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CAPLYTA (lumateperone tosylate)
- Schizophrenia
- Depression associated with bipolar disorder
42 mg capsule
- 1 capsule (42 mg) by oral route once daily
Schizophrenia
- 1 capsule (42 mg) by oral route once daily
- metoclopramide HCl
- Metozolv Odt
- Reglan
Contraindicated
- None
Severe
Moderate
- Aplenzin
- Apokyn
- apomorphine
- Buproban
- bupropion HBr
- bupropion HCl
- carbidopa-levodopa
- carbidopa-levodopa-entacapone
- Comtan
- entacapone
- Forfivo Xl
- Mirapex
- Mirapex Er
- pramipexole
- Requip
- Requip Xl
- ropinirole
- Sinemet
- Sinemet Cr
- Stalevo 100
- Stalevo 125
- Stalevo 150
- Stalevo 200
- Stalevo 50
- Stalevo 75
- Wellbutrin
- Wellbutrin Sr
- Wellbutrin Xl
- Zyban
- Child-pugh class B hepatic impairment
- Child-pugh class C hepatic impairment
Contraindicated
- Congenital long QT syndrome
- Neuroleptic malignant syndrome
- Senile dementia
- Tardive dyskinesia
Severe
Moderate
- Agranulocytosis
- Cerebrovascular disorder
- Chronic heart failure
- Dehydration
- Diabetes mellitus
- Esophageal dysmotility
- Hypotension
- Hypovolemia
- Leukopenia
- Lower seizure threshold
- Metabolic syndrome x
- Myocardial ischemia
- Neutropenic disorder
- Predisposition to aspiration
- Seizure disorder
CAPLYTA (lumateperone tosylate)
- Schizophrenia
- Depression associated with bipolar disorder
- None
- Drowsy
- Sedation
- Xerostomia
More Frequent
Severe
Less Severe
- Acquired dystonia
- Diabetes mellitus
- Extrapyramidal disease
- Hyperlipidemia
- Hypertriglyceridemia
- Increased alanine transaminase
- Increased aspartate transaminase
- Tardive dyskinesia
- Anorexia
- Dizziness
- Fatigue
- Hyperglycemia
- Increased creatine kinase level
- Nausea
- Vomiting
- Weight gain
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Accidental fall
- Dysphagia
- Esophageal dysmotility
- Fever
- Leukopenia
- Neuroleptic malignant syndrome
- Neutropenic disorder
- Orthostatic hypotension
- Seizure disorder
- Urticaria
Less Severe
- Pruritus of skin
- Skin rash
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Lumateperone
Safety and effectiveness not established in pediatric patients.
- 1 Day – 18 Years
- Safety and effectiveness not established in pediatric patients.
Lumateperone
- Severity Level:
2
- Additional Notes: Infants exposed in 3rd trimester may show signs of extrapyramidal symptoms.
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Lumateperone
Mfg does not rec breastfeeding during treatment
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Mfg does not rec breastfeeding during treatment |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Lumateperone
Neuro/Psych-Higher risk of tardive dyskinesia in the elderly. May cause sedation, worsen cognitive impairment and increase fall risk. Increased risk of death in senile dementia. Cardiovascular-May cause orthostatic hypotension.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | N | Y | Y | Y | N | N |
BEERS: Y HEDIS: N STOPP: N
No Known Risk
None
- There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.
| Depression associated with bipolar disorder | |
| F31.3 | Bipolar disorder, current episode depressed, mild or moderate severity |
| F31.30 | Bipolar disorder, current episode depressed, mild or moderate severity, unspecified |
| F31.31 | Bipolar disorder, current episode depressed, mild |
| F31.32 | Bipolar disorder, current episode depressed, moderate |
| F31.4 | Bipolar disorder, current episode depressed, severe, without psychotic features |
| F31.5 | Bipolar disorder, current episode depressed, severe, with psychotic features |
| Schizophrenia | |
| F20 | Schizophrenia |
| F20.0 | Paranoid schizophrenia |
| F20.1 | Disorganized schizophrenia |
| F20.2 | Catatonic schizophrenia |
| F20.3 | Undifferentiated schizophrenia |
| F20.5 | Residual schizophrenia |
| F20.8 | Other schizophrenia |
| F20.81 | Schizophreniform disorder |
| F20.89 | Other schizophrenia |
| F20.9 | Schizophrenia, unspecified |
| 0-9 | A-Z |
|---|---|
| F20 | Schizophrenia |
| F20.0 | Paranoid schizophrenia |
| F20.1 | Disorganized schizophrenia |
| F20.2 | Catatonic schizophrenia |
| F20.3 | Undifferentiated schizophrenia |
| F20.5 | Residual schizophrenia |
| F20.8 | Other schizophrenia |
| F20.81 | Schizophreniform disorder |
| F20.89 | Other schizophrenia |
| F20.9 | Schizophrenia, unspecified |
| F31.3 | Bipolar disorder, current episode depressed, mild or moderate severity |
| F31.30 | Bipolar disorder, current episode depressed, mild or moderate severity, unspecified |
| F31.31 | Bipolar disorder, current episode depressed, mild |
| F31.32 | Bipolar disorder, current episode depressed, moderate |
| F31.4 | Bipolar disorder, current episode depressed, severe, without psychotic features |
| F31.5 | Bipolar disorder, current episode depressed, severe, with psychotic features |
Formulary Reference Tool