Drug Guide
Lumateperone Tosylate
Classification
Therapeutic: Antipsychotic, atypical
Pharmacological: Dopamine-serotonin modulator
FDA Approved Indications
- Schizophrenia in adults
Mechanism of Action
Lumateperone modulates dopamine and serotonin receptors, acting as a dopamine D2 and serotonin 5-HT2A receptor antagonist, which helps balance neurotransmission implicated in schizophrenia.
Dosage and Administration
Adult: Starting dose of 42 mg once daily orally with or without food. Adjustments based on response and tolerability.
Pediatric:
Geriatric:
Renal Impairment: No specific adjustment required, but caution advised in severe impairment.
Hepatic Impairment: Use with caution; no specific dose adjustment recommended.
Pharmacokinetics
Absorption: Rapidly absorbed, Tmax approximately 1-2 hours.
Distribution: Widely distributed, highly protein-bound.
Metabolism: Primarily metabolized in the liver via CYP3A4.
Excretion: Excreted mainly in feces and urine.
Half Life: Approximately 21-27 hours.
Contraindications
- Known hypersensitivity to lumateperone or its components
Precautions
- History of QT prolongation, cardiac arrhythmias, neuroleptic malignant syndrome, or other significant cardiovascular conditions.
- Use with caution in elderly patients with dementia-related psychosis due to increased risk of death.
Adverse Reactions - Common
- Dizziness (Common)
- Somnolence (Common)
- Dry mouth (Common)
- Nausea (Common)
Adverse Reactions - Serious
- QT prolongation (Uncommon)
- Neuroleptic malignant syndrome (Rare)
- Tardive dyskinesia (Uncommon)
- Hyperglycemia or hypoglycemia (Uncommon)
Drug-Drug Interactions
- CYP3A4 inhibitors (increase lumateperone levels)
- CYP3A4 inducers (decrease levels)
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor for signs of neuroleptic side effects, including movement disorders, metabolic changes, and cardiovascular status.
Diagnoses:
- Risk for injury related to dizziness or sedation.
- Risk for metabolic imbalance.
Implementation: Administer according to prescribed schedule, monitor for adverse effects, and educate patient about symptoms to report.
Evaluation: Assess effectiveness in symptom control and monitor adverse effects.
Patient/Family Teaching
- Take medication as prescribed, without abrupt discontinuation.
- Report symptoms of movement disorders, QT prolongation (e.g., palpitations, dizziness), or significant side effects.
- Avoid alcohol and other CNS depressants.
- Be aware of potential for increased blood sugar levels.
Special Considerations
Black Box Warnings:
- Increased risk of death in elderly patients with dementia-related psychosis.
- Potential for suicidal thoughts and behaviors.
Genetic Factors: Genetic variations in CYP3A4 may affect metabolism.
Lab Test Interference: May slightly alter blood glucose or lipid levels.
Overdose Management
Signs/Symptoms: Dizziness, drowsiness, tachycardia, hypotension, or extrapyramidal symptoms.
Treatment: Supportive care, monitor vital signs, and consider gastric lavage or activated charcoal if ingestion is recent.
Storage and Handling
Storage: Store at room temperature, 20-25°C (68-77°F).
Stability: Stable until the expiration date on the container.