Rexulti

Schizophrenia in adults & ped patients ≥13 yr. Agitation associated w/ dementia due to Alzheimer's disease. Adjunctive treatment of major depressive disorder (MDD) in adults.

Schizophrenia Initially 1 mg once daily on days 1-4, titrated to 2 mg once daily on days 5-7, & can be increased to max of 4 mg daily on day 8. Childn 13-17 yr Initially 0.5 mg once daily of days 1-4. Titrate to 1 mg once daily on day 5 through 8, then to 2 mg on day 8. Wkly doses increase can be made in 1 mg increments. Recommended target dosage: 2-4 mg once daily. Max: 4 mg daily. Agitation associated w/ dementia due to Alzheimer's disease Initially 0.5 mg once daily on days 1-7, increased to 1 mg once daily on days 8-14, & to 2 mg once daily on day 15. Dose can be increased to max of 3 mg once daily after at least 14 days. Adjunctive treatment of MDD Initially 500 mcg or 1 mg once daily, titrated at wkly intervals to 1 mg once daily, then to target dosage of 2 mg once daily. Max: 3 mg daily. Moderate to severe hepatic impairment (Child-Pugh score ≥7) & patient w/ CrCl <60 mL/min Max: 2 mg once daily in patient w/ MDD or agitation associated w/ dementia due to Alzheimer's disease, & 3 mg once daily in patient w/ schizophrenia.

May be taken with or without food.

Hypersensitivity.

Not indicated as an "as needed" treatment for agitation associated w/ dementia due to Alzheimer's disease. Increased mortality in elderly patients w/ dementia-related psychosis. Not for treatment of patients w/ dementia-related psychosis w/o agitation associated w/ dementia due to Alzheimer's disease. Suicidal thoughts & behaviors in childn, adolescents & young adults. Monitor all antidepressant-treated patients for clinical worsening & emergence of suicidal thoughts & behaviors, especially during the initial few mth of drug therapy & at times of dosage changes. Consider changing therapeutic regimen, including possibly discontinuing use, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors. Cerebrovascular AR including stroke in elderly patients w/ dementia-related psychosis. Risk of NMS. Discontinue use if signs & symptoms of tardive dyskinesia appear; at the 1st sign of clinically significant decline in WBC in absence of other causative factors; in patients w/ severe neutropenia (ANC <1,000/mm³). Metabolic changes including hyperglycemia/DM, dyslipidemia & body wt gain. Perform CBC frequently during the 1st few mth of therapy in patients w/ history of clinically significant low WBC/ANC or drug-induced leukopenia/neutropenia. Monitor patients w/ clinically significant neutropenia for fever or other symptoms or signs of infection & treat promptly if such symptoms or signs occur. Patients at increased risk of orthostatic hypotension & syncope or at increased risk of developing complications from hypotension including dehydration, hypovolemia, treatment w/ antihypertensives, history of CV disease (eg, heart failure, MI, ischemia or conduction abnormalities), history of cerebrovascular disease, as well as patients who are antipsychotic-naive; history of seizures or w/ conditions that potentially lower seizure threshold; on conditions that may contribute to elevation in core body temp eg, exercising strenuously, exposure to extreme heat, receiving concomitant medication w/ anticholinergic activity or being subject to dehydration; at risk for aspiration pneumonia. Dysphagia. May cause somnolence, postural hypotension, motor & sensory instability which may lead to falls & fractures or other injuries. Caution when operating machinery including motor vehicles due to potential to impair judgment, thinking or motor skills. Impulse-control disorders/compulsive behaviors. CYP2D6 poor metabolizers. Patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Hepatic & renal impairment. Pregnancy & lactation. Safety & efficacy have not been established in ped patients w/ MDD.

Constipation, dyspepsia, diarrhea; fatigue; nasopharyngitis, UTI; increased wt & blood creatine phosphokinase, decreased blood cortisol; increased appetite; akathisia, headache, somnolence, tremor, dizziness, sedation; anxiety, restlessness, insomnia. Extrapyramidal symptoms, dystonia.

Increased exposure w/ strong & moderate CYP3A4 & CYP2D6 inhibitors or combination of both. Decreased exposure w/ strong CYP3A4 inducers.

Antipsychotics

N05AX16 - brexpiprazole ; Belongs to the class of other antipsychotics.

Rx