Cenobamate

Cenobamate (See-no-BAH-mate) is the generic name (non-brand name) of a seizure medicine with the brand name Xcopri from SK Biopharma

Xcopri

Used to treat

Focal Aware or Simple Partial Seizure

Forms

Strength Color/Shape Tablet Markings
12.5 mg Uncoated round white to off white tablets SK marking on one side and 12 on the other side
25 mg Film-coated round brown tablets

SK marking on one side and 25 on the other side

50 mg Film-coated round yellow tablets

SK marking on one side and 50 on the other side

100 mg Film-coated round brown tablets

SK marking on one side and 100 on the other side

150 mg Film-coated round light orange tablets

SK marking on one side and 150 on the other side

200 mg Film-coatd modified oval light orange tablets

SK marking on one side and 200 on the other side

 

Dosing

The recommened dosage and titration should not be modified, because it can potentially lead to serious adverse reactions. 

Initial Dosage

Week 1 & Week 2 12.5 mg QD

 

Titration

Week 3 & Week 4 25 mg QD
Week 5 & Week 6 50 mg QD
Week 7 & Week 8 100 mg QD
Week 9 & Week 10 150 mg QD


Maintenance Dosage

If needed, you may increase the dosage above 200 mg QD in increments of 50 mg QD every 2 weeks up to 400 mg of maximum QD.


Discontinuation

You must decrease the dosage gradually over the course of 2 weeks, unless instant withdrawal is needed due to serious adverse event.
  • People with liver problems (hepatic impairment), the maximum dosage to take daily may differ depending on Child-Pugh assessment.
  • Follow your prescribing doctor's instructions 
How to take and store Cenobamate?

How to take: 

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

  • Check the number of tablets and the strength of pills you get from the pharmacy. If your provider changes your dose, the strength of pills may be different. 
  • Cenobamate is usually taken ONCE A DAY. 
  • Cenobamate should be taken orally with liquid without crushing or chewing. 
  • It can be taken with or without food, but it’s best to take it the same way every day. 
  • Take only the amount that your provider tells you to take. If you take an extra dose, call your provider for advice. If you take a large number of pills or overdose, call the poison control center (800-222-1222) or call your hospital emergency room or dial 911 right a way. 

How to Store:

  • Store Cenobamate at room temperature between 68oF to 77oF (20oC to 25oC) or below 86oF, 30oC.
  • Properly discard medicine that is out of date or no longer needed. 
  • Keep Cenobamate and all medicines out of reach of children. 
What if I forget?

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 seizure medicine.

  • 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 go back to your usual schedule. 
  • Avoid taking multiple dosages at the same time as it can lead to serious adverse events. 
  • To avoid missing doses, you may utilize a pillbox, set a reminder on your watch or phone, or have a family member remind you.
  • Write down any missed doses in your seizure calendar. Share this with your health care provider at each visit. 
How does Cenobamate affect the brain?

Brain cells normally talk to each other using electrical signals and chemicals. Seizures can happen when the brain cells excitation goes up or brain cells’ ability for inhibition is not enough.

  • Cenobamate works in the brain by increasing the inhibition of the brain cells. The precise mechanism of action is unknown, however we do know that Cenobamate has sodium-channel blocking properties meaning that Cenobamate binds to a certain channel protein (located in brain) when it is in its inactivated state and Cenobamate slows the brain cells transition from inactivated to resting. 
How does the body digest Cenobamate?

How the body absorbs, digests, and breaks down or gets rid of a medicine is called metabolism. The way the body metabolizes a medicine affects how often it must be taken. This process can also affect if it will interact with other medicines. If a person has liver or kidney problems, a person's metabolism may be affected. 

Some important points about Cenobamate:

  • The highest blood levels are reached in 1 to 4 hours after taking a dose of this medicine 
How well does the Cenobamate work?

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

  • In the clinical study of Cenobamate, people that participated showed 51.6% reduction in seizure frequency
  • Most people did not have many problems with side effects in this study 
  • Study showed that Cenobamate does interact with other seizure medicine, so consult with your doctor before starting Cenobamate. 
What are the most common side effects of Cenobamate?
  • Feeling sleepy and tired
  • Dizziness
  • Double Vision
  • Headache

Notify your health care provider if you have any of these side effects. Changing the amount or the way it is taken may help. Do not stop taking Cenobamate or change the way it is taken without your doctor’s advice.

Tips:

  • Avoid driving, operating heavy machinery, or other dangerous activities until you see how Cenobamate affects you. 
  • Cenobamate may slow your thinking and motor skills and may affect your vision. 
  • Do not drink alcohol or take any other medicines that can make you either sleepy or dizzy while you are on Cenobamate without first talking to your health care provider. 
What are the most serious side effects of Cenobamate?

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

  • Read the package insert for more information
  • Talk to your Pharmacist to better understand this medication
  • Call your provider's office right away if any of these problems occur

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 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. This type of behavior was found consistent with people taking Cenobamate during the clinical study.

DRESS/Multiorgan hypersensitivity: This is a allergic reaction that may be delayed, meaning it might not happen right away. It can be severe. Common symptoms are fever, rash, swelling of lymph nodes. It can also affect other body organs. Although rare, this was reported in patients  taking cenobamate. This seems to be more likely in patients who increased their dose too quickly. This is why it is very important to follow dosing directions from your provider and pharmacy.

QT Shortening:  This is a rare heart condition that causes a disruption in your hearts normal rhythm, and can cause symptoms of dizziness and fainting. This condition is diagnosed by doing an electrocardiogram (EKG). Cenobamate does not cause this condition, but may problems in patients who have this condition already. People that have Familial Short QT syndrome should not be treated with cenobamate. Patients with heart conditions should discuss this with their provider.

Withdrawal of Antiepileptic drugs: Cenobamate like all other antiepileptic drugs should be withdrawn gradually because it can potentially increase the frequency of seizure occurrence and status epilepticus. Immediate withdrawal can be done if a person is experiencing serious adverse events.

  • Contact your health care provider before stopping any seizure medicine. This could possibly lead to worsening of seizure and mood. 
What else is Cenobamate used for?

Often medicine may be used for more than one purpose. It is legal to prescribe medicine for “off-label uses” even though the FDA has not formally approved such use

  • There are no specific reports of off-label use of Cenobamate
Can Cenobamate be taken with other medicines?
Drug Effect of Xcopri on Drug What to do clinically?
Lamotrigine ↓ Plasma concentration Increase dose of Lamotrigine as needed if concomitantly used with Xcopri 
Carbamazepine   ↓ Plasma concentration Increase dose of carbamazepine as needed if concomitantly used with Xcopri 
Phenytoin  ↑ Plasma concentration  Xcopri increases phenytoin levels by 2 fold, so gradually decrease phenytoin dose by 50% as Xcopri is being titrated 
Phenobarbital  ↑ Plasma concentration  Reduce dose if concomitantly used with Xcopri otherwise increase risk of adverse reaction 
Clobazam  ↑ Plasma concentration  Reduce dose if concomitantly used with Xcopri otherwise increase risk of adverse reaction 
Oral contraceptives  ↓ Plasma concentration Xcopri reduces contraceptives efficacy, consider alternative non-hormonal therapies 

Do not stop taking Cenobamate or change the way it is taken without your doctor’s advice. Refer to package insert for more information.

What are the effects of Cenobamate on Children?

Safety, effectiveness, and the extent of side effects in pediatric patients have not been established.

If a woman takes Cenobamate during pregnancy will it hurt the baby?

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. Currently there are no adequate date on the developmental risk that is associated with the use of Cenobamate in pregnant women. there have been some studies done on animals.

  • Studies in animal show possible harmful effects of Cenobamate to the developing fetus. Yet this needs to be studied in humans.
  • Talk to your health care provider 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 Cenobamate while pregnant, consider enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334. 

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: There is no data available of the presence of Cenobamate in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. 

  • 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: Women of reproductive potential concomitantly using oral contraceptive should consider alternative non-hormonal birth controls.

What are the effects of Cenobamate on Seniors

There is no adequate data on the use of Cenobamate in seniors. 

What are the dose ranges for Cenobamate?

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

  • The approved dose range of Cenobamate is between 200 mg and 400 mg daily depending on the individua and their health history. The medicine is usually started at lower doses and increased over the range 11- 19 weeks. 
  • Some people may be given alternate doses, depending on their individual situation.
  • See the package insert for doses used in children. 
Special Concerns for Cenobamate

This is not yet known.

Read the package insert of Cenobamate

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 Xcopri (Cenobamate) is found at:

  • https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf

Some of the information may differ in other countries. 

Learn how to read a package insert here

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