% higher AUCs) compared with healthy individuals.1 Pharmacokinetics not specifically evaluated in individuals with severe hepatic impairment.1

In geriatric individuals, AUCs and peak plasma concentrations (normalized for dosage and body weight) were approximately 20% higher compared with younger individuals, possibly related to differences in total body water and age-associated reductions in renal clearance.1

Stability

Storage

Oral

Tablets

20–25°C (may be exposed to 15–30°C).1

Parenteral

Injection for IV Infusion

20–25°C (may be exposed to 15–30°C).1

Discard any unused portion of the injection.1

When stored in glass or PVC bags at 15–30°C, injection that has been diluted with 5% dextrose injection, 0.9% sodium chloride injection, or lactated Ringer’s injection is stable for ≥24 hours.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility

Compatible1

Dextrose 5% in water

Ringer’s injection, lactated

Sodium chloride 0.9%

Actions

  • Exact mechanism(s) of anticonvulsant and antinociceptive action is unknown.1 2 4 5 7 8 14 15 16 19 21 22 25 26 27 41

  • In vitro electrophysiologic studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, which results in stablilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing.1 2 4 5 7 8 16 19 22 25 27

  • In some preclinical tests, lacosamide was found to bind to collapsin response mediator protein-2 (CRMP-2), a phosphoprotein that is mainly expressed in the nervous system and involved in neuronal differentiation, polarization, gene expression, and control of axonal outgrowth.1 7 8 13 16 25 27 28 30 It was suggested that this binding may contribute to the anticonvulsant and antinociceptive activity of the drug.1 7 8 13 16 25 27 28 30 However, binding was not confirmed in subsequent tests.41

  • Does not exhibit binding affinity for GABA, N-methyl-D-aspartic acid (NMDA), adenosine, muscarinic, serotonin, histamine, dopamine, or other receptors.14 20 26 Does not affect reuptake or metabolism of norepinephrine, dopamine, serotonin, or GABA.6 7 20 26 Does not affect voltage-activated calcium channels (L-, –, P/Q-, or T-type) or voltage-activated potassium channels and does not modulate delayed-rectifier or A-type potassium currents.6 20 22 26

Advice to Patients

  • Importance of providing copy of written patient information (medication guide) each time lacosamide is dispensed; importance of patient reading this information prior to taking the drug.1

  • Risk of suicidality (anticonvulsants, including lacosamide, may increase risk of suicidal thoughts or actions in about 1 in 500 people).1 10 12 Importance of patients, family, and caregivers being alert to day-to-day changes in mood, behavior, and actions and immediately informing clinician of any new or worrisome behaviors (e.g., talking or thinking about wanting to hurt oneself or end one’s life, withdrawing from friends and family, becoming depressed or experiencing worsening of existing depression, becoming preoccupied with death and dying, giving away prized possessions).1 10

  • Importance of taking lacosamide only as prescribed.1

  • Risk of dizziness, drowsiness, blurred vision, or problems with coordination and balance.1 6 35 Importance of advising patients not to drive, operate complex machinery, or engage in other hazardous activities until they have become accustomed to any such effects.1 35 37

  • Risk of dizziness, lightheadedness, fainting, or irregular heart beat, particularly in patients with underlying cardiovascular disease or cardiac conduction abnormalities and in those taking drugs that affect the heart.1 35 These symptoms are more likely to occur when rising quickly from a recumbent position.35 Importance of advising patients to lie down with their legs raised until they feel better if such symptoms develop and to contact their clinician promptly.1 35 Importance of patients also being aware of possible symptoms of cardiac rhythm and conduction abnormalities (e.g., atrial fibrillation and flutter), including palpitations, rapid heart beat, and shortness of breath; importance of patients contacting their clinician should any of these symptoms occur.1

  • Risk of serious hypersensitivity reactions affecting multiple organs (e.g., liver, kidney); lacosamide should be discontinued if serious hypersensitivity reactions are suspected.1 Importance of informing patients to contact their clinician promptly if symptoms suggestive of liver damage occur (e.g., fatigue, jaundice, dark urine).1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 35 Importance of clinicians informing women about the existence of and encouraging enrollment in pregnancy registries (see Pregnancy under Cautions).1

  • Importance of informing patients not to stop taking lacosamide without first talking to their clinician since stopping the drug suddenly can cause serious problems, including seizures.1 35

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illness (e.g., heart disease, kidney disease, liver disease, depression, bipolar disorder) or family history of suicidality or bipolar disorder.1 35

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Subject to control under the Federal Controlled Substances Act of 1970 as a schedule V (C-V) drug.

Lacosamide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

50 mg

Vimpat ( C-V)

UCB

100 mg

Vimpat ( C-V)

UCB

150 mg

Vimpat ( C-V)

UCB

200 mg

Vimpat ( C-V)

UCB

Parenteral

Injection, for IV infusion

10 mg/mL

Vimpat ( C-V; available in single-use glass vials)

UCB

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Vimpat 100MG Tablets (SCHWARZ PHARMA): 60/$454.99 or 180/$1,301.04

Vimpat 150MG Tablets (SCHWARZ PHARMA): 60/$439.99 or 180/$1,260.02

Vimpat 200MG Tablets (SCHWARZ PHARMA): 60/$475.97 or 180/$1,371.94

Vimpat 50MG Tablets (SCHWARZ PHARMA): 60/$291.00 or 180/$824.93

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions October 3, 2014. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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3. Chung S, Sperling M, Biton V et al. Lacosamide: efficacy and safety as oral adjunctive therapy in adults with partial-onset seizures. Epilepsia. 2007; 48 (Suppl. 7):57. Abstr. No. 065.

4. Halász P, Kälviäinen R, Mazurkiewicz-Beldzinska M et al. Adjunctive lacosamide for partial-onset seizures: efficacy and safety results from a randomized controlled trial. Epilepsia. 2009; 50:443-53. [PubMed 19183227]

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14. Rauck RL, Shaibani A, Biton V et al. Lacosamide in painful diabetic peripheral neuropathy: a phase 2 double-blind placebo-controlled study. Clin J Pain. 2007; 23:150-8. [PubMed 17237664]

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18. Shaibani A, Fares S, Selam JL et al. Lacosamide in painful diabetic neuropathy: an 18-week double-blind placebo-controlled trial. J Pain. 2009; 10:818-28. [PubMed 19409861]

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28. The European Agency for the Evaluation of Medicinal Products. Questions and answers on the withdrawal of the marketing application for lacosamide pain UCB Pharma. London, UK; 2008 Oct 23. From EMEA web site. Accessed on Nov 2, 2009.

29. The European Agency for the Evaluation of Medicinal Products. European Public Assessment Report on Vimpat. From EMEA web site.

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43. Reviewer comments’ (personal observations) on Lacsoamide 28:12.92.

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