Vimpat Side Effects

Generic Name: lacosamide

Please note - some side effects for Vimpat may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Vimpat - for the Consumer

Vimpat

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Vimpat:

Blurred vision; dizziness; drowsiness; headache; irritability; mild itching, pain, or redness at the injection site; nausea; tiredness; tremor; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Vimpat:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavioral changes (eg, aggression; agitation; anger; anxiety; hostility); confusion; dark urine; decreased coordination or loss of balance; double vision or other vision changes; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes (eg, new or worsening depression); new or worsening seizures; severe or persistent drowsiness, tiredness, or weakness; shortness of breath; suicidal thoughts or attempts; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Vimpat Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Vimpat Tablets:

Blurred vision; dizziness; drowsiness; headache; irritability; nausea; tiredness; tremor; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Vimpat Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavioral changes (eg, aggression; agitation; anger; anxiety; hostility); confusion; dark urine; decreased coordination or loss of balance; double vision or other vision changes; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes (eg, new or worsening depression); new or worsening seizures; severe or persistent drowsiness, tiredness, or weakness; shortness of breath; suicidal thoughts or attempts; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Vimpat Side Effects - for the Professional

Vimpat

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.

In all controlled and uncontrolled trials in patients with partial-onset seizures, 1327 patients have received Vimpat of whom 1000 have been treated for longer than 6 months and 852 for longer than 12 months.

Clinical Trials Experience

Controlled Trials

Adverse reactions leading to discontinuation

In controlled clinical trials, the rate of discontinuation as a result of an adverse event 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, and 5% in patients randomized to receive placebo. The adverse events most commonly (>1% in the Vimpat total group and greater than placebo) leading to discontinuation were dizziness, ataxia, vomiting, diplopia, nausea, vertigo, and vision blurred.

Most common adverse reactions

Table 2 gives the incidence of treatment-emergent adverse events that occurred in ≥2% of adult patients with partial-onset seizures in the total Vimpat group and for which the incidence was greater than placebo. The majority of adverse events in the Vimpat patients were reported with a maximum intensity of 'mild' or 'moderate'.

Table 2: Treatment-Emergent Adverse Event Incidence in Double-Blind, Placebo-Controlled Partial-Onset Seizure Trials (Events ≥2% of Patients in Vimpat Total and More Frequent Than in the Placebo Group)

System Organ Class/ Preferred Term	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
Vision blurred	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

Laboratory abnormalities

Abnormalities in liver function tests have been observed 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 was observed 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 in Patients with Partial-Onset Seizures

The following is a list of treatment-emergent adverse events reported by patients treated with Vimpat in all clinical trials in patients with partial-onset seizures, including controlled trials and long-term open-label extension trials. Events addressed in other tables or sections are not listed here. Events included in this list from the controlled trials occurred more frequently on drug than on placebo and were based on consideration of Vimpat pharmacology, frequency above that expected in the population, seriousness, and likelihood of a relationship to Vimpat. Events are further classified within system organ class.

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

Intravenous Adverse Reactions

Adverse reactions with intravenous administration generally appeared similar to those observed with the oral formulation, although intravenous administration was associated with local adverse events 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) was observed in a patient during a 15 minute infusion of 150mg Vimpat. This patient was on a beta-blocker. Infusion was discontinued and the patient experienced a rapid recovery.

Comparison of Gender and Race

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

Postmarketing Experience

The following adverse reactions have been identified during postapproval 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.

Cardiac disorders: Bradycardia

Skin and subcutaneous tissue disorders: Rash

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Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects including dizziness (31%), headache (13%), ataxia (8%), somnolence (7%), tremor (7%), nystagmus (5%), balance disorder (4%), memory impairment (2%), paresthesia, cognitive disorder, hypoesthesia, dysarthria, disturbance in attention, and cerebellar syndrome have been reported.

Gastrointestinal

Gastrointestinal side effects including vomiting (9%), diarrhea (4%), nausea (1%), constipation, dyspepsia, dry mouth, and oral hypoesthesia have been reported.

Ocular

Ocular side effects including diplopia (11%) and blurred vision (8%) have been reported.

General

General side effects including fatigue (9%), gait disturbance (2%), asthenia (2%), irritability, pyrexia, and feeling drunk have been reported.

Other

Other side effects including vertigo (4%), contusion (3%), skin laceration (3%), fall, and tinnitus have been reported.

Local

Local side effects following intravenous administration included injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%).

Psychiatric

Psychiatric side effects including depression (2%), confusional state, and altered mood have been reported.

Dermatologic

Dermatologic side effects including pruritus (2%) have been reported.

Cardiovascular

Cardiovascular side effects including palpitations have been reported.

One case of profound bradycardia (26 beats per minute: BP 100/60 mmHg) was observed in a patient during a 15 minute infusion of lacosamide. This patient was also on a beta-blocker. Infusion was discontinued and the patient experienced a rapid recovery.

Musculoskeletal

Musculoskeletal side effects including muscle spasms have been reported.

Hematologic

Hematologic side effects including neutropenia and anemia have been reported.

Hepatic

Abnormalities in liver function tests have been observed in controlled trials with lacosamide in adult patients with partial-onset seizures who were taking 1 to 3 concomitant antiepileptic drugs. Elevations of ALT to greater than or equal to 3 times the ULN occurred in 0.7% of lacosamide patients and 0% of placebo patients. One case of hepatitis with transaminases greater than 20 times the ULN was observed in one healthy subject 10 days after lacosamide treatment completion, along with nephritis (proteinuria and urine casts).

Hepatic side effects including abnormalities in liver function tests have been reported.

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