Caplyta

Approved Uses

Caplyta is used to manage specific mental health conditions in adults. Its primary indications include:

• Schizophrenia: It is used for the treatment of schizophrenia, a long-term mental health condition that can affect a person's thoughts, feelings, and behaviors.
• Bipolar Depression: It is used to treat depressive episodes associated with bipolar I or bipolar II disorder. In these cases, it may be used as a standalone treatment (monotherapy) or as an add-on treatment (adjunctive therapy) with other medications like lithium or valproate.

This medication is intended for use in adults only. It has not been established as safe or effective for use in children or adolescents.

Mechanism of Action

Caplyta belongs to a group of medicines called atypical antipsychotics. The exact way this medication works in the brain is not fully understood by scientists and medical professionals.

It is believed that Caplyta works by affecting the balance and activity of certain natural chemicals in the brain, known as neurotransmitters. These chemicals act as messengers between brain cells. The medication specifically targets two main neurotransmitters:

• Serotonin: Caplyta blocks certain serotonin receptors, which are involved in regulating mood and emotions.
• Dopamine: The medication also interacts with dopamine receptors, which help control behavior, movement, and thinking.

By adjusting the levels and activity of these substances, Caplyta helps to stabilize brain function and manage symptoms of certain mental health conditions.

Common Side Effects

The most frequently reported side effects of Caplyta include:

• Sleepiness or extreme tiredness
• Dry mouth
• Nausea
• Dizziness

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious symptoms:

• Uncontrolled movements: Known as tardive dyskinesia, this involves repetitive movements of the face, tongue, or other body parts.
• Severe physical reactions: Symptoms like high fever, stiff muscles, confusion, and rapid heart rate may indicate neuroleptic malignant syndrome (NMS).
• Metabolic issues: High blood sugar levels, increased cholesterol or fats in the blood, and weight gain.
• Low white blood cell count: This may lead to frequent infections or fever.
• Blood pressure changes: Feeling dizzy or lightheaded when standing up quickly, which can lead to fainting.
• Seizures: An increased risk of having a seizure.
• Trouble swallowing: Difficulty moving food or liquid through the throat.
• Overheating: Difficulty regulating body temperature, especially during exercise or in hot weather.

Boxed Warnings

Dementia-Related Psychosis: Elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death. Caplyta is not approved for the treatment of patients with dementia-related psychosis.

Suicidal Thoughts and Behaviors: Antipsychotics and antidepressants may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Patients of all ages starting this medication should be monitored closely for worsening symptoms, suicidal thoughts, or unusual changes in behavior.

Serious Reactions

Neuroleptic Malignant Syndrome (NMS): This is a rare but potentially fatal reaction to antipsychotic drugs. Symptoms may include high fever, muscle rigidity, delirium, and autonomic instability, such as irregular pulse or blood pressure.

Tardive Dyskinesia: This medication may cause involuntary, repetitive muscle movements, particularly in the face, tongue, or jaw. The risk of developing this condition and the likelihood it will become permanent increase with the duration of treatment and the total cumulative dose.

Metabolic and Blood Monitoring

• Metabolic Changes: Antipsychotic medications are associated with metabolic changes, including high blood sugar (hyperglycemia), diabetes mellitus, increased cholesterol and triglycerides (dyslipidemia), and weight gain. Regular monitoring of these levels is recommended.
• Blood Cell Counts: Cases of low white blood cell counts (leukopenia and neutropenia) have been reported. Patients with a history of low white blood cell counts may need frequent blood tests during the first few months of therapy.

Other Precautions

Orthostatic Hypotension and Falls: Caplyta may cause a drop in blood pressure when rising from a sitting or lying position, which can lead to dizziness or fainting. This increases the risk of falls, particularly in patients with conditions that predispose them to low blood pressure.

Seizures: This medication should be used with caution in patients with a history of seizures or conditions that lower the seizure threshold.

Body Temperature Regulation: Antipsychotics can disrupt the body's ability to reduce its core temperature. Caution is advised for patients engaging in strenuous exercise, exposure to extreme heat, or dehydration.

Cognitive and Motor Impairment: Somnolence (excessive sleepiness) and sedation are common. Patients should use caution when performing activities that require mental alertness, such as driving or operating machinery, until they know how the medication affects them.

Pregnancy Considerations

Information regarding the safety of Caplyta during pregnancy is limited. However, using antipsychotic medications during the third trimester of pregnancy may lead to complications in the newborn after delivery. These complications, known as extrapyramidal or withdrawal symptoms, may include:

• Difficulty breathing
• Feeding problems
• Muscle tremors or stiffness
• Agitation or irritability
• Drowsiness

If you are pregnant or planning to become pregnant, talk to your healthcare provider about the risks and benefits of continuing treatment. It is generally advised not to stop taking the medication without medical supervision, as the underlying condition may worsen. There is a pregnancy exposure registry that monitors outcomes for individuals who take antipsychotic medications while pregnant.

Breastfeeding Considerations

It is not yet known if lumateperone, the active ingredient in Caplyta, passes into breast milk or how it might affect a nursing infant. Because of the potential for side effects in the baby, healthcare providers typically recommend weighing the necessity of the drug for the mother against the benefits of breastfeeding. Consult your doctor to determine the safest feeding plan for your infant while you are using this medication.

Available Forms

Caplyta is supplied as a capsule to be taken by mouth. It is designed for once-daily administration and can be taken with or without food.

The medication is provided in various packaging options, such as bottles or blister packs, depending on the specific prescription requirements.

FDA Approval and Indications

Caplyta was approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults in 2019. In 2021, the FDA expanded its approval to include the treatment of depressive episodes associated with bipolar I or II disorder in adults, either as a standalone treatment or as an add-on therapy with lithium or valproate.

Boxed Warning

The FDA requires a boxed warning for Caplyta because elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death. Caplyta is not approved for the treatment of patients with dementia-related psychosis.

Safety Communications

The FDA also includes warnings regarding the risk of suicidal thoughts and behaviors in children, adolescents, and young adults taking antidepressant medications. Although Caplyta is not approved for pediatric use, patients of all ages should be monitored for clinical worsening or unusual changes in behavior.

Controlled Substance Status

Caplyta is a prescription medication and is not classified as a controlled substance. There is no Risk Evaluation and Mitigation Strategy (REMS) required for its distribution.

Weight Changes and Caplyta

Weight gain is a potential side effect of Caplyta. While many antipsychotic medications are associated with significant weight increases, clinical studies of Caplyta have shown that weight changes are generally small for most people. Some healthcare providers describe the medication as having a more favorable metabolic profile compared to older drugs in the same class.

Metabolic Monitoring

Because atypical antipsychotics can affect metabolism, healthcare providers typically monitor several health markers during treatment. These include:

• Body weight and body mass index (BMI)
• Blood sugar (glucose) levels
• Cholesterol and triglyceride levels

Managing Weight Changes

Individual responses to Caplyta vary. While some people may experience little to no change in weight, others may notice an increase in appetite or body mass. It is important to discuss any significant or rapid weight changes with a doctor. They can help determine if the change is related to the medication and may suggest lifestyle adjustments, such as changes in diet or physical activity, to help manage these effects.