Brexpa Tablet
Brexpiprazole
1 mg
Renata PLC.
| Pack size | 30's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 15.00 AED |
Available as:
Indications
Brexpa Tablet is used for:
Schizophrenia, Major depressive disorder, Agitation Associated With Alzheimer Dementia
Adult Dose
Oral
Schizophrenia
Indicated for treatment of schizophrenia
Days 1-4: 1 mg once daily
Day 5-7: Titrate to 2 mg once daily
Day 8: Titrate to 4 mg/day based on the patient’s clinical response and tolerability
Target dose: 2-4 mg once daily; not to exceed 4 mg/day
Periodically reassess to determine the continued need and appropriate dose
Depression
Indicated an adjunctive therapy to antidepressants for major depressive disorder (MDD)
0.5 mg or 1 mg once daily initially
Titrate according to clinical response and tolerability in weekly intervals to 1 mg/day and then up to 2 mg/day; not to exceed 3 mg/day
Periodically reassess to determine the continued need and appropriate dose
Agitation Associated With Alzheimer Dementia
Indicated for agitation associated with dementia due to Alzheimer disease
Days 1-7: 0.5 mg once daily
Days 8-14: Increase to 1 mg once daily
Days 15: Increase to 2 mg once daily
Target dose: 2 mg once daily
May increase to maximum recommended dosage of 3 mg once daily after at least 14 days, based on clinical response and tolerability
Child Dose
Renal Dose
Renal impairment
Moderate, severe, or ESRD (CrCl <60 mL/min)
MDD: Not to exceed 2 mg/day
Schizophrenia: Not to exceed 3 mg/day
Administration
May take with or without food
Contra Indications
Hypersensitivity; reactions have included rash, facial swelling, urticaria, and angioedema
Precautions
Increased mortality in elderly patients with dementia-related psychosis
Elderly patients with dementia-related psychosis when treated with antipsychotic drugs are at an increased risk of death
Not approved for treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer disease
Suicidal thoughts and behaviors
Antidepressants increase risk of suicidal thoughts and behaviors in children, adolescents, and young adults
Closely monitor for clinical worsening, and for emergence of suicidal thoughts and behaviors
Safety and effectiveness not established in pediatric patients with MDD
Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic
attack)
Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring.
Tardive Dyskinesia: Discontinue if clinically appropriate.
Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain.
Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation.
Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Consider discontinuing brexpiprazole if a clinically significant decline in WBC
occurs in absence of other causative factors.
Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure and warn patients with known cardiovascular or\ cerebrovascular disease, and risk of dehydration or syncope.
Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold.
Pregnancy-Lactation
Pregnancy
Adequate and well-controlled studies have not been conducted with brexpiprazole in pregnant females inform drug-associated risks
Clinical considerations
Neonates whose mothers are exposed to antipsychotic drugs, like brexpiprazole, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms (eg, agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder)
Animal studies
No teratogenicity was observed with oral administration to pregnant rats and rabbits during organogenesis at doses up to 73x and 146x, respectively, of maximum recommended human dose (MRHD) of 4 mg/day on a mg/m2 basis
However, when pregnant rats were administered brexpiprazole during organogenesis through lactation, the number of perinatal deaths of pups was increased at 73x the MRHD
Lactation
Unknown if distributed in human breast milk
Present in rat milk
The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interactions
Strong CYP3A4 inhibitors
Reduce brexpiprazole dose
Strong CYP3A4 inhibitors may increase exposure of brexpiprazole
Strong CYP2D6 inhibitors
Reduce brexpiprazole dose
Strong CY2D6 inhibitors may increase exposure of brexpiprazole
Both CYP3A4 and CYP2D6 inhibitors
Reduce brexpiprazole dose
Drugs that are strong or moderate CYP3A4 and CYP2D6 inhibitors may increase exposure of brexpiprazole
Strong CYP3A4 inducers
Increase brexpiprazole dose
Strong CYP3A4 inducers may decrease exposure of brexpiprazole
Contraindicated (3)
amisulpride
mavorixafor
thalidomide
Serious (33)
alfentanil
apalutamide
benzhydrocodone/acetaminophen
buprenorphine
buprenorphine buccal
buprenorphine subdermal implant
buprenorphine transdermal
buprenorphine, long-acting injection
butalbital
chloramphenicol
dacomitinib
fentanyl
fentanyl intranasal
fentanyl iontophoretic transdermal system
fentanyl transdermal
fentanyl transmucosal
fexinidazole
givosiran
hydrocodone
hydromorphone
ivosidenib
lonafarnib
methadone
metoclopramide intranasal
morphine
nelfinavir
olopatadine intranasal
oxycodone
oxymorphone
remifentanil
selinexor
tucatinib
zuranolone
Adverse Effects
Side effects of Brexpiprazole :
>10%
Akathisia (4-14%)
1-10%
Headache (4-9%)
Weight increased (3-8%)
Nasopharyngitis (1-7%)
Extrapyramidal symptoms, excluding akathisia (5-6%)
Somnolence (4-6%)
Dyspepsia (2-6%)
Constipation (1-6%)
Tremor (2-5%)
Fatigue/sedation (2-5%)
Dizziness (1-5%)
Increased CPK blood levels (2-4%)
Decreased cortisol levels (2-4%)
Anxiety (2-4%)
Restlessness (2-4%)
Increased appetite (2-3%)
Diarrhea (1-3%)
Frequency Unknown
Dystonia
Mechanism of Action
Serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors
Note
Brexpa 1 mg Tablet manufactured by Renata PLC.. Its generic name is Brexpiprazole. Brexpa is availble in Bangladesh.
Farmaco BD drug index information on Brexpa Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.