TREVICTA 175 mg prolonged release suspension for injection
TREVICTA 263 mg prolonged release suspension for injection
TREVICTA 350 mg prolonged release suspension for injection
TREVICTA 525 mg prolonged release suspension for injection
175 mg prolonged release suspension for injection
Each pre-filled syringe contains 273 mg paliperidone palmitate equivalent to 175 mg paliperidone.
263 mg prolonged release suspension for injection
Each pre-filled syringe contains 410 mg paliperidone palmitate equivalent to 263 mg paliperidone.
350 mg prolonged release suspension for injection
Each pre-filled syringe contains 546 mg paliperidone palmitate equivalent to 350 mg paliperidone.
525 mg prolonged release suspension for injection
Each pre-filled syringe contains 819 mg paliperidone palmitate equivalent to 525 mg paliperidone.
For the full list of excipients, see section 6.1.
Prolonged release suspension for injection.
The suspension is white to off-white. The suspension is pH neutral (approximately 7.0).
TREVICTA, a 3-monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1-monthly paliperidone palmitate injectable product (see section 5.1).
Posology
Patients who are adequately treated with 1-monthly paliperidone palmitate injectable (preferably for four months or more) and do not require dose adjustment may be switched to TREVICTA.
TREVICTA should be initiated in place of the next scheduled dose of 1-monthly paliperidone palmitate injectable (± 7 days). The TREVICTA dose should be based on the previous 1-monthly paliperidone palmitate injectable dose using a 3.5-fold higher dose shown in the following table:
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TREVICTA doses for patients adequately treated with 1-monthly paliperidone palmitate injectable
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If the last dose of 1-monthly paliperidone palmitate injectable is
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Initiate TREVICTA at the following dose
|
|
50 mg
|
175 mg
|
|
75 mg
|
263 mg
|
|
100 mg
|
350 mg
|
|
150 mg
|
525 mg
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There is no equivalent dose of TREVICTA for the 25 mg dose of 1-monthly paliperidone palmitate injectable which was not studied.
Following the initial TREVICTA dose, TREVICTA should be administered by intramuscular injection once every 3 months (± 2 weeks, see also Missed dose section).
If needed, dose adjustment of TREVICTA can be made every 3 months in increments within the range of 175 mg to 525 mg based on individual patient tolerability and/or efficacy. Due to the long-acting nature of TREVICTA, the patient's response to an adjusted dose may not be apparent for several months (see section 5.2). If the patient remains symptomatic, they should be managed according to clinical practice.
Switching from other antipsychotic medicinal products
TREVICTA is to be used only after the patient has been adequately treated with 1-monthly paliperidone palmitate injectable preferably for four months or more.
Switching from TREVICTA to other antipsychotic medicinal products
If TREVICTA is discontinued, its prolonged release characteristics must be considered.
Switching from TREVICTA to 1-monthly paliperidone palmitate injectable
For switching from TREVICTA to 1-monthly paliperidone palmitate injectable, 1-monthly paliperidone palmitate injectable should be administered at the time the next TREVICTA dose was to be administered using a 3.5-fold lower dose shown in the following table. The initiation dosing as described in the prescribing information for 1-monthly paliperidone palmitate injectable is not required. The 1-monthly paliperidone palmitate injectable should then continue to be dosed at monthly intervals as described within its prescribing information.
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Doses of 1-monthly paliperidone palmitate injectable for patients switching from TREVICTA
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If the last dose of TREVICTA is
|
Initiate 1-monthly paliperidone palmitate injectable 3 months later at the following dose
|
|
175 mg
|
50 mg
|
|
263 mg
|
75 mg
|
|
350 mg
|
100 mg
|
|
525 mg
|
150 mg
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Switching from TREVICTA to oral daily paliperidone prolonged release tablets
For switching from TREVICTA to paliperidone prolonged release tablets, the daily dosing of paliperidone prolonged release tablets should be started 3 months after the last TREVICTA dose and treatment continued with paliperidone prolonged release tablets as described in the table below. The following table provides recommended dose conversion regimens to allow patients previously stabilised on different doses of TREVICTA to attain similar paliperidone exposure with paliperidone prolonged release tablets.
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Doses of paliperidone prolonged release tablets for patients switching from TREVICTA*
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Last TREVICTA dose (Week 0)
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Week number after last TREVICTA dose
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Week 12 to Week 18, inclusive
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Week 19 to Week 24, inclusive
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From Week 25 onwards
|
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Daily dose of paliperidone prolonged release tablets
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175 mg
|
3 mg
|
3 mg
|
3 mg
|
|
263 mg
|
3 mg
|
3 mg
|
6 mg
|
|
350 mg |
