Rexulti

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

Schizophrenia Initially 1 mg once daily on days 1-4. Recommended target dose range: 2-4 mg once daily. Dose can be titrated to 2 mg once daily on day 5 through day 7, then 4 mg on day 8 depending on tolerability. Max: 4 mg once daily. Ped 13-17 yr Initially 0.5 mg once daily on days 1-4. Recommended target dose range: 2-4 mg once daily. Dose can be titrated to 2 mg once daily on day 5 through day 7, then 4 mg on day 8 depending on tolerability. Max: 4 mg once daily. Moderate to severe hepatic impairment (Child Pugh ≥7) & severe renal impairment Max: 3 mg once daily. Adjunctive treatment of major depressive disorder Initially 0.5 mg or 1 mg once daily. Titrate to 1 mg once daily, then up to target dose of 2 mg once daily. Increase dose at wkly intervals depending on tolerability. Max: 3 mg once daily. Moderate to severe hepatic impairment (Child Pugh ≥7) & severe renal impairment Max: 2 mg once daily. Agitation associated w/ dementia due to Alzheimer's disease Initially 0.5 mg once daily on days 1-7. Increase dose on days 8 through 14 to 1 mg once daily, and on day 15 to 2 mg once daily. Recommended target dose: 2 mg once daily. Dose can be increased to a max recommended daily dose of 3 mg once daily after at least 14 days, based on clinical response & tolerability. Moderate to severe hepatic impairment (Child Pugh ≥7) & severe renal impairment Max: 2 mg once daily.

May be taken with or without food.

Hypersensitivity.

Risk of suicidal ideation & behavior. Patients w/ known CV disease (history of MI or ischaemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, & treatment w/ antihypertensives) or HTN (including accelerated or malignant); family history of QT prolongation, electrolyte imbalance, or concomitant use w/ drugs that prolong QT interval. VTE. Orthostatic hypotension & syncope. Immediately discontinue if signs & symptoms of NMS & tardive dyskinesia develop. Known history of extrapyramidal symptoms; seizure disorder or other conditions that potentially lower the seizure threshold. Regularly monitor & assess fasting plasma glucose before or soon after the initiation of treatment for patients w/ DM; regularly monitor plasma glucose levels during long-term treatment. Monitor wt gain & lipid profile at baseline & during treatment. Disruption of the body's ability to reduce core body temp. Patients at risk for aspiration pneumonia. History of impulse control disorders. Frequently monitor CBC in patients w/ a preexisting low WBC or a history of drug-induced leukopenia/neutropenia during the 1st few mth of therapy; discontinue at the 1st sign of WBC decline or severe neutropenia (ANC <1,000/mm³). Prolactin levels elevation. Patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Minor to moderate influence on the ability to drive & use machines. Pregnancy & lactation. Elderly w/ dementia-related psychosis.

Increased blood prolactin. Rash; increased wt; akathisia, dizziness; tremor, sedation; diarrhoea, nausea, upper abdominal pain; back pain; pain in extremity; increased blood creatine phosphokinase.

Increased AUC by strong CYP3A4 inhibitors eg, itraconazole, ketoconazole, ritonavir & clarithromycin, & strong CYP2D6 inhibitors eg, quinidine, paroxetine, fluoxetine. Decreased C_max & AUC w/ strong CYP3A4 inducers eg, rifampicin. Drugs known to cause QT prolongation or electrolyte imbalance. Possible additive effect w/ creatine phosphokinase increase of drugs known to increase creatine phosphokinase; drugs known to cause QT prolongation or electrolyte imbalance. Alcohol or other CNS medicinal products w/ overlapping adverse reactions.

Antipsychotics

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

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