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About INVEGA® (paliperidone)
Extended-Release Tablets
Extended-Release Tablets
There's another treatment option for your patients with uncontrolled symptoms of schizophrenia.
INVEGA an Oral Atypical Antipsychotic
INVEGA combines:
- The active metabolite of RISPERDAL® (risperidone)
- Innovative OROS® extended-release technology
INVEGA demonstrated:
- Significant efficacy in the positive and negative symptoms of schizophrenia*
- Low weight gain and EPS rates comparable with placebo at the recommended 6-mg dose
- Total EPS-related adverse events at the 9-mg and 12-mg doses were 25% and 26%, respectively (versus 11% for placebo)
- The proportion of subjects having a weight gain of >7 body weight were comparable with placebo (5%) for 3 mg (7%) and 6 mg (6%). a higher incidence was seen for 9 mg (9%) and 12 mg (9%)
Extensively studied in:
- 1665 patients with moderate to severe schizophrenia
INVEGA—easy convenient dosing:
- Less than 10% of the dose is metabolized by any of the 4 identified metabolic pathways
- Not expected to cause clinically important interactions with drugs metabolized by the CYP450 pathway
- No dose adjustments for patients with mild to moderate hepatic impairment
The short-term efficacy of INVEGA (3 to 15 mg once daily) was established in three placebo-controlled and active-controlled (olanzapine), 6-week, fixed-dose trials in non-elderly adult subjects (mean age of 37) who met DSM-IV criteria for schizophrenia:
- INVEGA delivered a full range of symptom control as evidenced by the PANSS scale
- INVEGA offered an incidence of weight gain similar to that for placebo at the recommended 6 mg dose
- INVEGA delivered discontinuation rates due to adverse events that are similar to those for placebo across all doses
Please see Product Details.
Please see the full US Prescribing Information.
For additional medical or clinical information, please call our Customer Communications Center
at 1-800-JANSSEN (1-800-526-7736), 9 AM - 5 PM (ET), Monday through Friday.
INVEGA® (paliperidone) extended-release tablets are indicated for the acute and maintenance treatment of schizophrenia.
RISPERDAL® (risperidone) is indicated for the treatment of schizophrenia in adults and children aged 13-17 years.
IMPORTANT SAFETY INFORMATION FOR INVEGA® AND RISPERDAL ®
Increased Mortality in Elderly Patients with Dementia-Related
Psychosis
Elderly patients with dementia-related psychosis treated with atypical 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. INVEGA® (paliperidone) and RISPERDAL® (risperidone) are not approved for the treatment of patients with dementia-related psychosis.
Elderly patients with dementia-related psychosis treated with atypical 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. INVEGA® (paliperidone) and RISPERDAL® (risperidone) are not approved for the treatment of patients with dementia-related psychosis.
Cerebrovascular Adverse Events (CAEs): CAEs, including fatalities, have been reported in elderly patients with dementia-related psychosis taking atypical antipsychotics in clinical trials. INVEGA® and RISPERDAL® are not approved for treating these patients.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with the use of antipsychotic medications, including INVEGA® and RISPERDAL®. 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 medical monitoring, and treatment of any concomitant serious medical problems.
QT Prolongation: INVEGA® causes a modest increase in the corrected QT (QTc) interval. INVEGA® should be avoided in combination with other drugs that are known to prolong the QTc interval, in patients with congenital long QT syndrome or a history of cardiac arrhythmias. Certain circumstances may increase the risk 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. Elderly patients appeared to be at increased risk for TD. Prescribing should be consistent with the need to minimize the risk of TD. 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). 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.
Hyperprolactinemia: As with other drugs that antagonize dopamine
Potential for Gastrointestinal Obstruction: INVEGA® should ordinarily not be administered to patients with pre-existing severe gastrointestinal narrowing. Rare instances of obstructive symptoms have been reported in patients with known strictures taking nondeformable formulations. INVEGA® should only be used in patients who are able to swallow the tablet whole.
Orthostatic Hypotension and Syncope: INVEGA® and RISPERDAL® may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period. Monitoring should be considered in patients for whom this may be of concern. INVEGA® and RISPERDAL® should be used with caution in patients with known cardiovascular disease, and conditions that would predispose patients to hypotension.
Potential for Cognitive and Motor Impairment: INVEGA® and RISPERDAL® 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 INVEGA® and RISPERDAL® do not affect them adversely.
Seizures: INVEGA® and RISPERDAL® should be used cautiously in patients with a history of seizures.
Suicide: The possibility of suicide attempt is inherent in psychotic illnesses and close supervision of high-risk patients should accompany drug therapy.
Maintenance Treatment: Physicians who elect to use INVEGA® and RISPERDAL® for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.
Drug Interactions: Co-administration of INVEGA® 6 mg once daily with carbamazepine 200 mg twice daily caused a decrease of approximately 37% in the mean steady-state Cmax and AUC of paliperidone. On initiation of discontinuation of carbamazepine, the dose of INVEGA® should be re-evaluated and adjusted if necessary. Given the primary CNS effects of INVEGA®, INVEGA® should be used with caution in combination with other centrally acting drugs and the use of alcohol should be avoided.
Extrapyramidal Symptoms (EPS): Total EPS-related adverse events with INVEGA® in the higher 9-mg and 12-mg treatment groups were 25% and 26%, respectively, versus 11% for the placebo group.
Weight Gain: The proportion of subjects having a weight gain of >7% body weight with INVEGA® were comparable to placebo (5%) for 3 mg (7%) and 6 mg (6%). A higher incidence was seen for 9 mg (9%) and 12 mg (9%).
Renal Impairment: Dosing must be individualized according to the patient's renal function status. The maximum recommended dose of INVEGA® is 6 mg for patients with mild renal impairment and 3 mg for patients with moderate to severe renal impairment (see Dosing for Special Populations).
Elderly: No dosage adjustment is recommended based on age alone. However, dose adjustment may be required because of age-related decreases in creatinine clearance (see Dosing for Special Populations).
Commonly observed adverse reactions for INVEGA®: The most commonly observed adverse reactions, occurring at an incidence of >5% and at least 2 times placebo, were akathisia and extrapyramidal disorder.
Commonly observed adverse reactions for RISPERDAL®: The most common adverse reactions from all clinical trials (>10%) were: somnolence, appetite increased, fatigue, rhinitis, upper respiratory tract infection, vomiting, coughing, urinary incontinence, saliva increased, constipation, fever, Parkinsonism, dystonia, abdominal pain, anxiety, nausea, dizziness, dry mouth, tremor, rash, akathisia, and dyspepsia.
Use with Risperidone: Concomitant use of paliperidone with risperidone has not been studied. Since paliperidone is the major active metabolite of risperidone, consideration should be given to the additive paliperidone exposure if risperidone is co-administered.
01JN777R1
Please see the full US Prescribing Information for INVEGA and RISPERDAL.
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This page was last modified on: Jan 10 2008 at 16:39:58 EST