Caplyta 42mg Capsules
WARNING: There is a higher chance of death in older adults who take this drug for mental problems caused by dementia. Most of the deaths were linked to heart disease or infection. This drug is not approved to treat mental problems caused by dementia.Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like depression, nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur. @ COMMON USES: It is used to treat schizophrenia.It is used to treat depression in people with bipolar disorder.
Drug Class
Atypical antipsychotic
Pharmacologic Class
Serotonin-2A receptor antagonist; Dopamine D2 receptor partial agonist; Serotonin reuptake inhibitor
Pregnancy Category
Not available
FDA Approved
Dec 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Caplyta (lumateperone) is a medication used to treat schizophrenia and depressive episodes associated with bipolar disorder (manic-depressive illness) in adults. It works by affecting certain chemicals in the brain, like serotonin and dopamine, to help improve mood, thoughts, and behavior. It's taken once a day with food.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if you feel well, unless your doctor or healthcare provider tells you to stop.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if you feel well, unless your doctor or healthcare provider tells you to stop.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take Caplyta exactly as prescribed by your doctor, once daily with food.
- Do not stop taking Caplyta suddenly without talking to your doctor, as this can cause withdrawal symptoms or worsening of your condition.
- Avoid alcohol while taking Caplyta, as it can increase drowsiness and dizziness.
- Be careful when driving or operating machinery until you know how Caplyta affects you, as it can cause drowsiness or dizziness.
- Tell your doctor about all other medications you are taking, including over-the-counter drugs, supplements, and herbal products, especially St. John's Wort.
- Monitor your weight and blood sugar regularly, as this medication can sometimes affect these.
- Stay hydrated, especially if you experience dry mouth.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
42 mg orally once daily with food
Dose Range:
42 - 42 mg
Condition-Specific Dosing:
schizophrenia:
42 mg orally once daily with food
bipolar_depression_monotherapy:
42 mg orally once daily with food
bipolar_depression_adjunctive:
42 mg orally once daily with food (with lithium or valproate)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
Avoid use (not studied)
Dialysis:
Avoid use (not studied)
Hepatic Impairment:
Mild:
No dose adjustment needed
Moderate:
21 mg orally once daily with food
Severe:
Avoid use (not studied)
Pharmacology
Mechanism of Action
Lumateperone is an atypical antipsychotic. Its efficacy is thought to be mediated through a combination of potent serotonin 5-HT2A receptor antagonism and presynaptic partial agonism at dopamine D2 receptors. It also acts as a serotonin reuptake inhibitor (SERT). Lumateperone has affinity for dopamine D1 receptors and alpha1A-adrenergic receptors, but importantly, it does not have direct affinity for histaminergic or muscarinic receptors, which may contribute to its favorable metabolic and anticholinergic side effect profile.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified, but food increases absorption
Tmax:
1-2 hours
FoodEffect:
Administration with food increases AUC and Cmax by 2-3 times compared to fasting conditions.
Distribution:
Vd:
Approximately 2000 L
ProteinBinding:
Approximately 97%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 18 hours
Clearance:
Not precisely quantified, but primarily hepatic
ExcretionRoute:
Urine (approximately 50%), Feces (approximately 34%)
Unchanged:
Less than 1% (in urine)
Pharmacodynamics
OnsetOfAction:
Clinical effects may be observed within days to weeks, full therapeutic effect may take several weeks.
PeakEffect:
Not precisely defined for psychiatric symptom improvement; plasma concentrations peak within 1-2 hours.
DurationOfAction:
Once daily dosing supports 24-hour efficacy.
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Lumateperone is not approved for the treatment of patients with dementia-related psychosis. Suicidal Thoughts and Behaviors: Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over 24; there was a reduction in risk with antidepressant use in patients aged 65 and older. In adults, CAPLYTA is approved for the treatment of depressive episodes associated with bipolar I or bipolar II disorder. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. CAPLYTA is not approved for use in pediatric patients.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Severe dizziness or passing out
Seizures
Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking
Not sweating during activities or in warm temperatures
Low white blood cell counts, which can increase the risk of infection. If you have a history of low white blood cell counts, inform your doctor. Seek medical attention immediately if you experience signs of infection, such as:
+ Fever
+ Chills
+ Sore throat
Neuroleptic malignant syndrome (NMS), a rare but potentially life-threatening condition. Seek medical help immediately if you experience:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Change in thinking
+ Fast heartbeat
+ Irregular heartbeat
+ Excessive sweating
Tardive dyskinesia, a severe muscle problem that may occur, especially in people with diabetes and older adults, particularly older females. The risk increases with longer use or higher doses, but it can also occur after short-term use with low doses. Seek medical help immediately if you experience:
+ Trouble controlling body movements
+ Problems with your tongue, face, mouth, or jaw, such as:
- Tongue sticking out
- Puffing cheeks
- Mouth puckering
- Chewing
Other Possible Side Effects
Most people experience no side effects or only minor side effects while taking this medication. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Feeling dizzy or sleepy
Upset stomach
Dry mouth
Weight gain
Headache
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Severe dizziness or passing out
Seizures
Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking
Not sweating during activities or in warm temperatures
Low white blood cell counts, which can increase the risk of infection. If you have a history of low white blood cell counts, inform your doctor. Seek medical attention immediately if you experience signs of infection, such as:
+ Fever
+ Chills
+ Sore throat
Neuroleptic malignant syndrome (NMS), a rare but potentially life-threatening condition. Seek medical help immediately if you experience:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Change in thinking
+ Fast heartbeat
+ Irregular heartbeat
+ Excessive sweating
Tardive dyskinesia, a severe muscle problem that may occur, especially in people with diabetes and older adults, particularly older females. The risk increases with longer use or higher doses, but it can also occur after short-term use with low doses. Seek medical help immediately if you experience:
+ Trouble controlling body movements
+ Problems with your tongue, face, mouth, or jaw, such as:
- Tongue sticking out
- Puffing cheeks
- Mouth puckering
- Chewing
Other Possible Side Effects
Most people experience no side effects or only minor side effects while taking this medication. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Feeling dizzy or sleepy
Upset stomach
Dry mouth
Weight gain
Headache
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Fever, muscle stiffness, confusion, sweating, or changes in heart rate/blood pressure (signs of Neuroleptic Malignant Syndrome - NMS)
- Uncontrolled movements of your face, tongue, or other body parts (signs of Tardive Dyskinesia - TD)
- Dizziness, lightheadedness, or fainting, especially when standing up (orthostatic hypotension)
- New or worsening suicidal thoughts or behaviors, especially in young adults
- Increased thirst, increased urination, increased hunger, or weakness (signs of high blood sugar/diabetes)
- Severe allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)
- Seizures
- Difficulty swallowing
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease, as this may affect how your body processes the medication.
* Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, seizures, and other conditions, may interact with this drug and should not be taken together.
Please note that this is not an exhaustive list of all potential drug interactions or health problems that may be relevant to your treatment with this medication. To ensure your safety, it is vital to discuss all of your medications and health conditions with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor. This will help prevent any potential interactions or adverse effects and ensure that you receive the maximum benefit from your treatment.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease, as this may affect how your body processes the medication.
* Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, seizures, and other conditions, may interact with this drug and should not be taken together.
Please note that this is not an exhaustive list of all potential drug interactions or health problems that may be relevant to your treatment with this medication. To ensure your safety, it is vital to discuss all of your medications and health conditions with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor. This will help prevent any potential interactions or adverse effects and ensure that you receive the maximum benefit from your treatment.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.
Regular blood tests and other laboratory assessments are crucial, as directed by your doctor. Be aware that medications like this one can increase the risk of high blood sugar, diabetes, high cholesterol, and weight gain, which may contribute to heart and brain blood vessel disease. Monitor your blood sugar levels as advised by your doctor.
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, discuss the potential risks with your doctor. In hot weather or during physical activity, drink plenty of fluids to prevent dehydration, and avoid consuming grapefruit or grapefruit juice.
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication. Additionally, this medication can cause dizziness, drowsiness, and impaired balance, which may lead to falls and subsequent injuries, such as fractures.
Older adults with dementia who take medications like this one have a higher risk of experiencing strokes, which can be fatal. It is essential to note that this medication is not approved for treating dementia-related mental health issues. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
This medication may affect fertility, potentially leading to difficulties in becoming pregnant or fathering a child. If you plan to conceive, discuss the potential risks with your doctor before starting this medication. If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks to you and your baby. Taking this medication during the third trimester of pregnancy may cause side effects or withdrawal symptoms in the newborn.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.
Regular blood tests and other laboratory assessments are crucial, as directed by your doctor. Be aware that medications like this one can increase the risk of high blood sugar, diabetes, high cholesterol, and weight gain, which may contribute to heart and brain blood vessel disease. Monitor your blood sugar levels as advised by your doctor.
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, discuss the potential risks with your doctor. In hot weather or during physical activity, drink plenty of fluids to prevent dehydration, and avoid consuming grapefruit or grapefruit juice.
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication. Additionally, this medication can cause dizziness, drowsiness, and impaired balance, which may lead to falls and subsequent injuries, such as fractures.
Older adults with dementia who take medications like this one have a higher risk of experiencing strokes, which can be fatal. It is essential to note that this medication is not approved for treating dementia-related mental health issues. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
This medication may affect fertility, potentially leading to difficulties in becoming pregnant or fathering a child. If you plan to conceive, discuss the potential risks with your doctor before starting this medication. If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks to you and your baby. Taking this medication during the third trimester of pregnancy may cause side effects or withdrawal symptoms in the newborn.
Overdose Information
Overdose Symptoms:
- Sedation
- Dizziness
- Orthostatic hypotension
- Tachycardia
- Extrapyramidal symptoms
What to Do:
Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222. Treatment is supportive, including maintaining an open airway, ensuring adequate oxygenation and ventilation, and monitoring cardiovascular function. Gastric lavage and activated charcoal may be considered. There is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, itraconazole)
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort)
Major Interactions
- Moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin)
Moderate Interactions
Minor Interactions
- None specifically listed as minor, but caution with other drugs affecting blood pressure due to alpha1A antagonism.
Monitoring
Baseline Monitoring
Psychiatric evaluation
Rationale: To establish baseline symptom severity and guide treatment.
Timing: Prior to initiation
Weight, BMI, waist circumference
Rationale: To monitor for metabolic changes, as atypical antipsychotics can cause weight gain.
Timing: Prior to initiation
Fasting plasma glucose/HbA1c
Rationale: To screen for and monitor new-onset diabetes or worsening glycemic control.
Timing: Prior to initiation
Lipid panel (fasting)
Rationale: To screen for and monitor dyslipidemia.
Timing: Prior to initiation
Blood pressure
Rationale: To monitor for orthostatic hypotension.
Timing: Prior to initiation
Routine Monitoring
Psychiatric symptoms (efficacy)
Frequency: Regularly, especially during initial weeks and dose adjustments
Target: Reduction in target symptoms (e.g., hallucinations, delusions, mood symptoms)
Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation.
Weight, BMI
Frequency: Monthly for first few months, then quarterly
Target: Maintain stable weight or minimal gain
Action Threshold: Significant weight gain (e.g., >5% of baseline) may require intervention.
Fasting plasma glucose/HbA1c
Frequency: At 3 months, then annually (more frequently if risk factors or abnormalities)
Target: Normal glycemic levels
Action Threshold: Elevated levels may require intervention or change in therapy.
Lipid panel (fasting)
Frequency: At 3 months, then annually (more frequently if risk factors or abnormalities)
Target: Normal lipid levels
Action Threshold: Elevated levels may require intervention or change in therapy.
Blood pressure
Frequency: Regularly, especially during initial weeks
Target: Stable blood pressure, no significant orthostatic drops
Action Threshold: Symptomatic orthostatic hypotension or sustained hypertension.
Extrapyramidal symptoms (EPS)
Frequency: Regularly, especially during initial weeks
Target: Absence of or minimal EPS (e.g., akathisia, dystonia, parkinsonism)
Action Threshold: Development of significant EPS may require intervention or change in therapy.
Tardive Dyskinesia (TD)
Frequency: Periodically (e.g., every 6-12 months)
Target: Absence of involuntary movements
Action Threshold: Emergence of TD requires consideration of dose reduction or discontinuation.
Sedation/Somnolence
Frequency: Regularly, especially during initial weeks
Target: Tolerable level of sedation
Action Threshold: Excessive sedation impacting daily function.
Symptom Monitoring
- Changes in mental status (agitation, confusion)
- Fever, muscle rigidity, autonomic instability (signs of NMS)
- Involuntary movements (face, tongue, limbs, trunk)
- Dizziness or lightheadedness upon standing
- Excessive sleepiness or sedation
- Dry mouth
- Nausea
- Weight changes
- Symptoms of hyperglycemia (increased thirst, urination, hunger)
- Suicidal thoughts or behaviors (especially in young adults)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies showed developmental toxicity at high doses.
Second Trimester:
Limited human data.
Third Trimester:
Risk of extrapyramidal and/or withdrawal symptoms in neonates (e.g., agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, feeding disorder).
Lactation
It is not known if lumateperone or its metabolites are excreted in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Caplyta and any potential adverse effects on the breastfed infant from Caplyta or from the underlying maternal condition.
Infant Risk:
Unknown; potential for sedation, feeding difficulties, or other adverse effects.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Caplyta is not approved for use in pediatric patients. There is a Black Box Warning regarding increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults treated with antidepressants.
Geriatric Use
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Caplyta is not approved for the treatment of patients with dementia-related psychosis. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Caplyta is taken once daily with food. Taking it with food significantly increases its absorption.
- It has a unique mechanism of action, combining 5-HT2A antagonism, D2 partial agonism, and SERT inhibition, with minimal affinity for muscarinic and histaminergic receptors, which may lead to a more favorable metabolic and anticholinergic side effect profile compared to some other atypical antipsychotics.
- Dose adjustment is required for moderate hepatic impairment (21 mg daily). Avoid use in severe hepatic or renal impairment.
- Contraindicated with strong CYP3A4 inhibitors and inducers.
- Monitor for orthostatic hypotension, especially during the initial titration period.
- While generally having a better metabolic profile, routine monitoring of weight, glucose, and lipids is still recommended.
- Patients should be advised to avoid alcohol due to additive CNS depressant effects.
Alternative Therapies
- For Schizophrenia: First-generation antipsychotics, other atypical antipsychotics, psychosocial therapies.
- For Bipolar Depression: Mood stabilizers (e.g., lithium, valproate, lamotrigine), other atypical antipsychotics (e.g., quetiapine, lurasidone, cariprazine), antidepressants (often with a mood stabilizer), psychotherapy.
Cost & Coverage
Average Cost:
$1,400 - $1,800 per 30 capsules (42mg)
Insurance Coverage:
Specialty Tier (requires prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.