Excellent clinical efficacy

In clinical trials, RISPERDAL CONSTA demonstrated significant improvement in patients with schizophrenia as measured on the Positive and Negative Syndrome Scale (PANSS). PANSS is a composite scale designed to assess severity of psychopathology in adult patients. The scale emphasizes positive and negative symptom dimensions.

• Pivotal study demonstrates significant symptomatic improvement¹
  • 400 patients with schizophrenia participated in a 12-week, double-blind clinical trial
  • RISPERDAL CONSTA demonstrated significant improvement vs placebo
  • Improvement was seen in both inpatients as well as outpatients
  • Published in The American Journal of Psychiatry, June 2003

Innovative delivery system

• RISPERDAL CONSTA is the first and only long-acting, water-based atypical injection
• Only minimal pain was reported by patients on first injection, and that diminished with subsequent injections

RISPERDAL CONSTA provides established safety and tolerability

• The overall incidence of EPS-related adverse events in patients treated with 25 mg and 50 mg of RISPERDAL CONSTA and placebo, respectively,
  were^{* †}:
  — Akathisia (2%, 9%, 4%)
  — Parkinsonism, ie, bradykinesia, extrapyramidal
     disorder, hypokinesia (4%, 10%, 3%)
  — Tremor (0%, 3%, 0%)

• Incidence of discontinuation due to adverse events with RISPERDAL CONSTA vs placebo: 11% vs 13%^*

• Minimal weight gain^*
  — 1.1-lb mean change in the 25-mg group and 2.6 lb in the 50-mg group
  
  

  Commonly observed events: Treatment-emergent adverse events with an incidence of 5% or greater in at least one of the RISPERDAL CONSTA groups (25 mg or 50 mg) and at least twice that of placebo were: somnolence, akathisia, parkinsonism, dyspepsia, constipation, dry mouth, fatigue, and weight increase.

Confidence of assured coverage

• Professionally administered dose every two weeks
• Can help guide treatment decisions by providing knowledge of therapeutic coverage
• A long-acting, professionally administered injectable medication, while not guaranteeing medication adherence, allows you to recognize and intervene when a patient misses a dose.

Start the switch to RISPERDAL CONSTA

If patient has never received risperidone, rule out the possibility of hypersensitivity reaction prior to treatment with RISPERDAL CONSTA.

• 25 mg once every two weeks by IM gluteal injection
• Antipsychotic supplementation is needed during the first three weeks of therapy with RISPERDAL CONSTA

For additional medical or clinical information, please call the Customer Communications Center at 1-800-JANSSEN (1-800-526-7736). For questions regarding ordering or billing, please call 1-877-RISP-LAI (1-877-747-7524).

Important Safety Information

Commonly observed events: Treatment-emergent adverse events with an incidence of 5% or greater in at least one of the RISPERDAL CONSTA groups (25 mg or 50 mg) and at least twice that of placebo were: somnolence, akathisia, parkinsonism, dyspepsia, constipation, dry mouth, fatigue and weight increase.

Maintenance treatment: Patients should be periodically reassessed to determine the need for continued treatment.

Weight gain: In a 12 week trial, percentage of patients experiencing weight gain (≥7% of baseline body weight) was 6% placebo vs 9% RISPERDAL CONSTA.

Hyperglycemia & diabetes mellitus: Hyperglycemia, some cases extreme and associated with ketoacidosis, hyperosmolar coma or death has been reported in patients treated with atypical antipsychotics (APS), including RISPERDAL CONSTA. Patients starting treatment with APS who have or are at risk for diabetes, should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.

Orthostatic hypotension: Orthostatic hypotension was reported (<2%) in clinical trials.

Tardive dyskinesia: As with all antipsychotic medications, prescribing should be consistent with the need to minimize the risk of tardive dyskinesia; if its signs and symptoms appear, discontinuation of RISPERDAL CONSTA should be considered. In the integrated database of multiple-dose studies the incidence of tardive dyskinesia was 0.6% (9/1499 patients).

Extrapyramidal symptoms: The overall incidence of EPS-related adverse events in patients treated with 25 mg & 50 mg of RISPERDAL CONSTA and placebo respectively, were akathisia (2%, 9%, 4%), parkinsonism* (4%, 10%, 3%) and tremor (0%, 3%, 0%). *Bradykinesia, extrapyramidal disorder, and hypokinesia.

Additional considerations for special populations: Limited clinical trial data are available in elderly, renally or hepatically impaired patients, and RISPERDAL CONSTA should be used cautiously in these patients.

Cerebrovascular adverse events (CAEs): Cerebrovascular adverse events (CAEs), including fatalities, have been reported in elderly patients with dementia-related psychosis taking oral risperidone in clinical trials. The incidence of CAEs with oral risperidone was significantly higher than with placebo. RISPERDAL CONSTA is not approved for treating these patients.

NMS:  Neuroleptic malignant syndrome (NMS) has been reported rarely with this class of medications, including RISPERDAL CONSTA and appropriate management should be employed.

Hyperprolactinemia:  As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration.

Please see full Prescribing Information.

1. Kane JM, Eerdekens M, Lindenmayer J-P, Keith SJ, Lesem M, Karcher K. Long-acting injectable risperidone: efficacy and safety of the first longacting atypical antipsychotic. Am J Psychiatry. 2003;160:1125—1132.
2. Data on file, Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., Titusville, NJ.
   

^*As measured in a 12-week study.
^†Sontaneously reported EPS.