Rexulti Uses

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What is Rexulti?

Rexulti (Rexulti) is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Rexulti is used to treat the symptoms of schizophrenia.

Rexulti is also used together with other medications to treat major depressive disorder in adults.

Rexulti indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Rexulti is indicated for:

• Adjunctive treatment of major depressive disorder (MDD).

• Treatment of schizophrenia.

Uses of Rexulti in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Use: Labeled Indications

Major depressive disorder: Adjunctive treatment of major depressive disorder (MDD)

Schizophrenia: Treatment of schizophrenia

Off Label Uses

Psychosis/agitation associated with dementia

Based on the American Psychiatric Association practice guideline on the use of antipsychotics to treat agitation or psychosis in patients with dementia, antipsychotics, such as Rexulti, may be considered for the treatment of agitation and psychosis in certain patients with dementia; however, evidence for efficacy is modest and use should be limited to patients whose symptoms are dangerous, severe, or cause significant patient distress due to safety risks associated with antipsychotic use.

Rexulti description

Rexulti is a novel D2 dopamine and serotonin 1A partial agonist, called serotonin-dopamine activity modulator (SDAM), and a potent antagonist of serotonin 2A receptors, noradrenergic alpha 1B and 2C receptors. Rexulti is approved for the treatment of schizophrenia, and as an adjunctive treatment for major depressive disorder (MDD). Although it failed Phase II clinical trials for ADHD, it has been designed to provide improved efficacy and tolerability (e.g., less akathisia, restlessness and/or insomnia) over established adjunctive treatments for major depressive disorder (MDD).

Rexulti dosage

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Rexulti Dosage

Generic name: Rexulti 0.25mg

Dosage form: tablet

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Adjunctive Treatment of Major Depressive Disorder

The recommended starting dosage for REXULTI 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 REXULTI is 1 mg once daily on Days 1 to 4, taken orally with or without food.

The recommended target REXULTI 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. Periodically reassess to determine the continued need and appropriate dosage for treatment.

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.

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. If the coadministered drug is discontinued, adjust the REXULTI dosage to its original level. If the coadministered CYP3A4 inducer is discontinued, reduce the REXULTI dosage to the original level over 1 to 2 weeks.

Table 1: Dosage Adjustments of REXULTI for CYP2D6 Poor Metabolizers and for Concomitant Use with CYP3A4 and CYP2D6 Inhibitors and/or CYP3A4 Inducers

Factors

Adjusted REXULTI Dosage

CYP2D6 Poor Metabolizers

CYP2D6 poor metabolizers

Administer half of the usual dose

Known CYP2D6 poor metabolizers taking strong/moderate CYP3A4 inhibitors

Administer a quarter of the usual dose

Patients Taking CYP2D6 Inhibitors and/or CYP3A4 Inhibitors

Strong CYP2D6 inhibitors*

Administer half of the usual dose

Strong CYP3A4 inhibitors

Administer half of the usual dose

Strong/moderate CYP2D6 inhibitors with strong/moderate CYP3A4 inhibitors

Administer a quarter of the usual dose

Patients Taking CYP3A4 Inducers

Strong CYP3A4 inducers

Double usual dose over 1 to 2 weeks

*In clinical trials examining the adjunctive use of REXULTI in the treatment of MDD, dosage was not adjusted for strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine). Thus, CYP considerations are already factored into general dosing recommendations and REXULTI may be administered without dosage adjustment in patients with MDD.

More about Rexulti (Rexulti)

Consumer resources

Professional resources

Related treatment guides

Rexulti interactions

See also:
What other drugs will affect Rexulti?

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Drugs Having Clinically Important Interactions With REXULTI

Table 10: Clinically Important Drug Interactions with REXULTI

Strong CYP3A4 Inhibitors
Clinical Impact: Concomitant use of REXULTI with strong CYP3A4 inhibitors increased the exposure of Rexulti compared to the use of REXULTI alone
Intervention: With concomitant use of REXULTI with a strong CYP3A4 inhibitor, reduce the REXULTI dosage
Strong CYP2D6 Inhibitors*
Clinical Impact: Concomitant use of REXULTI with strong CYP2D6 inhibitors increased the exposure of Rexulti compared to the use of REXULTI alone
Intervention: With concomitant use of REXULTI with a strong CYP2D6 inhibitor, reduce the REXULTI dosage
Examples: paroxetine, fluoxetine, quinidine
Both CYP3A4 Inhibitors and CYP2D6 Inhibitors
Clinical Impact: Concomitant use of REXULTI with 1) a strong CYP3A4 inhibitor and a strong CYP2D6 inhibitor; or 2) a moderate CYP3A4 inhibitor and a strong CYP2D6 inhibitor; or 3) a strong CYP3A4 inhibitor and a moderate CYP2D6 inhibitor; or 4) a moderate CYP3A4 inhibitor and a moderate CYP2D6 inhibitor, increased the exposure of Rexulti compared to the use of REXULTI alone
Intervention: With concomitant use of REXULTI with 1) a strong CYP3A4 inhibitor and a strong CYP2D6 inhibitor; or 2) a moderate CYP3A4 inhibitor and a strong CYP2D6 inhibitor; or 3) a strong CYP3A4 inhibitor and a moderate CYP2D6 inhibitor; or 4) a moderate CYP3A4 inhibitor and a moderate CYP2D6 inhibitor, decrease the REXULTI dosage
Examples: 1) itraconazole + quinidine

2) fluconazole + paroxetine

3) itraconazole + duloxetine

4) fluconazole + duloxetine

Strong CYP3A4 Inducers
Clinical Impact: Concomitant use of REXULTI and a strong CYP3A4 inducer decreased the exposure of Rexulti compared to the use of REXULTI alone
Intervention: With concomitant use of REXULTI with a strong CYP3A4 inducer, increase the REXULTI dosage
Examples: rifampin, St. John’s wort
* In clinical trials examining the adjunctive use of REXULTI in the treatment of MDD, dosage was not adjusted for strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine). Thus, CYP considerations are already factored into general dosing recommendations and REXULTI may be administered without dosage adjustment in patients with MDD.

Drugs Having No Clinically Important Interactions With REXULTI

Based on pharmacokinetic studies, no dosage adjustment of REXULTI is required when administered concomitantly with CYP2B6 inhibitors (e.g., ticlopidine) or gastric pH modifiers (e.g., omeprazole). Additionally, no dosage adjustment for substrates of CYP2D6 (e.g., dextromethorphan), CYP3A4 (e.g., lovastatin), CYP2B6 (e.g., bupropion), BCRP (e.g., rosuvastatin), or P-gp (e.g., fexofenadine) is required when administered concomitantly with REXULTI.

Drug Abuse And Dependence

Controlled Substance

REXULTI is not a controlled substance.

Abuse

Animals given access to REXULTI did not self-administer the drug, suggesting that REXULTI does not have rewarding properties.

Dependence

Humans and animals that received chronic REXULTI administration did not demonstrate any withdrawal signs upon drug discontinuation. This suggests that REXULTI does not produce physical dependence.

Rexulti side effects

See also:
What are the possible side effects of Rexulti?

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

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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 1,054 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 8.

Table 8: 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 9: 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 Creatine 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 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 extrapyramidal symptoms (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 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 extrapyramidal symptoms (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

Rexulti contraindications

See also:
What is the most important information I should know about Rexulti?

REXULTI is contraindicated in patients with a known hypersensitivity to Rexulti or any of its components. Reactions have included rash, facial swelling, urticaria, and anaphylaxis.

Active ingredient matches for Rexulti:

Brexpiprazole

25mg/brexpiprazole 0


Unit description / dosage (Manufacturer)Price, USD
Rexulti tablet .25 mg/1 (Otsuka America Pharmaceutical, Inc. (US))
Rexulti tablet 3 mg/1 (Otsuka America Pharmaceutical, Inc. (US))
Rexulti tablet .5 mg/1 (Otsuka America Pharmaceutical, Inc. (US))
Rexulti tablet 4 mg/1 (Otsuka America Pharmaceutical, Inc. (US))
Rexulti tablet 1 mg/1 (Otsuka America Pharmaceutical, Inc. (US))
Rexulti tablet 2 mg/1 (Otsuka America Pharmaceutical, Inc. (US))

List of Rexulti substitutes (brand and generic names):

References

  1. DailyMed. "BREXPIPRAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "BREXPIPRAZOLE". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "BREXPIPRAZOLE". http://www.drugbank.ca/drugs/DB09128 (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Rexulti are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Rexulti. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

Consumer reported useful

No survey data has been collected yet


Consumer reported price estimates

No survey data has been collected yet


1 consumer reported time for results

To what extent do I have to use Rexulti before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 3 days and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Rexulti. To get the time effectiveness of using Rexulti drug by other patients, please click here.
Users%
3 days1
100.0%


2 consumers reported age

Users%
16-291
50.0%
30-451
50.0%


Consumer reviews


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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