Invega Trinza善妥達

Invega Trinza Dosage/Direction for Use

paliperidone

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Full Prescribing Info
Dosage/Direction for Use
Administration Instructions: INVEGA TRINZA should be administered once every 3 months.
Each injection must be administered only by a health care professional.
Parenteral drug products should be inspected visually for foreign matter and discoloration prior to administration. It is important to shake the syringe vigorously for at least 15 seconds to ensure a homogeneous suspension. Inject INVEGA TRINZA within 5 minutes of shaking vigorously (see Instructions for Use under Cautions for Usage).
INVEGA TRINZA is intended for intramuscular use only. Do not administer by any other route. Avoid inadvertent injection into a blood vessel. Administer the dose in a single injection; do not administer the dose in divided injections. Inject slowly, deep into the deltoid or gluteal muscle.
INVEGA TRINZA must be administered using only the thin wall needles that are provided in the INVEGA TRINZA pack. Do not use needles from the 1-month paliperidone palmitate extended-release injectable suspension pack or other commercially-available needles to reduce the risk of blockage.
Deltoid Injection: The recommended needle size for administration of INVEGA TRINZA into the deltoid muscle is determined by the patient's weight: For patients weighing less than 90 kg, the 1-inch, 22 gauge thin wall needle is recommended.
For patients weighing 90 kg or more, the 1½-inch, 22 gauge thin wall needle is recommended.
Administer into the center of the deltoid muscle. Deltoid injections should be alternated between the two deltoid muscles.
Gluteal Injection: Regardless of patient weight, the recommended needle size for administration of INVEGA TRINZA into the gluteal muscle is the 1½-inch, 22 gauge thin wall needle. Administer into the upper-outer quadrant of the gluteal muscle. Gluteal injections should be alternated between the two gluteal muscles.
Incomplete Administration: To avoid an incomplete administration of INVEGA TRINZA, ensure that the prefilled syringe is shaken vigorously for at least 15 seconds within 5 minutes prior to administration to ensure a homogeneous suspension and ensure the needle does not get clogged during injection (see Instructions for Use under Cautions for Usage).
However, in the event of an incompletely administered dose, do not re-inject the dose remaining in the syringe and do not administer another dose of INVEGA TRINZA. Closely monitor and treat the patient with oral supplementation as clinically appropriate until the next scheduled 3-month injection of INVEGA TRINZA.
Schizophrenia: Adults: INVEGA TRINZA is to be used only after INVEGA SUSTENNA (1-month paliperidone palmitate extended-release injectable suspension) has been established as adequate treatment for at least four months. In order to establish a consistent maintenance dose, it is recommended that the last two doses of INVEGA SUSTENNA be the same dosage strength before starting INVEGA TRINZA.
Initiate INVEGA TRINZA when the next 1-month paliperidone palmitate dose is scheduled with an INVEGA TRINZA dose based on the previous 1-month injection dose, using the equivalent 3.5-fold higher dose as shown in Table 1. INVEGA TRINZA may be administered up to 7 days before or after the monthly time point of the next scheduled paliperidone palmitate 1-month dose. (See Table 1.)

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Following the initial INVEGA TRINZA dose, INVEGA TRINZA should be administered every 3 months. If needed, dose adjustment 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 INVEGA TRINZA, the patient's response to an adjusted dose may not be apparent for several months (see Pharmacology: Pharmacokinetics under Actions).
Missed Doses: Dosing Window: Missing doses of INVEGA TRINZA should be avoided. If necessary, patients may be given the injection up to 2 weeks before or after the 3-month time point.
Missed Dose 3½ Months to 4 Months Since Last Injection: If more than 3½ months (up to but less than 4 months) have elapsed since the last injection of INVEGA TRINZA, the previously administered INVEGA TRINZA dose should be administered as soon as possible, then continue with the 3-month injections following this dose.
Missed Dose 4 Months to 9 Months Since Last Injection: If 4 months up to and including 9 months have elapsed since the last injection of INVEGA TRINZA, do NOT administer the next dose of INVEGA TRINZA. Instead, use the re-initiation regimen shown in Table 2. (See Table 2.)

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Missed Dose Longer than 9 Months Since Last Injection: If more than 9 months have elapsed since the last injection of INVEGA TRINZA, re-initiate treatment with the 1-month paliperidone palmitate extended-release injectable suspension as described in the prescribing information for that product. INVEGA TRINZA can then be resumed after the patient has been adequately treated with the 1-month paliperidone palmitate extended-release injectable suspension for at least 4 months.
Use with Risperidone or with Oral Paliperidone: Since paliperidone is the major active metabolite of risperidone, caution should be exercised when INVEGA TRINZA is coadministered with risperidone or oral paliperidone for extended periods of time. Safety data involving concomitant use of INVEGA TRINZA with other antipsychotics is limited.
Dosage Adjustment in Renal Impairment: INVEGA TRINZA has not been systematically studied in patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions). For patients with mild renal impairment (creatinine clearance ≥ 50 mL/min to < 80 mL/min [Cockcroft-Gault Formula], adjust dosage and stabilize the patient using the 1-month paliperidone palmitate extended-release injectable suspension, then transition to INVEGA TRINZA (see Table 1 as previously shown). (See also Use in Specific Populations: Renal Impairment under Precautions and Pharmacology: Pharmacokinetics under Actions.)
INVEGA TRINZA is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min) (see Use in Specific Populations: Renal Impairment under Precautions and Pharmacology: Pharmacokinetics under Actions).
Switching from INVEGA TRINZA to the 1-Month Paliperidone Palmitate Extended-Release Injectable Suspension: For switching from INVEGA TRINZA to INVEGA SUSTENNA (1-month paliperidone palmitate extended-release injectable suspension), the 1-month paliperidone palmitate extended-release injectable suspension should be started 3 months after the last INVEGA TRINZA dose, using the equivalent 3.5-fold lower dose as shown in Table 3. The 1-month paliperidone palmitate extended-release injectable suspension should then continue, dosed at monthly intervals. (See Table 3.)

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Switching from INVEGA TRINZA to Oral Paliperidone Extended-Release Tablets: For switching from INVEGA TRINZA to oral paliperidone extended-release tablets, the daily dosing of the paliperidone extended-release tablets should be started 3 months after the last INVEGA TRINZA dose and transitioned over the next several months following the last INVEGA TRINZA dose as described in Table 4. Table 4 provides dose conversion regimens to allow patients previously stabilized on different doses of INVEGA TRINZA to attain similar paliperidone exposure with once daily paliperidone extended-release tablets. (See Table 4.)

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