Risperdal Consta® (paliperidone palmitate) Patient Support
Helping you help your patients get started with the RISPERDAL CONSTA® treatment you prescribed and supporting them along the way
Once you've determined that RISPERDAL CONSTA® is right for your patients, we're committed to helping them get started on treatment and stay on track. Click here for the Janssen CarePath Resource Guide.
You can select the following treatment support resources for your patient on the Patient Enrollment Form (PEF).
Download the PEF here.
For tips on completing the PEF, click here.
Care Transition Support
Janssen CarePath can help coordinate care as the patient transitions from one healthcare setting to the next. If requested, after verifying insurance coverage, Janssen CarePath can notify the outpatient facility of the patient's discharge, medication and next injection due date. Janssen CarePath can then confirm the outpatient facility's ability to administer the injection by the needed date. If the outpatient facility is unable to provide the injection on the scheduled date, Janssen CarePath will locate an alternate site of care, if requested by the inpatient healthcare provider.
Alternate Site of Care Options for Injection
Janssen CarePath supports patients who need an injection appointment at an alternate site of care if the next healthcare setting cannot provide the patient's injection by the needed date. If requested, we can schedule an injection appointment with an alternate site of care in the JANSSEN CONNECT® Network (if available in the patient's geographic area).
Injection Site Locator
To find a JANSSEN CONNECT® Network Injection Location, visit JanssenConnectLocator.com.
Or call Janssen CarePath at 877-524-3579, Monday-Friday, 8:00 AM to 8:00 PM ET.
Injection Appointment Reminder Alerts
Janssen CarePath offers reminder alerts that may help patients overcome the challenge of keeping up with their injection appointments. The patient will be contacted the day before the injection appointment at the prescribing healthcare provider's office. You can request reminder alert phone calls for your patient, or the patient can elect on the Patient Enrollment Form to receive these via text messages.
If you have any questions, please call Janssen CarePath at 877-524-3579, Monday-Friday, 8:00 AM to 8:00 PM ET.
RISPERDAL CONSTA® (risperidone) long-acting injection is indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder and for the treatment of schizophrenia.
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. RISPERDAL CONSTA® is not approved for use in patients with dementia-related psychosis.
Contraindications: RISPERDAL CONSTA® is contraindicated in patients with a known hypersensitivity to risperidone, paliperidone, or to any excipients in RISPERDAL CONSTA®.
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. RISPERDAL CONSTA® 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. 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.
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 appear 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, some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, have 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 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. Monitor glucose regularly in patients with diabetes or at risk for diabetes. 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.
Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.
Orthostatic Hypotension and Syncope: RISPERDAL CONSTA® may induce orthostatic hypotension in some patients due to its alpha-adrenergic blocking activity. RISPERDAL CONSTA® 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.
Falls: Somnolence, postural hypotension, motor and sensory instability have been reported with the use of antipsychotics, including RISPERDAL CONSTA®, which may lead to falls and, consequently, fractures or other fall-related injuries. For patients, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects, assess the risk of falls when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.
Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including RISPERDAL CONSTA®. 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® 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® 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®. Since RISPERDAL CONSTA® has 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® does not adversely affect them.
Seizures: RISPERDAL CONSTA® 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.
Body Temperature Regulation: Disruption of body temperature regulation has been attributed to antipsychotic agents. Both hyperthermia and hypothermia have been reported in association with RISPERDAL CONSTA® use.
Thrombotic Thrombocytopenic Purpura (TTP) has been reported.
Administration: For intramuscular injection only. Care should be taken to avoid inadvertent injection into a blood vessel.
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).
Pregnancy/Nursing: RISPERDAL CONSTA® may cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare professional if they become pregnant or intend to become pregnant during treatment with RISPERDAL CONSTA®. Patients should be advised that there is a pregnancy registry that monitors outcomes in women exposed to RISPERDAL CONSTA® during pregnancy. RISPERDAL CONSTA® can pass into human breast milk. The benefits of breastfeeding should be considered along with the mother’s clinical need for RISPERDAL CONSTA® and any potential adverse effect on the breastfed infant from RISPERDAL CONSTA® or the mother’s underlying condition.
Fertility: RISPERDAL CONSTA® may cause a reversible reduction in fertility in females.
Commonly Observed Adverse Reactions for RISPERDAL CONSTA®: The most common adverse reactions in clinical trials in patients with schizophrenia (≥5%) were headache, Parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremities, and dry mouth. The most common adverse reactions in clinical trials in patients with bipolar disorder were weight increased (5% in monotherapy trial) and tremor and Parkinsonism (≥10% in adjunctive therapy trial).
Please read the full Prescribing Information, including Boxed WARNING, for RISPERDAL CONSTA®.