Brexpiprazole Safety in a 25-Year-Old Male
Brexpiprazole is generally safe for a 25-year-old male when used for approved indications (schizophrenia or adjunctive treatment of major depressive disorder), though specific monitoring for suicidal ideation, extrapyramidal symptoms, metabolic changes, and akathisia is essential in this age group. 1
Critical Age-Related Safety Concern
The FDA includes a black box warning specifically relevant to your patient's age: increased risk of suicidal thoughts and behaviors in adolescents and young adults. 1 While this warning primarily targets those under 24 years with depression, vigilance remains warranted at age 25, particularly if brexpiprazole is being used adjunctively for major depressive disorder. The risk of suicidal ideation has been documented with SSRIs in patients under 18, with elevated concern in those with co-morbid depressive disorders. 2
Common Adverse Effects by Indication
For Schizophrenia (if applicable):
- Akathisia occurs in 6% of brexpiprazole-treated patients versus 5% with placebo 1, yielding a modest number needed to harm of 112 (non-significant). 3
- Weight gain affects 4% of patients, with mean increases of 2.74 times placebo risk 4
- Extrapyramidal symptoms occur in 5% versus 4% with placebo 1
- Somnolence/sedation affects 2% of patients 1
For Major Depressive Disorder (if applicable):
- Akathisia is more problematic as adjunctive therapy: 9% versus 2% with placebo 1, with a number needed to harm of 15. 3
- Weight gain is more pronounced: 7% of patients experience increases 1
- Fatigue affects 3% of patients 1
- Discontinuation due to adverse events remains low at 3% versus 1% with placebo 1
Essential Monitoring Requirements
Baseline Assessment:
- Document any pre-existing abnormal movements to avoid later misattribution as medication side effects 2
- Assess for suicidal ideation given age and black box warning 1
- Obtain baseline weight, body mass index, waist circumference, blood pressure, fasting glucose, and fasting lipid panel 2
Ongoing Monitoring:
- Monitor body mass index monthly for 3 months, then quarterly 2
- Blood pressure, fasting glucose, and lipids should be rechecked after 3 months, then yearly 2
- Use the Abnormal Involuntary Movement Scale (AIMS) at least every 3-6 months to detect tardive dyskinesia early 5
- Assess for akathisia using the Barnes Akathisia Rating Scale (BARS), as this symptom is commonly misinterpreted as psychotic agitation or anxiety 5
- Regular evaluation for extrapyramidal symptoms using the Simpson-Angus Rating Scale 1
Specific Safety Advantages
Brexpiprazole demonstrates minimal QT prolongation (0-5 ms) compared to other antipsychotics 5, reducing cardiac risk in this young patient. The drug shows less intrinsic activity at D2 receptors than aripiprazole, predicting lower propensity for activating adverse events and extrapyramidal symptoms. 6
Dosing Considerations for Safety
For schizophrenia, use 2-4 mg/day; for major depressive disorder, use 2 mg/day as the target dose. 3 The 2 mg dose is associated with significantly less risk of akathisia and somnolence compared to 4 mg. 4 Dose adjustments are required if the patient takes CYP2D6 or CYP3A4 inhibitors/inducers, as brexpiprazole is a major substrate of these enzymes. 7
Contraindications and Precautions
- Avoid in patients with uncontrolled seizure disorders 1
- Use cautiously if risk factors for aspiration exist due to potential esophageal dysmotility 1
- Counsel about operating hazardous machinery until certain the medication does not cause impairment 1
- Monitor for pathological gambling and other compulsive behaviors, which have been reported with dopamine agonists 1
Management of Common Adverse Effects
For akathisia: Consider dose reduction when clinically feasible; beta-blockers and benzodiazepines may provide relief. 5
For acute dystonia (if occurs): Anticholinergic medications are effective treatment. 5
For weight gain: Follow American Dietetic Association recommendations for managing weight gain with antipsychotics, including dietary counseling and exercise. 2