Caplyta is used to treat adults with schizophrenia, depression associated with bipolar I or bipolar II disorder (manic depression), or along with antidepressant medicines to treat major depressive disorder (MDD). Caplyta is a once-daily capsule. When used to treat bipolar disorder, this medicine can be used alone or with lithium or valproic acid.

Clinical trials have reported improvement in the positive and negative symptoms of schizophrenia within one week of starting Caplyta (lumateperone), but symptoms may take longer to resolve when used for depression .

Important Information

Caplyta carries a Boxed Warning for increased risk of death in elderly patients with dementia-related psychosis and an increased risk of suicidal thoughts and behaviors in younger patients.

• Increased risk of death in elderly people with dementia related psychosis. Medicines like Caplyta can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Caplyta is not approved for the treatment of people with dementia-related psychosis.
• Increased risk of suicidal thoughts and actions. Caplyta and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
  • Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.

How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

• • Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when Caplyta or the antidepressant medicine is started or when the dose is changed.
  • Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
  • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• • Thoughts about suicide or dying
  • New or worse depression
  • Feeling very agitated or restless
  • Trouble sleeping
  • Acting aggressively, being angry, or violent
  • An extreme increase in activity and talking (mania)
  • Suicide attempts
  • New or worse anxiety
  • Panic attacks
  • New or worse irritability
  • Acting on dangerous impulses
  • Other unusual changes in behavior or mood.

Side Effects

Common side effects

The most common side effects of Caplyta are:

• Sleepiness
• Dizziness
• Nausea
• Dry mouth
• Feeling tired
• Diarrhea.

Caplyta may cause fertility problems in females and males. Talk to your healthcare provider if this is a concern for you.

Caplyta does not appear to be associated with weight gain like many other antipsychotics are.

Serious Side Effects

Caplyta can also cause the following other serious side effects:

• Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis, which can lead to death. Caplyta is not approved for the treatment of people with dementia-related psychosis.
• Neuroleptic malignant syndrome (NMS) a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:
  • High fever
  • Confusion
  • Changes in your breathing, heart rate, and blood pressure
  • Stiff muscles
  • Increased sweating.
• Uncontrolled body movements (tardive dyskinesia). Caplyta may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking Caplyta. Tardive dyskinesia may also start after you stop taking Caplyta.
• Problems with your metabolism, such as:
  • High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take Caplyta. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start, or soon after you start Caplyta, and then regularly during long-term treatment with Caplyta.

Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with Caplyta:

• • • Feel very thirsty
    • Need to urinate more than usual
    • Feel very hungry
    • Feel weak or tired
    • Feel sick to your stomach
    • Feel confused, or your breath smells fruity.
  • Increased fat levels (cholesterol and triglycerides) in your blood. Your healthcare provider should check the fat levels in your blood before you start, or soon after you start Caplyta, and then periodically during treatment with Caplyta.
  • Weight gain. Weight gain is uncommon, but you and your healthcare provider should check your weight before you start and regularly during treatment with Caplyta.
• Low white blood cell counts. Your healthcare provider may do blood tests during the first few months of treatment with Caplyta.
• Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position after taking Caplyta.
• Falls. Caplyta may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills, which may lead to falls that can cause fractures or other injuries.
• Seizures (convulsions). Caplyta may increase your risk of seizures.
• Sleepiness, drowsiness, feeling tired, difficulty thinking, and doing normal activities.
• Difficulty swallowing, which can cause food or liquid to get into your lungs. Tell your healthcare provider immediately if this happens.
• Problems controlling your body temperature so that you feel too warm.

This is not a complete list of Caplyta side effects, and others may occur. Call your doctor for medical advice about side effects.

How Does Caplyta Work?

Caplyta works by changing the activity of neurotransmitters in the brain, such as dopamine, glutamate, and serotonin, to increase or balance their levels. This helps to relieve symptoms such as hallucinations, delusions, and disorganized thoughts associated with schizophrenia, and low mood associated with depression. 

Caplyta belongs to the drug class called atypical antipsychotics.

Caplyta Cost and Insurance Coverage

Eligible patients may pay as little as $0 for 30-day or 90-day prescriptions with the Caplyta Savings Card. 

• Text Caplyta to 26789 to download a digital Caplyta Savings Card to your phone and receive useful text messages about your prescription.
• 90% of Americans with commercial insurance have coverage for Caplyta.
• Caplyta is covered for more than 99% of people with Medicaid and Medicare Part D.

Before taking this medicine

Do not use Caplyta if you are allergic to Caplyta, lumateperone, or any of the ingredients in the capsules. Caplyta may also increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Before taking Caplyta, tell your healthcare provider about all your medical conditions, including if you: 

• Have or have had heart problems or a stroke
• Have or have had low or high blood pressure
• Have or have had diabetes or high blood sugar, or a family history of diabetes or high blood sugar. 
• Have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol
• Have or have had a low white blood cell count
• Have or have had seizures (convulsions)
• Have or have had kidney or liver problems
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed.

Pregnancy

Caplyta may harm your unborn baby. Taking Caplyta during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take Caplyta during pregnancy.

• Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with Caplyta.
• There is a pregnancy registry for females who are exposed to Caplyta during pregnancy. If you become pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to https://womensmentalhealth.org/research/pregnancyregistry/

Breastfeeding

Caplyta passes into your breast milk. Talk to your healthcare provider about the risks and benefits of breastfeeding and the best way to feed your baby during treatment with Caplyta.

Fertility

This medicine may affect fertility in both men and women.

How should I take Caplyta?

Take Caplyta as prescribed by your healthcare provider. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

• Take Caplyta 1 time each day with or without food.
• You can take Capylta in the morning or at night, but try to take it around the same time each day.

What happens if I miss a dose?

Take Caplyta as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I take too much?

If you take too much Caplyta, call your healthcare provider or Poison Help Line or go to the nearest hospital emergency room right away.

Dosing Information

Dose of Caplyta for Schizophrenia

• 42 mg orally once daily with or without food.

Dose of Caplyta for Depression Associated with MDD or Bipolar I or II Disorder

• 42 mg orally once daily with or without food.
• Use in addition to antidepressants for MDD.
• Use as monotherapy or as adjunctive therapy with lithium or valproate for Bipolar I or II disorder.

Liver Impairment

• Moderate to severe liver disease: 21 mg orally once daily with or without food.

What to avoid while taking Caplyta?

Do not drive, operate machinery, or do other dangerous activities until you know how Caplyta affects you. Caplyta may make you drowsy.

Do not become too hot or dehydrated during treatment with Caplyta.

• Do not exercise too much.
• In hot weather, stay inside in a cool place if possible.
• Stay out of the sun.
• Do not wear too much clothing or heavy clothing.
• Drink plenty of water

What other drugs will affect Caplyta?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Caplyta and other medicines may affect each other, causing possible serious side effects. Caplyta may affect the way other medicines work, and other medicines may affect how Caplyta works. Especially tell your doctor if you take:

• An antibiotic, antifungal, or antiviral medicine
• Blood pressure medication
• Bronchodilator asthma medication
• Cold or allergy medicine (Benadryl and others)
• Medicine to treat depression, anxiety, mood disorders, or mental illness
• Medicine to treat an overactive bladder
• Medicine to treat Parkinson’s disease
• Medicine to treat stomach problems, motion sickness, or irritable bowel syndrome
• Seizure medication

Briviact (brivaracetam) is an anti-epileptic drug (also called an anticonvulsant) that may be used to treat partial onset seizures in adults and children 1 month and older with epilepsy.

• Briviact is often used along with other seizure medicines to give better control over seizures.

Briviact works in the brain to help control seizures and is thought to target a specific protein called SV2A that helps nerve cells communicate with each other. By attaching to this protein, Briviact helps balance the brain’s electrical activity and this mechanism can stop the sudden bursts of electricity that cause seizures.

Briviact gained FDA approval on February 18, 2016. There is currently no Briviact generic available.

Is Briviact a controlled substance?

Briviact is a federally controlled substance (Schedule V) because it can be abused or lead to dependence.

Keep Briviact in a safe place to prevent misuse and abuse. Selling or giving away Briviact may harm others and is against the law. 

Briviact side effects

The most common side effects of Briviact are:

• sleepiness
• dizziness
• feeling tired
• nausea and vomiting.

Side effects of Briviact in children 1 month to less than 16 years of age are similar to those seen in adults.

Serious side effects and warnings

Briviact may cause the following serious side effects.

Suicidal thoughts and behaviors. Like other antiepileptic drugs, Briviact may cause suicidal thoughts or actions in a very small number of people; about 1 in 500 people taking it. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• new or worse depression
• feeling agitated or restless
• trouble sleeping (insomnia)
• acting aggressive, feeling angry, or being violent
• an extreme increase in activity and talking (mania)
• attempts to commit suicide
• new or worse anxiety
• panic attacks
• new or worse irritability
• acting on dangerous impulses
• other unusual changes in behavior or mood.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop Briviact without first talking to a healthcare provider. Stopping Briviact suddenly can cause seizures that will not stop (status epilepticus). 

Nervous system problems. Drowsiness, tiredness, and dizziness are common with Briviact but can be severe. Do not drive or operate machinery until you know how Briviact affects you. Briviact can also cause problems with balance and coordination.

Mental (psychiatric) symptoms. Briviact can cause mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability. Irritability and anxiety are common with Briviact and can be severe. People who take Briviact can also get psychotic symptoms such as hallucinations (seeing or hearing things that are not there), delusions (false or strange thoughts or beliefs), and unusual behavior.

Get emergency medical help if you have signs of an allergic reaction to Briviact: hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

These are not all the possible side effects of Briviact. For more information, ask your healthcare provider or
pharmacist. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects.

Before taking this medicine

You should not use Briviact if you are allergic to brivaracetam, Briviact, or any of the inactive ingredients in the formulation you are taking/receiving.

Before taking Briviact, tell your healthcare provider about all of your medical conditions, including if you:

• have or had depression, mood problems, or suicidal thoughts or behavior
• have liver problems
• have abused or been dependent on prescription medicines, street drugs, or alcohol
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Briviact is not approved for use by anyone younger than 1 month of age.

Pregnancy

It is not known if Briviact will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Briviact. You and your healthcare provider will have to decide if you should take Briviact while you are pregnant. Follow your doctor’s instructions about taking seizure medication if you are pregnant. Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Do not start or stop taking this medicine without your doctor’s advice, and tell your doctor right away if you become pregnant.

If you do become pregnant while taking Briviact, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of Briviact and other antiepileptic medicines during pregnancy.

Breastfeeding

Briviact passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Briviact.

How should I take Briviact?

Take Briviact exactly as prescribed by your doctor. Your healthcare provider will tell you how much Briviact to take and when to take it. Your healthcare provider may change your dose if needed. Do not change your dose without talking to your healthcare provider.

• Briviact is usually taken/given 2 times a day.

Take Briviact oral tablets or oral solution with or without food.

• Swallow Briviact tablets whole with a liquid and do not chew or crush the tablets before swallowing.
• Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Briviact injection is given as an infusion into a vein. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

Briviact may be habit-forming and is a federally controlled substance (Schedule V). Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Do not stop using Briviact suddenly, even if you feel fine. Stopping suddenly may cause serious medical problems or increased seizures. Follow your doctor’s instructions about tapering your dose.

Briviact dosing information

Usual Briviact Adult Dose for Epilepsy

Initial oral dose: Briviact 50 mg orally 2 times a day

• Adjust the dose up or down based on individual patient tolerability and response.

Maintenance dose: 25 mg to 100 mg orally twice a day based on clinical response and tolerability

Maximum dose: 200 mg/day

IV Administration: Briviact 50 mg by IV injection over 2 to 15 minutes

• May be used when oral administration is temporarily not feasible.
• Administer at the same dose and frequency as oral formulations.
• Experience with IV injection is limited to 4 consecutive days of treatment.

Usual Briviact Child Dose for Epilepsy

Briviact doses are based on weight in children. Your child’s dose needs may change if the child gains or loses weight.

Briviact ablets, oral solution, and injection can be used interchangeably.

1 month to 16 years

Weight: Less than 11 kg: Initial dose: Briviact 0.75 to 1.5 mg/kg orally twice a day; Maintenance dose: 0.75 to 3 mg/kg orally twice a day
Weight: 11 kg to less than 20 kg: Initial dose: Briviact 0.5 to 1.25 mg/kg orally twice a day; Maintenance dose: 0.5 to 2.5 mg/kg orally twice a day
Weight: 20 kg to less than 50 kg: Initial dose: Briviact 0.5 to 1 mg/kg orally twice a day; Maintenance dose: 0.5 to 2 mg/kg orally twice a day
Weight: 50 kg or greater: Initial dose: Briviact 25 to 50 mg orally twice a day; Maintenance dose: 25 to 100 mg orally twice a day

16 years of age and older

Initial dose: Briviact 50 mg orally 2 times a day.
Maintenance dose: 25 mg to 100 mg orally twice a day.

IV Administration may be used in patients 16 years or older when oral administration is temporarily not feasible.

• Administer at the same dose and same frequency as oral formulations.
• Experience with the IV injection is limited to 4 consecutive days of treatment.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I take too much Briviact?

If you take too much Briviact call your Poison Control Center or go to the nearest emergency room right away. 

What to avoid

Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

What other drugs will affect Briviact?

Other drugs may interact with brivaracetam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your other medicines. Especially tell your healthcare provider if you take:

• Rifampin — the dosage of Briviact may need to be increased
• Carbamazepine — the dosage of carbamazepine may need to be reduced
• Phenytoin — the dosage of phenytoin may need to be reduced.

Levetiracetam — Briviact had no added therapeutic benefit when coadministered with levetiracetam.

When you start or stop taking Briviact, your doctor may need to adjust the doses of any other medicines you take regularly.

Not all possible drug interactions are listed here. See the Briviact Prescribing Information for a full list of interactions. 

Storage

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze. Throw away unused liquid after 5 months.

Briviact ingredients

Active ingredient: brivaracetam

Tablet inactive ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, and magnesium stearate.

Tablet film coating contains the inactive ingredients listed below:

• 10 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide
• 25 mg and 100 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, black iron oxide
• 50 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide
• 75 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide, black iron oxide. 

Oral solution inactive ingredients: sodium citrate, anhydrous citric acid, methylparaben, sodium
carboxymethylcellulose, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water.