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Caplyta is an oral capsule that is used to treat mental health conditions, including schizophrenia and bipolar disorder. Common side effects include dizziness, drowsiness, dry mouth, and nausea. Caplyta can affect your alertness or coordination. It can also affect your body’s ability to regulate temperature. Try to avoid getting overheated, stay hydrated, and wear light and breathable clothing while you are taking Caplyta.

Uses

What is Caplyta used for?

Caplyta (lumateperone) is commonly used to treat the following mental health conditions.

Learn more about Caplyta for Schizophrenia and Bipolar Depression.

Caplyta may also be used for other conditions as determined by your healthcare provider.

How does Caplyta work (mechanism of action)?

Caplyta belongs to a group of medicines called second-generation (atypical) antipsychotics. It is thought to work by balancing brain chemicals called serotonin and dopamine. These chemicals are known to affect thoughts and mood.

How is Caplyta supplied (dosage forms)?

Brands and other names

  • Caplyta

Dosage forms and strengths

  • 10.5 mg oral capsules
  • 21 mg oral capsules
  • 42 mg oral capsules

How should I store Caplyta?

Caplyta should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Caplyta?

The most common side effects of Caplyta are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

There may be other side effects of Caplyta that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Caplyta?

While less common, the most serious side effects of Caplyta are described below, along with what to do if they happen.

Severe Allergic Reactions. Caplyta may cause allergic reactions, which can be serious. Stop taking Caplyta and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Uncontrolled Movements. Caplyta can cause some people to have movements that they cannot control. This condition, called tardive dyskinesia (TD), can cause jerky movements of the face, tongue, or body. TD can be permanent. Call your healthcare provider right away if you have any of the following symptoms of TD.

  • Tongue sticking out
  • Lip smacking or puckering
  • Grimacing
  • Rapid eye blinking
  • Jerking or twisting motion of the arms, legs, or trunk

Blood Disorders. Caplyta can cause blood disorders, such as low white blood cell levels (leukopenia, neutropenia, or agranulocytosis). Keep all appointments with your healthcare provider to check your blood work. Stop taking Caplyta and get help right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

Neuroleptic Malignant Syndrome (NMS). Antipsychotic medicines, like Caplyta, may cause a rare but serious condition called neuroleptic malignant syndrome. NMS can lead to death. Stop taking Caplyta and contact your healthcare provider right away if you have any of the following symptoms.

  • High fever
  • Muscle stiffness or rigidity, where it is hard to move
  • Confusion 
  • Changes in your breathing or heart rate
  • Increased sweating

Metabolism Problems. Caplyta can cause high blood sugar levels or diabetes, high cholesterol levels, and weight gain. Keep all appointments with your healthcare provider to check your blood work and weight. Call your healthcare provider if you gain weight or develop the following symptoms of high blood sugar.

  • Thirsty more than usual
  • Peeing more than usual
  • Increase in hunger
  • Tiredness
  • Feeling sick to your stomach
  • Confusion
  • Your breath smelling fruity

Low Blood Pressure Upon Standing (Orthostatic Hypotension) and Falls. Caplyta may cause a sudden drop in blood pressure when standing up from a seated or lying position. This may increase your risk of falling. To help prevent this, be careful not to get up too quickly. If you feel dizzy, sit or lie down right away until the dizziness stops, then take your time getting up again. Tell your healthcare provider right away if you have any of the following symptoms of orthostatic hypotension.

  • Dizziness, feeling lightheaded, or fainting upon standing
  • Blurred vision
  • Confusion
  • Feeling weak

Seizures. Some people who have taken Caplyta have reported having seizures. There are many different types of seizures and some of them are not easy to recognize. Stop taking Caplyta and call your healthcare provider if you have any of the following signs that a seizure is happening or could happen.

  • Muscle twitching, jerking, spasms, tremors, or other uncontrolled movements
  • Stiffening of your arms and legs
  • Feeling anxious, nervous, confused, or a sense of dread
  • Feeling dizzy or lightheaded
  • Falling or losing consciousness

Decreased Alertness or Coordination. Caplyta can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Caplyta affects you.

Trouble Swallowing. Caplyta can cause trouble swallowing (dysphagia), which can increase your risk of choking while eating or drinking. Eat small amounts of food, and chew your food well. Get emergency help if you are choking or have food stuck in your esophagus that is not passing.

Body Temperature Regulation. Caplyta can affect your ability to regulate your body temperature. This could make you become very hot, especially in hot weather or after exercising a lot. You should drink water and avoid overheating and dehydration. Call your healthcare provider right away if you are severely ill and have the following symptoms of dehydration.

  • Excessive or no sweating
  • Dry mouth
  • Feeling very hot
  • Feeling thirsty 
  • Not able to pee

Suicidal Thoughts or Actions. Caplyta or other medicines used to treat depression may increase the risk of suicidal thoughts or actions in a small number of children, teenagers, or young adults. The risk is higher in the first few months of taking the medicine or when the dose is changed. Depression or other serious mental health conditions are the most important causes of suicidal thoughts or actions. If you or your child is about to harm themselves, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety, depression, or other unusual changes in your mood or behavior

Warnings & Precautions

Who should not use Caplyta?

Allergies to Ingredients. People who are allergic to any of the following should not take Caplyta.

  • Caplyta
  • Lumateperone
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Caplyta.

What should I know about Caplyta before using it?

Do not take Caplyta unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share Caplyta with other people, even if they have the same condition as you. It may harm them.

Keep Caplyta out of the reach of children.

Because Caplyta can make it hard for you to regulate your body temperature, try to avoid becoming too hot or dehydrated. Drink plenty of water, limit your exposure to the heat and sun, do not overexercise, and wear light and breathable clothing.

If you can become pregnant or get your partner pregnant, taking Caplyta may make this more difficult. Talk to your healthcare provider if you have any concerns.

What should I tell my healthcare provider before using Caplyta?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Caplyta is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. In particular, tell your healthcare provider if you have or have had any of the following.

Other Medicines and Supplements. Caplyta may interact with other medicines and supplements. Before taking Caplyta, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Psychosis Related to Dementia. There is a higher risk of death, stroke, or ministroke in older adults who take Caplyta or another antipsychotic and have memory loss or psychosis related to dementia. Caplyta is not approved to treat dementia-related psychosis.

Pregnancy. Caplyta taken later in pregnancy may lead to an increased risk of certain problems in your newborn. Tell your healthcare provider if you are or plan to become pregnant while taking Caplyta. Your healthcare provider will advise you if you should take Caplyta while you are pregnant or trying to get pregnant. If you become pregnant while taking Caplyta, you can register with the National Pregnancy Registry for Psychiatric Medications by calling 866-961-2388 or at womensmentalhealth.org/research/pregnancyregistry. This registry collects safety information about the use of psychiatric medicines during pregnancy.

Breastfeeding. Caplyta passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Caplyta while breastfeeding.

How can I get more information about Caplyta?

For more information about Caplyta, you can visit the manufacturer’s website at www.caplyta.com or call them at 888-252-4824.

Interactions

Does Caplyta interact with foods or drinks?

There are no known interactions between Caplyta and foods or drinks.

It is unknown if drinking alcohol will affect Caplyta. Drinking alcohol while taking Caplyta could increase your risk of sleepiness, dizziness, feeling lightheaded, or fainting upon standing.

Does Caplyta interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. 

In particular, make sure that you discuss if you are using any of the following before taking Caplyta.

  • Any medicine for seizures, such as carbamazepine, phenytoin, or phenobarbital
  • Ketoconazole, itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), fluconazole (Diflucan), or voriconazole (Vfend), which is a medicine used for fungal infections
  • Rifampin (Rifadin) or rifapentine (Priftin), which is a medicine commonly used to treat an infection called tuberculosis
  • Rifabutin (Mycobutin), which is a medicine used to prevent Mycobacterium avium complex infection
  • Diltiazem (Cardizem CD and others), which is a medicine used for high blood pressure and other conditions

Many medicines may alter the blood levels of Caplyta. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Caplyta. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Caplyta?

If you or someone else has taken too much Caplyta, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Caplyta?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

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