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REXULTI SIDE EFFECTS

  • Generic Name: brexpiprazole tablets
  • Brand Name: Rexulti
  • Drug Class: Serotonin-Dopamine Activity Modulators (SDAM)
Last updated on MDtodate: 10/10/2022

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • 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

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Major Depressive Disorder

The safety of REXULTI was evaluated in 1054 patients (18 to 65 years of age) diagnosed with MDD who participated in two 6-week placebo-controlled, fixed-dose clinical trials in patients with major depressive disorder in which REXULTI was administered at doses of 1 mg to 3 mg daily as adjunctive treatment to continued antidepressant therapy; patients in the placebo group continued to receive antidepressant therapy.

Adverse Reactions Reported as Reasons for Discontinuation of Treatment

A total of 3% (17/643) of REXULTI-treated patients and 1% (3/411) of placebo-treated patients discontinued due to adverse reactions.

Common Adverse Reactions

Adverse reactions associated with the adjunctive use of REXULTI (incidence of 2% or greater and adjunctive REXULTI incidence greater than adjunctive placebo) that occurred during acute therapy (up to 6-weeks in patients with MDD) are shown in Table 1.

Table 1: Adverse Reactions in Pooled 6-Week Placebo-Controlled, Fixed-Dose MDD Trials (Studies 1 and 2)*

Placebo
(N=411)
REXULTI
1 mg/day
(N=226)
2 mg/day
(N=188)
3 mg/day
(N=229)
All REXULTI
(N=643)
Gastrointestinal Disorders
Constipation 1% 3% 2% 1% 2%
General Disorders and Administration Site Conditions
Fatigue 2% 3% 2% 5% 3%
Infections and Infestations
Nasopharyngitis 2% 7% 1% 3% 4%
Investigations
Weight Increased 2% 7% 8% 6% 7%
Blood Cortisol Decreased 1% 4% 0% 3% 2%
Metabolism and Nutrition
Increased Appetite 2% 3% 3% 2% 3%
Nervous System Disorders
Akathisia 2% 4% 7% 14% 9%
Headache 6% 9% 4% 6% 7%
Somnolence 0.5% 4% 4% 6% 5%
Tremor 2% 4% 2% 5% 4%
Dizziness 1% 1% 5% 2% 3%
Psychiatric Disorders
Anxiety 1% 2% 4% 4% 3%
Restlessness 0% 2% 3% 4% 3%
* Adverse reactions that occurred in ≥2% of REXULTI-treated patients and greater incidence than in placebo-treated patients

 

Dose-Related Adverse Reactions in the MDD Trials

In Studies 1 and 2, among the adverse reactions that occurred at ≥2% incidence in the patients treated with REXULTI + ADT, the incidences of akathisia and restlessness increased with increases in dose.

Schizophrenia

The safety of REXULTI was evaluated in 852 patients (18 to 65 years of age) diagnosed with schizophrenia who participated in two 6-week placebo-controlled, fixed-dose clinical trials in which REXULTI was administered at daily doses of 1 mg, 2 mg and 4 mg.

Common Adverse Reactions

Adverse reactions associated with REXULTI (incidence of 2% or greater and REXULTI incidence greater than placebo) during short-term (up to 6 weeks) trials in patients with schizophrenia are shown in Table 9.

Table 2: Adverse Reactions in Pooled 6-Week Placebo-Controlled, Fixed-Dose Schizophrenia Trials (Studies 3 and 4)*

Placebo
(N=368)
REXULTI
1 mg/day
(N=120)
2 mg/day
(N=368)
4 mg/day
(N=364)
ALL REXULTI
(N=852)
Gastrointestinal Disorders
  Dyspepsia 2% 6% 2% 3% 3%
  Diarrhea 2% 1% 3% 3% 3%
Investigations
  Weight Increased 2% 3% 4% 4% 4%
  Blood Creatinine Phosphokinase Increased 1% 4% 2% 2% 2%
Nervous System Disorders
  Akathisia 5% 4% 5% 7% 6%
  Tremor 1% 2% 2% 3% 3%
  Sedation 1% 2% 2% 3% 2%
* Adverse reactions that occurred in ≥2% of REXULTI-treated patients and greater incidence than in placebo-treated patients

 

Extrapyramidal Symptoms

Major Depressive Disorder

The incidence of reported extrapyramidal symptoms (EPS)-related adverse reactions, excluding akathisia, was 6% for REXULTI + ADT-treated patients versus 3% for placebo + ADT-treated patients. The incidence of akathisia events for REXULTI + ADT-treated patients was 9% versus 2% for placebo + ADT-treated patients.

In the 6-week placebo-controlled MDD studies, data was objectively collected on the Simpson-Angus Rating Scale (SAS) for EPS, the Barnes Akathisia Rating Scale (BARS) for akathisia and the Abnormal Involuntary Movement Score (AIMS) for dyskinesia. The mean change from baseline at last visit for REXULTI + ADT-treated patients for the SAS, BARS and AIMS was comparable to placebo-treated patients. The percentage of patients who shifted from normal to abnormal was greater in REXULTI + ADT-treated patients versus placebo + ADT-treated patients for the BARS (4% versus 0.6%) and the SAS (4% versus 3%).

Schizophrenia

The incidence of reported EPS-related adverse reactions, excluding akathisia, was 5% for REXULTI-treated patients versus 4% for placebo-treated patients. The incidence of akathisia events for REXULTI-treated patients was 6% versus 5% for placebo-treated patients.

In the 6-week placebo-controlled, fixed-dose schizophrenia studies, data was objectively collected on the Simpson-Angus Rating Scale (SAS) for EPS, the Barnes Akathisia Rating Scale (BARS) for akathisia and the Abnormal Involuntary Movement Scale (AIMS) for dyskinesia. The mean change from baseline at last visit for REXULTI-treated patients for the SAS, BARS and AIMS was comparable to placebo-treated patients. The percentage of patients who shifted from normal to abnormal was greater in REXULTI-treated patients versus placebo for the BARS (2% versus 1%) and the SAS (7% versus 5%).

Dystonia

Symptoms of dystonia may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first-generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Other Adverse Reactions Observed During The Premarketing Evaluation Of REXULTI

Other adverse reactions (≥1% frequency and greater than placebo) within the short-term, placebo-controlled trials in patients with MDD and schizophrenia are shown below. The following listing does not include adverse reactions: 1) already listed in previous tables or elsewhere in the labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have clinically significant implications, or 5) which occurred at a rate equal to or less than placebo.

Eye Disorders: Vision Blurred

Gastrointestinal Disorders: Nausea, Dry Mouth, Salivary Hypersecretion, Abdominal Pain, Flatulence

Infections and Infestations: Urinary Tract Infection

Investigations: Blood Prolactin Increased

Musculoskeletal and Connective Tissue Disorders: Myalgia

Psychiatric Disorders: Abnormal Dreams, Insomnia

Skin and Subcutaneous Tissue Disorders:Hyperhidrosis

Postmarketing Experience

The following adverse reaction has been identified during post-approval use of REXULTI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nervous System disorders: Neuroleptic Malignant Syndrome

 

SRC: NLM .

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