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Rexulti

Rexulti

brexpiprazole

Manufacturer:

Lundbeck

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Brexpiprazole
Indications/Uses
Schizophrenia & agitation associated w/ Alzheimer's dementia (AAD) in adults. Adjunctive therapy to antidepressants for major depressive disorder (MDD) in adults.
Dosage/Direction for Use
Schizophrenia Recommended target dose range: 2-4 mg once daily. Initially 1 mg once daily on days 1-4. Titrate to 2 mg once daily on days 5-7, then to 4 mg once daily on day 8. Max: 4 mg daily. Maintenance dose range: 2-4 mg daily. AAD Recommended target dose range: 2 mg once daily. Initially 0.5 mg once daily on days 1-7. Titrate to 1 mg on days 8-14, then to 2 mg once daily on day 15. After at least 14 days at 2 mg once daily, may increase dose to max recommended daily dose of 3 mg. Adjunctive treatment of MDD Initially 0.5 or 1 mg once daily. Titrate to 1 mg daily & up to target dose of 2 mg daily at intervals of up to 1 wk. Moderate to severe hepatic impairment (Child-Pugh score ≥7) & moderate, severe or end-stage renal impairment (CrCl <60 mL/min) Schizophrenia Max: 3 mg once daily. MDD or AAD Max: 2 mg once daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Hypersensitivity. Not indicated for dementia-related psychosis w/o symptoms of AAD; as an as-needed treatment for AAD. Discontinue use if NMS occurs & ANC <1,000/mm3. Suicidal risk, thoughts & behaviours; tardive dyskinesia; metabolic changes including hyperglycemia, DM, dyslipidemia & wt gain; elevated prolactin levels; rare cases of priapism; VTE; leukopenia, neutropenia & agranulocytosis; orthostatic hypotension & syncope; QT prolongation; falls; seizures; body temp regulation; pathological gambling & other compulsive behaviours. Patients w/ known CV & cerebrovascular disease, conditions predisposing patients to hypotension or HTN; at risk of aspiration pneumonia; history or at risk of sleep apnea. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Hepatic & renal impairment. Pregnancy & lactation. Ped patients. Elderly patients w/ dementia-related psychosis.
Adverse Reactions
Dizziness. Schizophrenia & MDD: Increased wt; akathisia, tremor. MDD & AAD: Nasopharyngitis; somnolence; insomnia. Schizophrenia: Diarrhoea, nausea; increased blood creatinine phosphokinase; back pain. AAD: UTI; headache. MDD: Blurred vision; constipation, dry mouth; fatigue; increased appetite; restlessness, anxiety.
Drug Interactions
Increased exposure w/ strong CYP3A4 (eg, itraconazole, clarithromycin, ketoconazole) & CYP2D6 (eg, paroxetine, fluoxetine, quinidine) inhibitors. Decreased exposure w/ strong CYP3A4 inducers eg, rifampin, St. John's wort. Concomitant use w/ medicinal products causing QT prolongation or electrolyte imbalance.
MIMS Class
Antipsychotics
ATC Classification
N05AX16 - brexpiprazole ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Rexulti FC tab 1 mg
Packing/Price
28's
Form
Rexulti FC tab 2 mg
Packing/Price
28's
Form
Rexulti FC tab 3 mg
Packing/Price
28's
Form
Rexulti FC tab 4 mg
Packing/Price
28's
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