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Product Details:
- Powerful Efficacy for the Minds of Your Patients
- Delivered a Full Range of Symptom Control
- The Only Oral Atypical That Delivers Smooth Plasma Levels Over 24 Hours
- Safety and Tolerability That Considers the Body
- A Powerful Therapy Patients Can Stay With
- Patients experienced significant improvements in PANSS total scores
at endpoint with INVEGA 6 mg versus placebo (P<0.001)*
Data on file. Results from a 6-week, double-blind, placebo-controlled study (Kane study—trial 303) involving 628 patients with acute schizophrenia. Patients received once-daily INVEGA (6 mg, 9 mg, or 12 mg) or placebo.
In all 3 pivotal studies, INVEGA demonstrated significantimprovements in PANSS total scores at all doses (3 mg,6 mg, 9 mg, 12 mg) versus placebo (P<0.001).
Please see full Prescribing Information for INVEGA and RISPERDAL.
*Due to the properties of the molecule and the extended-release delivery technology of INVEGA, the milligram dosing for INVEGA is independent of dosing for RISPERDAL
- All PANSS factors were significantly improved with
INVEGA 6 mg versus placebo at endpoint (P<0.05)
Data on file.Results from a 6-week, double-blind, placebo-controlled study (Kane study—trial 303) involving 628 patients with acute schizophrenia. Patients received once-daily INVEGA (6 mg, 9 mg, or 12 mg) or placebo. All P values versus placebo.
The study was not powered to draw conclusions of efficacy for individual factors of the PANSS.
- In a separate trial, the following PANSS subscales did not reach statistical significance: anxiety/depression (6- and 12-mg doses) and disorganized thoughts (6-mg dose)
- In all other trials, all doses of INVEGA (3 mg, 6 mg, 9 mg, 12 mg) demonstrated significant improvements on all PANSS Factors versus placebo
Please see full Prescribing Information for INVEGA.
- The Personal and Social Performance (PSP) scale is a reliable clinical measurement of function in the following critical areas: socially useful activities including work and study, personal and social relationships, self-care, and disturbing and aggressive behavior
- INVEGA was superior to placebo in improvement of PSP scores in all pivotal trials†
Please see full Prescribing Information for INVEGA.
Data on file. Results from a 6-week, double-blind, placebo-controlled study (Kane study—trial 303). Efficacy was evaluated by measuring the degree of difficulty patients exhibited from baseline to endpoint in 4 domains of personal and social performance. Each domain was assessed on a 6-category severity scale ranging from "absent" to "very severe."
†In one study, the 12-mg dose did not reach statistical significance versus placebo.
- OROS technology uses osmotic pressure to release the drug at a controlled rate for consistent plasma levels over 24 hours
*Correlation to clinical effect has not been established.
†Based on pharmacokinetic data from individual studiesat steady state.
Please see full Prescribing Information for INVEGA and RISPERDAL.
Pooled results from three 6-week pivotal trials.
*Not otherwise specified.
§Dyskinesia group includes: dyskinesia, muscle twitching, tardive dyskinesia.
Extrapyramidal symptoms (EPS)
- INVEGA 3-mg and 6-mg doses were comparable with placebo across all EPS scales and rates of adverse events
- Total EPS-related adverse events in the higher 9-mg and 12-mg treatment groups were 25% and 26%, respectively, versus 11% for the placebo group
Prolactin
- The prolactin-elevating effect with INVEGA is similar to that with RISPERDAL® (risperidone)
Please see full Prescribing Information for INVEGA and RISPERDAL.
Data on file. Pooled results from three 6-week pivotal trials. The proportion of patients gaining ≤7% of body weight with INVEGA 3 mg, 9 mg, and 12 mg was 7%, 9%, and 9%, respectively.
Data on file. Pooled results from three 6-week pivotal trials.
No difference between INVEGA (3 mg, 6 mg, 9 mg, 12 mg) and
placebo in the number of patients experiencing changes in lipids or fasting glucose.
No difference between INVEGA (3 mg, 6 mg, 9 mg, 12 mg) and
placebo in the number of patients experiencing changes in lipids or fasting glucose.
*Laboratory Test Abnormalities. INVEGA Prescribing Information.
†Please see Hyperglycemia and Diabetes warning below.
Please see full Prescribing Information for INVEGA.
Data on file. Pooled results from three 6-week pivotal trials.
Please see full Prescribing Information for INVEGA.
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.
IMPORTANT SAFETY INFORMATION FOR INVEGA®
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) is 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) is 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® is 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®. 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 D2 receptors, INVEGA® elevates prolactin levels and the elevation persists during chronic administration.
Potential for Gastrointestinal 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® 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® 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® 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 INVEGA® does not affect them adversel
Seizures: INVEGA® 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® 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 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 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: The most commonly observed adverse reactions, occurring at an incidence of >5% and at least 2 times placebo, were akathisia and extrapyramidal disorder.
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.
01JN776R1
Please see the full US Prescribing Information.
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This page was last modified on: Jan 16 2008 at 10:32:41 EST