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Vimpat

Last reviewed on RxList: 11/20/2017
Vimpat Side Effects Center

Last reviewed on RxList 11/20/2017

Vimpat (lacosamide) is an antiepileptic drug used together with other medications to treat partial-onset seizures in people with epilepsy who are at least 17 years old. Common side effects of Vimpat include:

  • dizziness,
  • spinning sensation,
  • drowsiness,
  • blurred/double vision,
  • nausea,
  • vomiting,
  • tiredness,
  • loss of balance or coordination,
  • difficulty walking,
  • shakiness (tremor),
  • headache, or
  • memory problems.

These side effects of Vimpat are more common when you first start taking the drug and usually lessen as your body adjusts to the medication. You may have suicidal thoughts while taking Vimpat. Tell your doctor if this occurs. Seek immediate medical attention if you have rare but serious side effects of Vimpat including:

  • fast/slow/irregular/pounding heartbeat,
  • shortness of breath,
  • severe dizziness, or
  • fainting.

Dosage of Vimpat is based on the patient's medical condition and response to treatment. There may be other drugs that can interact with Vimpat. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor. During pregnancy, Vimpat should be used only when prescribed. It is not known whether this drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breastfeeding.

Our Vimpat (lacosamide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Vimpat Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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, flu-like symptoms, muscle aches, swelling in your legs, tiredness, dark urine, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using lacosamide.

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;
  • shortness of breath; or
  • fast, slow, or pounding heartbeats, fluttering in your chest.

Common side effects may include:

  • headache, dizziness;
  • double vision; or
  • 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.

Read the entire detailed patient monograph for Vimpat (Lacosamide Tablet and Injection)

Vimpat Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

VIMPAT Tablet And Oral Solution

In the premarketing development of adjunctive therapy for partial-onset seizures, 1327 adult patients received VIMPAT tablets in controlled and uncontrolled trials, of whom 1000 were treated for longer than 6 months, and 852 for longer than 12 months. The monotherapy development program included 425 adult patients, 310 of whom were treated for longer than 6 months, and 254 for longer than 12 months.

Monotherapy Historical-Control Trial (Study 1)

In the monotherapy trial, 16% of patients randomized to receive VIMPAT at the recommended doses of 300 and 400 mg/day discontinued from the trial as a result of an adverse reaction. The adverse reaction most commonly (≥1% on VIMPAT) leading to discontinuation was dizziness.

Adverse reactions that occurred in this study were generally similar to those that occurred in adjunctive placebo-controlled studies. One adverse reaction, insomnia, occurred at a rate of ≥2% and was not reported at a similar rate in previous studies. This adverse reaction has also been observed in postmarketing experience [see ADVERSE REACTIONS]. Because this study did not include a placebo control group, causality could not be established.

Dizziness, headache, nausea, somnolence, and fatigue all occurred at lower incidences during the AED Withdrawal Phase and Monotherapy Phase, compared with the Titration Phase [see Clinical Studies].

Adjunctive Therapy Controlled Trials (Studies 2, 3, and 4)

In adjunctive therapy controlled clinical trials, the rate of discontinuation as a result of an adverse reaction was 8% and 17% in patients randomized to receive VIMPAT at the recommended doses of 200 and 400 mg/day, respectively, 29% at 600 mg/day (1.5 times greater than the maximum recommended dose), and 5% in patients randomized to receive placebo. The adverse reactions most commonly (>1% on VIMPAT and greater than placebo) leading to discontinuation were dizziness, ataxia, vomiting, diplopia, nausea, vertigo, and blurred vision.

Table 3 gives the incidence of adverse reactions that occurred in ≥2% of adult patients with partial-onset seizures in the VIMPAT total group and for which the incidence was greater than placebo.

Table 3: Adverse Reactions Incidence in Adjunctive Therapy Pooled, Placebo-Controlled Trials in Adult Patients with Partial-Onset Seizures (Studies 2, 3, and 4)

Adverse Reaction Placebo
N=364
%
VIMPAT 200 mg/day
N=270
%
VIMPAT 400 mg/day
N=471
%
VIMPAT 600 mg/day*
N=203
%
VIMPAT Total
N=944
%
Ear and labyrinth disorder
  Vertigo 1 5 3 4 4
Eye disorders
  Diplopia 2 6 10 16 11
  Blurred Vision 3 2 9 16 8
Gastrointestinal disorders
  Nausea 4 7 11 17 11
  Vomiting 3 6 9 16 9
  Diarrhea 3 3 5 4 4
General disorders and administration site conditions
  Fatigue 6 7 7 15 9
  Gait disturbance <1 <1 2 4 2
  Asthenia 1 2 2 4 2
Injury, poisoning and procedural complications
  Contusion 3 3 4 2 3
  Skin laceration 2 2 3 3 3
Nervous system disorders
  Dizziness 8 16 30 53 31
  Headache 9 11 14 12 13
  Ataxia 2 4 7 15 8
  Somnolence 5 5 8 8 7
  Tremor 4 4 6 12 7
  Nystagmus 4 2 5 10 5
  Balance disorder 0 1 5 6 4
  Memory impairment 2 1 2 6 2
Psychiatric disorders
  Depression 1 2 2 2 2
Skin and subcutaneous disorders
  Pruritus 1 3 2 3 2
*600 mg dose is 1.5 times greater than the maximum recommended dose.

The overall adverse reaction rate was similar in male and female patients. Although there were few non-Caucasian patients, no differences in the incidences of adverse reactions compared to Caucasian patients were observed.

Pediatric Patients (4 To Less Than 17 Years Of Age)

Safety of VIMPAT was evaluated in clinical studies of pediatric patients 4 to less than 17 years of age for the treatment of partial-onset seizures. Across studies in pediatric patients with partial-onset seizures, 328 patients 4 to less than 17 years of age received VIMPAT oral solution or tablet, of whom 148 received VIMPAT for at least 1 year. Adverse reactions reported in clinical studies of pediatric patients 4 to less than 17 years of age were similar to those seen in adult patients.

Laboratory Abnormalities

Abnormalities in liver function tests have occurred in controlled trials with VIMPAT in adult patients with partial-onset seizures who were taking 1 to 3 concomitant anti-epileptic drugs. Elevations of ALT to ≥3× ULN occurred in 0.7% (7/935) of VIMPAT patients and 0% (0/356) of placebo patients. One case of hepatitis with transaminases >20x ULN occurred in one healthy subject 10 days after VIMPAT treatment completion, along with nephritis (proteinuria and urine casts). Serologic studies were negative for viral hepatitis. Transaminases returned to normal within one month without specific treatment. At the time of this event, bilirubin was normal. The hepatitis/nephritis was interpreted as a delayed hypersensitivity reaction to VIMPAT.

Other Adverse Reactions

The following is a list of adverse reactions reported by patients treated with VIMPAT in all clinical trials in adult patients with partial-onset seizures, including controlled trials and long-term open-label extension trials. Adverse reactions addressed in other tables or sections are not listed here.

Blood and lymphatic system disorders: neutropenia, anemia

Cardiac disorders: palpitations

Ear and labyrinth disorders: tinnitus

Gastrointestinal disorders: constipation, dyspepsia, dry mouth, oral hypoaesthesia

General disorders and administration site conditions: irritability, pyrexia, feeling drunk

Injury, poisoning, and procedural complications: fall

Musculoskeletal and connective tissue disorders: muscle spasms

Nervous system disorders: paresthesia, cognitive disorder, hypoaesthesia, dysarthria, disturbance in attention, cerebellar syndrome

Psychiatric disorders: confusional state, mood altered, depressed mood

VIMPAT Injection

Adverse reactions with intravenous administration to adult patients generally were similar to those that occurred with the oral formulation, although intravenous administration was associated with local adverse reactions such as injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%). One case of profound bradycardia (26 bpm: BP 100/60 mmHg) occurred in a patient during a 15-minute infusion of 150 mg VIMPAT. This patient was on a beta-blocker. Infusion was discontinued and the patient experienced a rapid recovery.

The safety of a 15-minute loading dose administration of VIMPAT Injection 200 mg to 400 mg followed by oral administration of VIMPAT given twice daily at the same total daily dose as the initial intravenous infusion was assessed in an open-label study in adult patients with partial-onset seizures. Patients had to have been maintained on a stable dose regimen of 1 to 2 marketed antiepileptics for at least 28 days prior to treatment assignment. Treatment groups were as follows:

  • Single dose of intravenous VIMPAT Injection 200 mg followed by oral VIMPAT 200 mg/day (100 mg every 12 hours)
  • Single dose of intravenous VIMPAT Injection 300 mg followed by oral VIMPAT 300 mg/day (150 mg every 12 hours)
  • Single dose of intravenous VIMPAT Injection 400 mg followed by oral VIMPAT 400 mg/day (200 mg every 12 hours).

Table 4 gives the incidence of adverse reactions that occurred in ≥5% of adult patients in any VIMPAT dosing group.

Table 4: Adverse Reactions in a 15-minute Infusion Study in Adult Patients with Partial-Onset Seizures

Adverse Reaction VIMPAT
200 mg
N=25
%
VIMPAT
300 mg
N=50
%
VIMPAT
400 mg
N=25
%
VIMPAT Total
N=100
%
Eye disorders
  Diplopia 4 6 20 9
  Blurred Vision 0 4 12 5
Gastrointestinal disorders
  Nausea 0 16 24 14
  Dry mouth 0 6 12 6
  Vomiting 0 4 12 5
  Oral Paresthesia 4 4 8 5
  Oral Hypoesthesia 0 6 8 5
  Diarrhea 0 8 0 4
General disorders/administration site conditions
  Fatigue 0 18 12 12
  Gait disturbance 8 2 0 3
  Chest pain 0 0 12 3
Nervous system disorders
  Dizziness 20 46 60 43
  Somnolence 0 34 36 26
  Headache 8 4 16 8
  Paresthesia 8 6 4 6
  Tremor 0 6 4 4
  Abnormal Coordination 0 6 0 3
Skin & subcutaneous tissue disorders
  Pruritus 0 6 4 4
  Hyperhidrosis 0 0 8 2

Adverse reactions that occurred with infusion of VIMPAT 200 mg over 15-minutes followed by VIMPAT 100 mg administered orally twice per day were similar in frequency to those that occurred in 3-month adjunctive therapy controlled trials. Considering the difference in period of observations (1 week vs. 3 months), the incidence of CNS adverse reactions, such as dizziness, somnolence, and paresthesia may be higher with 15minute administration of VIMPAT Injection than with administration over a 30-to 60-minute period.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of VIMPAT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: Agranulocytosis

Psychiatric disorders: Aggression, agitation, hallucination, insomnia, psychotic disorder

Skin and subcutaneous tissue disorders: Angioedema, rash, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis.

DRUG INTERACTIONS

Strong CYP3A4 Or CYP2C9 Inhibitors

Patients with renal or hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to VIMPAT. Dose reduction may be necessary in these patients.

Concomitant Medications That Prolong PR Interval

VIMPAT should be used with caution in patients on concomitant medications that prolong PR interval, because of a risk of AV block or bradycardia, e.g., beta-blockers and calcium channel blockers. In such patients, obtaining an ECG before beginning VIMPAT, and after VIMPAT is titrated to steady-state, is recommended. In addition, these patients should be closely monitored if they are administered VIMPAT through the intravenous route [see WARNINGS AND PRECAUTIONS].

Drug Abuse And Dependence

Controlled Substance

VIMPAT is a Schedule V controlled substance.

Abuse

In a human abuse potential study, single doses of 200 mg and 800 mg lacosamide produced euphoria-type subjective responses that differentiated statistically from placebo; at 800 mg, these euphoria-type responses were statistically indistinguishable from those produced by alprazolam, a Schedule IV drug. The duration of the euphoria-type responses following lacosamide was less than that following alprazolam. A high rate of euphoria was also reported as an adverse event in the human abuse potential study following single doses of 800 mg lacosamide (15% [5/34]) compared to placebo (0%) and in two pharmacokinetic studies following single and multiple doses of 300-800 mg lacosamide (ranging from 6% [2/33] to 25% [3/12]) compared to placebo (0%). However, the rate of euphoria reported as an adverse event in the VIMPAT development program at therapeutic doses was less than 1%.

Dependence

Abrupt termination of lacosamide in clinical trials with diabetic neuropathic pain patients produced no signs or symptoms that are associated with a withdrawal syndrome indicative of physical dependence. However, psychological dependence cannot be excluded due to the ability of lacosamide to produce euphoria-type adverse events in humans.

Read the entire FDA prescribing information for Vimpat (Lacosamide Tablet and Injection)

Related Resources for Vimpat

Read the Vimpat User Reviews »

© Vimpat Patient Information is supplied by Cerner Multum, Inc. and Vimpat Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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