Pronunciation:

la-KOE-sa-mide

Brand Names:

• Vimpat

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Anticonvulsant

Uses of This Medicine:

Lacosamide injection is used to treat partial-onset seizures. It is also used with other medicines to treat primary generalized tonic-clonic seizures. It acts on the central nervous system (CNS) to reduce the number and severity of seizures.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lacosamide injection in children younger than 4 years of age to treat primary generalized tonic-clonic seizures and in children younger than 1 month of age to treat partial-onset seizures. Safety and efficacy have not been established.

Older adults—

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.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Acecainide
• Acepromazine
• Ajmaline
• Alfentanil
• Alprazolam
• Amiodarone
• Amitriptyline
• Amlodipine
• Amobarbital
• Anileridine
• Aprindine
• Aranidipine
• Aripiprazole
• Aripiprazole Lauroxil
• Asenapine
• Atazanavir
• Atenolol
• Baclofen
• Benperidol
• Benzhydrocodone
• Bepridil
• Betaxolol
• Bisoprolol
• Bretylium
• Bromazepam
• Buprenorphine
• Buspirone
• Butabarbital
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Carteolol
• Carvedilol
• Celiprolol
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Cilnidipine
• Clevidipine
• Clobazam
• Clonazepam
• Clorazepate
• Clozapine
• Codeine
• Cyclobenzaprine
• Daridorexant
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Disopyramide
• Dofetilide
• Dolasetron
• Doxylamine
• Dronedarone
• Droperidol
• Encainide
• Enflurane
• Esketamine
• Eslicarbazepine Acetate
• Esmolol
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Felodipine
• Fentanyl
• Flecainide
• Flibanserin
• Flunitrazepam
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxyzine
• Ibutilide
• Indecainide
• Isoflurane
• Isradipine
• Ketamine
• Ketazolam
• Ketobemidone
• Labetalol
• Lercanidipine
• Levobunolol
• Levocetirizine
• Levorphanol
• Lidocaine
• Lopinavir
• Lorazepam
• Loxapine
• Magnesium Oxybate
• Manidipine
• Meclizine
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metipranolol
• Metoprolol
• Mexiletine
• Midazolam
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nadolol
• Nalbuphine
• Nebivolol
• Nicardipine
• Nicomorphine
• Nifedipine
• Nimodipine
• Nisoldipine
• Nitrazepam
• Nitrendipine
• Nitrous Oxide
• Olanzapine
• Opium
• Opium Alkaloids
• Orlistat
• Orphenadrine
• Oxazepam
• Oxprenolol
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Penbutolol
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Pimozide
• Pindolol
• Piperacetazine
• Pipotiazine
• Piritramide
• Potassium Oxybate
• Prajmaline
• Prazepam
• Primidone
• Procainamide
• Prochlorperazine
• Promazine
• Promethazine
• Propafenone
• Propofol
• Propranolol
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Ramelteon
• Remifentanil
• Remimazolam
• Remoxipride
• Ritonavir
• Saquinavir
• Secobarbital
• Sertindole
• Sodium Oxybate
• Sotalol
• Sparteine
• Sufentanil
• Sulpiride
• Suvorexant
• Tapentadol
• Tedisamil
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tilidine
• Timolol
• Tizanidine
• Tocainide
• Tolonium Chloride
• Topiramate
• Tramadol
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Verapamil
• Zaleplon
• Zolpidem
• Zopiclone
• Zotepine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brugada syndrome (genetic disease) or
• Depression, history of or
• Drug or alcohol abuse or dependence, history of or
• Heart attack or
• Heart block or
• Heart disease (eg, heart failure, myocardial ischemia) or
• Heart failure or
• Heart rhythm problems (eg, prolonged PR interval) or
• Mental illness, history of or
• Sick sinus syndrome (type of abnormal heart rhythm), without pacemaker—Use with caution. May make these conditions worse.

• Diabetic neuropathy (nerve problem caused by diabetes) or
• Heart or blood vessel disease—May increase risk for more serious side effects.

• Kidney disease, severe or
• 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.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. It is given through a needle placed into one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 15 to 60 minutes.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Ask your doctor if you have any questions.

Your doctor may give you a few doses of this medicine until your condition improves, and then you may be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.. Blood and urine tests may be needed to check for unwanted effects.

If you develop any unusual or strange thoughts and behavior while receiving lacosamide injection, be sure to discuss it with your doctor. Some changes that have occurred in people receiving this medicine are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, drowsiness, sleepiness, or trouble with thinking. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If these side effects are especially bothersome, check with your doctor.

This medicine can cause changes in heart rhythms, including a condition called PR prolongation. It may change the way your heart beats and cause lightheadedness, fainting, or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, including fast, slow, or irregular heartbeats.

Lacosamide injection may cause a condition called drug reaction with eosinophilia and systemic symptoms (DRESS), which is a serious allergic reaction affecting multiple body organs (eg, liver or kidney). Check with your doctor right away if you have fever, dark urine, headache, rash, stomach pain, swollen, painful, or tender lymph glands in the neck, armpit, or groin, unusual tiredness, or yellow eyes or skin.

Breastfeeding during treatment with this medicine may cause your baby to be more sleepy. Talk with your doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Dizziness

shakiness and unsteady walk

sleepiness or unusual drowsiness

trembling or shaking of the hands or feet

unsteadiness, trembling, or other problems with muscle control or coordination

Less common

Being forgetful

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

discouragement

feeling sad or empty

irritability

itching skin

lack of appetite

loss of balance control

loss of interest or pleasure

mood or mental changes

tearing of the skin

tiredness

trouble concentrating

trouble with sleeping

trouble with walking

Rare

Chest pain or discomfort

flushing or redness of the skin

lightheadedness, dizziness, or fainting

slow or irregular heartbeat

unusual tiredness

unusually warm skin

Incidence not known

Abnormal or decreased touch sensation

black, tarry stools

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

changes in patterns and rhythms of speech

chills

continuing ringing or buzzing or other unexplained noise in the ears

cough

fast, irregular, pounding, or racing heartbeat or pulse

feeling drunk

fever

hearing loss

lower back or side pain

painful or difficult urination

pale skin

slurred speech

sore throat

trouble breathing

trouble performing routine tasks

trouble with balance

trouble with speaking

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Blurred vision

double vision

headache

nausea

seeing double

vomiting

Less common

Diarrhea

feeling of constant movement of self or surroundings

lack or loss of strength

sensation of spinning

uncontrolled eye movements

Incidence not known

Acid or sour stomach

belching

blistering, peeling, loosening of the skin

constipation

difficulty having a bowel movement

dry mouth

heartburn

increased sweating

indigestion

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

muscle spasms

red irritated eyes

red skin lesions, often with a purple center

stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.