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    / Lundbeck


    Active Ingredient
    Brexpiprazole 0.5, 1, 2, 3, 4 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    28 X 0.5 mg

    not in the basket chart

    Film Coated Tablets

    28 X 1 mg

    not in the basket chart

    Film Coated Tablets

    28 X 2 mg

    not in the basket chart

    Film Coated Tablets

    28 X 3 mg

    not in the basket chart

    Film Coated Tablets

    28 X 4 mg

    not in the basket chart

    Related information


    Dosage

    Adjunctive Treatment of Major Depressive Disorder: The recommended starting dosage for brexipiprazole as adjunctive treatment is 0.5 mg or 1 mg once daily, taken orally with or without food.
    Titrate to 1 mg once daily, then up to the target dosage of 2 mg once daily. Dosage increases should occur at weekly intervals based on the patient’s clinical response and tolerability. The maximum recommended daily dosage is 3 mg. Periodically reassess to determine the continued need and appropriate dosage for treatment.
    Treatment of Schizophrenia: The recommended starting dosage for brexipiprazole is 1 mg once daily on Days 1 to 4, taken orally with or without food.
    The recommended target brexipiprazole dosage is 2 mg to 4 mg once daily. Titrate to 2 mg once daily on Day 5 through Day 7, then to 4 mg on Day 8 based on the patient’s clinical response and tolerability. The maximum recommended daily dosage is 4 mg.
    Dosage Adjustments for Hepatic Impairment: For patients with moderate to severe hepatic impairment (Child-Pugh score ≥7), the maximum recommended dosage is 2 mg once daily for patients with MDD, and 3 mg once daily for patients with schizophrenia.
    Dosage Adjustments for Renal Impairment: For patients with moderate, severe or end-stage renal impairment (creatinine clearance CLcr<60 mL/minute), the maximum recommended dosage is 2 mg once daily for patients with MDD and 3 mg once daily for patients with schizophrenia.


    Indications

    As adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).
    For treatment of schizophrenia.


    Contra-Indications

    Patients with a known hypersensitivity to brexpiprazole or any of its component.
    Reactions have included rash, facial swelling, urticaria, and anaphylaxis.


    Special Precautions

    Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
    Suicidal Thoughts and Behaviors in Children, Adolescents and Young Adults: In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes): in patients age 24 years and younger was greater in antidepressant-treated patients than in placebo-treated patients.
    No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide. See prescribing information for full details.
    Cerebrovascular Adverse Reactions Including Stroke in Elderly Patients with Dementia-Related Psychosis: In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. Brexipiprazole is not approved for the treatment of patients with dementia-related psychosis.
    Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex sometimes referred to as neuroleptic malignant syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including brexipiprazole.
    Tardive Dyskinesia: Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. The risk appears to be highest among the elderly, especially elderly women, but it is not possible to predict which patients are likely to develop the syndrome.
    Metabolic Changes: Atypical antipsychotic drugs, including Brexipiprazole, have caused metabolic changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and body weight gain. Although all of the drugs in the class to date have been shown to produce some metabolic changes, each drug has its own specific risk profile.
    Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. There have been reports of hyperglycemia in patients treated with Brexipiprazole. Assess fasting plasma glucose before or soon after initiation of antipsychotic medication and monitor periodically.
    See prescribing information for full details.


    Side Effects

    Increased Mortality in Elderly Patients with Dementia-Related Psychosis.
    Suicidal Thoughts and Behaviors in Adolescents and Young Adults.
    Cerebrovascular Adverse Reactions Including Stroke in Elderly Patients with Dementia-Related Psychosis.
    Neuroleptic Malignant Syndrome (NMS).
    Tardive Dyskinesia.
    Metabolic Changes.
    Pathological Gambling and Other Compulsive Behaviors.
    Leukopenia, Neutropenia, and Agranulocytosis.
    Orthostatic Hypotension and Syncope.
    Falls.
    Seizures.
    Body Temperature Dysregulation.
    Dysphagia.
    Potential for Cognitive and Motor Impairment.
    See prescribing information for full details.


    Drug interactions

    Dosage Modifications for CYP2D6 Poor Metabolizers and for Concomitant Use with CYP Inhibitors or Inducers: Dosage adjustments are recommended in patients who are known cytochrome P450 (CYP) 2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers (see Table 1 at the attached doctor’s leaflet). If the coadministered drug is discontinued, adjust the brexipiprazole dosage to its original level. If the coadministered CYP3A4 inducer is discontinued, reduce the brexipiprazole dosage to the original level over 1 to 2 week.
    See prescribing information for full details.


    Pregnancy and Lactation

    PregnancyAdequate and well-controlled studies have not been conducted with brexipiprazole in pregnant women to inform drug-associated risks.
    LactationLactation studies have not been conducted to assess the presence of brexpiprazole in human milk, the effects of brexpiprazole on the breastfed infant, or the effects of brexpiprazole on milk production.
    See prescribing information for full details.


    Overdose

    There is limited clinical trial experience regarding human overdosage with BREXIPIPRAZOLE.


    Manufacturer
    H. Lundbeck A/S, Denmark
    Licence holder
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