Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
INVEGA is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older.
INVEGA is indicated for the treatment of schizoaffective disorder in adults.
The recommended dose of INVEGA for the treatment of schizophrenia in adults is 6 mg once daily, administered in the morning. Initial dose titration is not required. Some patients may benefit from lower or higher doses within the recommended range of 3 mg to 12 mg once daily. Dosage adjustment, if indicated, should occur only after clinical reassessment. When dose increases are indicated, increments of 3 mg/day are recommended and generally should occur at intervals of more than 5 days.
The recommended dose of INVEGA for the treatment of schizoaffective disorder in adults is 6 mg once daily, administered in the morning. Initial dose titration is not required. Some patients may benefit from higher doses within the recommended range of 6 mg to 12 mg once daily. Dosage adjustment, if indicated, should occur only after clinical reassessment. When dose increases are indicated, increments of 3 mg/day are recommended and generally should occur at intervals of more than 4 days.
There are no systematically collected data to specifically address switching patients from INVEGA to other antipsychotic medicinal products. Due to different pharmacodynamic and pharmacokinetic profiles among antipsychotic medicinal products, supervision by a clinician is needed when switching to another antipsychotic product is considered medically appropriate.
Dosing recommendations for elderly patients with normal renal function (≥80 mL/min) are the same as for adults with normal renal function. However, because elderly patients may have diminished renal function, dose adjustments may be required according to their renal function status (see Renal impairment below). INVEGA should be used with caution in elderly patients with dementia with risk factors for stroke (see section 4.4). Safety and efficacy of INVEGA in patients >65 years of age with schizoaffective disorder have not been studied.
No dose adjustment is required in patients with mild or moderate hepatic impairment. As INVEGA has not been studied in patients with severe hepatic impairment, caution is recommended in such patients.
For patients with mild renal impairment (creatinine clearance ≥50 to <80 mL/min), the recommended initial dose is 3 mg once daily. The dose may be increased to 6 mg once daily based on clinical response and tolerability.
For patients with moderate to severe renal impairment (creatinine clearance 10 to <50 mL/min), the recommended initial dose of INVEGA is 3 mg every other day, which may be increased to 3 mg once daily after clinical reassessment. As INVEGA has not been studied in patients with creatinine clearance below 10 mL/min, use is not recommended in such patients.
The recommended starting dose of INVEGA for the treatment of schizophrenia in adolescents 15 years and older is 3 mg once daily, administered in the morning.
Adolescents weighing <51 kg: the maximum recommended daily dose of INVEGA is 6 mg.
Adolescents weighing ≥51 kg: the maximum recommended daily dose of INVEGA is 12 mg.
Dosage adjustment, if indicated, should occur only after clinical reassessment based on the individual need of the patient. When dose increases are indicated, increments of 3 mg/day are recommended and generally should occur at intervals of 5 days or more. The safety and efficacy of INVEGA in the treatment of schizophrenia in adolescents between 12 and 14 years old has not been established. Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made. There is no relevant use of INVEGA in children aged less than 12 years.
The safety and efficacy of INVEGA in the treatment of schizoaffective disorder in patients aged 12 to 17 years has not been studied or established. There is no relevant use of INVEGA in children aged less than 12 years.
No dose adjustment for INVEGA is recommended based on gender, race, or smoking status.
INVEGA is for oral administration. It must be swallowed whole with liquid, and must not be chewed, divided, or crushed. The active substance is contained within a non-absorbable shell designed to release the active substance at a controlled rate. The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.
The administration of INVEGA should be standardised in relation to food intake (see section 5.2). The patient should be instructed to always take INVEGA in the fasting state or always take it together with breakfast and not to alternate between administration in the fasting state or in the fed state.
In general, expected signs and symptoms are those resulting from an exaggeration of paliperidone’s known pharmacological effects, i.e. drowsiness and sedation, tachycardia and hypotension, QT prolongation, and extrapyramidal symptoms. Torsade de pointes and ventricular fibrillation have been reported in association with overdose. In the case of acute overdosage, the possibility of multiple medicinal product involvement should be considered.
Consideration should be given to the prolonged-release nature of the product when assessing treatment needs and recovery. There is no specific antidote to paliperidone. General supportive measures should be employed. Establish and maintain a clear airway and ensure adequate oxygenation and ventilation. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring for possible arrhythmias. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluid and/or sympathomimetic agents. Administration of activated charcoal together with a laxative should be considered. In case of severe extrapyramidal symptoms, anticholinergic agents should be administered. Close supervision and monitoring should continue until the patient recovers.
2 years.
Bottles: Do not store above 30°C. Keep the bottle tightly closed in order to protect from moisture.
Blisters: Do not store above 30°C. Store in the original package in order to protect from moisture.
Bottles: White high-density polyethylene (HDPE) bottle with induction sealing and polypropylene child-resistant closure. Each bottle contains two 1 g dessicant silica gel (silicone dioxide) pouches (pouch is food approved polyethylene).
Pack sizes of 30 and 350 prolonged-release tablets.
Blisters:
Polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/aluminium push-through layer.
Pack sizes of 14, 28, 30, 49, 56, and 98 prolonged-release tablets.
Or
White polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/aluminium push-through layer.
Pack sizes of 14, 28, 30, 49, 56, and 98 prolonged-release tablets.
Or
Oriented polyamide (OPA)-aluminium-polyvinyl chloride (PVC)/aluminium push-through child-resistant blister.
Pack sizes of 14, 28, 49, 56, and 98 prolonged-release tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
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