Please see below for an overview of the program rules for the INVEGA SUSTENNA® Inpatient Hospital Pharmacy Free Trial Program.
In order to receive free trial units for your patients, you must agree and adhere to all program rules which can be found on the website upon log-in:

ELIGIBILITY -

  • The free trial product requested must be for an inpatient hospital licensed as a hospital under applicable state law.
  • The program is only available for an inpatient hospital that is unable to accept PDMA samples.
  • Retail pharmacies are not eligible for program participation.
  • There is no requirement for subsequent use of INVEGA SUSTENNA® for any patient receiving a free trial unit.
  • This program, as amended from time to time, will be available through December 31, 2016. Program available only in the
    United States and Puerto Rico.*†
ANNUAL ENROLLMENTS -
  • Annual enrollment is required with valid state license numbers from at least one of each of the following:
    (1) inpatient hospital pharmacist
    (2) inpatient hospital pharmacy
    (3) inpatient hospital
    (4) inpatient hospital prescriber.
PATIENT & PRESCRIBER QUANTITY LIMITS -
  • Pharmacists may order and receive for patients determined to be appropriate up to 2 free trial units per calendar year per patient.
  • Inpatient hospital pharmacies and inpatient hospitals must have the ability to track utilization of this program by each patient and establish adequate controls to ensure that product received under this program is appropriately segregated and tracked as if it were a PDMA sample.
  • Additional quantity limits may apply.
PROHIBITION ON SEPARATE BILLING -
  • Free trial units are commercially labeled as trade product and not labeled as sample products.
  • Do not separately bill the patient, the patient's insurance carrier, or the government for any INVEGA SUSTENNA® dispensed as part of this program.
  • Free trial product received pursuant to this program may not be sold, traded, bartered, or returned for credit.
DISPENSE DATE -
  • Orders requesting free trial units must be submitted within 30 days of the dispense date.
PHARMACIST ACKNOWLEDGMENT OF RECEIPT (AOR) -
  • Failure to complete AOR{s) within a timely manner will result in suspension of the program.
TRANSPARENCY -
  • Hospital, pharmacy, pharmacist, and prescriber information and the free trial disbursement{s) may be reported as required by state or federal law. Once reported, this information may be made available for public view.
*Janssen Pharmaceuticals, Inc., may terminate the program prior to December 31, 2016, upon 60 days' notice to all participating inpatient pharmacies, or upon less or no notice if there is a change in interpretation of federal or stale laws supporting the continuation of the program.
Shipments will not be processed Friday through Sunday or on holidays. These factors may result in a delay in shipment.
For questions about this program or if you no longer wish to participate, please call 1-855-463-1912, Monday through Friday, between 8AM and 8 PM ET.

 
INVEGA SUSTENNA® (paliperidone palmitate) is indicated for the treatment of

      •Schizophrenia.
      •Schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers or antidepressants.


IMPORTANT SAFETY INFORMATION FOR INVEGA SUSTENNA® (paliperidone palmitate)

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS.

See full Prescribing Information for complete Boxed Warning.
  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
  • INVEGA SUSTENNA® is not approved for the treatment of patients with dementia-related psychosis.
 
Contraindications: Paliperidone is contraindicated in patients with a known hypersensitivity to either paliperidone, risperidone, or to any excipients of the formulation.

Cerebrovascular Adverse Reactions: Cerebrovascular Adverse Reactions (e.g., stroke, transient ischemic attacks), including fatalities, were reported in placebo-controlled trials in elderly patients with dementia-related psychosis taking oral risperidone, aripiprazole, and olanzapine. The incidence of cerebrovascular adverse reactions was significantly higher than with placebo. INVEGA SUSTENNA® is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with the use of antipsychotic medications, including paliperidone. Clinical manifestations include muscle rigidity, fever, altered mental status, and evidence of autonomic instability (see full Prescribing Information). Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and close medical monitoring, and treatment of any concomitant serious medical problems.

QT Prolongation: Paliperidone causes a modest increase in the corrected QT (QTc) interval. Avoid the use of drugs that also increase QTc interval and in patients with risk factors for prolonged QTc interval. Paliperidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias. Certain circumstances may increase the risk of the occurrence of torsades de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval.

Tardive Dyskinesia (TD): TD is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may develop in patients treated with antipsychotic medications. The risk of developing TD and the likelihood that dyskinetic movements will become irreversible are believed to increase with duration of treatment and total cumulative dose, but can develop after relatively brief treatment at low doses. Elderly female patients appeared to be at increased risk for TD, although it is impossible to predict which patients will develop the syndrome. Prescribing should be consistent with the need to minimize the risk of TD (see full Prescribing Information). Discontinue drug if clinically appropriate. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.

Hyperglycemia and Diabetes Mellitus: Hyperglycemia and diabetes mellitus, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death have been reported in patients treated with all atypical antipsychotics (APS). Patients starting treatment with APS who have or are at risk for diabetes mellitus should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia during treatment should also undergo fasting blood glucose testing. All patients treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia. Some patients require continuation of antidiabetic treatment despite discontinuation of the suspect drug.

Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics.

Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Orthostatic Hypotension and Syncope: INVEGA SUSTENNA® may induce orthostatic hypotension in some patients due to its alpha-blocking activity. INVEGA SUSTENNA® should be used with caution in patients with known cardiovascular disease, cerebrovascular disease or conditions that would predispose patients to hypotension (e.g., dehydration, hypovolemia, treatment with antihypertensive medications). Monitoring should be considered in patients for whom this may be of concern.

Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including paliperidone. Patients with a history of clinically significant low white blood cell count (WBC) or drug-induced leukopenia/neutropenia should have frequent complete blood cell counts during the first few months of therapy. At the first sign of a clinically significant decline in WBC, and in the absence of other causative factors, discontinuation of INVEGA SUSTENNA® should be considered. Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count <1000/mm3) should discontinue INVEGA SUSTENNA® and have their WBC followed until recovery.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, INVEGA SUSTENNA® elevates prolactin levels and the elevation persists during chronic administration. Paliperidone has a prolactin-elevating effect similar to risperidone, which is associated with higher levels of prolactin elevation than other antipsychotic agents.

Potential for Cognitive and Motor Impairment: Somnolence, sedation, and dizziness were reported as adverse reactions in subjects treated with INVEGA SUSTENNA®. INVEGA SUSTENNA® has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about performing activities that require mental alertness such as operating hazardous machinery, including motor vehicles, until they are reasonably certain that INVEGA SUSTENNA® does not adversely affect them.

Seizures: INVEGA SUSTENNA® should be used cautiously in patients with a history of seizures or with conditions that potentially lower seizure threshold. Conditions that lower seizure threshold may be more prevalent in patients 65 years or older.

Administration: For intramuscular injection only by a healthcare professional. Care should be taken to avoid inadvertent injection into a blood vessel.

Drug Interactions: Strong CYP3A4/P-glycoprotein (P-gp) inducers: It may be necessary to increase the dose of INVEGA SUSTENNA® when a strong inducer of both CYP3A4 and P-gp (e.g. carbamazepine, rifampin, St. John’s wort) is co-administered. Conversely, on discontinuation of the strong inducer, it may be necessary to decrease the dose of INVEGA SUSTENNA®.

Pregnancy/Nursing: Patients should be advised to notify their physician if they become pregnant/intend to become pregnant or intend to nurse during treatment with INVEGA SUSTENNA®.

Commonly Observed Adverse Reactions for INVEGA SUSTENNA®: The most common adverse reactions in clinical trials in patients with schizophrenia (≥5% and twice placebo) were injection site reactions, somnolence/sedation, dizziness, akathisia and extrapyramidal disorder. No adverse events occurred at a rate of ≥5% and twice placebo during the long-term double-blind, placebo-controlled study in patients with schizoaffective disorder. The following adverse reactions occurred more frequently (a ≥2% difference vs. placebo) in the long-term study in patients with schizoaffective disorder: weight increased, nasopharyngitis, headache, hyperprolactinemia, and pyrexia.

037717-150728

Please see the full Prescribing Information and Boxed WARNING.

© Janssen Pharmaceuticals, Inc., 2016. All rights reserved.
Your use of the information on this site is subject to the terms of our Legal Notice. Please see our Privacy Policy
.

This site is published by Janssen Pharmaceuticals, Inc., which is solely responsible for its contents. This information is intended for the use of our healthcare professionals in the United States only. Janssen Pharmaceuticals, Inc., recognizes that the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States including Puerto Rico.

Capitalized product names are trademarks of Janssen Pharmaceuticals, Inc.

Some documents on this site are stored in Adobe PDF format and require the free Adobe® Reader® to view.

This page was last modified on: 02/03/2016 at 12:55 EDT



046757-160204