Two 6-week, fixed-dose trials: REXULTI—adverse reactions that occurred in ≥2% of patients and greater incidence vs placebo from two 6-week pivotal trials1
- Most common adverse reaction occurring in ≥4% of patients and at least twice the rate of placebo was weight increased1
- In both trials, akathisia occurred most often during the first 3 weeks of treatment, and no incidences resulted in treatment discontinuation2,3
- The safety population included patients receiving 1 mg/day1
Important Warning and Precaution for Tardive Dyskinesia (TD)
Risk of TD, and the potential to become irreversible, are believed to increase with duration of treatment and total cumulative dose of antipsychotic drugs. TD can develop after a relatively brief treatment period, even at low doses, or after discontinuation of treatment. For chronic treatment, use the lowest dose and shortest duration of REXULTI needed to produce a clinical response. If signs and symptoms of TD appear, drug discontinuation should be considered.
Additional safety information across 2 pivotal trials
REXULTI—safety considerations evaluated over 6 weeks1,4
|REXULTI (all doses)
|Prolactin4||No clinically meaningful changes|
|Electrocardiogram1||Did not prolong the QTc interval to any clinically relevant extent|
QTc, corrected QT.
Important Warning and Precaution for Potential for Cognitive and Motor Impairment
REXULTI has the potential to impair judgment, thinking, or motor skills. Patients should not drive or operate hazardous machinery until they are reasonably certain REXULTI does not affect them adversely.
Additional safety information for REXULTI evaluated at 6 weeks and 52 weeks, across all doses
Metabolic data across all doses in short- and long-term trials
REXULTI—percentage of patients whose values shifted from baseline to post-baseline1,5,6
fixed-dose pivotal trials
|Fasting serum glucose, % of patients who shifted from5:|
<100 mg/dL ≥100 to <126 mg/dL ≥126 mg/dL
|Similar rates between
REXULTI and placebo1
|10% of patients1|
|Triglycerides, % of patients who shifted from5:|
<150 mg/dL ≥200 to <500 mg/dL
|9% of patients6||6% of patients1||13% of patients1|
<150 mg/dL ≥500 mg/dL
|0.2% of patients6||0% of patients1||0.4% of patients1|
<150 mg/dL ≥150 to <200 mg/dL ≥500 mg/dL
|0.2% of patients6||0% of patients1||0.6% of patients1|
|Cholesterol, % of patients who shifted from5:|
Fasting total cholesterol
<200 mg/dL ≥240 mg/dL
|Similar rates between
REXULTI and placebo1
|6% of patients1|
Fasting LDL cholesterol
<100 mg/dL ≥160 mg/dL
|2% of patients1|
Fasting HDL cholesterol
≥40 mg/dL <40 mg/dL
|17% of patients1|
Weight change in short- and long-term trials
REXULTI—weight change and discontinuation results across all doses1,5,7-10
fixed-dose pivotal trials7-10
|Mean weight increasedb||1.2 kg7||0.2 kg1||2.0 kg1|
Weight change≥7% increase in body weight
|10% of patients8||4% of patients1||20% of patients1|
|≥7% decrease in body weight||2% of patients9||2% of patients9||10% of patients1|
|Discontinuation due to weight increased across all doses||0% of patients10||0% of patients10||0.6% of patients10|
bSD for mean weight increased at 6 weeks were 3.4 kg for REXULTI and 2.7 kg for placebo, and at 52 weeks was 7.3 kg for REXULTI.5,7
aAfter the conclusion of the 6-week trial, patients who elected to remain in the trial, patients from the Phase 2 trial, and de novo patients were treated with flexible doses of REXULTI (1 mg to 6 mg) in a 52-week, open-label trial, and no placebo control was included. Safety data were collected at regular intervals throughout the 52 weeks. The overall N was 813; n values for individual parameters varied.5
HDL, high-density lipoprotein; LDL, low-density lipoprotein; SD, standard deviation.
Important Warning and Precaution for Metabolic Changes
Atypical antipsychotic drugs have caused metabolic changes including:
- Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Assess fasting plasma glucose before or soon after initiation of antipsychotic medication, and monitor periodically during long-term treatment.
- Dyslipidemia: Atypical antipsychotics cause adverse alterations in lipids. Before or soon after initiation of antipsychotic medication, obtain a fasting lipid profile at baseline and monitor periodically during treatment.
- Weight Gain: Weight gain has been observed in patients treated with REXULTI. Monitor weight at baseline and frequently thereafter.