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

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 The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.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 D 2 receptors, INVEGA and RISPERDAL elevate prolactin levels and the elevation persists during chronic administration.

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: 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 or RISPERDAL for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.

Drug Interactions: Given the primary CNS effects of INVEGA, INVEGA should be used with caution in combination with other centrally acting drugs and alcohol.

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.

01JN641R1

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 16:40:11 EST