Pharmacy & Therapeutics - March 2008 - (Page 153) INVEGA—Powerful Efficacy With Safety and Tolerability Plus additional features to consider Metabolism and Excretion • CYP450 isozymes play a limited role in the overall metabolism of INVEGA — Less than 10% of the dose is metabolized by each of the 4 identified metabolic pathways* • Primarily excreted unchanged via the kidneys — 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 *Dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission. Innovative Drug Delivery System • Innovative OROS® extended-release technology for reduced peak/ trough fluctuations†1 PLASMA LEVEL VARIATION AT STEADY STATE Oral risperidone (Immediate Release) INVEGA (Extended Release) Plasma concentration INVEGA peak INVEGA trough † Correlation to clinical effect has not been established. Days Pharmacokinetic simulation. OROS is a registered trademark of ALZA Corporation. 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. 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. 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. 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. Orthostatic Hypotension: 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. 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). 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. Reference: 1. Conley R, Gupta SK, Sathyan G. Clinical spectrum of the osmotic-controlled release oral delivery system (OROS), an advanced oral delivery form. Curr Med Res Opin. 2006;22(10):1879-1892. Please see brief summary of full Prescribing Information for INVEGA on adjacent page.
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