Lacosamide

Lacosamide is a prescription medication used to treat partial-onset seizures and primary generalized tonic-clonic seizures

• Lacosamide is available under the following different brand names: Vimpat

Adult and pediatric dosage

Tablet: Schedule V

• 50mg
• 100mg
• 150mg
• 200mg

Injectable solution: Schedule V

• 200mg/20mL

Oral solution: Schedule V

• 10mg/mL

Partial Onset Seizures

• Adult dosage
• Monotherapy
  • 100 mg orally/IV every 12 hours initially, then increase dose at weekly intervals by 50 mg Orally/IV twice daily up to recommended dose of 150-200 mg twice daily (300-400 mg/day) or
  • 200 mg orally/IV as a single loading dose, followed 12 hours later by 100 mg orally/IV twice daily; then increase dose at weekly intervals by 50 mg twice daily; up to a recommended dose of 150-200 mg twice daily (300-400 mg/day)
• Adjunct therapy
  • Initial: 50 mg orally/IV every 12 hours
  • Based on response and tolerability, increase dose at weekly intervals by 50 mg orally/IV twice daily; up to a recommended dose of 100-200 mg twice daily (200-400 mg/day)
• Pediatric dosage
  • Children younger than 1 month of age: Safety and efficacy not established
  • Children 1 month to 17 years: 
  • Weighing less than 6 kg: 
    • IV: 0.66 mg/kg thrice daily, then, based on response and tolerability, increase dose at weekly intervals by 0.66 mg/kg three times daily; up to recommended 2.5-5 mg/kg thrice daily (7.5-15 mg/kg/day)
    • Orally: 1 mg/kg twice daily (2 mg/kg/day), then, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg twice daily (2 mg/kg/day), up to 3.75-7.5 mg/kg twice daily (7.5-15 mg/kg/day)
  • Weighing 6 kg but less than 30 kg: 1 mg/kg orally/IV twice daily, then, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg orally/IV twice daily, up to recommended 3-6 mg/kg orally/IV twice daily (6-12 mg/kg/day)
    • Weighing 30 kg but less than 50 kg: 1 mg/kg orally/IV twice daily, then, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg orally/IV twice daily, up to recommended 2-4 mg/kg orally twice daily (4-8 mg/kg/day)
    • Weighing 50 kg or over: 50 mg orally/IV twice daily, then, based on response and tolerability, increase dose at weekly intervals by 50 mg orally/IV twice daily, up to recommended 150-200 mg orally/IV twice daily (300-400 mg/day) for monotherapy or 100-200 mg orally/IV twice daily (200-400 mg/day) for adjunctive therapy
• Primary Generalized Tonic-Clonic Seizures
• Adult dosage
  • Initial: 50 mg orally/IV every 12 hours
  • Based on response and tolerability, increase dose at weekly intervals by 50 mg orally/IV twice daily; up to a recommended dose of 100-200 mg twice daily (200-400 mg/day).
• Pediatric dosage
  • Children younger than 4 years of age: Safety and efficacy not established
  • Children 4-17 years: 
  • Weighing 11 kg but less than 30 kg: 1 mg/kg orally/IV twice daily, then, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg orally/IV twice daily, up to recommended 3-6 mg/kg orally/IV twice daily (6-12 mg/kg/day)
  • Weighing 30 kg but less than 50 kg: 1 mg/kg orally/IV twice daily, then, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg orally/IV twice daily, up to recommended 2-4 mg/kg orally/IV twice daily (4-8 mg/kg/day)
  • Weighing 50kg or above: 50 mg orally/IV twice daily, then, based on response and tolerability, increase dose at weekly intervals by 50 mg orally/IV twice daily, up to recommended 150-200 mg orally/IV twice daily (300-400 mg/day) for monotherapy or 100-200 mg orally/IV twice daily (200-400 mg/day) for adjunctive therapy

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Lacosamide include:

• headache, 
• dizziness, 
• drowsiness, 
• double vision, and 
• nausea

Serious side effects of Lacosamide include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• skin rash, 
• fever, 
• swollen glands, 
• muscle aches, 
• severe weakness, 
• unusual bruising, 
• yellowing of the skin or eyes (jaundice), 
• mood or behavior changes, 
• depression, 
• anxiety, 
• panic attacks, 
• trouble sleeping, 
• impulsive behavior, 
• irritableness, 
• agitation, 
• hostility, 
• aggression, 
• restlessness, 
• hyperactivity (mental or physical), 
• thoughts of self-harm, 
• lightheadedness, 
• severe dizziness, 
• problems with balance or muscle movement, 
• chest pain, 
• shortness of breath, 
• fast or pounding heartbeats, 
• very slow heartbeats, and
• dark urine

Rare side effects of Lacosamide include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Lacosamide has severe interactions with no other drugs.
• Lacosamide has serious interactions with the following drugs:
  • adametapir
  • apalutamide
  • fexinidazole
  • idelalisib
  • ivosidenib
  • metoclopramide intranasal
  • tucatinib
  • voxelotor
• Lacosamide has moderate interactions with at least 55 other drugs.
• Lacosamide has minor interactions with at least 17 other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• None.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Lacosamide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lacosamide?”

Cautions

• Increase the risk of suicidal thoughts or behavior; monitor for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
• Dizziness and ataxia reported; may impair ability to perform hazardous tasks
• Blurred vision and diplopia may occur during therapy; consider increased monitoring in patients with preexisting ocular conditions or vision-related issues
• Oral solution contains aspartame, a source of phenylalanine; 200 mg dose (20 mL) contains 0.32 mg of phenylalanine
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, reported with antiepileptic drugs; some of these events have been fatal or life- threatening; monitor for signs and symptoms of possible disparate manifestations associated with lymphatic hepatic, renal, and/or hematologic organ systems; may require gradual discontinuation and conversion to alternate therapy
• Use caution in renal and hepatic impairment; dosage adjustments may be required
• Withdraw gradually over 1 week; do not discontinue abruptly because of risk for increased frequency of seizures
• Cardiac rhythm and conduction
  • Both atrial fibrillation and atrial flutter reported in open label partial-onset seizure trials and in postmarketing experience; therapy may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular disease. Cardiac arrhythmias reported, including bradycardia, AV block, and ventricular tachyarrhythmia, which have rarely resulted in asystole, cardiac arrest, and death
  • Most, although not all, cases occurred in patients with underlying proarrhythmic conditions, or in those taking concomitant medications that affect cardiac conduction or prolong the PR interval
  • Events occurred with both oral or IV administration and at prescribed doses, as well as in the setting of overdose
  • Caution with underlying proarrhythmic conditions (eg, marked first-degree AV block, second-degree or higher AV block and sick sinus syndrome without pacemaker), severe cardiac disease, including myocardial ischemia or heart failure, or structural heart disease, and cardiac sodium disorders (eg, Brugada Syndrome)
• Drug interactions overview
  • Patients with renal or hepatic impairment who are taking strong CYP3A4 and CYP2C9 inhibitors may have a significant increase in exposure to Lacosamide; dose reduction may be necessary
• Concomitant medications that prolong PR interval
  • Use with caution when administered concomitantly with medications that affect cardiac conduction, including sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers, and medications that prolong the PR interval; obtain an ECG before beginning therapy, and after titrating to steady-state maintenance dose, in such patients; closely monitor if intravenous route used to administer medication
  • Obtain an ECG before initiating and after titrated to steady-state; additionally, monitor closely if administered IV

Pregnancy and Lactation

• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs); to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/
• There are no adequate data on the developmental risks associated with Lacosamide use in pregnant women
• Lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy
• Developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy.  
• There are no data on the presence of Lacosamide in human milk, the effects on the breastfed infant, or the effects on milk production
• Studies in lactating rats have shown excretion of Lacosamide and/or its metabolites in milk
• Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Lacosamide and any potential adverse effects on the breastfed infant from Lacosamide or from the underlying maternal condition.