Rexulti

Brexpiprazole

Adjunctive treatment of major depressive disorder (MDD). Schizophrenia.

Adjunctive treatment of major depressive disorder Initially 500 mcg or 1 mg once daily. Titrate to 1 mg once daily, then up to the target dosage of 2 mg once daily. Dosage increases should occur at wkly intervals based on patient's clinical response & tolerability. Max: 3 mg daily. Schizophrenia Initially 1 mg once daily on Days 1-4. Recommended target dose: 2-4 mg once daily. Titrate to 2 mg once daily on Day 5 through Day 7, then to 4 mg on Day 8 based on patient's clinical response & tolerability. Max: 4 mg daily. Moderate to severe hepatic impairment (Child-Pugh score ≥7); moderate, severe or end-stage renal impairment (CrCl <60 mL/min) Max: 2 mg once daily for patient w/ MDD, & 3 mg once daily for patient w/ schizophrenia.

May be taken with or without food.

Hypersensitivity.

Increased mortality in elderly patients w/ dementia-related psychosis. 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 neuroleptic malignant syndrome. 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 (absolute neutrophil count <1,000/mm³). Metabolic changes including hyperglycemia/DM, dyslipidemia & body wt gain. Perform complete blood count frequently during the 1st few mth of therapy in patients w/ history of clinically significant low WBC/absolute neutrophil count 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. Potential for cognitive & motor impairment. Impulse-control disorders/compulsive behaviors. CYP2D6 poor metabolizers. Hepatic & renal impairment. Pregnancy & lactation. Childn. Elderly.

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

Increased exposure w/ strong (eg, itraconazole, clarithromycin, ketoconazole) & moderate (eg, fluconazole) CYP3A4 inhibitors, strong (eg, paroxetine, fluoxetine, quinidine) & moderate (eg, duloxetine) CYP2D6 inhibitors or combination of both. Decreased exposure w/ strong CYP3A4 inducers (eg, rifampin, St. John's wort).

Antipsychotics

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

Rx