What it's for (Indications)
- Treatment of schizophrenia in adults and adolescents (13-17 years of age).
- Monotherapy for the treatment of depressive episodes associated with Bipolar I Disorder in adults and pediatric patients (10-17 years of age).
- Adjunctive therapy with lithium or valproate for the treatment of depressive episodes associated with Bipolar I Disorder in adults.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | Administer orally once daily with food (at least 350 calories). Schizophrenia (Adults): Initial dose is 40 mg/day. The recommended dose range is 40 to 160 mg/day. Maximum recommended dose is 160 mg/day. Schizophrenia (Adolescents 13-17 years): Initial dose is 40 mg/day. The recommended dose range is 40 to 80 mg/day. Maximum recommended dose is 80 mg/day. Bipolar Depression (Adults, Monotherapy or Adjunctive): Initial dose is 20 mg/day. The recommended dose range is 20 to 120 mg/day. Maximum recommended dose is 120 mg/day. Bipolar Depression (Pediatric 10-17 years, Monotherapy): Initial dose is 20 mg/day. The recommended dose range is 20 to 80 mg/day. Maximum recommended dose is 80 mg/day. Dosage adjustment for renal impairment (CrCl <50 mL/min) and moderate to severe hepatic impairment (Child-Pugh B or C): Maximum recommended dose is 80 mg/day. Coadministration with moderate CYP3A4 inhibitors: Reduce lurasidone dose by half of the recommended starting and maximum doses (e.g., if the normal maximum is 160mg, reduce to 80mg). |
Safety & Warnings
Common Side Effects
- Common side effects include somnolence, akathisia, nausea, parkinsonism (e.
- g.
- , tremor, bradykinesia), dystonia, dizziness, agitation, dyspepsia, vomiting, and sedation.
- Serious adverse reactions include Neuroleptic Malignant Syndrome (NMS), tardive dyskinesia, metabolic changes (hyperglycemia/diabetes mellitus, dyslipidemia, weight gain), orthostatic hypotension and syncope, leukopenia/neutropenia/agranulocytosis, seizures, cerebrovascular adverse reactions (including stroke) in elderly patients with dementia-related psychosis, and an increased risk of suicidal thoughts and behaviors (especially in children, adolescents, and young adults when used for bipolar depression).
Serious Warnings
- Black Box Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Lurasidone is not approved for the treatment of patients with dementia-related psychosis. Antidepressants (including lurasidone when used for bipolar depression) increased the risk compared to placebo of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies.
- Increased mortality in elderly patients with dementia-related psychosis.
- Increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders; close monitoring is required.
- Neuroleptic Malignant Syndrome (NMS) is a potentially fatal syndrome; discontinue lurasidone immediately if NMS is suspected.
- Tardive Dyskinesia, a syndrome of potentially irreversible, involuntary dyskinetic movements, may develop; consider discontinuation if signs appear.
- Metabolic changes, including hyperglycemia and diabetes mellitus, dyslipidemia, and weight gain, can occur.
- Orthostatic hypotension and syncope can occur, particularly at treatment initiation or dose escalation; use with caution in patients with cardiovascular disease or predisposition to hypotension.
- Leukopenia, neutropenia, and agranulocytosis have been reported; monitor CBC in patients with a history of low WBC count.
- Seizures can occur; use with caution in patients with a history of seizures or conditions lowering the seizure threshold.
- May impair judgment, thinking, or motor skills; patients should be cautioned about operating hazardous machinery.
- Disruption of body temperature regulation may occur.
- Esophageal dysmotility and aspiration have been associated with antipsychotic drug use.
- Avoid concomitant use with strong CYP3A4 inhibitors (e.
- g.
- , ketoconazole, clarithromycin) and strong CYP3A4 inducers (e.
- g.
- , rifampin, St.
- John's Wort) due to significant pharmacokinetic interactions.
How it Works (Mechanism of Action)
Lurasidone is an atypical antipsychotic agent thought to exert its therapeutic effects through a combination of antagonism at dopamine D2 receptors, serotonin 5-HT2A receptors, and alpha2C-adrenergic receptors. It also acts as a partial agonist at serotonin 5-HT1A receptors. Lurasidone has no appreciable affinity for histaminic H1 or muscarinic M1 receptors, which may explain its lower incidence of sedation and anticholinergic side effects compared to some other antipsychotics.
Commercial Brands (Alternatives)
No other brands found for this formula.