LACOSAMIDE

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Created Aug 2019 | Updated Oct 2020

LACOSAMIDE

  • [VIMPAT]

DEA CODE 2746: Schedule 5

What is Vimpat?
Vimpat (lacosamide) is an anti-epileptic drug, also called an anticonvulsant.

Vimpat is used together with other medications to treat partial-onset seizures in adults and children with epilepsy. Vimpat tablets and oral solution are for use in adults and children who are at least 4 years old. Vimpat injection is for use only in adults.

Important Information:

Do not stop using Vimpat suddenly or you may have increased seizures.

Some people have thoughts about suicide while using Vimpat. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

You may feel faint while using Vimpat. Call your doctor right away if you have fast or pounding heartbeats, shortness of breath, and sudden dizziness.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Interactions:

Drug Interactions (78) Alcohol/Food Interactions (1) Disease Interactions (4)


What other drugs will affect Vimpat?
Other drugs may interact with lacosamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your other medicines, especially:
  • heart or blood pressure medication.
This list is not complete. Other drugs may interact with lacosamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

A total of 78 drugs are known to interact with Vimpat.

  • 6 major drug interactions
  • 72 moderate drug interactions

Lacosamide is used alone or together with other medicines to help control partial seizures (convulsions) in the treatment of epilepsy. It acts on the central nervous system (CNS) to reduce the number and severity of seizures. However, this medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it.

Pediatric:
Appropriate studies have not been performed on the relationship of age to the effects of lacosamide injection in children younger than 17 years of age.

Safety and efficacy have not been established.

Geriatric:
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lacosamide injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving lacosamide injection.

Other Medical Problems:
Make sure you tell your doctor if you have any other medical problems, especially:

  • Brugada syndrome (genetic disease)
  • Depression, history of
  • Drug or alcohol abuse or dependence, history of
  • Heart attack
  • Heart block
  • Heart disease (eg, heart failure, myocardial ischemia)
  • Heart failure
  • Heart rhythm problems (eg, prolonged PR interval)
  • Mental illness, history of
  • Sick sinus syndrome (type of abnormal heart rhythm), without pacemaker - Use with caution. May make these conditions worse
  • Diabetic neuropathy
  • Heart or blood vessel disease - May increase risk for more serious side effects
  • Kidney disease, severe
  • Liver disease, mild to moderate - Use with caution. The effects may be increased because of slower removal of the medicine from the body
  • Liver disease, severe - Should not be used in patients with this condition

VIMPAT is approved in the U.S. as tablets, injection and oral solution as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in people with epilepsy ages 17 years and older. VIMPAT injection is a short-term replacement when oral administration is not feasible in these patients. The availability of the oral tablets, oral solution, and intravenous (IV) injection formulations permits flexibility in administration. Since the initial launch of VIMPAT tablets and injection in May 2009, there have been more than 200,000* VIMPAT patient exposures in the U.S. In the European Union, VIMPAT (film-coated tablets, syrup and solution for infusion) is approved as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy.

Vimpat is the brand name of an anti-epileptic drug that contains lacosamide as its active ingredient. Vimpat is used either alone or in combination with other medications to prevent partial epileptic seizures.

The drug is not meant to stop a seizure once it has started.


Lacosamide is an anticonvulsant that is FDA approved for the treatment of partial-onset seizures. The precise mechanism by which lacosamide exerts its antiepileptic effects in humans remains to be fully elucidated. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing Common adverse reactions include diplopia, headache, dizziness, nausea. Patients with renal or hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to Lacosamide tablets.

Epilepsy Foundation Vimpat Thread:

  • I have been on Vimpat since 2013. I tried 8 other ones and this has help me stay seizure free. The medication is very costly but it does work at least for me. I do have problem with memory but now I know that was all the damage from the seizure to my brain. Try it. Milwaukee.

    • I actually googled 'Vimpat Unpopular' because no one in any of my Reddit/FB groups ever mention taking it. It's worked for me, it's the only medicine that I've felt mentally normal on, I feel like myself. So that alone was enough to make me stay on it. But it cut my seizures by about 1/3 and then when I started taking hormones, they completely disappeared! I'm going on 10 months now. I do have a poorer memory but since this all started who knows if it's actually this medicine. But my doctor said it is the medicine - as in not my brain.

      • I have been on Vimpat for 3 months. I liked it better then Keppra and I was allergic to Zonnegran. I'm new to seizures never had them and then suddenly I had one at 59 and then 2 more when I turned 60. Keppra is horrible, I look like a druggie on it and it caused more pain then the Trigimenal Neuralgia I was being treated for. Now I'm on vimpat. 200 mg per day. I like it a lot but my memory has suffered. I prided myself on my extensive vocabulary and now I struggle for simple words. I have been experiencing itchy skin and electric zaps all over my body. I felt I was overdosing I decided to cut it down to 100 mg and after the 3rd day I had 3 seizures in a row.

Webmd Vimpat Oral User Reviews:

  • It help better control seizures. It created low BP. I can't think freely. I'm not able to live anymore. Too busy trying to remember thing. Or not able observe and be part of environment. I'd rather have seizures, than be on this medication.

    • HATE this drug. gained 20 lbs, depressed, miserable. dizzy, spinning sensation, hard to walk and see sometimes. libido gone, this is awful

      • This medication is *HORRIBLE* The medication itself worked for my Simple Complex seizures. But the side effects are awful. I struggle with everything I do. I'm now transposeing numbers, my spelling is so bad, I'm walking into the corners of hallways, my coordination is off, I'm referring to people, objects by saying the wrong name, I'm studering, I keep falling.

The use of lacosamide in partial epilepsy: Does it work and is it harmful?
Review authors found that lacosamide reduced the frequency of seizures. The added antiepileptic drug was over one and a half times better at reducing seizures than placebo. The higher the dose of lacosamide, the better it was at reducing the number of seizures. Also patients who took lacosamide were more likely to have no seizures at all than those who took the placebo, but they were more likely to withdraw from lacosamide largely because of side effects. Side effects included blurred or double vision, problems with co-ordination and feelings of dizziness and nausea.

Breastfeeding:

Summary of Use During Lactation:
Limited information indicates that a maternal dose of 200 mg daily produce low levels in milk.

Dosages up to 400 mg daily appeared to not adversely affect development in 3 infants who were breastfed for 7 to 9 months.

Until more data are available lacosamide should only be used with careful monitoring during breastfeeding, especially while nursing a newborn or preterm infant.

Alternate Drugs to Consider:

  • (Seizure Disorder) Carbamazepine
  • Divalproex
  • Gabapentin
  • Lamotrigine
  • Oxcarbazepine
  • Phenytoin
  • Valproic Acid

Liver:
Lacosamide therapy is associated with a low rate of transient serum enzyme elevations and has been linked to rare instances of clinically apparent liver injury.

Lacosamide Hepatotoxicity:
In prelicensure clinical trials, addition of lacosamide to standard anticonvulsant therapy was reported to be associated with ALT elevations above 3 times the upper limit of normal (ULN) in 7 of 935 patients (0.7%) compared to none of 356 treated with placebo. A single case of hepatitis with jaundice during lacosamide therapy was also reported. Since approval, there have been rare isolated reports of clinically apparent liver injury associated with lacosamide used, but the clinical features suggested that hepatic ischemia or other anticonvulsants combined with lacosamide may have been responsible. The onset was within a few days to several months after starting and the presentation was with a hepatocellular pattern of serum enzyme elevations, one case being asymptomatic and mild and the other severe. In both instances, there was rapid recovery.

D Likelihood score: D (possible rare cause of clinically apparent liver injury)


What is the most important information I should know about lacosamide (Vimpat)?
Do not stop using lacosamide suddenly or you may have increased seizures. Some people have thoughts about suicide while taking this medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor. You may feel faint while taking lacosamide. Call your doctor right away if you have fast or pounding heartbeats, shortness of breath, and sudden dizziness.

Vimpat (lacosamide)
Maximum Dosage:
Prescribers Digital Reference
Adults:400 mg/day PO or IV.
Geriatric:400 mg/day PO or IV.
Adolescents:17 years: 400 mg/day PO or IV.
Adolescents:13 to 16 years and weighing 50 kg or more: 400 mg/day PO.
Adolescents:13 to 16 years and weighing 30 to 49 kg: 8 mg/kg/day PO.
Adolescents:13 to 16 years and weighing 11 to 29 kg: 12 mg/kg/day PO.
Children:4 to 12 years and weighing 50 kg or more: 400 mg/day PO.
Children:4 to 12 years and weighing 30 to 49 kg: 8 mg/kg/day PO.
Children:4 to 12 years and weighing 11 to 29 kg: 12 mg/kg/day PO.
Children:1 to 4 years: Safety and efficacy have not been established.

Vimpat (lacosamide tablet and injection)
Side Effects:
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
RxList
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
  • a light-headed feeling, like you might pass out
  • severe dizziness
  • problems with balance or muscle movement
  • chest pain, shortness of breath
  • fast or pounding heartbeats
  • very slow heartbeats
  • dark urine
Common side effects may include:
  • headache, dizziness
  • double vision
  • nausea
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.

FDA PDF Lacosamide

Rxisk PDF Lacosamide

Medicinesforchildren PDF Lacosamide

Caymanchem PDF Lacosamide

When administered orally in healthy individuals, lacosamide is rapidly absorbed from the gastrointestinal tract. Little of the drug is lost via the first pass effect, and thus has an oral bioavailability of nearly 100%. Lacosamide is initially prescribed in oral doses of 50 mg twice per day, with a total dose of 100 mg/day. The dosing can be increased by 100 mg/day following a twice-daily dose up to a total dose of 200 - 400 mg/day. Clinical trials showed that a dose of 600 mg/day was not more effective than a dose of 400 mg/day, but resulted in more adverse reactions. Lacosamide was generally well tolerated in adult patients with partial-onset seizures. The side-effects most commonly leading to discontinuation were dizziness, ataxia, vomiting, diplopia (double vision), nausea, vertigo, and blurred vision. These adverse reactions were observed in at least 10% of patients. Less common side-effects include forgetfulness, discouragement, feelings of sadness, and lack of appetite.

  
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Prenatal exposure to antiseizure medications and fetal growth: a population-based cohort study from the Nordic countries - Prenatal exposure to carbamazepine, oxcarbazepine, clonazepam, and topiramate was associated with increased risk of being born small for gestational age in both the overall population and in children ...
Thursday February 08, 2024 - thelancet.com

  
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