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Manufactured for: Janssen Pharmaceuticals, Inc. The following are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see BOXED WARNING and WARNINGS AND PRECAUTIONS ] Cerebrovascular adverse reactions, including stroke, in elderly patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS ] Neurolepticmalignant syndrome [see WARNINGS AND PRECAUTIONS ] QT prolongation [see WARNINGS AND PRECAUTIONS ] Tardive dyskinesia [see WARNINGS AND PRECAUTIONS ] Metabolic changes [see WARNINGS AND PRECAUTIONS ] Orthostatic hypotension and syncope [see WARNINGS AND PRECAUTIONS ] Falls [see WARNINGS AND PRECAUTIONS ] Leukopenia, neutropenia, and agranulocytosis [see WARNINGS AND PRECAUTIONS ] Hyperprolactinemia [See WARNINGS AND PRECAUTIONS ] Potential for cognitive and motor impairment [see WARNINGS AND PRECAUTIONS ] Seizures [see WARNINGS AND PRECAUTIONS ] Dysphagia [see WARNINGS AND PRECAUTIONS ] Priapism [see WARNINGS AND PRECAUTIONS ] Disruption of body temperature regulation [see WARNINGS AND PRECAUTIONS ] The most common (at least 5% in any INVEGA SUSTENNA’ group) and likely drug-related (adverse events for which the drug rate is at least twice the placebo rate) adverse reactions from the double-blind, placebo-controlled trials in subjects with schizophrenia were injection site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder. No occurrences of adverse events reached this threshold in the long-term double-blind, placebo-controlled study in subjects with schizoaffective disorder. The data described in this section are derived from a clinical trial database consisting of a total of 3817 subjects (approximately 1705 patient-years exposure) with schizophrenia who received at least one dose of INVEGA SUSTENNA’ in the recommended dose range of 39 mg to 234 mg and a total of 510 subjects with schizophrenia who received placebo. Among the 3817 INVEGA SUSTENNA’-treated subjects, 1293 received INVEGA SUSTENNA’ in four fixed-dose, double-blind, placebo-controlled trials (one 9-week and three 13-week studies), 849 received INVEGA SUSTENNA’ in the maintenance trial (median exposure 229 days during the initial 33-week open-label phase of this study, of whom 205 continued to receive INVEGA SUSTENNA’ during the double-blind placebo-controlled phase of this study [median exposure 171 days]), and 1675 received INVEGA SUSTENNA’ in five non-placebo controlled trials (three noninferiority active-comparator trials, one long-term open-label pharmacokinetic and safety study, and an injection site [deltoid-gluteal] cross-over trial). One of the 13-week studies included a 234 mg INVEGA SUSTENNA’ initiation dose followed by treatment with either 39 mg, 156 mg, or 234 mg every 4 weeks. The safety of INVEGA SUSTENNA’ was also evaluated in a long-term study in adult subjects with schizoaffective disorder. A total of 667 subjects received INVEGA SUSTENNA’ during the initial 25-week open-label period of this study (median exposure 147 days); 164 subjects continued to receive INVEGA SUSTENNA’ during the 15-month double-blind placebo-controlled period of this study (median exposure 446 days). Adverse reactions that occurred more frequently in the INVEGA SUSTENNA’ than the placebo group (a 2% difference or more between groups) were weight increased, nasopharyngitis, headache, hyperprolactinemia, and pyrexia. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Commonly Reported Adverse Reactions In Double-Blind, Placebo-Controlled Clinical Trials. Table 10 lists the adverse reactions reported in 2% or more of INVEGA SUSTENNA’-treated subjects and at a greater proportion than in the placebo group with schizophrenia in the four fixed-dose, double-blind, placebo-controlled trials. Table 10: Incidence of Adverse Reactions in ? 2% of INVEGA SUSTENNA’-Treated Subjects (and greater than Placebo) with Schizophrenia in Four Fixed-Dose, Double-Blind, Placebo-Controlled Trials System Organ Class Adverse Event Placebo a (N=510) INVEGA SUSTENNA’ 39 mg (N=130) 78 mg (N=302) 156 mg (N=312) 234/39 mg b (N=160) 234/156 mg b (N=165) 234/234 mg b (N=163) Total percentage of subjects with adverse event 70 75 68 69 63 60 63 Gastrointestinal disorders Abdominal discomfort/abdominal pain upper 2 2 4 4 1 2 4 Diarrhea 2 0 3 2 1 2 2 Dry mouth 1 3 1 0 1 1 1 Nausea 3 4 4 3 2 2 2 Toothache 1 1 1 3 1 2 3 Vomiting 4 5 4 2 3 2 2 General disorders and administration site conditions Asthenia 0 2 1 a Placebo group is pooled from all studies and included either deltoid or gluteal injection depending on study design. Other dose groups (39 mg, 78 mg, and 156 mg) are from studies involving only gluteal injection. The following terms were combined: somnolence/sedation, breast tenderness/breast pain, abdominal discomfort/abdominal pain upper/stomach discomfort, and tachycardia/sinus tachycardia/heart rate increased. All injection site reaction-related adverse events were collapsed and are grouped under ‘Injection site reactions’, buy cabgolin 0.25 mg antiestrogens cabaser. Other Adverse Reactions Observed During The Clinical Trial Evaluation Of INVEGA SUSTENNA’ The following list does not include reactions: 1) already listed in previous tables or elsewhere in labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, or 4) which were not considered to have significant clinical implications.

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