REXULTI Tablet (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Otsuka America Pharmaceutical, Inc.

Λέξεις κλειδιά

59148-035 59148-036 59148-037 59148-038 59148-039 59148-040

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BOXED WARNING SECTION

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis ...

1. Indications and Usage

REXULTI is indicated for: Adjunctive treatment of major depressive disorder (MDD) [see Clinical Studies (14.1)]. Treatment of schizophrenia [see Clinical Studies (14.2)].

2. Dosage and Administration

2.1 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 [see Clinical ...

3. Dosage Forms and Strengths

REXULTI tablets are available in 6 strengths (see Table 2). Table 2. REXULTI Tablet Strengths and Identifying Features: Tablet Strength Tablet Color/Shape Tablet Markings 0.25 mg light brown ...

4. Contraindications

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

5. Warnings and Precautions

5.1 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. Analyses ...

6. Adverse Reactions

The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning, Warnings ...

6.1. 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 ...

6.2. 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 ...

7. Drug Interactions

7.1 Drugs Having Clinically Important Interactions with REXULTI Table 10. Clinically Important Drug Interactions with REXULTI: Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use ...

8. Use in Specific Populations

8.6 CYP2D6 Poor Metabolizers Dosage adjustment is recommended in known CYP2D6 poor metabolizers, because these patients have higher brexpiprazole concentrations than normal metabolizers of CYP2D6. Approximately ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to REXULTI during pregnancy. For more information contact the National Pregnancy Registry ...

8.2. Lactation

Risk Summary Lactation 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 ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning, Warnings and ...

8.5. Geriatric Use

Clinical studies of the efficacy of REXULTI did not include any patients aged 65 or older to determine whether they respond differently from younger patients. In general, dose selection for an elderly ...

8.7. Hepatic Impairment

Reduce the maximum recommended dosage in patients with moderate to severe hepatic impairment (Child-Pugh score ≥7). Patients with moderate to severe hepatic impairment (Child-Pugh score ≥7) generally had ...

8.8. Renal Impairment

8.8 Renal Impairment Reduce the maximum recommended dosage in patients with moderate, severe, or end-stage renal impairment (CLcr<60 mL/minute). Patients with impaired renal function (CLcr<60 mL/minute) ...

9.1. Controlled Substance

REXULTI is not a controlled substance.

9.2. Abuse

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

9.3. 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.

10. Overdosage

There is limited clinical trial experience regarding human overdosage with REXULTI. Consult a Certified Poison Control Center (1-800-222-1222 or www.poison.org) for up-to-date guidance and advice regarding ...

11. Description

Brexpiprazole, an atypical antipsychotic, is available as REXULTI (brexpiprazole) tablets. Brexpiprazole is 7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. ...

12.1. Mechanism of Action

The mechanism of action of brexpiprazole in the treatment of major depressive disorder or schizophrenia is unknown. However, the efficacy of brexpiprazole may be mediated through a combination of partial ...

12.2. Pharmacodynamics

Brexpiprazole has affinity (expressed as Ki) for multiple monoaminergic receptors including serotonin 5-HT1A (0.12 nM), 5-HT2A (0.47 nM), 5-HT2B (1.9 nM), 5-HT ...

12.3. Pharmacokinetics

Absorption After single-dose administration of REXULTI tablets, the peak plasma brexpiprazole concentrations occurred within 4 hours after administration, and the absolute oral bioavailability was 95%. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Lifetime carcinogenicity studies were conducted in ICR mice and Sprague Dawley rats. Brexpiprazole was administered orally for two years to male and female mice at doses of 0.75, 2, and ...

14. Clinical Studies

14.1 Adjunctive Treatment of Major Depressive Disorder The efficacy of REXULTI in the adjunctive treatment of major depressive disorder (MDD) was evaluated in two 6-week double-blind, placebo-controlled, ...

16.1. How Supplied

REXULTI (brexpiprazole) tablets have markings on one side and are available in the following strengths and package configurations (see Table 13): Table 13. Package Configuration for REXULTI Tablets: ...

16.2. Storage and Handling

Store REXULTI tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially ...