Fasting glucose in 6-week studies*†

VRAYLAR similar to placebo for the percentage of patients with shifts in fasting glucose1,5

*Data shown from baseline to endpoint (Week 6) by modal daily dose, defined as most frequently administered dose per patient.1,5

Recommended dose range of VRAYLAR 1.5-6 mg/day. A dose-related increase in certain adverse reactions, particularly above 6 mg, was observed.1

Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics. Assess fasting glucose before or soon after initiation of treatment, and monitor periodically during long-term treatment.

Long-term, 48-week schizophrenia studies

In 2 open-label, uncontrolled, flexible-dose studies1,5
Fasting glucose (mg/dL) +3.0

  Based on mean change from baseline to Week 48 at doses ranging from 1.5-9 mg/day.

Recommended dose range of VRAYLAR is 1.5-6 mg/day. A dose-related increase in certain adverse reactions, particularly above 6 mg, was observed.1


Total cholesterol and fasting triglycerides in 6-week studies*†

VRAYLAR similar to placebo for the percentage of patients with shifts in total cholesterol or fasting triglycerides1,5

*Data shown from baseline to endpoint (Week 6) by modal daily dose, defined as most frequently administered dose per patient.1,5

Recommended dose range of VRAYLAR is 1.5-6 mg/day. A dose-related increase in certain adverse reactions, particularly above 6 mg, was observed.1

Dyslipidemia: Atypical antipsychotics cause adverse alterations in lipids. Before or soon after starting an antipsychotic, obtain baseline fasting lipid profile and monitor periodically during treatment.

Long-term, 48-week schizophrenia studies

In 2 open-label, uncontrolled, flexible-dose studies1,5
Total cholesterol (mg/dL) -2.7
Fasting triglycerides (mg/dL) +7.7

  Based on mean change from baseline to Week 48 at doses ranging from 1.5-9 mg/day.

Recommended dose range of VRAYLAR is 1.5-6 mg/day. A dose-related increase in certain adverse reactions, particularly above 6 mg, was observed.1


Body weight in 6-week studies*†

Mean change from baseline to endpoint1
  Placebo
(n = 573)
VRAYLAR
1.5-3 mg/day
(n = 512)
VRAYLAR
4.5-6 mg/day
(n = 570)
Weight
(kg)
+0.3 +0.8 +1

*Data shown from baseline to endpoint (Week 6) by modal daily dose, defined as most frequently administered dose per patient.1,5

Recommended dose range of VRAYLAR is 1.5-6 mg/day. A dose-related increase in certain adverse reactions, particularly above 6 mg, was observed.1

Weight Gain: Weight gain has been observed with VRAYLAR. Monitor weight at baseline and frequently thereafter.

Long-term, 48-week schizophrenia studies

In 2 open-label, uncontrolled, flexible-dose studies1,5
Weight (kg) +2.5

  Based on mean change from baseline to Week 48 at doses ranging from 1.5-9 mg/day.

Recommended dose range of VRAYLAR is 1.5-6 mg/day. A dose-related increase in certain adverse reactions, particularly above 6 mg, was observed.1

Prolactin in 6-week studies*†

No clinically relevant changes in prolactin levels were observed in short-term studies5

*Data shown from baseline to endpoint (Week 6) by modal daily dose, defined as most frequently administered dose per patient.1,5

Recommended dose range of VRAYLAR is 1.5-6 mg/day. A dose-related increase in certain adverse reactions, particularly above 6 mg, was observed.1

Long-term, 48-week schizophrenia studies

In 2 open-label, uncontrolled, flexible-dose studies1,5
Prolactin (ng/mL) -18.3

  Based on mean change from baseline to Week 48 at doses ranging from 1.5-9 mg/day.

Recommended dose range of VRAYLAR is 1.5-6 mg/day. A dose-related increase in certain adverse reactions, particularly above 6 mg, was observed.1


Most common adverse reactions in 6-week studies

Adverse reactions (≥ 5% and at least twice that of placebo)1

    Recommended dose range
  Placebo
(n = 584)
VRAYLAR 1.5-3
mg/day
(n = 539)
VRAYLAR 4.5-6
mg/day
(n = 575)
VRAYLAR 9-12
mg/day
(n = 203)
Extrapyramldal symptoms (EPS)* 8% 15% 19% 20%
Akathlsia 4% 9% 13% 14%
Most patients with EPS (98.7%) and akathisia (97.3%) experienced symptoms of mild or moderate severity5

*EPS included bradykinesia, cogwheel rigidity, drooling, dyskinesia, dystonia, extrapyramidal disorder, hypokinesia, masked facies, muscle rigidity, muscle tightness, musculoskeletal stiffness, oculogyric crisis, oromandibular dystonia, parkinsonism, salivary hypersecretion, tardive dyskinesia, torticollis, tremor, and trismus.

Data shown from baseline to endpoint (Week 6) by modal daily dose, defined as most frequently administered dose per patient.1,5

Discontinuation rates due to adverse reactions1

  • Overall, there was a 9% discontinuation rate due to adverse reactions for VRAYLAR-treated patients vs 12% with placebo5
    • These data include patients who discontinued due to worsening of schizophrenia (ie, untreated illness)
  • No single adverse reaction leading to discontinuation occured in VRAYLAR-treated patients at a rate of ≥ 2% and at least twice the rate of placebo1
EPS

0.3%

discontinuation rate (excluding akathisia and restlessness) in VRAYLAR-treated patients vs 0.2% for placebo1

Akathisia

0.5%

discontinuation rate in VRAYLAR-treated patients vs 0.2% for placebo1

  • Time to resolution of EPS after treatment discontinuation was similar between VRAYLAR- and placebo-treated patients (Kaplan-Meier analyses)5
    • Median time to resolution of EPS adverse events was 9 days with VRAYLAR and 12 days with placebo
  • Median time to resolution of akathisia adverse events was 8 days with VRAYLAR. Median time to resolution of akathisia could not be calculated in the placebo group, due to the high percentage of unresolved events (13 of 16, 81.3%)5