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Rexulti

Rexulti

brexpiprazole

Manufacturer:

Otsuka

Distributor:

Zuellig
Concise Prescribing Info
Contents
Brexpiprazole
Indications/Uses
Treatment of schizophrenia in adults. Adjunctive treatment of major depressive disorder (MDD) in adults w/ inadequate response to prior antidepressant treatments during the current episode.
Dosage/Direction for Use
Schizophrenia Recommended starting dose: 1 mg once daily on days 1-4. Dose can be titrated to 2 mg once daily on days 5-7, then to 4 mg on day 8. Max: 4 mg once daily. Patients w/ moderate to severe hepatic or renal impairment Max recommended dose: 3 mg once daily. Adjunctive treatment in MDD Recommended starting dose: 0.5 or 1 mg once daily. Dose can be titrated at wkly intervals to 1 mg once daily, then up to recommended target dose 2 mg once daily. Max: 2 mg once daily. Patients w/ moderate to severe hepatic or renal impairment Max recommended dose: 1.25 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Elderly patients w/ dementia.
Special Precautions
Disruption of body's ability to reduce core body temp; orthostatic hypotension; QTc prolongation; hyperglycemia & DM; metabolic changes including wt gain; dyslipidemia; elevation of prolactin levels; leukopenia/neutropenia, agranulocytosis; venous thromboembolism; neuroleptic malignant syndrome; tardive dyskinesia. Caution in patients w/ history of seizure disorder or w/ conditions that lower the seizure threshold. Potential for cognitive & motor impairment. Monitor patients for signs of suicidal ideation & behaviour; impulse-control disorders/compulsive behaviors. May cause somnolence, postural hypotension, motor & sensory instability which may lead to falls & consequently, fractures or other injuries. Rare cases of priapism w/ antipsychotic use. Post-marketing reports of serious hypersensitivity reactions & drug reaction w/ eosinophilia & systemic symptoms (DRESS). Rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption. Pregnancy. Women receiving Rexulti should not breastfeed. Not recommended in childn <18 yr. Elderly >65 yr. CYP2D6 poor metabolisers.
Adverse Reactions
Diarrhoea, dyspepsia, dry mouth, abdominal pain upper, constipation, flatulence; wt increased, blood creatinine phosphokinase increased, blood cortisol decreased, blood prolactin increased; increased appetite; back pain, pain in extremity, myalgia; akathisia, tremor, sedation, dizziness, headache, somnolence; restlessness, insomnia, anxiety, irritability; rash; vision blurred; fatigue, asthenia; nasopharyngitis.
Drug Interactions
Increased AUC w/ strong CYP3A4 inhibitors (itraconazole, ketoconazole, ritonavir, clarithromycin); strong CYP2D6 inhibitors (quinidine, paroxetine, fluoxetine). Decreased AUC & Cmax w/ strong CYP3A4 inducers (eg, rifampicin). Exercise caution when concomitantly used w/ medicinal products known to cause QT-prolongation or electrolyte imbalance. Avoid combination w/ alcohol or other CNS medicinal products w/ overlapping adverse reactions eg, sedation.
MIMS Class
ATC Classification
N05AX16 - brexpiprazole ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Rexulti FC tab 0.5 mg
Packing/Price
30's
Form
Rexulti FC tab 1 mg
Packing/Price
30's
Form
Rexulti FC tab 3 mg
Packing/Price
30's
Form
Rexulti FC tab 2 mg
Packing/Price
30's
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