Lurasitor 40/Lurasitor 80

Schizophrenia in adults & adolescents (13-17 yr). Monotherapy of adult & ped patients (10-17 yr) or adjunctive treatment w/ lithium or valproate in adults w/ major depressive episodes associated w/ bipolar I disorder (bipolar depression).

Schizophrenia Adult Initially 40 mg once daily, dose range 40-160 mg/day. Max: 160 mg/day. Adolescent (13-17 yr) Initially 40 mg once daily, dose range 40-80 mg/day. Max: 80 mg/day. Depressive episodes associated w/ bipolar I disorder Adult Initially 20 mg once daily, dose range 20-120 mg/day. Max: 120 mg/day. Ped patient (10-17 yr) Initially 20 mg once daily as monotherapy, may be increased after 1 wk w/in dose range of 20-80 mg/day. Max: 80 mg/day. Patient w/ moderate (CrCl 30 to <50 mL/min) & severe (CrCl <30 mL/min) renal impairment Initially 20 mg/day. Max: 80 mg/day. Patient w/ moderate (Child-Pugh Score 7-9) & severe (Child-Pugh Score 10-15) hepatic impairment Initially 20 mg/day. Max: 80 mg/day in moderate hepatic impairment & 40 mg/day in severe hepatic impairment.

Should be taken with food.

Hypersensitivity. Strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil). Strong CYP3A4 inducers (eg, rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine). Grapefruit & grapefruit juice.

Not approved for treatment of patients w/ dementia-related psychosis. Reports of neuromalignant syndrome; leukopenia/neutropenia; agranulocytosis. Risk of tardive dyskinesia. Associated w/ metabolic changes that may increase CV/cerebrovascular risk (including hyperglycemia, dyslipidemia, body wt gain); esophageal dysmotility & aspiration. Elevates prolactin levels. May cause orthostatic hypotension & syncope. Caution in patients w/ history of seizures or w/ conditions that lower seizure threshold eg, Alzheimer's dementia; patients at risk of aspiration pneumonia. May disrupt body's ability to reduce core body temp. Can increase risk of developing manic or hypomanic episode, particularly in patients w/ bipolar disorder. Increased sensitivity to antipsychotic medication in patients w/ Parkinson's disease or dementia w/ lewy bodies. Monitor for clinical worsening & emergence of suicidal thoughts & behaviors, especially during the initial few mth of therapy & at times of dose changes. Potential to impair judgment, thinking or motor skills; caution when operating hazardous machinery, including motor vehicles. Neonates exposed to antipsychotic drugs during 3rd trimester of pregnancy are at risk of extrapyramidal &/or w/drawal symptoms following delivery. Pregnancy & lactation. Not approved for ped patients w/ depression. Increased mortality in elderly patients w/ dementia-related psychosis.

Somnolence, akathisia, extrapyramidal symptoms, nausea, vomiting, diarrhea & anxiety. Tachycardia; blurred vision; abdominal pain, diarrhea; increased CPK; decreased appetite; rash, pruritus; HTN.

Increased exposure w/ strong (eg, ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil) & moderate (eg, diltiazem, atazanavir, erythromycin, fluconazole, verapamil) CYP3A4 inhibitors. Decreased exposure w/ strong (eg, rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine) & moderate (eg, bosentan, efavirenz, etravirine, modafinil, nafcillin) CYP3A4 inducers.

Antipsychotics

N05AE05 - lurasidone ; Belongs to the class of indole derivatives antipsychotics.

Rx