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Table 8: Change in Fasting Lipids from an Open-Label and Double-Blind Periods of a Long-Term Study in Subjects with Schizoaffective Disorder Open-Label Period INVEGA SUSTENNA’ DoubleBlind Period Placebo INVEGA SUSTENNA’ Mean change from baseline (mg/dL) Cholesterol n=198 n=119 n=132 Change from baseline -3. Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended. Data on mean changes in body weight and the proportion of subjects meeting a weight gain criterion of ? 7% of body weight from the four placebo-controlled (one 9-week and three 13-week), fixed-dose studies in subjects with schizophrenia are presented in Table 9. Table 9: Mean Change in Body Weight (kg) and the Proportion of Subjects with ? 7% Gain in Body Weight from Four Placebo-Controlled, 9-to 13-Week, Fixed-Dose Studies in Subjects with Schizophrenia Placebo INVEGA SUSTENNA’ 39 mg 78 mg 156 mg 234/39 mg a 234/156 mg a 234/234 mg a Weight (kg) n=451 n=116 n=280 n=267 n=137 n=144 n=145 Change from baseline Weight Gain -0. Other dose groups (39 mg, 78 mg, and 156 mg) are from studies involving only gluteal injection. In a long-term open-label pharmacokinetic and safety study in which the highest dose available (234 mg) was evaluated, INVEGA SUSTENNA’ was associated with a mean change in weight of +2. During the initial 25-week open-label period of a long-term study in subjects with schizoaffective disorder, INVEGA SUSTENNA’ was associated with a mean change in weight of +2. At the endpoint of the subsequent 15-month double-blind period of the study, INVEGA SUSTENNA’ was associated with a mean change in weight of -0. Orthostatic Hypotension And Syncope. Paliperidone can induce orthostatic hypotension and syncope in some patients because of its alpha-blocking activity. Syncope was reported in. No cases of overdose were reported in premarketing studies with INVEGA SUSTENNA’. Because INVEGA SUSTENNA’ is to be administered by health care professionals, the potential for overdosage by patients is low. While experience with paliperidone overdose is limited, among the few cases of overdose reported in premarketing trials with oral paliperidone, the highest estimated ingestion was 405 mg. Observed signs and symptoms included extrapyramidal symptoms and gait unsteadiness. Other potential signs and symptoms include those resulting from an exaggeration of paliperidone’s known pharmacological effects, i. Torsades de pointes and ventricular fibrillation have been reported in a patient in the setting of overdose with oral paliperidone. 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