Brexpiprazole 2 mg/1
Brexpiprazole · TABLET · Ajanta Pharma USA Inc.
Brexpiprazole is an atypical antipsychotic tablet taken by mouth that is used to treat schizophrenia and as an add-on treatment for depression. It works by helping to balance certain chemicals in the brain that affect mood and thinking.
Key Facts
- Brand Name
- Brexpiprazole
- Generic Name
- Brexpiprazole
- NDC Code (Product)
27241-207- Manufacturer
- Ajanta Pharma USA Inc.
- Strength
- 2 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA213718
- Drug Class
- Atypical Antipsychotic [EPC]
- Marketing Start
- 02/03/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Brexpiprazole tablets are indicated for: Adjunctive treatment of major depressive disorder (MDD) in adults. Treatment of schizophrenia in adults. Brexpiprazole tablets is an atypical antipsychotic indicated for: Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults ( 1 , 14.1 ) Treatment of schizophrenia in adults
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer brexpiprazole tablets once daily with or without food. ( 2.1 , 2.2 , 12.3 ) Indication Starting Dose Recommended Dose Maximum Dose MDD Adults ( 2.1 ) 0.5 mg/day or 1 mg/day 2 mg/day 3 mg/day Schizophrenia Adults ( 2.2 ) 1 mg/day 2 to 4 mg/day 4 mg/day Moderate to Severe Hepatic Impairment (Child-Pugh score greater than or equal to 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 (CrCl less than 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 ) 2.1 Adjunctive Treatment of Major Depressive Disorder (Adults) The recommended starting dosage for brexpiprazole tablets as adjunctive treatment of MDD in adults is 0.5 mg or 1 mg once daily, taken orally with or without food [see Clinical Pharmacology ( 12.3 )]. 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 c…
Contraindications
4 CONTRAINDICATIONS Brexpiprazole tablets are contraindicated in patients with a known hypersensitivity to brexpiprazole or any of its components. Reactions have included rash, facial swelling, urticaria, and anaphylaxis. Known hypersensitivity to brexpiprazole tablets or any of its components ( 4 )
Drug Interactions
7 DRUG INTERACTIONS * Brexpiprazole tablets may be administered without dosage adjustment in patients with MDD when administered with strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine). Factors Dosage Adjustments for brexpiprazole tablets ( 2.5 ) Strong CYP2D6* or CYP3A4 inhibitors Administer half of usual dose. Strong/moderate CYP2D6 with Strong/moderate CYP3A4 inhibitors Administer a quarter of usual dose. Known CYP2D6 poor metabolizers taking strong/moderate CYP3A4 inhibitors Administer a quarter of usual dose. Strong CYP3A4 inducers Double the usual dose and further adjust based on clinical response. 7.1 Drugs Having Clinically Important Interactions with Brexpiprazole Tablets Table 9: Clinically Important Drug Interactions with Brexpiprazole Tablets * In the clinical trials examining the adjunctive use of brexpiprazole tablets 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 brexpiprazole tablets may be administered without dosage adjustment in patients with MDD. Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of bre…
Adverse Reactions
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 and Precautions ( 5.1 )] Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Boxed Warning, Warnings and Precautions ( 5.2 )] Cerebrovascular Adverse Reactions Including Stroke in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions ( 5.3 )] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions ( 5.4 )] Tardive Dyskinesia [see Warnings and Precautions ( 5.5 )] Metabolic Changes [see Warnings and Precautions ( 5.6 )] Pathological Gambling and Other Compulsive Behaviors [see Warnings and Precautions ( 5.7 )] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.8 )] Orthostatic Hypotension and Syncope [see Warnings and Precautions ( 5.9 )] Falls [see Warnings and Precautions ( 5.10 )] Seizures [see Warnings and Precautions ( 5.11 )] Body Temperature Dysregulation [see Warnings and Precautions ( 5.12 )] Dysphagia [see Warnings and Precautions ( 5.13 )] Potential for Cognitive and Motor Impair…
Frequently Asked Questions
What is Brexpiprazole used for?
Brexpiprazole is an atypical antipsychotic tablet taken by mouth that is used to treat schizophrenia and as an add-on treatment for depression. It works by helping to balance certain chemicals in the brain that affect mood and thinking.
Is Brexpiprazole a controlled substance?
Brexpiprazole is not classified as a controlled substance by the DEA.
What is the generic name for Brexpiprazole?
The generic name for Brexpiprazole is Brexpiprazole. There are 6 other brand versions of Brexpiprazole.
What is the NDC code for Brexpiprazole 2 mg/1?
The NDC (National Drug Code) for Brexpiprazole 2 mg/1 is 27241-207, listed by Ajanta Pharma USA Inc..