Caplyta (Lumateperone): Uses, Dosage, Side Effects, & Warnings

What Is Caplyta (Lumateperone)?

Caplyta is a third-generation oral antipsychotic drug that works by blocking certain receptors in the brain. Blockage of these receptors increases levels of dopamine, serotonin, and glutamate in the brain, all of which are important chemicals that help regulate mood.^{1, 3} Caplyta is FDA-approved for the treatment of schizophrenia and depressive episodes associated with both bipolar I and II.^{1, 4}

How Is Caplyta Different from Other Antipsychotics?

Caplyta stands apart from other antipsychotic medications because of its distinct effects. Caplyta has a much higher selectivity for dopamine receptors in the brain than other antipsychotics and is the first antipsychotic medication to affect glutamate receptors, which allows for more effective treatment of schizophrenia.

The increased blocking of dopamine receptors is also associated with decreased side effects of movement dysfunction. Unlike other antipsychotic medications, Caplyta has also shown a reduced occurrence of typical antipsychotic side effects due to its decreased binding to other receptors in the body responsible for undesirable physiological effects.^{2, 3, 5}

Is Caplyta a Mood Stabilizer or Antipsychotic?

Caplyta is classified as an antipsychotic medication. Caplyta reaches its peak concentration in the body within hours of taking a dose, which is similar to other antipsychotic medications. On the other hand, mood stabilizers have a delayed onset of action of at least 7-10 days after starting therapy.^{2, 3, 6}

Is Caplyta Better Than Seroquel?

Research suggests that Caplyta, a third-generation antipsychotic medication, has a reduced occurrence of side effects and is more effective in the treatment of schizophrenia than second-generation antipsychotic medications such as Seroquel. However, there has not been any research done comparing the safety and effectiveness of Caplyta to Seroquel head-to-head. Therefore, it is unknown if Caplyta is truly superior to Seroquel.^{2, 3, 7}

How Does Caplyta Work?

Caplyta works by blocking receptors of chemicals in the brain, such as dopamine and serotonin, although it is more selective for serotonin receptors. Blocking these receptors increases serotonin and dopamine levels in the brain to regulate mood and emotions to help relieve symptoms of depressive episodes associated with bipolar disorder. Also, through blocking serotonin and dopamine receptors, Caplyta is effective in decreasing the incidence of the negative symptoms of schizophrenia, such as reduced ability to express emotions, motivation, and experience of pleasure.^{3, 5, 8}

What Is Caplyta Used to Treat?

Caplyta is FDA-approved for the treatment of schizophrenia and depressive episodes associated with both bipolar I and II disorders. FDA approval means that after rigorous testing, the FDA determined that Caplyta was determined to be both safe and effective for its intended population of schizophrenia and bipolar depression patients. There are no off-label uses for Caplyta.^{1, 4}

Common Side Effects of Caplyta

The most common side effects of Caplyta include drowsiness, dizziness, and nausea. While some individuals might not require medical attention for these effects, close monitoring of the symptoms is crucial to address any severe or chronic symptoms promptly. It is recommended to maintain open communication with a healthcare professional, such as your prescriber and pharmacist, to ensure proper management and support during Caplyta treatment.^{1, 2}

Common side effects of Caplyta include:¹

• Drowsiness
• Nausea
• Dizziness
• Dry mouth
• Fatigue
• Headache
• Weight gain

*All medications, including Caplyta, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor and pharmacist about any questions you have and to understand the potential side effects and benefits of any medication.

Serious Side Effects of Caplyta

Caplyta has the potential to cause serious side effects that require immediate medical attention. Caplyta is associated with an increased risk of extrapyramidal symptoms, which are symptoms that may impair the patient’s ability to move and maintain normal muscular function. Caplyta may also cause changes in metabolic function in patients, such as changes in blood sugar and cholesterol levels. Elderly patients taking Caplyta are at a higher risk for stroke and should watch for trouble speaking, walking, and understanding.^{1, 3, 5}

Serious side effects of Caplyta include:¹

• Increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults
• Changes in blood sugar levels
• Changes in cholesterol levels
• Changes in muscle function
• Increased risk of type II diabetes mellitus
• Stroke
• Seizures

*All medications, including Caplyta, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor and pharmacist about any questions you have and to understand the potential side effects and benefits of any medication.

Caplyta Warnings & Precautions

Caplyta has two boxed warnings associated with it: (1) increased chance of death in elderly patients with dementia-related psychosis and (2) increased risk of suicidal behavior and thoughts in children, adolescents, and young adults. All patients being treated with Caplyta should be monitored by healthcare professionals and their caregivers for worsening of depression, suicidality, or any unusual changes in behavior, especially at the beginning of treatment and following any dose changes.¹

Caplyta may cause the following:¹

• Dementia-related psychosis: Elderly patients taking Caplyta are at increased risk for death due to cardiovascular and infectious causes. Caplyta is not approved for elderly patients with dementia-related psychosis due to the increased incidence of stroke while taking antipsychotics.
• Suicidal behavior in children, adolescents, or young adults: The incidence of suicidal behavior and thoughts in patients under 24 years old was higher in patients taking Caplyta in testing.
• Neuroleptic malignant syndrome: Neuroleptic malignant syndrome is a potentially fatal syndrome that causes muscle stiffness, high fever, or kidney failure associated with Caplyta. If any of these symptoms occur while taking Caplyta, seek medical attention immediately.
• Tardive dyskinesia: Tardive dyskinesia is a potentially irreversible disorder causing involuntary muscle movements often associated with taking antipsychotics. The longer the duration and higher the dose of Caplyta therapy, the higher the incidence of this disorder.
• Metabolic changes: Caplyta is associated with weight gain, higher incidence of type II diabetes mellitus, and changes in cholesterol levels.
• Leukocytopenia, neutropenia, and granulocytosis: Low levels of white blood cells are associated with Caplyta, especially for patients with low levels before therapy.
• Orthostatic hypotension and syncope: Caplyta may cause dizziness when standing up, also known as orthostatic hypotension, or fainting, also known as syncope. Monitor patients taking Caplyta, especially during initial therapy, and dose changes for dizziness and fainting.
• Falls: Caplyta may increase the risk of dizziness and drowsiness and may lead to falls, fractures, and other injuries.
• Seizures: Caplyta increases the risk for seizures, especially in patients with conditions that also increase the risk for seizures.
• Potential for cognitive and motor impairment: Caplyta may increase the risk for impaired thinking and decision skills as well as movement dysfunction.
• Body temperature dysregulation: Caplyta decreases the body’s ability to adjust to extreme temperatures and may lead to a high fever in some cases.
• Difficulty swallowing: Caplyta should be used with caution for patients who have an increased risk of aspiration (when food, liquid, or other material enters a person’s airway or the lungs by accident).

Caplyta Dosages for FDA-Approved Treatment

Caplyta is FDA-approved for the treatment of schizophrenia and depressive episodes associated with both bipolar I and II. Caplyta can be used as a single therapy or along with lithium or valproic acid. The recommended initial and continued dosage for most patients is 42 mg per day, although Caplyta is available in lower doses for patients with liver impairment or other conditions. Caplyta is approved for patients older than 18 years of age but should be avoided in elderly patients with dementia-related psychosis and pregnant and breastfeeding women.^{1, 5}

Caplyta Forms & Strengths

Caplyta is an oral capsule available in three dosage strengths: 10.5 mg, 21 mg, and 42 mg. Most patients will start therapy at 42 mg per day, but lower dosages may be used for patients who may not tolerate the side effects of higher doses. Caplyta is not available as an extended or delayed-release formulation. All dosage strengths of Caplyta will have their peak effects on the body within a few hours of administration.^{1, 2}

Caplyta is available in the following forms and strengths:¹

• 10.5 milligram (mg) oral capsule
• 21 mg oral capsule
• 42 mg oral capsule

How Should I Take Caplyta?

Patients should take Caplyta exactly as directed by their prescriber. Caplyta is taken once daily with or without food. However, taking Caplyta with a high-fat meal may decrease the absorption of the drug and lead to decreased effectiveness. Patients are advised to take Caplyta at bedtime because it can sometimes cause drowsiness.^{1, 2, 3}

What Happens If I Miss a Dose of Caplyta?

If a patient misses a dose of Caplyta, they should take the dose as soon as they remember unless it’s close to the time of their next scheduled dose. If the latter is the case, they should skip the missed dose and resume their regular dosing schedule. Do not double up on doses or take extra doses to catch up on missed doses. If you are unsure of whether you should take a missed dose, contact your doctor or pharmacist. You should not change your dosing schedule or stop taking Caplyta without talking to your prescriber first as well.¹

Can You Overdose on Caplyta?

Yes, you can overdose on Caplyta. However, there are no known cases of Caplyta overdoses, and the toxic dose has not yet been established. If you have taken too much Caplyta, you may experience symptoms similar to the side effects described above or common overdose symptoms of Caplyta, such as agitation, hallucinations, and tiredness. There are no specific antidotes known for Caplyta.^{1, 9}

What Should You Do If You Take Too Much Caplyta?

If you have taken more than the recommended dosage of Caplyta prescribed by your provider, you should seek medical attention immediately. They may provide supportive care and consider the possibility of a drug interaction for patients who have overdosed on Caplyta. You can also call the poison control center (800-222-1222) for further directions.¹

What to Avoid When Taking Caplyta

Caplyta has the potential to interact with different substances within the body, including multiple types of medications. Caplyta has the potential to interact with medications with antidepressant and sedative effects. The effects of Caplyta may be altered if combined with other substances that either block or utilize the same enzyme within the body as Caplyta, so it is important that the patient’s prescriber is aware of the patient’s full medication list. Caplyta may also enhance the effects of alcoholic beverages, so patients should avoid alcohol while on this medication.^{1, 3}

When combined with specific harmful substances, Caplyta has the potential to cause serious, life-threatening effects. It is important that individuals prescribed desipramine maintain open communication with their prescriber about all medications, including over-the-counter medications, and any herbal substances they may be taking to ensure a safe and effective treatment.¹

3 substances you should avoid while taking Caplyta include:¹

• Drugs that interact with CYP3A4 (e.g. ciprofloxacin, fluconazole): CYP3A4 is an enzyme in the body used to metabolize (break down in the body) many medications and other substances. If a patient takes another medication that interacts with this enzyme while taking Caplyta, they may have decreased effectiveness or increased risk of side effects of Caplyta (kumataperone).
• Alcohol: Caplyta may cause additive effects to sedation or drowsiness caused by alcohol intoxication.
• Sedative medications: Caplyta may cause additive effects to sedation or drowsiness caused by other sedative medications, such as benzodiazepines.

This is not a comprehensive list of the possible interactions with Caplyta. You should talk with your healthcare provider and your pharmacist about all prescription and over-the-counter medications, herbs, and supplements you take before starting Caplyta.

How to Get a Prescription for Caplyta

Caplyta must be prescribed by an authorized medical professional such as a primary-care physician or psychiatrist. If an individual believes that they may be eligible for treatment of bipolar depression or schizophrenia with Caplyta, they will need a psychiatric evaluation by a qualified medical professional to determine if Caplyta is the right course of treatment for them.¹

Questions to Ask Your Healthcare Provider About Caplyta

When patients are diagnosed with bipolar depression or schizophrenia, they may want to learn more about Caplyta from their doctor, psychiatrist, pharmacist, or therapist. Patients should ask their prescriber about the possible benefits, risks, and side effects of Caplyta. Patients should also be concerned about whether Caplyta will interact with their current medications, past medical history, or other aspects of their typical lifestyle.¹

In the case where a patient may need to change prescribers, online psychiatry services may be a convenient option for patients to ensure consistent mental health services.¹

Questions to ask your care team about Caplyta include:¹

• What are the potential common side effects of Caplyta that I should be aware of?
• Do I need to change any of my current medications if I start taking Caplyta?
• Are there alternative treatments for bipolar depression or schizophrenia that I should consider before starting Caplyta?
• How long does it typically take for the effects of Caplyta to start working?
• How long will it take for me to adjust to taking Caplyta?
• How will Caplyta impact my overall quality of life and well-being?
• Am I at increased risk for any serious conditions while taking Caplyta?
• What signs or symptoms should I look for that may indicate that I may need to talk to my doctor or pharmacist about discontinuing Caplyta?
• Does Caplyta work differently than other medications used to treat my condition?