Caplyta

Last updated on RxList: 12/7/2020
Caplyta Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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 BOX 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 1724 adult patients with schizophrenia exposed to one or more doses. Of these patients, 811 participated in short-term (4- to 6-week), placebo-controlled trials with doses ranging from 14 to 84 mg/day. A total of 329 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.

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

Table 1: Adverse Reactions Reported in ≥2% of CAPLYTA-Treated Patients in 4- to 6-week Schizophrenia Trials

CAPLYTA
42 mg
(N=406)
Placebo
(N=412)
Somnolence/ Sedation24%10%
Nausea9%5%
Dry Mouth6%2%
Dizziness15%3%
Creatine Phosphokinase Increased4%1%
Fatigue3%1%
Vomiting3%2%
Hepatic Transaminases Increased22%1%
Decreased Appetite2%1%
1 Dizziness, dizziness postural
2 ALT, AST, “hepatic enzymes” increased, or liver function test abnormal

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

In the 4- to 6-week, placebo-controlled 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 trials, data were collected using 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). 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.

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.

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