REXULTI (brexpiprazole) tablets - America[美国药品]

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REXULTI (brexpiprazole) tablets

2015-07-24 16:02:11 来源: 作者: 【大中小】浏览:491次评论:0条

BOXED WARNING(What is this)

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS

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. REXULTI is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].

Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behaviors in patients aged 24 years and younger in short-term studies. Monitor closely for clinical worsening and for emergence of suicidal thoughts and behaviors. The safety and efficacy of REXULTI have not been established in pediatric patients [see Warnings and Precautions (5.2), Use in Specific Populations (8.4)].

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use REXULTI ® safely and effectively. See full prescribing information for REXULTI.

REXULTI ® (brexpiprazole) tablets, for oral use
Initial U.S. Approval: 2015
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. REXULTI is not approved for the treatment of patients with dementia-related psychosis (5.1).

• Antidepressants increase the risk of suicidal thoughts and behaviors in

patients aged 24 years and younger. Monitor for clinical worsening and emergence of suicidal thoughts and behaviors (5.2).

• Safety and effectiveness of REXULTI have not been established in pediatric patients (8.4).

INDICATIONS AND USAGE

REXULTI is an atypical antipsychotic indicated for:

•: Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) ( 1, 14.1)
•: Treatment of schizophrenia ( 1, 14.2)
DOSAGE AND ADMINISTRATION

•: Administer REXULTI once daily with or without food ( 2.1, 2.2, 12.3)

Indication

Starting Dose

Recommended Dose

Maximum Dose

MDD (2.1)

0.5 mg/day or

1 mg/day

2 mg/day

3 mg/day

Schizophrenia (2.2)

1 mg/day

2 to 4 mg/day

4 mg/day

•: Moderate to Severe Hepatic Impairment (Child-Pugh score ≥7): Maximum recommended dosage is 2 mg once daily for patients with MDD and 3 mg once daily for patients with schizophrenia ( 2.3)
•: Moderate, Severe or End-Stage Renal Impairment (CLcr<60 mL/minute): Maximum recommended dosage is 2 mg once daily for patients with MDD and 3 mg once daily for patients with schizophrenia ( 2.4)
•: Known CYP2D6 Poor Metabolizers: Reduce the usual dosage by half ( 2.5)

DOSAGE FORMS AND STRENGTHS

Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (3)
CONTRAINDICATIONS

Known hypersensitivity to REXULTI or any of its components (4)
WARNINGS AND PRECAUTIONS

•: Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g. stroke, transient ischemic attack) ( 5.3)
•: Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring ( 5.4)
•: Tardive Dyskinesia: Discontinue if clinically appropriate ( 5.5)
•: Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain ( 5.6)
•: 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 REXULTI if a clinically significant decline in WBC occurs in absence of other causative factors ( 5.7)
•: 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 ( 5.8)
•: Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold ( 5.9)