Lacosamide

How to take tablets and oral solution:

Take lacosamide exactly as your health care provider prescribes it. Do not change your dose without talking to your provider first. Stopping a seizure medicine suddenly can cause generalized tonic-clonic seizures and seizures that will not stop (status epilepticus).

• Check the number of tablets and the strength of the pills you get from the pharmacy. If your provider changes your dose, the strength of the pills may be different. 
• Lacosamide is usually given twice a day, about 12 hours part. Sometimes it may be given more often to lessen side effects if they occur. 
• Swallow the tablets whole with a glass of water - do not chew them. They can be crushed and mixed with food if swallowing is a problem, but they may have a bitter taste. 
• Lacosamide is absorbed well from the stomach. It can be taken with or without food, but take it the same way each time.
• The oral solution form can be used if people have trouble swallowing pills. 
  • Always check the bottle for the amount to take and the strength. Vimpat solution comes as 10 mg in every ml.
  • Shake the bottle well before measuring a dose. 
  • Always use an accurate measuring spoon or syringe to make sure the amount is correct. Do not use a regular teaspoon. 
• Take only the amount your provider tells you to take. If you take an extra dose, call your provider for advice. If you take a larger number of pills or overdose, call the poison control center (800-222-1222) or call your hospital emergency room. 

How to store tablets and oral solution:

• Store lacosamide at room temperature (below 86^oF, 30^oC).
• Keep them away from light and moisture.
• Keep all medicines out of reach of children.
• The oral solution should be used within 7 weeks of opening the bottle. Any unused solution of lacosamide should be thrown out after this time.  

How to give and store the injection form:

• The injection form can be given directly into a vein (intravevous or IV) or mixed with a recommended solution.
• Giving the injection form can lead to changes in the heart rate. Checking an electrocardiogram or ECG (test of a person's heart rate and rhythm) is recommended before giving lacosamide IV. 
• The medicine is generally given over 30 to 60 minutes. It can be given over 15 minutes, if needed. 
• The IV form is intended for temporary use - not longer than 5 days. 
• The IV form can be kept at room temperature for up to 4 hours. 
• Throw out any unused lacosamide from the single dose vial. 

Taking the right amount of seizure medicine on time every day is the most important way to control seizures. Try these steps to help you remember when to take lacosamide. 

• If you miss a dose, take it as soon as you remember it. 
• If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. If you are not sure what to do, call your doctor's office for more advice. 
• Avoid taking two doses at the same time or taking extra doses, unless your provider has asked you to do this. 
• To avoid missed doses, use a pillbox or set an alarm on your watch or phone.
• Send reminders to yourself with an online seizure diary or text message system like Texting 4 Control. 
• Ask your pharmacist to prefill the medicine in blisterpaks. 
• Write down any missed doses in your seizure calendar. Share this with your provider at each visit. 

• Brain cells work and talk to each other by generating electrical discharges. These discharges must be sent or fire at a certain rate to function normally. Sodium channels are like gates in brain cells - they help to spread electrical activity from one cell to another. 
• Most seizure medicines slow down the electrical discharges in some way.
• Lacosamide may help to slow down or turn off sodium channels in the brain. This may help stop a seizure and allow brain cells to recover. 

How the body absorbs, digests, and gets rid of a medicine or food is called metabolism. The way the body breaks down a medicine affects how often it should be taken and if it will interact other medicines or food. Some medical conditions such as liver disease can also affect a drug's metabolism.  

• After taking lacosamide, the highest blood levels are reached in 1 to 4 hours. 
• It takes about 13 hours for the amount of medicine in the bloodstream to fall by at least 50%. This means that the medicine should be taken twice a day, about 12 hours apart.
• Lacosamide is broken down in the liver. The kidneys clear the medicine from the body.
• People with poor kidney function may need a lower dose of drug, as it may stay in the bloodstream longer. 

Not all seizure medicines work for everyone. Your health care provider may try a series of medicines or more than one seizure medicine at a time to find one that works best for you. 

In studies of lacosamide, when it was used with other seizure medicines in people with uncontrolled seizures, the following benefits were seen.

• Number of seizures was reduced by about 35 to 40%
• About 40% of people had their seizures lowered by 50%
• A study using lacosamide alone (as monotherapy) in people with uncontrolled seizures was also helpful to control focal seizures.

Th most common side effects include: 

• Coordination problems 
• Dizziness
• Double vision
• Headache
• Nausea, vomiting
• Sleepiness
• Unsteady walking

Problems with coordination and walking usually get better over a few weeks. Tell your provider if the problems continue. 

• Do not operate any heavy machinery or do other dangerous activities if you are having side effects affecting coordination, walking or safety.
• Talk to your provider about driving and do not drive if you are still having seizures. 

In clinical trials, some people stopped taking lacosamide more often due to dizziness than for other side effects.

Less common side effects: 

• Change in blood tests of liver function and blood counts have been seen in small numbers of people. These could make a person prone to anemia or infections. 
• Electrocardiograms (ECGs) of heart rhythms showed a slowing of electrical signal in the heart (called PR prolongation) in some people. The chance of this happening may be related to the dose used. 
  • People with known heart rhythm or conduction problems should talk to their doctor before using this medicine. 

Very few people have serious side effects from lacosamide. It is important to be aware of possible reactions and what to do if they happen. 

• Read the package insert for more information.
• Call your provider's office right away if any of these problems occur. 

Heart rhythm problems: Electrocardiograms (ECGs) of heart rhythms showed a slowing of electrical signal in the heart (called PR prolongation) in some people. The risk of a heart rhythm problem called atrial fibrillation may be higher. These heart rhythm problems are usually rare. 

• People with heart problems or on higher doses of lacosamide may be at higher risk.

 Low white blood cells: Rarely, a drop in white blood cells may be seen. 

Allergic reactions: Allergic reactions happen rarely, but can cause symptoms such as low blood pressure, hives, rash, breathing difficulties, and swelling. It can happen after the first dose or any time when taking lacosamide. Since this can be life-threatening, if these symptoms occur, get immediate medical help.  

Suicidal thoughts and behavior: In 2008, the Food and Drug Administration (FDA) reviewed data from drug studies that showed a possible relationship between many seizure medicines and suicidal thoughts and behavior. Together, these thoughts and behavior are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, more had symptoms of suicidality than people taking a placebo or inactive substance - 3.5 of 1,000 people taking a seizure medicine had suicidality compared to 1 of 1,000 people taking a placebo. The FDA has provided the following information for patients, family members, and caregivers at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm.

• Taking seizure medicines may increase the risk of having suicidal thoughts or actions.
• Do not make any changes to the medicines without first talking to the prescribing health care provider.
• Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
• Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
  • Talking or thinking about wanting to hurt yourself or end your life
  • Withdrawing from friends and family
  • Becoming depressed or having your depression get worse
  • Becoming preoccupied with death and dying
  • Giving away prized possessions
• Contact your health care provider before stopping any seizure meicine. This could possibly lead to worsening of seizure and mood. 

People should not take lacosamide if they have had an allergic reaction to it or any of the inactive ingredients. 

People with phenylketonuria (PKU) are sensitive to phenylalanine. Since lacosamide oral solution has some aspartame in it, talk to your doctor before using this form. Phenylalanine can be found in aspartame. 

Sometimes one kind of medicine changes the way another one works in the body. This can happen with prescription and over-the-counter medicines, herbal products, vitamins, and some foods. Tell your health care providers any time a new medicine is given to you or any time you take other products or substances. 

• Lacosamide may interact with phenytoin (Dilantin) or Clonazepam (Klonopin). Talk to your doctor if you are on one of these medicines or if changes are seen when taking other seizure medicines. The dose of medicines may need to be changed.  
• Changes in heart rate may be seen if lacosamide is taken with certain medicines that slow the heart rate. Talk to your provider if you are on these medicines so you are checked more closely.  
• Lacosamide is not known to affect hormonal birth control.  

Lacosamide is approved for use in children 4 years and older.  

• The dosing of lacosamide in children is based on weight. See the package insert for details on starting and dosing of this medicine in children. 
• Side effects of lacosamide seen in children are similar to those in adults. 

Effect of seizure medicines during pregnancy: In the United States, the FDA assigns each medication to a Pregnancy Category according to whether it has been proven to be harmful in pregnancy. Lacosamide is listed in Pregnancy Category C. This means that caution is advised, but the benefits of the medicine may outweigh the potential risks.

• Talk to your health care providers if you are pregnant or plan to become pregnant.
• The risk of birth defects is generally higher in children of women who:
  • Take more than one seizure medicine at the same time
  • Have a family history of birth defects

All women who are capable of becoming pregnant should take at least 0.4 mg (400 mcg) each day of the vitamin called folic acid (also called folate). This vitamin is thought to help prevent birth defects affecting the brain and spinal cord, called neural tube defects. The most common of these is known as spina bifida.

• Women at high risk of having a child with a birth defect (such as those with a birth defect in a previous pregnancy or taking certain seizure medicines) may be asked to take 4 mg (4000 mcg) daily before and during pregnancy.
• Talk to your health care provider about using folic acid and how much to take.
• Start taking this vitamin before you become pregnant.

If you were taking lacosamide while pregnant, consider enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 (www.aedpregnancyregistry.org).

Seizures during pregnancy: Some women may have more seizures during pregnancy, because of hormone changes and how seizure medicine is handled by your body.

• Talk to your health care provider before pregnancy about seizures and if medicine changes may be needed.
• Know when to check blood levels of medicine during and after pregnancy.
• The dose of seizure medicine may need to be adjusted during and after pregnancy.

Breastfeeding: The amount of lacosamide found in breastmilk is not known for certain. The way lacosamide works in the body suggests there may be a relatively large amount passed into breastmilk.

• Women who wish to breastfeed should talk to their doctor about the best medicine to use during pregnancy and when breastfeeding.
• If you choose to breastfeed, check the baby for drowsiness and keep track of their weight gain and development, especially if you are taking more than one seizure medicine.
• Talk to your health care team about any concerns that arise and if you have any problems with breastfeeding.

Contraception: Lacosamide does not appear to affect hormonal birth control.

Information on use of lacosamide in older adults is limited. 

• Seniors may have a higher risk of drug interactions, as they may be taking more medicines in general. For example, older adults taking a medicine that may affect heart rate should be watched closely.
• Older adults may be more sensitive to certain side effects, for example, dizziness, sleepiness, poor coordination or unsteady walking. These problems could lead to falls or accidents, so seniors should report any side effects to their provider.

The best amount of seizure medicine is the amount that controls seizures without causing bothersome side effects. This depends on many factors, which are different for every person. 

• The approved dose range of lacosamide for adults is 200 to 400 mg daily.
• When used as the only seizure medicine, the lowest recommended dose is 300 mg.
• Lower doses may be used if people have side effects or the amount may be increased more slowly.
• Higher doses may be needed in some people as well, though higher doses may cause more side effects.

In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called "prescribing information") online. The U.S. package insert for Vimpat (lacosamide) is found at:

• http://www.vimpat.com/pdf/vimpat_PI.pdf

Learn how to read a package insert here.