Brand Name(s):

Vimpat^® I.V.

WHY is this medicine prescribed?

Lacosamide injection is used in combination with other medications to control certain types of seizures in people who cannot take oral medications. Lacosamide injection is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

HOW should this medicine be used?

Lacosamide injection comes as a solution (liquid) to be given through a needle or catheter placed in your vein. It is usually infused (injected slowly) intravenously (into a vein) over a period of 30 to 60 minutes, twice a day (morning and night). You may receive lacosamide injection in a hospital or you may use the medication at home. If you are using lacosamide injection at home, use it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or health care provider to explain any part you do not understand. Use lacosamide injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

If you will be using lacosamide injection at home, your health care provider will show you how to infuse the medication. Be sure that you understand these directions, and ask your health care provider if you have any questions. Ask your health care provider what to do if you have any problems infusing lacosamide injection.

Your doctor will probably start you on a low dose of lacosamide injection and gradually increase your dose, not more often than once a week.

Lacosamide injection may help control your condition but will not cure it. It may take a few weeks or longer before you feel the full benefit of lacosamide injection. Continue to use lacosamide injection even if you feel well. Do not stop using lacosamide injection without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop using lacosamide injection, your seizures may happen more often. Your doctor will probably decrease your dose gradually.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using lacosamide injection,

tell your doctor and pharmacist if you are allergic to lacosamide, any other medications, or any of the ingredients in lacosamide injection. Ask your pharmacist for a list of the ingredients.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had an irregular heartbeat; a heart attack; heart failure; diabetic neuropathy (nerve damage caused by diabetes); or heart, liver, or kidney disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using lacosamide injection, call your doctor.
you should know that lacosamide injection may make you dizzy or drowsy and may cause blurred vision or problems with coordination and balance. Do not drive a car, operate machinery, or participate in activities requiring alertness or coordination until you know how this medication affects you.
you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are using lacosamide injection. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants like lacosamide injection to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as 1 week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as lacosamide injection, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling asleep or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
you should know that lacosamide injection may cause dizziness, lightheadedness, fainting, or irregular heartbeat, especially when you get up too quickly from a lying position. If you develop these symptoms, lie down with your legs raised until you feel better, and call your doctor right away.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If only a few hours have passed since you were scheduled to inject the dose, inject the missed dose as soon as you remember it. However, if more than a few hours have passed, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Your healthcare provider will tell you how to store your medication. Store your medication only as directed. Make sure you understand how to store your medication properly.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online athttps://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Lacosamide injection is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS^® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2016.