Lumateperone

Lumateperone is a prescription medication used to treat the symptoms of schizophrenia and bipolar disorder in adults.

• Lumateperone is available under the following different brand names: Caplyta

Adult dosage

Capsule

• 10.5mg
• 21mg
• 42mg

Schizophrenia

Adult dosage

• 42 mg orally once a day

Bipolar Disorder

Adult dosage

• 42 mg orally once a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Lumateperone include:

• drowsiness,
• dry mouth,
• nausea,
• dizziness,
• increased creatine phosphokinase,
• fatigue,
• vomiting,
• increased liver transaminases, and
• decreased appetite

Serious side effects of Lumateperone include:

• feeling unsteady,
• uncontrolled muscle movements in the face (chewing, lip smacking, frowning, tongue movement, blinking, or eye movement);
• tightness in the neck or throat, trouble swallowing;
• trouble breathing or speaking;
• a seizure;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
• low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing; or
• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, light-headedness.

Rare side effects of Lumateperone include:

• None

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Lumateperone has severe interactions with the following drugs:
  • amisulpride
• Lumateperone has serious interactions with at least 38 other drugs.
• Lumateperone has moderate interactions with at least 73 other drugs.
• Lumateperone has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concern.

Contraindications

• History of hypersensitivity; reactions have included pruritus, rash (.g, allergic dermatitis, papular rash, and generalized rash), and urticaria

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Lumateperone?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lumateperone?”

Cautions 

• Geriatric patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk of death
• Geriatric patients with dementia who were treated with antipsychotics had a higher incidence of stroke and transient ischemic attacks, including fatal stroke
• Monitor all antidepressant-treated patients for any indication of clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes; counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider; consider changing the therapeutic regimen, including possibly discontinuing therapy, in patients whose depression is persistently worse, or who are experiencing suicidal thoughts or behaviors
• Neuroleptic malignant syndrome (NMS), a potentially fatal symptom complex, is reported with the administration of antipsychotic drugs; if NMS is suspected, immediately discontinue lumateperone and provide intensive symptomatic treatment and monitoring
• Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs; risk appears to be highest among elderly individuals, especially women, but it is not possible to predict which patients are likely to develop the syndrome
• May cause metabolic changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain
• Leukopenia and neutropenia were reported with antipsychotic agents, including lumateperone; agranulocytosis was reported with other agents in the class
• May cause orthostatic hypotension and syncope; risk is greatest during initial dose administration
• Antipsychotics, including lumateperone, may cause somnolence, postural hypotension, and motor and sensory instability, which may lead to falls and, consequently, fractures and other injuries
• May cause seizures; risk is greatest with a history of seizures or with conditions that lower seizure threshold
• It May cause somnolence and has the potential to impair judgment, thinking, and motor skills
• May disrupt the body’s ability to reduce core body temperature; strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevated core body temperature
• Esophageal dysmotility and aspiration reported with antipsychotic drug use
• Drug interaction overview
  • CYP3A4 inhibitors
    • Strong inhibitors: Reduce lumateperone dose to 10.5 mg/day
    • Moderate inhibitors: Reduce lumateperone dose to 21 mg/day
    • Moderate or strong CYP3A4 inhibitors increase the systemic exposure of lumateperone
  • CYP3A4 inducers
    • Avoid coadministration
    • CYP3A4 inducers decrease the systemic exposure of lumateperone

Pregnancy and Lactation

• Neonates exposed to antipsychotic drugs during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery
• Available data from case reports on use in pregnant women are insufficient to establish any drug-associated risks for birth defects, miscarriage, or adverse maternal or fetal outcomes
• Clinical considerations
  • There is a risk to the mother from untreated schizophrenia, including an increased risk of relapse, hospitalization, and suicide
  • Schizophrenia is associated with increased adverse perinatal outcomes, including preterm birth; unknown if this is a direct result of the illness or other comorbid factors
• Infertility
  • Based on findings from animal studies, lumateperone may impair male and female fertility
• Lactation
  • Data are not available regarding the presence of lumateperone or its metabolites in human milk, its effect on breastfed infants, or its effect on milk production