Schizophrenia

Schizophrenia Tolerability & Safety

Metabolics, prolactin, and weight change (schizophrenia studies)

Shifts from baseline to endpoint in pivotal studies1,2*†

Fasting glucose Proportion of patients with metabolic shifts was similar to placebo
Total cholesterol
Fasting triglycerides
Prolactin (ng/mL) No meaningful
increase in mean levels

Weight change in 6-week pivotal studies1†‡

 
  Mean
change
at endpoint		 Proportion of patients
with weight increase ≥7%
Placebo (n=573) +0.7 lb 5%
VRAYLAR 1.5-3 mg/day (n=512) +1.8 lb 8%
VRAYLAR 4.5-6 mg/day (n=570) +2.2 lb 8%

*Metabolic shift defined as: fasting glucose: normal (<100 mg/dL) to high (≥126 mg/dL), borderline (≥100 mg/dL and <126 mg/dL) to high; total cholesterol: normal/borderline (<240 mg/dL) to high (≥240 mg/dL); fasting triglycerides: normal/borderline (<200 mg/dL) to high (≥200 mg/dL)1,2

†Data shown from baseline to endpoint (Week 6) by modal daily dose, defined as most frequently administered dose per patient.1,2

‡Recommended dose range of VRAYLAR is 1.5–6 mg/day for schizophrenia. Doses above 6 mg daily did not appear to have additional benefit over lower doses and a dose-related increase in certain adverse reactions was observed.1

Most common adverse reactions from short-term schizophrenia studies (≥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)§
EPSII 8% 15% 19% 20%
Akathisia 4% 9% 13% 14%

>97% of EPS and akathisia events in short-term schizophrenia studies were mild or moderate2

§Data shown from baseline to endpoint (Week 3) by modal daily dose, defined as most frequently administered dose per patient.1

IIEPS 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.1

EPS=extrapyramidal symptoms.

Discontinuation rates1,2

Overall, 9% of the patients who received VRAYLAR discontinued treatment due to an adverse reaction, compared with 12% of placebo-treated patients in these trials.

These data include patients who discontinued due to worsening of schizophrenia (ie, untreated illness).

  Placebo VRAYLAR
EPS (excluding akathisia/restlessness) 0.2% 0.3%
Akathisia 0.2% 0.5%

Monitor patients when initiating or changing the dose of VRAYLAR1

EPS and akathisia are among the most common adverse reactions and are most frequently observed following initiation or up-titration.1,19

Long-term maintenance treatment of schizophrenia in adults was assessed in a 92-week study of VRAYLAR1,16

Following a 20-week, open-label phase on a stable dose of VRAYLAR, patients were randomized to VRAYLAR 3-9 mg/day or placebo for a 72-week, double-blind phase.1,16

  72-week, double-blind phase
  Placebo
(n=99)		 VRAYLAR 3-9 mg/day
(n=101)
Weight change (lb) +2.1 +2.5
Fasting glucose (mg/dL) +4.1 +5.4
Fasting triglycerides (md/dL) -7.6 +2.8
Total cholesterol (mg/dL) -6.5 -4.1
Prolactin (ng/mL) -6.4 -6.7

Recommended dose range of VRAYLAR is 1.5-6 mg/day. Doses above 6 mg daily did not appear to have additional benefit over lower doses, and a dose-related increase in certain adverse reactions was observed.

Proportion of patients with weight gain ≥7% was 10.6% during the open-label phase and 27.0% and 32.3% for VRAYLAR and placebo-treated patients, respectively, during the double-blind phase.16

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