Caplyta

Medical Author: John P. Cunha, DO, FACOEP Last updated on RxList: 5/17/2022
Caplyta Side Effects Center

What Is Caplyta?

Caplyta (lumateperone) is an atypical antipsychotic used to treat schizophrenia in adults.

What Are Side Effects of Caplyta?

Side effects of Caplyta include:

Dosage for Caplyta

The recommended dosage of Caplyta is 42 mg once daily.

Caplyta In Children

Safety and effectiveness of Caplyta have not been established in pediatric patients.

What Drugs, Substances, or Supplements Interact with Caplyta?

Caplyta may interact with other medicines such as:

  • amprenavir,
  • ciprofloxacin,
  • cyclosporine,
  • diltiazem,
  • erythromycin,
  • fluconazole,
  • fluvoxamine,
  • verapamil,
  • clarithromycin,
  • grapefruit juice,
  • itraconazole,
  • voriconazole,
  • nefazodone,
  • ritonavir,
  • nelfinavir,
  • carbamazepine,
  • phenytoin,
  • rifampin,
  • St. John's wort,
  • bosentan,
  • efavirenz,
  • etravirine,
  • modafinil,
  • nafcillin,
  • aprepitant,
  • armodafinil,
  • pioglitazone,
  • prednisone
  • ,
  • valproic acid, and
  • probenecid

Tell your doctor all medications and supplements you use.

Caplyta During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Caplyta: It may cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including Caplyta, during pregnancy. It is unknown if Caplyta passes into breast milk. Because of the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended while using Caplyta.

Additional Information

Our Caplyta (lumateperone) Capsules, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Schizophrenia: Symptoms, Types, Causes, Treatment See Slideshow
Caplyta Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of lumateperone can cause a serious movement disorder that may not be reversible. The longer you use lumateperone, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Call your doctor at once if you have:

  • feeling unsteady, feeling like you might pass out;
  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
  • tightness in your 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, feeling like you might pass out.

Common side effects may include:

  • weight gain;
  • drowsiness; or
  • dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Caplyta (Lumateperone Capsules)

QUESTION

Schizophrenia is the most disabling mental illness. See Answer
Caplyta Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in detail in other sections of the labeling:

  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
  • Suicidal Thoughts and Behaviors [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
  • Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis [see WARNINGS AND PRECAUTIONS]
  • Neuroleptic Malignant Syndrome [see WARNINGS AND PRECAUTIONS]
  • Tardive Dyskinesia [see WARNINGS AND PRECAUTIONS]
  • Metabolic Changes [see WARNINGS AND PRECAUTIONS]
  • Leukopenia, Neutropenia, and Agranulocytosis [see WARNINGS AND PRECAUTIONS]
  • Orthostatic Hypotension and Syncope [see WARNINGS AND PRECAUTIONS]
  • Falls [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Potential for Cognitive and Motor Impairment [see WARNINGS AND PRECAUTIONS]
  • Body Temperature Dysregulation [see WARNINGS AND PRECAUTIONS]
  • Dysphagia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of CAPLYTA has been evaluated in placebo-controlled clinical trials in 2664 adult patients with schizophrenia and bipolar depression exposed to one or more doses. A total of 402 CAPLYTA-exposed patients had at least 6 months of exposure and 108 had at least 1 year of exposure to the 42-mg dose of CAPLYTA.

Schizophrenia

The following findings are based on the pooled short-term (4- to 6-week), placebo-controlled studies in adult patients with schizophrenia in which CAPLYTA was administered at a daily dose of 42 mg (N=406).

There was no single adverse reaction leading to discontinuation that occurred at a rate of >2% in CAPLYTA-treated patients.

The most common adverse reactions (incidence of at least 5% of patients exposed to CAPLYTA and greater than twice the rate of placebo) are somnolence/sedation and dry mouth.

Adverse reactions associated with CAPLYTA (incidence of at least 2% in patients exposed to CAPLYTA and greater than placebo) are shown in Table 2.

Table 2: Adverse Reactions Reported in >2% of CAPLYTA-Treated Patients and Occurred at a Greater Incidence than in Placebo-Treated Patients in 4- to 6-week Schizophrenia Trials

CAPLYTA 42 mg
(N=406)
Placebo
(N=412)
Somnolence/Sedation 24% 10%
Nausea 9% 5%
Dry Mouth 6% 2%
Dizziness1 5% 3%
Creatine Phosphokinase Increased 4% 1%
Fatigue 3% 1%
Vomiting 3% 2%
Hepatic Transaminases Increased2 2% 1%
Decreased Appetite 2% 1%
1 Dizziness, dizziness postural
2 ALT, AST, “hepatic enzymes” increased, or liver function test abnormal

Bipolar Depression - Monotherapy

The following findings are based on the pooled short-term (6-week), placebo-controlled monotherapy bipolar depression studies in adult patients treated with CAPLYTA administered at a daily dose of 42 mg (N=372).

There was no single adverse reaction leading to discontinuation that occurred at a rate of >2% in CAPLYTA-treated patients.

The most common adverse reactions (incidence of at least 5% of patients exposed to CAPLYTA and greater than twice the rate of placebo) are somnolence/sedation, dizziness, nausea, and dry mouth.

Adverse reactions associated with CAPLYTA (incidence of at least 2% in patients exposed to CAPLYTA and greater than placebo) are shown in Table 3.

Table 3: Adverse Reactions Reported in ≥2% of CAPLYTA-Treated Patients and that Occurred at Greater Incidence than in the Placebo-Treated Patients in Pooled 6-week Monotherapy Bipolar Depression Trials

CAPLYTA 42 mg
(N=372)
Placebo
(N=374)
Headache 14% 8%
Somnolence/Sedation 13% 3%
Dizziness1 8% 4%
Nausea 8% 3%
Dry mouth 5% 1%
Diarrhea 4% 2%
Vomiting 4% 0%
Abdominal pain2 2% 1%
Upper respiratory tract infection 2% 1%
1 Dizziness, dizziness postural
2 Abdominal discomfort, abdominal pain, abdominal pain upper and lower

Bipolar Depression - Adjunctive Therapy With Lithium Or Valproate

The following findings are based on a 6-week, placebo-controlled adjunctive therapy bipolar depression study in adult patients treated with CAPLYTA administered at a daily dose of 42 mg (N=177).

There was no single adverse reaction leading to discontinuation that occurred at a rate of >2% in CAPLYTA-treated patients.

The most common adverse reactions (incidence of at least 5% of patients exposed to CAPLYTA and greater than twice the rate of placebo) are somnolence/sedation, dizziness, nausea, and dry mouth.

Adverse reactions associated with CAPLYTA (incidence of at least 2% in patients exposed to CAPLYTA and greater than placebo) are shown in Table 4.

Table 4: Adverse Reactions Reported in ≥2% of CAPLYTA-Treated Patients and that Occurred at Greater Incidence than in the Placebo-Treated Patients in a 6-Week Adjunctive Therapy Bipolar Depression Trial

CAPLYTA 42 mg
(N=177)
Placebo
(N=175)
Somnolence/Sedation 13% 3%
Dizziness1 11% 2%
Nausea 9% 4%
Dry mouth 5% 1%
Vomiting 4% 0%
Diarrhea 3% 2%
Upper respiratory tract infection 3% 1%
Blurred vision 3% 1%
Increased blood prolactin 2% 0%
1 Dizziness, dizziness postural

Dystonia

Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. Although these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and higher doses of first-generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Extrapyramidal Symptoms (EPS)

In the short-term, placebo-controlled schizophrenia and bipolar depression studies, data was objectively collected on the Simpson-Angus Scale (SAS) for EPS (total score ranges from 0 to 40), the Barnes Akathisia Rating Scale (BARS) for akathisia (total score ranges from 0 to 14) and the Abnormal Involuntary Movement Scale (AIMS) for dyskinesia (total score ranges from 0 to 28).

Schizophrenia

In the 4- to 6-week, placebo-controlled schizophrenia trials, the frequency of reported events related to extrapyramidal symptoms (EPS), including akathisia, extrapyramidal disorder, muscle spasms, restlessness, musculoskeletal stiffness, dyskinesia, dystonia, muscle twitching, tardive dyskinesia, tremor, drooling, and involuntary muscle contractions was 6.7% for CAPLYTA and 6.3% for placebo.

In the 4- to 6-week schizophrenia trials, the mean changes from baseline for CAPLYTA-treated patients and placebo-treated patients were 0.1 and 0 for the SAS, -0.1 and 0 for the BARS, and 0.1 and 0 for the AIMS, respectively.

Bipolar Depression

In the 6-week, monotherapy bipolar depression trials, the frequency of reported reactions related to EPS, including muscle spasms, dyskinesia, extrapyramidal disorder, movement disorder, tremor, restlessness, and akathisia was 1.3% for CAPLYTA and 1.1% for placebo.

In a 6-week, adjunctive therapy bipolar depression trial, the frequency of reported reactions related to EPS, including tremor, muscle spasms, akathisia, extrapyramidal disorder, gait disturbance, and restlessness was 4.0% for CAPLYTA and 2.3% for placebo.

In the 6-week, monotherapy bipolar depression trials, the mean changes from baseline for CAPLYTA-treated patients and placebo-treated patients were 0 and 0 for the SAS, -0.1 and -0.1 for the BARS, and 0 and 0 for the AIMS, respectively. In the 6-week adjunctive therapy bipolar depression trial, the mean changes from baseline for CAPLYTA-treated patients and placebo-treated patients were 0 and 0 for the SAS, 0 and -0.1 for the BARS, and 0 and 0 for the AIMS, respectively.

DRUG INTERACTIONS

Drugs Having Clinically Important Interactions With CAPLYTA

Table 5: Clinically Important Drug Interactions with CAPLYTA

CYP3A4 Inducers
Clinical Impact Concomitant use of CAPLYTA with CYP3A4 inducers decreases the exposure of lumateperone [see CLINICAL PHARMACOLOGY].
Intervention Avoid concomitant use of CAPLYTA with CYP3A4 inducers.
Moderate or Strong CYP3A4 Inhibitors
Clinical Impact Concomitant use of CAPLYTA with moderate or strong CYP3A4 inhibitors increases lumateperone exposure [see CLINICAL PHARMACOLOGY], which may increase the risk of adverse reactions.
Intervention Reduce CAPLYTA dose when used concomitantly with moderate or strong CYP3A4 inhibitors [see DOSAGE AND ADMINISTRATION].

Read the entire FDA prescribing information for Caplyta (Lumateperone Capsules)

© Caplyta Patient Information is supplied by Cerner Multum, Inc. and Caplyta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors