INVEGA EXTENDED-RELEASE TABLET 6MG [SIN13381P]

Product Info

INVEGA EXTENDED-RELEASE TABLET 6MG

[SIN13381P]

Therapeutic indications

INVEGA® is indicated for the treatment of schizophrenia.

INVEGA® is indicated for the acute treatment of schizoaffective disorder as monotherapy and as an adjunct to antidepressants and/or mood stabilizers.

Posology and method of administration

INVEGA® is for oral administration. INVEGA® must be swallowed whole with the aid of liquids, 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.

Adults

Schizophrenia

The recommended dose of INVEGA® is 6 mg once daily, administered in the morning. The administration of INVEGA® should be standardized in relation to food intake (see section on Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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. Initial dose titration is not required. Some patients may benefit from lower or higher doses within the recommended range of 3 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.

Schizoaffective Disorder

The recommended dose of INVEGA® for the treatment of schizoaffective disorder 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 dose range of 3 to 12 mg once daily. A general trend for greater effects was seen with higher doses. This trend must be weighed against dose-related increase in adverse reactions. Dosage adjustment, if indicated, should occur only after clinical reassessment. Dose increases, if indicated, generally should occur at intervals of more than 4 days. When dose increases are indicated, increments of 3 mg/day are recommended. The maximum recommended dose is 12 mg/day.

Patients with hepatic impairment
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.

Patients with renal impairment
For patients with mild renal impairment (creatinine clearance ≥ 50 to < 80 ml/min), the recommended initial dose of INVEGA® is 3 mg once daily. The dose may be increased to 6mg 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 then 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.

Elderly
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 Patients with Renal Impairment above). INVEGA® should be used with caution in elderly patients with dementia with risk factors for stroke (see section on Special warnings and special precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatrics
Safety and effectiveness of INVEGA® in patients < 18 years of age have not been studied. There is no experience in children.

Other special populations
No dose adjustment for INVEGA® is recommended based on gender, race, or smoking status. (For pregnant women and breast-feeding mothers, see section on Pregnancy and lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.)

Switching to other antipsychotic medicinal products
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.

Contraindications

• Hypersensitivity to paliperidone or to any of the excipients.

• Hypersensitivity to risperidone since paliperidone is an active metabolite of risperidone.