Important safety information

Other relevant warnings and precautions:

• Body temperature regulation.
• REXULTI tablets contain lactose.
• For patients with diseases, conditions, or medications that could exacerbate somnolence, postural hypotension, motor and sensory instability, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.
• Orthostatic hypotension; generally at highest risk at the beginning of treatment and during dose escalation.
• Risk of QT interval prolongation; exercise particular care when administering REXULTI to patients who are suspected to be at an increased risk of experiencing torsade de pointes.
• Patients should be evaluated carefully for a history of drug abuse.
• Patients should be cautioned about performing activities requiring mental alertness, such as operating hazardous machinery, including motor vehicles, until they are reasonably certain that REXULTI therapy does not affect them adversely.
• Patients should have baseline and periodic monitoring of blood glucose and body weight. Any patient treated with atypical antipsychotics should also be monitored for symptoms of hyperglycemia. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing.
• Patients with risk factors for diabetes mellitus who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control.
• Antipsychotic drugs have been associated with metabolic changes, including weight gain.
• Clinical monitoring of weight is recommended.
• Undesirable alterations in lipids have been observed in subjects treated with atypical antipsychotics. Patients should have baseline and periodic monitoring of fasting lipid profile.
• Like other antipsychotics, REXULTI can elevate prolactin levels. Elevations associated with REXULTI treatment are generally mild and may decline during administration, however, in some infrequent cases the effect may persist during chronic administration.
• Rare cases of priapism have been reported with antipsychotic use.
• Events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents. Agranulocytosis has also been reported. Therefore, it is recommended that patients have their complete blood count (CBC) tested prior to starting REXULTI and then periodically throughout treatment. Patients with a history of a clinically significant low white blood cell count (WBC) or drug-induced leukopenia/neutropenia should have their CBC monitored frequently during the first few months of therapy and discontinuation of REXULTI should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
• Venous thromboembolism.
• Serious hypersensitivity reactions, such as anaphylaxis, angioedema and facial swelling, rash and urticaria.
• Monitoring and laboratory tests: blood glucose, fasting lipid profile and body weight, complete blood count (CBC), white blood cell (WBC) and differential counts, prolactin and blood pressure, should be monitored at baseline and periodically throughout treatment.
• Neuroleptic malignant syndrome is a potentially fatal symptom complex that has been reported in association with antipsychotic drugs including brexpiprazole.
• Tardive dyskinesia may develop in patients treated with antipsychotic drugs.
• Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold.
• Completed suicide, attempted suicide, suicidal behavior and suicidal ideation have been reported during post-market use of REXULTI.
• Patients with a prior history of impulse-control disorder may be at increased risk and should be monitored carefully.
• Consider dose reduction or stopping REXULTI in patients who develop compulsive behaviors that may result in self-harm and harm to others.
• Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with atypical antipsychotic exposure. Discontinue REXULTI if SCARs occur.
• REXULTI should not be used during pregnancy unless the expected benefits to the mother markedly outweigh the potential risks to the fetus. It is recommended that women receiving REXULTI should not breast-feed.
• Geriatrics (>65 years of age): Dose selection should be cautious, usually starting at the low end of the dosing range. In placebo-controlled trials with some atypical antipsychotics, there was a higher incidence of cerebrovascular adverse events including fatalities compared to placebo-treated subjects. Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, including REXULTI.