Caplyta is a brand-name prescription drug. It’s FDA-approved to treat the following conditions in adults:

When used for depressive episodes, Caplyta may be prescribed by itself or with the drugs lithium (Lithobid) and valproate.

Drug details

Caplyta contains the active drug lumateperone. It belongs to a class of drugs called atypical antipsychotics. Atypicals are newer antipsychotic drugs. They’re also known as second-generation antipsychotics.

Caplyta comes as a capsule that you swallow. It’s available in three strengths: 10.5 milligrams (mg), 21 mg, and 42 mg. You’ll likely take Caplyta once per day.

FDA approval

In December 2019, the Food and Drug Administration (FDA) approved Caplyta to treat schizophrenia. And in December 2021, the FDA also approved Caplyta to treat depressive episodes related to bipolar disorder.

Effectiveness

For information about the effectiveness of Caplyta, see the “Caplyta for schizophrenia” and “Caplyta for bipolar disorder” sections below.

Caplyta is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Caplyta can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Caplyta. These lists don’t include all possible side effects.

For more information about the possible side effects of Caplyta, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Caplyta, you can do so through MedWatch.

Mild side effects

Mild side effects of Caplyta are described in the table below. This table includes which condition people were taking Caplyta for when the side effect occurred in clinical trials.

Note: This is a partial list of mild side effects from Caplyta. To learn about other mild side effects, talk with your doctor or pharmacist, or view Caplyta’s prescribing information.

In people taking Caplyta for schizophreniaIn people taking Caplyta for bipolar disorder
sleepiness*XX
dry mouthXX
nausea or vomitingXX
dizzinessXX
lack of appetiteX
fatigueX
weight gainXX
increased levels of liver enzymes (which may be a sign of liver damage)X
headacheX
diarrheaX
abdominal painX
upper respiratory infection, such as the common coldX
blurry visionX
increased blood levels of prolactin (a hormone with various functions in the body)X

Most of these side effects should go away or be manageable. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* For more information about this side effect, see “Side effect details” below.

Serious side effects

In general, serious side effects from Caplyta aren’t common. But they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

* This side effect was not reported in clinical trials of Caplyta. However, this has occurred with other antipsychotic drugs. It may also occur with Caplyta.
Caplyta has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA.
‡ For more information about this side effect, see “Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause.

Increased risk of death in certain older people

Older people may have an increased risk of death when treated with antipsychotic drugs, such as Caplyta, for psychosis that’s related to dementia. Because of this risk, Caplyta shouldn’t be used to treat dementia-related psychosis in older people. In fact, this drug has a boxed warning for this risk. A boxed warning is the most serious warning from the FDA. The warning alerts doctors and patients about drug effects that may be dangerous.

Psychosis is a mental health condition in which people lose their perception of reality. Dementia is a group of life-impacting symptoms related to a decline or change in memory, thinking, talking skills, and behavior.

In addition, older people may have an increased risk of stroke when treated with antipsychotic drugs, such as Caplyta, for psychosis that’s related to dementia.

Caplyta hasn’t been studied in people ages 65 years and older. But other atypical antipsychotic drugs have caused strokes and, in some cases, death when used to treat dementia-related psychosis in older people. (Caplyta is an atypical antipsychotic.)

Causes of death have included:

If a loved one has psychosis that’s related to dementia, talk with their doctor about treatment options other than Caplyta.

Suicidal thoughts and behaviors

People ages 24 years and younger may have an increased risk of suicidal thoughts and behaviors occurring or worsening while taking Caplyta. In fact, this drug has a boxed warning for this risk.

Caplyta is only prescribed for use in adults, and not children. Caplyta hasn’t been studied in children. However, drugs used to treat depression have been shown to increase the risk of suicidal thoughts and behaviors when used in children and adults ages 24 years and younger. This risk applies to Caplyta because it’s used to treat depressive episodes caused by bipolar I or bipolar II disorder.

Suicidal thoughts and behaviors may be more likely to occur during the first several months of Caplyta treatment, and after any dosage changes. It’s also possible for suicidal thoughts and actions to be a symptom of mental health conditions, including the conditions Caplyta treats.

You and your doctor will work together to monitor you for any changes in behavior while you’re taking Caplyta. Your doctor may recommend having people close to you, such as friends or family members, watch for any changes in your behavior during Caplyta treatment as well.

If your condition gets worse, or if you experience new or worsening suicidal thoughts or actions, be sure to talk with your doctor. They may recommend lowering your Caplyta dose, or stopping Caplyta treatment.

Sleepiness

Caplyta use may cause sleepiness. In clinical trials of the drug, sleepiness was the most common side effect.

This side effect is generally mild and may ease after a few weeks or months. But it can affect your ability to think clearly or use your motor skills (muscle movements or actions). So you shouldn’t drive or operate machinery until you know how Caplyta affects you.

If you have lasting sleepiness with this drug, talk with your doctor. They may suggest that you take your Caplyta dose before bedtime to help prevent sleepiness during the day.

Before you start taking Caplyta, talk with your doctor as well as your caregiver, loved ones, or friends. They may be able to help you with tasks that you may be too tired to perform, such as shopping, cooking, and doing household chores.

Abnormal muscle or body movements

The use of Caplyta may cause abnormal muscle or body movements, which are also called extrapyramidal effects. Symptoms can include:

  • muscle spasms, stiffness, or rigidity
  • floppy muscles
  • jerking, tremor, or twitching
  • drooling
  • sticking out your tongue or smacking your lips
  • throat tightness or difficulty swallowing
  • body movements that keep repeating or that you can’t control
  • inability to move muscles

One type of extrapyramidal effect is a movement disorder called dystonia. It’s unclear how often dystonia symptoms, such as muscle spasms, twitches, and stiffness, occur with Caplyta. They usually happen more often with older antipsychotic drugs. (Caplyta is a newer drug known as an atypical antipsychotic.) Dystonia symptoms may occur more often in males* or younger people. To find out how often dystonia occurred in clinical studies, see Caplyta’s prescribing information.

Another kind of extrapyramidal effect is tardive dyskinesia. It can be serious and usually causes movements in your face that you can’t control. Tardive dyskinesia may go away once you stop taking Caplyta, it may return, or it may be permanent.

If you have any of the symptoms mentioned above while taking Caplyta, tell your doctor right away. They may lower your dose or recommend a different drug instead.

* Sex and gender exist on spectrums. Use of the term “male” in this article refers to sex assigned at birth.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Caplyta.

Rarely, Caplyta has caused symptoms of a mild allergic reaction, including:

  • rash
  • itchiness
  • hives

Flushing is another possible symptom of mild allergic reactions.

Although uncommon, a more severe allergic reaction is also possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Caplyta, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

If you have an allergic reaction to Caplyta, your doctor will typically have you switch to a different medication.

The Food and Drug Administration (FDA) approves prescription drugs such as Caplyta to treat certain conditions. Caplyta may also be used off-label for other conditions. Off-label drug use means prescribing a drug for a purpose other than what it’s been approved for by the FDA.

Caplyta is FDA-approved to treat schizophrenia in adults. This use is described just below. Caplyta is also FDA-approved to treat depressive episodes related to bipolar disorder, which is described in the “Caplyta for bipolar disorder” section below.

About schizophrenia

Schizophrenia is a serious and complex mental health condition that can change feelings, perceptions, thoughts, and behavior.

The symptoms of schizophrenia can vary. But you may feel like your perception of reality is altered. This is called psychosis. You may have psychotic symptoms, such as hallucinations (hearing or seeing things that aren’t real) or delusions (untrue thoughts or beliefs). You may also have other symptoms, such as:

  • having depression
  • feeling withdrawn, unmotivated, or emotionless
  • having trouble concentrating or focusing
  • feeling less pleasure with life or relationships
  • having difficulty making decisions or solving problems

Treatment for schizophrenia

Treatment for schizophrenia has two main parts:

  • Symptom management. Antipsychotic drugs are the primary medications used to treat symptoms of schizophrenia. Caplyta is a type of antipsychotic.
  • Solutions for everyday living. To help you and others with relationships, day-to-day tasks, and activities, your doctor may recommend various forms of support. Examples include therapy, support groups or education for family or caregivers, and other specialized programs.

To learn more about caring for your mental health, visit our mental health hub.

Effectiveness for schizophrenia

In two clinical trials, Caplyta was shown to be effective for treating the symptoms of schizophrenia.

Also, according to treatment guidelines, the American Psychiatric Association highly recommends that all people with schizophrenia be treated with an antipsychotic. (Caplyta is a type of antipsychotic.)

Caplyta and children

Caplyta isn’t approved to treat schizophrenia in children. It’s unknown if the drug is safe and effective for use in children.

The Food and Drug Administration (FDA) approves prescription drugs such as Caplyta to treat certain conditions. Caplyta may also be used off-label for other conditions. Off-label drug use means prescribing a drug for a purpose other than what it’s been approved for by the FDA.

Caplyta is FDA-approved to treat depressive episodes that are caused by bipolar I or bipolar II disorder in adults. This use is described just below. Caplyta is also FDA-approved to treat schizophrenia, which is described in the “Caplyta for schizophrenia” section above.

About bipolar disorder

Bipolar I disorder and bipolar II disorder are mental health conditions that involve episodes of mania or hypomania (mania that’s less extreme) and episodes of depression. Symptoms of mania or hypomania may include increased energy or extreme levels of confidence. Depressive episodes, also referred to as bipolar depression, may cause sadness or loneliness, or a lack of desire to do things that you usually enjoy.

Caplyta is used to treat depressive episodes related to bipolar I and bipolar II in adults. For this use, your doctor might prescribe the drug by itself or in combination with lithium (Lithobid) or valproate. These are other drugs that may be used to treat bipolar disorder.

Treatment for bipolar disorder

Treatment for bipolar disorder may consist of:

  • Symptom management. Antipsychotic drugs, antidepressants, and other types of drugs may be prescribed to help manage symptoms of bipolar disorder. Caplyta is a type of antipsychotic.
  • Solutions for everyday living. To help you and others with relationships, day-to-day tasks, and activities, your doctor may recommend various forms of support. Examples include therapy, support groups or education for family or caregivers, and other specialized programs.

For more information about caring for your mental health, visit our mental health hub.

Effectiveness for bipolar disorder

In two clinical trials, Caplyta was shown to be effective for treating the symptoms of depressive episodes in people with bipolar I or bipolar II.

For information about how the drug performed in clinical trials, see Caplyta’s prescribing information.

Caplyta and children

Caplyta isn’t approved to treat depressive episodes related to bipolar disorder in children. It’s unknown if the drug is safe and effective for use in children.

As with all medications, the cost of Caplyta can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Caplyta. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor or your insurance company.

Before approving coverage for Caplyta, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Caplyta, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Caplyta, or if you need help understanding your insurance coverage, help is available.

A savings card and other resources are available for Caplyta. For more information and to find out if you’re eligible for financial support, visit the program website.

Mail-order pharmacies

Caplyta may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Caplyta, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor and your insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Caplyta isn’t available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

Caplyta is used to treat schizophrenia and depressive episodes caused by bipolar I and bipolar II disorder in adults.

Schizophrenia is a mental health condition that can change feelings, perceptions, thoughts, and behavior. Bipolar disorder is also a mental health condition, and can cause episodes of mania or hypomania and episodes of depression.

The exact causes of schizophrenia and depressive episodes of bipolar disorder are unknown. But experts believe symptoms of these conditions are partly caused by the unbalanced activity of neurotransmitters (brain chemicals). Examples of neurotransmitters include dopamine and serotonin. They help control your mood, thinking, perceptions, and behaviors.

How Caplyta works to treat schizophrenia and bipolar disorder

How a drug works is called its mechanism of action. Caplyta’s mechanism of action in treating schizophrenia and depressive episodes caused by bipolar disorder is unclear.

But it is known how drugs like Caplyta work. Caplyta is a type of drug called an antipsychotic. And antipsychotics are thought to work by changing the activity of dopamine and serotonin in the brain. When these brain chemicals and their receptors are affected, symptoms of schizophrenia and depressive episodes of bipolar disorder may be reduced. (Receptors are proteins in the brain that neurotransmitters must attach to in order to produce their effects.)

How long does it take to work?

After starting Caplyta treatment, it may take about a week until the level of the drug in your body becomes high enough for Caplyta to begin working. And it may take another few weeks or more for you to notice a change in your symptoms.

In two clinical trials, people’s schizophrenia symptoms eased significantly after taking Caplyta for 4 weeks. In two additional clinical trials, people’s depressive symptoms caused by bipolar disorder eased within 6 weeks of starting the drug.

If you’re taking Caplyta for schizophrenia and are concerned that it’s not working, talk with your doctor.

The following information describes the Caplyta dosage that is commonly used or recommended. However, your doctor will determine the best dosage to fit your needs. Be sure to take the exact Caplyta dosage that your doctor prescribes for you.

Drug forms and strengths

Caplyta comes as a capsule that you swallow. It’s available in three strengths: 10.5 milligrams (mg), 21 mg, and 42 mg.

Dosage for schizophrenia

Caplyta is approved to treat schizophrenia in adults. The typical dosage for this condition is 42 mg once per day.

Your doctor may prescribe a lower dosage of Caplyta if you have liver problems or if you’re taking certain medications.

You can take Caplyta with or without food. But you shouldn’t take the drug with grapefruit or grapefruit juice.

See the “Caplyta interactions” section below for details about what to avoid with Caplyta and examples of drugs that may interact with Caplyta.

Dosage for bipolar disorder

Caplyta is approved to treat depressive episodes caused by bipolar I and bipolar II in adults. The typical dosage for this condition is 42 mg once per day.

Your doctor may prescribe a lower dosage of Caplyta if you have liver problems or if you’re taking certain medications.

You can take Caplyta with or without food. However, you shouldn’t take the drug with grapefruit or grapefruit juice.

See the “Caplyta interactions” section below for details about what to avoid with Caplyta and examples of drugs that may interact with Caplyta.

What if I miss a dose?

Try to take your Caplyta dose at the same time every day. If you forget a dose, take it as soon as you remember. But if it’s almost time for your next dose, skip the missed dose and return to your normal schedule. Don’t double up or take more Caplyta to make up for missed doses.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

Yes, it’s likely that you’ll use Caplyta long term.

Schizophrenia and bipolar disorder are considered long-term mental health conditions. Your doctor will likely recommend long-term treatment, such as antipsychotic medication. (Caplyta is a type of antipsychotic drug.)

If you and your doctor feel that Caplyta is safe and effective for you, it will be a long-term part of your mental health treatment plan.

Here are answers to some frequently asked questions about Caplyta.

Will I be able to drive or use machinery while I’m taking Caplyta?

You shouldn’t drive or operate any machinery until you know how Caplyta affects you. Doing so can put both you and others in danger. This is because sleepiness is a side effect of the drug. In fact, sleepiness was the most common side effect in clinical trials of Caplyta.

Feeling sleepy can also:

  • affect your ability to think clearly
  • make it harder to concentrate
  • affect your motor skills (muscle movements or actions)
  • slow your reaction time

Sleepiness may go away in time or you may be able to manage it. For example, your doctor may suggest that you take Caplyta before bedtime to help prevent daytime sleepiness.

If you’re concerned about sleepiness while using Caplyta, talk with your doctor. You can also refer to “Sleepiness” in the “Caplyta side effects” section above.

Do I need to have lab tests done while using Caplyta?

Yes, your doctor will typically order some lab tests before and during your Caplyta treatment. These tests help check for serious side effects of the drug.

Below are common lab tests needed with Caplyta:

  • Blood sugar. Antipsychotic drugs, such as Caplyta, can cause high blood sugar levels. If left untreated, high blood sugar lead can to serious or life threatening problems such as diabetic ketoacidosis (dangerously high levels of ketones in the blood). To check for this side effect, your doctor will test your blood sugar levels before and during Caplyta treatment.
  • Cholesterol and triglycerides. Antipsychotics can also affect your cholesterol and triglyceride levels. Changes in the levels of these blood fats can increase the risk of heart or blood vessel disease. To check for this side effect, your doctor will test your blood levels of cholesterol and triglycerides before and during Caplyta treatment.
  • White blood cell counts. Although rare, Caplyta may cause low levels of white blood cells, including neutrophils (a type of white blood cell that fights infection). Other antipsychotics have caused a serious, life threatening low level of white blood cells called agranulocytosis. If you have or had a low level of white blood cells, your doctor will check your levels often during the first months of Caplyta treatment. If your levels decrease, they may recommend that you stop taking the drug.

If you have more questions about which lab tests you’ll need with your Caplyta treatment, talk with your doctor.

Alcohol doesn’t interact with Caplyta. But drinking alcohol while taking Caplyta may worsen some side effects of the drug. These include nausea, vomiting, dizziness, sleepiness, and fatigue (lack of energy even with rest).

In addition, it’s possible that drinking alcohol when you have a mental health condition, such as schizophrenia or bipolar disorder, could lead to alcohol dependence. With dependence, your body needs the drug to function like usual. Alcohol use disorder is more common in people with mental health conditions than in people who don’t have them.

If you drink alcohol and are interested in taking Caplyta, talk with your doctor.

Caplyta can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Caplyta and other medications

Below is a list of medications that can interact with Caplyta. This list does not contain all drugs that may interact with Caplyta.

Before taking Caplyta, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Taking Caplyta with certain drugs may affect how your body breaks down or processes Caplyta. The level of Caplyta could become too high, which could increase the risk of side effects.

Examples of drugs that may increase the level of Caplyta in your body include:

  • ciprofloxacin (Cipro)
  • diltiazem (Cardizem CD, Cartia XT, Tiazac)
  • fluconazole (Diflucan)
  • clarithromycin
  • ritonavir (Norvir)
  • valproic acid

If you take these medications with Caplyta, your doctor may prescribe a lower dosage of the drug than is typical. See the “Caplyta dosage” section above for details about the drug’s dosage.

Other medications could cause the level of Caplyta to become too low, so the drug isn’t effective at treating your condition. Examples of drugs that may decrease the level of Caplyta in your body include:

  • carbamazepine (Tegretol)
  • phenytoin (Dilantin)
  • prednisone (Rayos)
  • rifampin (Rifadin)
  • efavirenz (Sustiva)

Your doctor will tell you whether you can take Caplyta with these medications, or whether a dosage change is needed if you’re taking Caplyta.

Caplyta and herbs and supplements

During Caplyta treatment, you shouldn’t take any products that contain the herb St. John’s wort. Doing so could make your liver break down too much Caplyta. This means that the level of Caplyta in your body could become too low to be effective at treating your condition.

Many people use St. John’s wort and other herbs to improve their mental health. But these products may not be safe or may not have been proven to be effective. Be sure to check with your doctor or pharmacist before taking any herbs or supplements.

Caplyta and foods

Throughout your Caplyta treatment, you shouldn’t eat grapefruit or drink grapefruit juice. Drinking or eating grapefruit products may make it harder for your liver to break down Caplyta. This means that the level of Caplyta in your body could become too high and cause side effects. (For more about side effects, see the “Caplyta side effects” section above to learn more.)

If you have any questions about grapefruit and Caplyta, talk with your doctor or pharmacist.

You should take Caplyta according to the instructions your doctor or other healthcare professional gives you.

Caplyta comes as a capsule that you swallow.

When to take

You’ll likely take Caplyta once a day. You can take it at any time. But always try to take it around the same time each day.

If you feel overly sleepy with Caplyta, talk with your doctor. They may advise you to take your dose before bedtime to help prevent daytime sleepiness.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Caplyta with food

You can take Caplyta with or without food.

But it’s important that you don’t eat grapefruit or drink grapefruit juice at any time during your Caplyta treatment. Doing so could increase the risk of side effects. For more details, see “Caplyta and foods” in the “Caplyta interactions” section above.

Can Caplyta be crushed, opened, or chewed?

No, you shouldn’t crush, open, or chew Caplyta capsules. For the drug to work as it’s meant to, you should swallow the capsules whole.

If you have trouble swallowing Caplyta, talk with your doctor or pharmacist right away. It’s important to stay on track with your schizophrenia treatment plan and not miss any doses.

It’s not known if Caplyta is safe to take during pregnancy.

Caplyta is a type of drug called an atypical antipsychotic. Newborns who are exposed to this kind of medication as fetuses in the last trimester (week 27 until delivery) may have abnormal muscle movements, drug withdrawal, or both. The symptoms may include:

  • tremor or twitching
  • rigid or floppy muscles
  • agitation (restlessness)
  • sleepiness
  • problems with breathing or feeding

In animal trials, Caplyta harmed fetuses when given to pregnant animals. But outcomes in animals don’t always predict effects in humans.

If you’re pregnant or plan to become pregnant, talk with your doctor. They can discuss the risks and benefits of taking Caplyta during pregnancy.

Note: It’s important that mental health conditions, such as schizophrenia and bipolar disorder, are treated during pregnancy to help you and your child stay safe and healthy.

Caplyta pregnancy registry

If you decide to take Caplyta while pregnant, talk with your doctor about joining the pregnancy exposure registry for the drug. The National Pregnancy Registry for Atypical Antipsychotics tracks the health effects of using atypical antipsychotics (such as Caplyta) during pregnancy and the effects on children. The information can help doctors and people make informed choices about treating mental health conditions during pregnancy.

If you’d like to learn more about the registry, talk with your doctor. You can also visit the registry site, which is linked above.

Caplyta and fertility

Caplyta may cause fertility problems in both males* and females.* This means taking Caplyta may affect your ability to become pregnant or make a female* pregnant.

This warning is based on fertility trials in animals, which may not predict effects in humans.

If you’re concerned about fertility problems with Caplyta, talk with your doctor.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Caplyta. This is because it’s not known if Caplyta is safe to take during pregnancy.

For more information about taking Caplyta during pregnancy, see the “Caplyta and pregnancy” section above.

You shouldn’t breastfeed while taking Caplyta.

It’s not known if the drug is safe to use while breastfeeding. However, children exposed to other antipsychotic drugs through breast milk have had negative effects. These include sleepiness and abnormal muscle or body movements. (Caplyta is a type of antipsychotic.) Also, animal trials have shown that Caplyta was unsafe for the offspring of lactating animals.

If you’re breastfeeding or considering breastfeeding, talk with your doctor. They may be able to recommend a treatment other than Caplyta. They can also advise you on healthy ways to feed your child.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings about the following risks. These are the most serious warnings from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Increased risk of death in older people with dementia-related psychosis. Older people may have an increased risk of death when treated with antipsychotic drugs, such as Caplyta, for psychosis that’s related to dementia. Because of this risk, Caplyta shouldn’t be used to treat dementia-related psychosis in older people.

Psychosis is a mental health condition in which people lose their perception of reality. Dementia is a group of life-impacting symptoms related to a decline or change in memory, thinking, talking skills, and behavior.

Increased risk of suicidal thoughts and behaviors in children and young adults. People ages 24 years and younger may have an increased risk of suicidal thoughts and behaviors occurring or worsening with drugs used to treat depression. This risk applies to Caplyta because it’s used to treat depressive episodes caused by bipolar I or bipolar II disorder.

Because of this risk, Caplyta is not prescribed for use in children. You and your doctor will work together to monitor you for any changes in behavior while you’re taking Caplyta.

For more information, see “Side effect details” in the “Caplyta side effects” section above.

Other precautions

Before taking Caplyta, talk with your doctor about your health history. In addition to the FDA warnings described just above, Caplyta may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Low white blood cell level. Caplyta may lower your level of white blood cells, including neutrophils. Your risk is higher if you have or had a low level. Be sure to tell your doctor if you’ve had low white blood cell levels in the past. To learn more, see “Do I need to have lab tests done while using Caplyta?” in the “Common questions about Caplyta” section above.
  • Low blood pressure. Caplyta may increase the risk of orthostatic hypotension. Your risk is higher if you have low blood pressure or take blood pressure medication. Before taking Caplyta, talk with your doctor. If you have low blood pressure, they may monitor you more often than usual during your treatment.
  • Cardiovascular disease. Caplyta may increase the risk of orthostatic hypotension. Your risk is higher if you have cardiovascular disease. Before using Caplyta, be sure to talk with your doctor. If you have cardiovascular disease, they may monitor you more often than usual during your treatment.
  • Seizures or epilepsy. Caplyta may increase the risk of seizures. Your risk is higher if you’ve had seizures or have epilepsy. Be sure to tell your doctor whether you have a history of these conditions. They can help determine whether Caplyta is a good choice for you.
  • Dehydration or overheating. Caplyta may make it harder for your body to regulate its temperature. This means you may become overheated, which could be dangerous. Caplyta may also cause orthostatic hypotension. Your risk for these side effects may be higher if you’re dehydrated or tend to become overheated. Be sure to stay hydrated while taking Caplyta. Also, you should avoid doing heavy exercise, using saunas, and entering hot areas until you know how Caplyta affects you. Before starting treatment, talk with your doctor about any risks of overheating.
  • Liver disease. If you have liver disease, talk with your doctor before starting Caplyta. If your liver disease is mild, it’s likely safe for you to take the drug at its typical dosage. If your liver disease is moderate or severe, your doctor might prescribe Caplyta in a lower dosage than is typical.
  • Allergic reaction. If you’ve had an allergic reaction to Caplyta or any of its ingredients, you shouldn’t take Caplyta. Ask your doctor what other medications are better options for you.
  • Pregnancy. It’s not known if Caplyta is safe to take during pregnancy. For more information, see the “Caplyta and pregnancy” section above.
  • Breastfeeding. Caplyta isn’t safe to use while breastfeeding. For more information, see the “Caplyta and breastfeeding” section above.

Note: For more information about the potential negative effects of Caplyta, see the “Caplyta side effects” section above.

Do not use more Caplyta than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Caplyta

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Caplyta from the pharmacy, the pharmacist will add an expiration date to the label on the box. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good to use can depend on many factors, including how and where you store the medication.

You should keep Caplyta capsules at room temperature, preferably in the original blister packaging. You can also put them in a tight, child-resistant medication bottle. You shouldn’t store Caplyta in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Caplyta and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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