Caplyta 10.5mg Capsules

Lumateperone is a serotonin-dopamine activity modulator (SDAM) that acts as a potent antagonist at serotonin 5-HT2A receptors, a postsynaptic partial agonist at dopamine D2 receptors, and a serotonin reuptake inhibitor (SERT). It also has affinity for dopamine D1 receptors and alpha1A-adrenergic receptors. The precise mechanism of action in schizophrenia and bipolar depression is unknown but is thought to be mediated through a combination of antagonism at 5-HT2A receptors and presynaptic partial agonism and postsynaptic antagonism at D2 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 or seek immediate 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 (rarely, infections can be fatal)
Signs of infection, such as fever, chills, or sore throat (especially if you have a history of low white blood cell count)
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 occur, especially in people with diabetes or older adults (particularly older females), characterized by:
+ 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

Most people experience few or no side effects while taking this medication. However, some common side effects may occur, including:

Dizziness or drowsiness
Upset stomach
Dry mouth
Weight gain
Headache

If any of these side effects or other symptoms bother you or do not go away, contact your doctor or seek medical attention. 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: 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 the safety and efficacy of 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 concurrently.

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. Therefore, it is vital to discuss all of your medications and health problems with your doctor and pharmacist to ensure safe and effective treatment.

To guarantee your safety, always check with your doctor before starting, stopping, or changing the dose of any medication. This includes prescription and OTC drugs, natural products, and vitamins, as well as any changes to your dosage regimen. By sharing this information and following your doctor's guidance, you can minimize potential risks and maximize the benefits of your treatment.

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.

Regularly check your blood work and other laboratory tests as advised 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 directed by your doctor.

Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult 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. Discuss your risk of seizures with your doctor. Additionally, this medication can cause dizziness, drowsiness, and impaired balance, which may lead to falls and resulting 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. 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 this with your doctor before starting the 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.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir)
• Strong or moderate CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John's Wort)

• Moderate CYP3A4 inhibitors (e.g., fluconazole, diltiazem, erythromycin) - consider dose reduction of lumateperone to 21 mg
• Other CNS depressants (e.g., alcohol, benzodiazepines, opioids) - additive CNS depression

• Antihypertensives (additive hypotensive effects)
• Drugs that prolong QT interval (theoretical risk, monitor)

• Not specifically identified as minor interactions with clinical significance requiring intervention.

• Changes in mood or behavior (e.g., agitation, aggression, suicidal ideation)
• Signs of metabolic changes (e.g., increased thirst, urination, hunger)
• Dizziness or lightheadedness (especially upon standing)
• Involuntary movements (e.g., tremors, restlessness, grimacing)
• Sedation or somnolence
• Nausea, vomiting, or diarrhea
• Dry mouth

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including Caplyta, during pregnancy. Available data from published observational studies on atypical antipsychotics have not reported a clear association with major birth defects or miscarriage. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Use only if the potential benefit justifies the potential risk to the fetus.

Lumateperone and its metabolites are present in the milk of lactating rats. It is unknown if lumateperone is present 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. Monitor breastfed infants for sedation, irritability, poor feeding, and abnormal movements.

Safety and effectiveness have not been established in pediatric patients. A Black Box Warning regarding increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders applies to this class of drugs, though Caplyta is not approved for pediatric 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 clinical trials for schizophrenia and bipolar depression, no overall differences in safety or effectiveness were observed between geriatric and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment for moderate hepatic impairment applies to all adults, including geriatric patients.

• Always take Caplyta with food to ensure proper absorption and minimize gastrointestinal side effects.
• Lumateperone is a unique antipsychotic with a distinct mechanism of action (SDAM) that may offer a different side effect profile compared to other atypical antipsychotics, particularly regarding metabolic effects (less weight gain, less impact on glucose/lipids).
• Monitor for orthostatic hypotension, especially at treatment initiation and during dose adjustments.
• Due to its CYP3A4 metabolism, careful consideration of drug-drug interactions is crucial, especially with strong CYP3A4 inhibitors and inducers, which are contraindicated.
• While the 10.5mg capsule exists, the approved therapeutic dose for schizophrenia and bipolar depression is 42mg once daily. The lower strengths are not for maintenance therapy in these indications.
• Patients should be advised about the potential for sedation and to avoid activities requiring mental alertness until they know how the drug affects them.

• Other atypical antipsychotics (e.g., olanzapine, risperidone, quetiapine, aripiprazole, lurasidone, cariprazine, brexpiprazole)
• Mood stabilizers (e.g., lithium, valproate, lamotrigine, carbamazepine) for bipolar depression
• Antidepressants (e.g., SSRIs, SNRIs) for bipolar depression (often used in combination with mood stabilizers or antipsychotics)

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 with 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 amount, and the time it occurred.