Loading…
REXULTI is a brand name for Brexpiprazole, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 01/2024 1 INDICATIONS, 1.2 Geriatrics 01/2024 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 01/2024 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 01/2024 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 01/2024 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment, 4.2.1…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 01/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .........................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................
4 1 INDICATIONS ................................................................................................................... 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 5 2 CONTRAINDICATIONS ...................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................ 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ............................................................................................
2 Recommended Dose and Dosage Adjustment ....................................................... 1 Discontinuing Treatment ...................................................................................... 4 Administration ..........................................................................................................
5 Missed Dose ............................................................................................................ 8 5 OVERDOSAGE ................................................................................................................
8
). REXULTI should only be prescribed in patients with MDD by clinicians who are aware of the importance and are experienced in the early detection and management of the safety issues associated with this class of drugs. The efficacy and safety of REXULTI in the adjunctive treatment of MDD were demonstrated in 6-week, double-blind, placebo-controlled trials in adult patients.
Therefore, the required length of adjunctive treatment with REXULTI is not known. 2 Recommended Dose and Dosage Adjustment, Adjunctive Treatment in Major Depressive Disorder (MDD)). Clinical trials evaluating REXULTI in MDD did not include REXULTI monotherapy treatment arms.
It is, therefore, not known whether efficacy in adjunct treatment is due to REXULTI alone or from combined treatment with an antidepressant. REXULTI is not indicated as an as needed (prn) treatment for AAD. 1 Clinical Trials by Indication, Agitation Associated with Alzheimer’s Dementia (AAD)).
The efficacy and safety of REXULTI in the treatment of AAD were demonstrated in two 12-week, randomized, double-blind, placebo-controlled, fixed-dose trials in adult patients. 4 Geriatrics) and the risk predictors for stroke or existing cardiovascular comorbidities.
1 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of REXULTI have not been established in patients less than 18 years of age. 3 Pediatrics). 2 Geriatrics Geriatrics (> 65 years of age): The safety and efficacy of REXULTI have not been systematically evaluated in schizophrenia or MDD patients 65 years of age or older, or in AAD patients 90 years of age or older.
4 Geriatrics and 10 CLINICAL PHARMACOLOGY). 2 CONTRAINDICATIONS REXULTI is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
4 Geriatrics 01/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .........................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................
4 1 INDICATIONS ................................................................................................................... 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 5 2 CONTRAINDICATIONS ...................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................ 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ............................................................................................
2 Recommended Dose and Dosage Adjustment ....................................................... 1 Discontinuing Treatment ...................................................................................... 4 Administration ..........................................................................................................
5 Missed Dose ............................................................................................................ 8 5 OVERDOSAGE ................................................................................................................
REXULTI is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
5 Post-Market Adverse Reactions).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 5 Post-Market Adverse Reactions). 1 Dosing Considerations • REXULTI is taken orally, once daily with or without food (see 10 CLINICAL PHARMACOLOGY). • Dosage increases are based on clinical response and tolerability.
• Dosage should be maintained at the lowest effective level and patients should be periodically reassessed to determine continued need and appropriate dosage for treatment. • Patients should have baseline and periodic monitoring of blood glucose, fasting lipid profile and body weight.
• It is recommended that patients have their complete blood count (CBC), white blood cell (WBC) and differential counts prior to starting REXULTI and then periodically throughout treatment as neutropenia, granulocytopenia and agranulocytosis have been reported during antipsychotic use.
Serious Warnings and Precautions WARNING:
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA Increased Mortality in Elderly Patients with Dementia Elderly patients with dementia treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo.
6-fold increase in the death rate in the drug-treated patients. 4 Geriatrics). 5 mg/day 2 mg/day 3 mg/day Schizophrenia The recommended starting dosage for REXULTI is 1 mg once daily on Days 1 to 4. The recommended target REXULTI dosage is 2 mg to 4 mg once daily.
In short-term fixed-dose clinical trials, the dose was titrated to 2 mg once daily on Day 5 through Day 7, then to 4 mg on Day 8. The maximum recommended daily dosage is 4 mg. Patients should be treated with the lowest effective dose that provides optimal clinical response and tolerability.
Adjunctive Treatment in Major Depressive Disorder (MDD) The dose range of 1 to 3 mg/day was evaluated as adjunctive treatment in clinical trials. 1 Clinical Trials by Indication, Adjunctive Treatment in Major Depressive Disorder (MDD)).
The required length of adjunctive treatment with REXULTI is not known. 1 Clinical Trials by Indication, Adjunctive Treatment in Major Depressive Disorder (MDD)). The […]
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ......................... 9 7 WARNINGS AND PRECAUTIONS .................................................................................. 9 General ...........................................................................................................................
10 Cardiovascular ................................................................................................................ 10 Dependence/Tolerance ...................................................................................................
11 Driving and Operating Machinery .................................................................................... 12 Endocrine and Metabolism ..............................................................................................
12 Genitourinary ................................................................................................................... 13 Hematologic ....................................................................................................................
13 Immune ........................................................................................................................... 14 Monitoring and Laboratory Tests ....................................................................................
14 Neurologic ....................................................................................................................... 14 REXULTI® (Brexpiprazole tablets) Page 3 of 66 Psychiatric .......................................................................................................................
16 Skin ................................................................................................................................. 1 Special Populations ...............................................................................................
1 Pregnant Women ............................................................................................... 2 Breast-feeding ................................................................................................... 3 Pediatrics ...........................................................................................................
4 Geriatrics ........................................................................................................... 17 8 ADVERSE REACTIONS .................................................................................................
2 Clinical Trial Adverse Reactions ............................................................................ 3 Less Common Clinical Trial Adverse Reactions ................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................
5 Post-Market Adverse Reactions ............................................................................ 41 9 DRUG INTERACTIONS .................................................................................................. 2 Drug Interactions Overview ...................................................................................
3 Drug-Behavioural Interactions ............................................................................... 4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions ..........................................................................................
6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions ......................................................................... 44 10 CLINICAL PHARMACOLOGY […]