Pharmacy & Therapeutics - October 2008 - (Page 585)

INVEGA —Powerful Efficacy With Safety and Tolerability Plus additional features to consider Metabolism and Excretion CE L ® E ATING 50 Y E BR S AR TM EN TA L H E • 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 Immediate Release Anti-Psychotic 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. 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® 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 adversely. 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: 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. 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. LT IN M A H

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Pharmacy & Therapeutics - October 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Medical Management of Parkinson’s Disease Why Is Health Care Regulation So Complex? The Next President’s Prescription for Action on Drugs Trends in Managing Multiple Sclerosis Product Profiler: Sancuso®

Pharmacy & Therapeutics - October 2008

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