Rexulti Tablets / Film-coated
Brexpiprazole
4 mg
H. Lundbeck A/S
| Pack size | 28’s (7's Blister x 4) |
|---|---|
| Dispensing mode | CD |
| Source | DENMARK |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 501.00 AED |
Available as:
Indications
Rexulti Tablets / Film-coated is used for:
Indicated for schizophrenia, Indicated as adjunctive treatment for major depressive disorder
Adult Dose
Schizophrenia
Indicated for schizophrenia
Recommended starting dose: 1 mg PO qDay on Days 1 through 4
Recommended target dose: 2-4 mg PO qDay; titrate to 2 mg qDay on Days 5 through 7, and then to 4 mg/day on Day 8 based on the patient’s clinical response and tolerability
Not to exceed 4 mg/day
Periodically reassess to determine the continued need and appropriate dose
Depression
Indicated as adjunctive treatment for major depressive disorder
Recommended starting dose: 0.5 mg or 1 mg PO qDay
Recommended target dose: 2 mg PO qDay; at weekly intervals, titrate to 1 mg/day, and then up to 2 mg/day
Titrate according to clinical response and tolerability
Not to exceed 3 mg/day
Periodically reassess to determine the continued need and appropriate dose
Hepatic impairment
Moderate-to-severe hepatic impairment (Child-Pugh ?7)
MDD: Not to exceed 2 mg/day
Schizophrenia: Not to exceed 3 mg/day
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; in placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly patients with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks), including fatalities, compared with placebo
Suicidal thoughts and behaviors reported in children, adolescents, and young adults who are taking antidepressant drugs
Potentially fatal neuroleptic malignant syndrome (NMS) reported in association with administration of antipsychotic drugs; if NMS is suspected, immediately discontinue therapy and provide intensive symptomatic treatment and monitoring
Potentially irreversible, involuntary, dyskinetic movements (ie, tardive dyskinesia) reported with antipsychotic drugs; incidence highest in elderly persons, especially elderly women
Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus (including extreme cases associated with ketoacidosis or hyperosmolar coma or death), dyslipidemia, and body weight gain;
May cause leukopenia, neutropenia, and agranulocytosis; monitor and discontinue
Orthostatic hypotension or syncope may occur (rare); generally, the risk is greatest during initial dose titration and when increasing the dose; orthostatic vital signs should be monitored in patients who are vulnerable to hypotension, (e.g., elderly patients, patients with dehydration, hypovolemia, concomitant treatment with antihypertensive medication, patients with known cardiovascular disease, and patients with cerebrovascular disease)
May cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries; perform complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy
Caution with a history of seizures or with conditions/drugs that potentially lower the seizure threshold
Lactation
Unknown if distributed in human breast milk
Pregnancy-Lactation
Pregnancy
Adequate and well-controlled studies have not been conducted with brexpiprazole in pregnant women to inform drug-associated risks; however, 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 reproduction studies
No teratogenicity was observed with oral administration of brexpiprazole to pregnant rats and rabbits during organogenesis at doses up to 73 and 146 times, respectively, of maximum recommended human dose (MRHD) of 4 mg/day on a mg/m² basis
However, when pregnant rats were administered brexpiprazole during the period of organogenesis through lactation, the number of perinatal deaths of pups was increased at 73 times 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
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
Rexulti 4 mg Tablets / Film-coated manufactured by H. Lundbeck A/S. Its generic name is Brexpiprazole. Rexulti is availble in United Arab Emirates.
Farmaco UAE drug index information on Rexulti Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.