Caplyta 21mg Capsules

Lumateperone is an atypical antipsychotic. Its efficacy in schizophrenia and bipolar depression is thought to be mediated through a combination of antagonist activity at serotonin 5-HT2A receptors, postsynaptic partial agonist activity at dopamine D2 receptors, and serotonin reuptake inhibition (SERT). It also has affinity for D1 receptors and alpha1A-adrenergic receptors.

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 immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion or feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing or fast breathing
+ Breath that smells like fruit
Severe dizziness or fainting
Seizures
Trouble controlling body movements, twitching, or changes in balance
Difficulty swallowing or speaking
Inability to sweat during physical activity or in warm temperatures
Low white blood cell count, which can increase the risk of infection (especially if you have a history of low white blood cell count)
Signs of infection, such as fever, chills, or sore throat
Neuroleptic malignant syndrome (NMS), a rare but potentially life-threatening condition, characterized by:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion or changes in thinking
+ Fast or irregular heartbeat
+ Excessive sweating
Tardive dyskinesia, a severe muscle problem that may cause:
+ Involuntary movements or twitching
+ Trouble controlling body movements
+ Problems with the tongue, face, mouth, or jaw (such as tongue sticking out, puffing cheeks, mouth puckering, or chewing)

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Dizziness or drowsiness
Upset stomach
Dry mouth
Weight gain
Headache

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have liver disease, as this may affect the medication's safety and efficacy.
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 be avoided.
Please note that this is not an exhaustive list of all potential drug interactions or health problems that may be relevant to this medication.

To ensure your safety, it is vital to disclose all your medications and health problems to your doctor and pharmacist. They will help you verify that it is safe to take this medication in conjunction with your other drugs and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure they are aware of any potential interactions or complications.

When starting this medication, be cautious when performing tasks that require alertness, such as driving, until you understand how it affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be mindful when navigating stairs.

Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your health while taking this medication. Be aware that drugs like this one have been associated with increased risks of high blood sugar, diabetes, high cholesterol, and weight gain, which may contribute to the development of heart and brain blood vessel disease. Follow your doctor's instructions for monitoring your blood sugar levels.

Before consuming alcohol, marijuana, or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor. Additionally, exercise caution in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration. Avoid consuming grapefruit and grapefruit juice, as they may interact with this medication.

This medication may increase the risk of seizures, particularly in individuals with a history of seizure disorders. Discuss your individual risk with your doctor. Dizziness, drowsiness, and impaired balance may occur, which can increase the risk of 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 conceiving or fathering a child. If you plan to become pregnant or father a child, discuss the potential risks and benefits with your doctor before starting this medication.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the benefits and risks of this medication with you. Taking this medication during the third trimester of pregnancy may cause side effects or withdrawal symptoms in the newborn.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, itraconazole, indinavir, nelfinavir, saquinavir, telithromycin, voriconazole, grapefruit juice)
• Strong/Moderate CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort, bosentan, efavirenz, etravirine, modafinil, nafcillin, phenobarbital)

• Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil, fluconazole, ciprofloxacin, fluvoxamine, aprepitant, imatinib, cimetidine, crizotinib, idelalisib, nefazodone, ranolazine, ticagrelor, zileuton) - reduce lumateperone dose to 21 mg once daily.

• CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedatives) - additive sedative effects.
• Antihypertensives - potential for additive hypotensive effects due to alpha1A-adrenergic receptor antagonism.

• Sedation/somnolence
• Dizziness/orthostatic hypotension
• Nausea
• Dry mouth
• Fatigue
• Extrapyramidal symptoms (e.g., tremor, akathisia, dystonia)
• Tardive dyskinesia (involuntary movements, especially of face and tongue)
• Weight gain
• Signs of hyperglycemia (e.g., polyuria, polydipsia, polyphagia)
• Signs of dyslipidemia
• Suicidal thoughts or behaviors (especially in young adults)
• Neuroleptic Malignant Syndrome (NMS) symptoms (e.g., fever, muscle rigidity, altered mental status, autonomic instability)
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) symptoms (e.g., rash, fever, lymphadenopathy, organ involvement)

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics during pregnancy. Pregnant women should be advised of 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. Use during pregnancy should only occur if the potential benefit justifies the potential risk to the fetus.

It is unknown if lumateperone or its metabolites are excreted in human milk. The developmental and health benefits of breastfeeding should be considered 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. A decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness have not been established in pediatric patients under 18 years of age. A Black Box Warning exists regarding increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults treated with antidepressants for major depressive disorder and other psychiatric disorders.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death (Black Box Warning). Lumateperone is not approved for this indication. Elderly patients may be more sensitive to the adverse effects of antipsychotics, including orthostatic hypotension and falls. Dosage adjustments are generally not needed based on age alone, but careful monitoring is advised.

• Caplyta (lumateperone) must be taken with food (at least 350 calories) to ensure adequate absorption and efficacy. Taking it without food significantly reduces absorption.
• The 21mg capsule is an available strength, but the standard therapeutic dose for both approved indications (schizophrenia and bipolar depression) is 42mg once daily. The 21mg dose is used when co-administered with moderate CYP3A4 inhibitors.
• Patients should be monitored for metabolic changes (weight, glucose, lipids) as with other atypical antipsychotics, although lumateperone has shown a relatively favorable metabolic profile in clinical trials compared to some other agents.
• Due to its mechanism of action, lumateperone has a lower propensity for certain side effects like hyperprolactinemia and significant QTc prolongation compared to some other antipsychotics, but monitoring is still important.
• Counsel patients on the risk of orthostatic hypotension and sedation, especially during initiation of therapy.

• Other atypical antipsychotics for schizophrenia (e.g., aripiprazole, olanzapine, quetiapine, risperidone, paliperidone, lurasidone, cariprazine, brexpiprazole, ziprasidone, asenapine)
• Other atypical antipsychotics for bipolar depression (e.g., quetiapine, lurasidone, cariprazine, olanzapine/fluoxetine combination)
• Mood stabilizers (e.g., lithium, valproate, lamotrigine, carbamazepine) for bipolar disorder

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its safe and effective use. It is essential to read this guide carefully when you first start taking the medication and each time you receive a refill. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.