What is Vimpat (lacosamide), and how does it work?
Vimpat is a prescription medicine used to treat partial-onset seizures in people 4 years of age and older.
- It is not known if Vimpat injection is safe for use in children. Children age 4 years and older should only take
Vimpat by mouth. Vimpat injection is only for use in people 17 years of age and older. - It is not known if Vimpat is safe and effective in children under 4 years of age.
What are the side effects of Vimpat?
Do not stop taking Vimpat without first talking to your healthcare provider. Stopping
Vimpat suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
Vimpat can cause serious side effects, including:
- Like other antiepileptic drugs, Vimpat may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- attempt to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
- Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
- Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
- Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
- Vimpat may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking. Do not drive, operate heavy machinery, or do other dangerous activities until you know how
Vimpat affects you. - Vimpat may cause you to have an irregular heartbeat or may cause you to faint. In rare cases, cardiac arrest has been reported. Call your healthcare provider right away if you:
- have a fast, slow, or pounding heartbeat or feel your heart skip a beat
- have shortness of breath
- have chest pain
- feel lightheaded
- fainted or if you feel like you are going to faint
If you have fainted or feel like you are going to faint you should lay down with your legs raised.
Vimpat may cause other serious side effects including:
- A serious allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. Call your healthcare provider right away if you have:
The most common side effects of Vimpat in adults include:
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
Side effects of Vimpat in children are similar to those seen in adults. These are not all of the possible side effects of
Vimpat. For more information ask your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Does Vimpat cause addiction and withdrawal symptoms?
Vimpat is a federally controlled substance (CV) because it can be abused or lead to drug dependence. Keep your
Vimpat in a safe place, to protect it from theft. Never give your Vimpat to anyone else, because it may harm them. Selling or giving away this medicine is against the law.
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.
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What is the dosage for Vimpat?
- Take Vimpat exactly as your healthcare provider tells you.
- Your healthcare provider will tell you how much Vimpat to take and when to take it.
- Your healthcare provider may change your dose if needed.
- Do not stop Vimpat without first talking to a healthcare provider. Stopping
Vimpat suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). - Vimpat may be taken with or without food.
- Swallow Vimpat tablets whole with liquid. Do not cut Vimpat tablets.
- If your healthcare provider has prescribed Vimpat oral solution, be sure to ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of
Vimpat oral solution. Do not use a household teaspoon. Ask your pharmacist for instructions on how to use the measuring device the right way. - If you take too much Vimpat, call your healthcare provider or local Poison Control Center right away.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how
Vimpat affects you. Vimpat may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking.
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What drugs interact with Vimpat?
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 Affect Cardiac Conduction
Vimpat should be used with caution in patients on concomitant medications that affect cardiac conduction (sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers) including those that prolong PR interval (including sodium channel blocking AEDs), because of a risk of AV block, bradycardia, or ventricular tachyarrhythmia. 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.
Is Vimpat safe to take while pregnant or breastfeeding?
Before you take Vimpat, tell your healthcare provider about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant. It is not known if Vimpat can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking
Vimpat. You and your healthcare provider will decide if you should take
Vimpat while you are pregnant.- If you become pregnant while taking Vimpat, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.
- are breastfeeding or plan to breastfeed. It is not known if Vimpat passes into your breast milk or if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take
Vimpat.