Lacosamide (Intravenous)

Lacosamide injection is used to treat partial-onset seizures. It is also used with other medicines to treat primary generalized tonic-clonic seizures. It works on the central nervous system (CNS) to decrease the frequency and intensity of seizures.

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

Your doctor will closely monitor your progress while you are receiving this medicine. This will help your doctor determine if the medicine is working correctly and if you should continue using it. Blood and urine tests may be necessary to check for unwanted effects.

If you notice any unusual or strange thoughts and behavior while receiving lacosamide injection, make sure to talk to your doctor. Some changes seen in people taking this medicine are similar to those seen in people who consume too much alcohol. Other changes may include confusion, worsening depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine can cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, drowsiness, sleepiness, or difficulties with thinking. Do not drive or engage in any activities that could be dangerous until you understand how this medicine affects you. If these side effects are particularly bothersome, consult your doctor.

This medicine may lead to changes in heart rhythms, including a condition known as PR prolongation. It might alter the way your heart beats and cause lightheadedness, fainting, or serious side effects in some patients. Contact your doctor immediately if you experience any symptoms of heart rhythm problems, such as fast, slow, or irregular heartbeats.

Lacosamide injection may result in a serious allergic reaction called drug reaction with eosinophilia and systemic symptoms (DRESS), which affects multiple organs in the body (e.g., liver or kidney). Consult your doctor right away if you experience 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 while using this medicine may cause your baby to be sleepier. Discuss any concerns with your doctor.

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

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this drug or any other medicines. Also inform 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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of lacosamide injection in the elderly. Nevertheless, elderly patients are more likely to have age-related liver, kidney, or heart issues, 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 medicine during breastfeeding. Weigh the potential benefits against the potential risks before taking this medicine while breastfeeding.

Interactions with Medicines

Although certain medications 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 clinician may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially essential 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 drug with any of the following medicines is typically not advised, but may be required in some cases. If both drugs are prescribed together, your doctor may change the dose or how frequently you use one or both of the medications.

• 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

Interactions with Food/Tobacco/Alcohol

Certain drugs 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 medications 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 normally not advised, but may be unavoidable in some cases. If used together, your clinician may change the dose or how frequently you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Issues

The presence of other medical issues may affect the use of this drug. Make sure you tell your physician if you have any other medical issues, 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 raise chance for more severe adverse effects.

• Kidney disease, serious or
• Liver disease, slight to moderate—Use with caution. The effects may be increased because of slower removal of the drug from the body.

• Liver disease, severe—Should not be used in patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away 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 healthcare professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare 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.

In the U.S.

• Vimpat

Available Dosage Forms:

• Solution

Therapeutic Class: Anticonvulsant

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.