New Service Helps Practitioners Coordinate Care for Patients Receiving Company’s Long-Acting Injectable Therapies
Titusville, NJ (January 31, 2011) – Janssen®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced today the launch in California of Janssen® Connect™, a new service for psychiatrists and other healthcare professionals and their patients who have been prescribed a Janssen® long-acting injectable atypical antipsychotic medicine. These medicines are INVEGA® SUSTENNA® (paliperidone palmitate), for the treatment of schizophrenia, and RISPERDAL® CONSTA® (risperidone), for the treatment of schizophrenia and longer-term treatment of Bipolar I Disorder.
Janssen® Connect™ is a service designed to help make it easier for patients to access Janssen® long-acting injectable therapies. Janssen® partners with treatment teams that request to be a part of the program and works directly with them to provide their patients with support and resources, including: alternate injection sites of care, such as pharmacies; trained healthcare professionals to provide injections; facilities that may be more conveniently located for patients; access and reimbursement services; appointment reminders; and scheduling of future injection appointments.
“We are pleased to offer this program to prescribers and patients, as part of our long-standing commitment to people with mental illness,” said Denice Torres, president of Janssen®.
The move from an inpatient to an outpatient setting may be complicated for some people with mental illness, and this transition is critical to the process of recovery. Janssen® Connect™ assists with this transition by keeping inpatient and outpatient healthcare professionals and planners informed about timing of injections, doses of medication, adverse events or patient concerns. Healthcare professionals also will be notified if a patient has missed an appointment or was not given medication for any reason, which can help identify situations in which a physician may need to intervene.
Janssen® Connect™ reimbursement-support services and care-coordination services are provided as a service by Proherant Health Inc., under contract for Janssen®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. These support services are made available as a convenience to patients, and no additional compensation is required from or paid to patients or prescribers. Proherant Health, Inc. and other providers are responsible for the services they provide.
For more information about the program and local participating care sites, visit www.JanssenConnect.com or contact a Janssen® Connect™ representative at 877-JC-HELP9 (877-524-3579).
About Janssen®
Janssen®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in Titusville, NJ, and is the only large pharmaceutical company in the United States dedicated solely to mental health. Janssen® currently markets prescription medications for the treatment of schizophrenia, Bipolar I Disorder and Schizoaffective Disorder. Ortho-McNeil-Janssen Pharmaceuticals, Inc., is a member of the Johnson & Johnson family of companies. For more information about Janssen®, visit http://www.janssen.com.
INVEGA® SUSTENNA® (paliperidone palmitate) extended-release injectable suspension is indicated for the acute and maintenance treatment of schizophrenia in adults.
RISPERDAL® CONSTA® (risperidone) long-acting injection is indicated for the treatment of schizophrenia and for the maintenance treatment of Bipolar I Disorder.
IMPORTANT SAFETY INFORMATION FOR INVEGA® SUSTENNA® (paliperidone palmitate) and RISPERDAL® CONSTA® (risperidone)
WARNING: Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Neither INVEGA®SUSTENNA®nor RISPERDAL® CONSTA® is approved for the treatment of patients with dementia-related psychosis.
Contraindications: RISPERDAL® CONSTA® is contraindicated in patients with a known hypersensitivity to the product. Paliperidone is contraindicated in patients with a known hypersensitivity to either paliperidone, risperidone, or to any components of the formulation.
Cerebrovascular Adverse Events (CAEs): CAEs (e.g. stroke, transient ischemia attacks), including fatalities, were reported in placebo-controlled trials in elderly patients with dementia-related psychosis taking oral risperidone. The incidence of CAEs was significantly higher than with placebo. Neither paliperidone nor RISPERDAL® CONSTA® is 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. 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 QT interval and in patients with risk factors for prolonged QT 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 torsade 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 women 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.
Hyperglycemia and Diabetes: 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® and INVEGA® SUSTENNA®. 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 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 anti-diabetic treatment despite discontinuation of the suspect drug.
Weight Gain: Weight gain has been observed with INVEGA® SUSTENNA® and other atypical antipsychotic medications. Monitor weight gain.
Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, risperidone and paliperidone elevate prolactin levels and the elevation persists during chronic administration. Paliperidone has a prolactin-elevating effect similar to risperidone. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.
Orthostatic Hypotension and Syncope: INVEGA® SUSTENNA® and RISPERDAL® CONSTA® may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period. INVEGA® SUSTENNA® and RISPERDAL® CONSTA® should be used with caution in patients with known cardiovascular disease (e.g. heart failure, history of MI or ischemia, conduction abnormalities), cerebrovascular disease or conditions that would predispose patients to hypotension (e.g. dehydration, hypovolemia) and additionally elderly patients with renal or hepatic impairment. Monitoring should be considered in patients for whom this may be of concern.
Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including RISPERDAL® CONSTA® and 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 RISPERDAL® CONSTA® or 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 RISPERDAL® CONSTA® or INVEGA® SUSTENNA® and have their WBC followed until recovery.
Potential for Cognitive and Motor Impairment: Somnolence was reported in multiple trials in subjects treated with RISPERDAL® CONSTA® or INVEGA® SUSTENNA®. Since RISPERDAL® CONSTA® and INVEGA® SUSTENNA® have the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that RISPERDAL® CONSTA® or INVEGA® SUSTENNA® does not adversely affect them.
Seizures: RISPERDAL® CONSTA® and INVEGA® SUSTENNA® should be used cautiously in patients with a history of seizures.
Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer’s dementia. Use cautiously in patients at risk for aspiration pneumonia.
Priapism has been reported. Severe priapism may require surgical intervention.
Thrombotic Thrombocytopenic Purpura (TTP) has been reported.
Administration: For intramuscular injection only. Care should be taken to avoid inadvertent injection into a blood vessel.
Suicide: The possibility of suicide attempt is inherent in schizophrenia or bipolar disorder. Close supervision of high-risk patients should accompany drug therapy.
With RISPERDAL® CONSTA®, increased sensitivity in patients with Parkinson’s disease or those with dementia with Lewy bodies has been reported. Manifestations and features are consistent with NMS.
Use RISPERDAL® CONSTA® with caution in patients with conditions and medical conditions that could affect metabolism or hemodynamic responses (e.g. recent myocardial infarction or unstable cardiac disease).
Commonly Observed Adverse Reactions: The most common adverse reactions in clinical trials for: RISPERDAL® CONSTA® - In patients with bipolar disorder were weight increase (5% in monotherapy trial) and tremor and Parkinsonism (≥10% in adjunctive therapy trial). In patients with schizophrenia (≥ 5%) were headache, Parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremities, and dry mouth.
INVEGA® SUSTENNA® - In patients with schizophrenia (≥5% and twice placebo) were injection site reactions, somnolence/sedation, dizziness, akathisia and extrapyramidal disorder.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see the full Prescribing Information for INVEGA® SUSTENNA®.
Please see the full Prescribing Information for RISPERDAL® CONSTA®.
# # #
New Service Helps Practitioners Coordinate Care for Patients Receiving Company’s Long-Acting Injectable Therapies
Titusville, NJ (January 31, 2011) – Janssen®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced today the launch in California of Janssen® Connect™, a new service for psychiatrists and other healthcare professionals and their patients who have been prescribed a Janssen® long-acting injectable atypical antipsychotic medicine. These medicines are INVEGA® SUSTENNA® (paliperidone palmitate), for the treatment of schizophrenia, and RISPERDAL® CONSTA® (risperidone), for the treatment of schizophrenia and longer-term treatment of Bipolar I Disorder.
Janssen® Connect™ is a service designed to help make it easier for patients to access Janssen® long-acting injectable therapies. Janssen® partners with treatment teams that request to be a part of the program and works directly with them to provide their patients with support and resources, including: alternate injection sites of care, such as pharmacies; trained healthcare professionals to provide injections; facilities that may be more conveniently located for patients; access and reimbursement services; appointment reminders; and scheduling of future injection appointments.
“We are pleased to offer this program to prescribers and patients, as part of our long-standing commitment to people with mental illness,” said Denice Torres, president of Janssen®.
The move from an inpatient to an outpatient setting may be complicated for some people with mental illness, and this transition is critical to the process of recovery. Janssen® Connect™ assists with this transition by keeping inpatient and outpatient healthcare professionals and planners informed about timing of injections, doses of medication, adverse events or patient concerns. Healthcare professionals also will be notified if a patient has missed an appointment or was not given medication for any reason, which can help identify situations in which a physician may need to intervene.
Janssen® Connect™ reimbursement-support services and care-coordination services are provided as a service by Proherant Health Inc., under contract for Janssen®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. These support services are made available as a convenience to patients, and no additional compensation is required from or paid to patients or prescribers. Proherant Health, Inc. and other providers are responsible for the services they provide.
For more information about the program and local participating care sites, visit www.JanssenConnect.com or contact a Janssen® Connect™ representative at 877-JC-HELP9 (877-524-3579).
About Janssen®
Janssen®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in Titusville, NJ, and is the only large pharmaceutical company in the United States dedicated solely to mental health. Janssen® currently markets prescription medications for the treatment of schizophrenia, Bipolar I Disorder and Schizoaffective Disorder. Ortho-McNeil-Janssen Pharmaceuticals, Inc., is a member of the Johnson & Johnson family of companies. For more information about Janssen®, visit http://www.janssen.com.
INVEGA® SUSTENNA® (paliperidone palmitate) extended-release injectable suspension is indicated for the acute and maintenance treatment of schizophrenia in adults.
RISPERDAL® CONSTA® (risperidone) long-acting injection is indicated for the treatment of schizophrenia and for the maintenance treatment of Bipolar I Disorder.
IMPORTANT SAFETY INFORMATION FOR INVEGA® SUSTENNA® (paliperidone palmitate) and RISPERDAL® CONSTA® (risperidone)
WARNING: Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Neither INVEGA®SUSTENNA®nor RISPERDAL® CONSTA® is approved for the treatment of patients with dementia-related psychosis.
Contraindications: RISPERDAL® CONSTA® is contraindicated in patients with a known hypersensitivity to the product. Paliperidone is contraindicated in patients with a known hypersensitivity to either paliperidone, risperidone, or to any components of the formulation.
Cerebrovascular Adverse Events (CAEs): CAEs (e.g. stroke, transient ischemia attacks), including fatalities, were reported in placebo-controlled trials in elderly patients with dementia-related psychosis taking oral risperidone. The incidence of CAEs was significantly higher than with placebo. Neither paliperidone nor RISPERDAL® CONSTA® is 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. 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 QT interval and in patients with risk factors for prolonged QT 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 torsade 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 women 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.
Hyperglycemia and Diabetes: 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® and INVEGA® SUSTENNA®. 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 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 anti-diabetic treatment despite discontinuation of the suspect drug.
Weight Gain: Weight gain has been observed with INVEGA® SUSTENNA® and other atypical antipsychotic medications. Monitor weight gain.
Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, risperidone and paliperidone elevate prolactin levels and the elevation persists during chronic administration. Paliperidone has a prolactin-elevating effect similar to risperidone. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.
Orthostatic Hypotension and Syncope: INVEGA® SUSTENNA® and RISPERDAL® CONSTA® may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period. INVEGA® SUSTENNA® and RISPERDAL® CONSTA® should be used with caution in patients with known cardiovascular disease (e.g. heart failure, history of MI or ischemia, conduction abnormalities), cerebrovascular disease or conditions that would predispose patients to hypotension (e.g. dehydration, hypovolemia) and additionally elderly patients with renal or hepatic impairment. Monitoring should be considered in patients for whom this may be of concern.
Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including RISPERDAL® CONSTA® and 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 RISPERDAL® CONSTA® or 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 RISPERDAL® CONSTA® or INVEGA® SUSTENNA® and have their WBC followed until recovery.
Potential for Cognitive and Motor Impairment: Somnolence was reported in multiple trials in subjects treated with RISPERDAL® CONSTA® or INVEGA® SUSTENNA®. Since RISPERDAL® CONSTA® and INVEGA® SUSTENNA® have the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that RISPERDAL® CONSTA® or INVEGA® SUSTENNA® does not adversely affect them.
Seizures: RISPERDAL® CONSTA® and INVEGA® SUSTENNA® should be used cautiously in patients with a history of seizures.
Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer’s dementia. Use cautiously in patients at risk for aspiration pneumonia.
Priapism has been reported. Severe priapism may require surgical intervention.
Thrombotic Thrombocytopenic Purpura (TTP) has been reported.
Administration: For intramuscular injection only. Care should be taken to avoid inadvertent injection into a blood vessel.
Suicide: The possibility of suicide attempt is inherent in schizophrenia or bipolar disorder. Close supervision of high-risk patients should accompany drug therapy.
With RISPERDAL® CONSTA®, increased sensitivity in patients with Parkinson’s disease or those with dementia with Lewy bodies has been reported. Manifestations and features are consistent with NMS.
Use RISPERDAL® CONSTA® with caution in patients with conditions and medical conditions that could affect metabolism or hemodynamic responses (e.g. recent myocardial infarction or unstable cardiac disease).
Commonly Observed Adverse Reactions: The most common adverse reactions in clinical trials for: RISPERDAL® CONSTA® - In patients with bipolar disorder were weight increase (5% in monotherapy trial) and tremor and Parkinsonism (≥10% in adjunctive therapy trial). In patients with schizophrenia (≥ 5%) were headache, Parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremities, and dry mouth.
INVEGA® SUSTENNA® - In patients with schizophrenia (≥5% and twice placebo) were injection site reactions, somnolence/sedation, dizziness, akathisia and extrapyramidal disorder.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see the full Prescribing Information for INVEGA® SUSTENNA®.
Please see the full Prescribing Information for RISPERDAL® CONSTA®.
# # #