INVEGA TRINZA is to be used only after the 1-month paliperidone palmitate injectable product 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 the 1-month injection be the same dosage strength before starting INVEGA TRINZA.
Initiate INVEGA TRINZA at the time when the next 1-month paliperidone palmitate dose was to be scheduled with a INVEGA TRINZA dose based on the previous 1-month injection 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).
Switching from Other Antipsychotics: INVEGA TRINZA is to be used only after the patient has been adequately treated with the 1-month paliperidone palmitate injectable product for at least 4 months (see Indications/Uses and Dosage & Administration).
If INVEGA TRINZA is discontinued, its prolonged-release characteristics must be considered. As recommended with other antipsychotic medications, the need for continuing existing extrapyramidal symptoms (EPS) medication should be re-evaluated periodically.
Switching from INVEGA TRINZA to the 1-Month Paliperidone Palmitate Injectable Product: For switching from INVEGA TRINZA to the 1-month paliperidone palmitate injectable product, the 1-month paliperidone palmitate injectable product should be administered at the time the next INVEGA TRINZA dose was to be administered using the equivalent 3.5-fold lower dose as shown in Table 2. The 1-month paliperidone palmitate injectable product should then continue to be dosed at monthly intervals. (See Table 2.)
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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 3. Table 3 provides dose conversion regimens to allow patients previously stabilised on different doses of INVEGA TRINZA to attain similar paliperidone exposure with once daily paliperidone extended-release tablets. (See Table 3.)
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Dosage in Special Populations: 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 to < 80 mL/min), dose adjustment is done when initiating treatment with the 1-month paliperidone palmitate injectable product; no dose adjustment of INVEGA TRINZA is required. Transition to INVEGA TRINZA is with a dose in a 3.5 to 1 ratio to the previous stabilised 1-month paliperidone palmitate injectable product as described in Dosage as previously mentioned. The maximum recommended dose of INVEGA TRINZA in patients with mild renal impairment is 350 mg.
INVEGA TRINZA is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min).
Hepatic Impairment: INVEGA TRINZA has not been studied in patients with hepatic impairment. Based on a study with oral paliperidone, no dose adjustment is required in patients with mild or moderate hepatic impairment. Paliperidone has not been studied in patients with severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric Use: Safety and effectiveness of INVEGA TRINZA in patients < 18 years of age have not been studied. Use in these patients is not recommended.
Use in the Elderly: In general, recommended dosing of INVEGA TRINZA for elderly patients with normal renal function is the same as for younger adult patients with normal renal function. As elderly patients may have reduced renal function, see Renal impairment previously mentioned for dosing recommendations in patients with renal impairment.
Other populations: No dose adjustment for INVEGA TRINZA is recommended based on gender, race, or smoking status. (For pregnant women and nursing mothers, see Use in Pregnancy & Lactation).
Missed Doses: Dosing Window. Missing doses of INVEGA TRINZA should be avoided. However, on exceptional occasions, patients may be given the injection up to 2 weeks before or after the 3-month time point.
Missed Dose > 3½ Months up to 4 Months: If more than 3½ months (up to 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 up to 9 Months: If more than 4 months (up to 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 4.
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Missed Dose > 9 Months: If more than 9 months have elapsed since the last injection of INVEGA TRINZA, re-initiate treatment with the 1-month paliperidone palmitate injectable product 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 injectable product for at least 4 months.
Administration Instructions: Parenteral drug products should be inspected visually for foreign matter and discoloration prior to administration. Within 5 minutes prior to administration of INVEGA TRINZA to the patient, it is important to shake the syringe vigorously for at least 15 seconds to ensure a homogeneous suspension (see Instructions for Use as follows).
INVEGA TRINZA is intended for intramuscular use only. Do not administer intravascularly or subcutaneously. Avoid inadvertent injection into a blood vessel. Each injection must be administered only by a healthcare professional. Administer the dose in a single injection; do not administer the dose in divided injections. Inject slowly, deep into the deltoid or gluteal muscle. Product is for single use in one patient only. Discard any residue.
INVEGA TRINZA must be administered using only the thin wall needles that are provided in the INVEGA TRINZA pack. Needles from the 1-month paliperidone palmitate injectable product pack or other commercially-available needles are not to be used when administering INVEGA TRINZA.
The recommended needle size for administration of INVEGA TRINZA into the deltoid muscle is determined by the patient's weight. For those ≥ 90 kg (≥ 200 lbs), the 1½-inch, 22-gauge thin wall needle is recommended. For those < 90 kg (< 200 lbs), the 1-inch, 22-gauge thin wall needle is recommended. Administer into the centre of the deltoid muscle. Deltoid injections should be alternated between the two deltoid muscles.
The recommended needle size for administration of INVEGA TRINZA into the gluteal muscle regardless of body weight 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.
Since paliperidone is the active metabolite of risperidone, caution should be exercised when INVEGA TRINZA is co-administered with risperidone or with oral paliperidone for extended periods of time. Safety data involving concomitant use of INVEGA TRINZA with other antipsychotics is limited.
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 (see Dosage & Administration). 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. Closely monitor and treat the patient appropriately until the next scheduled 3-month injection of INVEGA TRINZA.
Instructions for Use: Administer once every 3 months; Shake syringe vigorously for at least 15 seconds.
For intramuscular injection only. Do not administer by any other route.
INVEGA TRINZA should be administered by a healthcare professional as a single injection. Do not divide dose into multiple injections.
INVEGA TRINZA is intended for intramuscular use only. Inject slowly, deep into the muscle taking care to avoid injection into a blood vessel.
Read complete instructions prior to use.
Dosing: This medication should be administered once every 3 months.
Preparation: Peel off tab label from the syringe and place in patient record.
INVEGA TRINZA requires longer and more vigorous shaking than INVEGA SUSTENNA (1-month paliperidone palmitate modified-release injectable suspension). Shake the syringe vigorously, with the syringe tip pointing up, for at least 15 seconds within 5 minutes prior to administration (see Step 2).
Thin Wall Safety Needle Selection: Thin wall safety needles are designed to be used with INVEGA TRINZA. Therefore, it is important to only use the needles provided in the INVEGA TRINZA kit.
1) Select needle: Needle selection is determined by injection area and patient weight.
If administering a Deltoid injection: If patient weighs: Less than 90 kg: Pink hub: 22G x 1"; 90 kg or more: yellow hub: 22G x 1½".
If administering a Gluteal injection: Regardless of patient weight: Yellow hub: 22G x 1½".
Immediately discard the unused needle in an approved sharps container. Do not save for future use.
2) Prepare for injection: Shake vigorously for at least 15 seconds: With the syringe tip pointing up, SHAKE VIGOROUSLY with a loose wrist for at least 15 seconds to ensure a homogeneous suspension.
NOTE: This medication requires longer and more vigorous shaking than the 1-month paliperidone palmitate modified-release injectable suspension.
Proceed to the next step immediately after shaking. If more than 5 minutes pass before injection, shake vigorously, with the syringe tip pointing up, again for at least 15 seconds to re-suspend the medication.
Check suspension: After shaking the syringe for at least 15 seconds, check the liquid in the viewing window.
The suspension should appear uniform and milky white in colour.
It is also normal to see small air bubbles.
Open needle pouch and remove cap: First, open needle pouch by peeling the cover back half way. Place on a clean surface.
Then, holding the syringe upright, twist and pull the rubber cap to remove.
Grasp needle pouch: Fold back needle cover and plastic tray. Then, firmly grasp the needle sheath through the pouch.
Attach needle: With the other hand, hold the syringe by the luer connection and attach it to the safety needle with a gentle clockwise twisting motion.
Do not remove the pouch until the syringe and needle are securely attached.
Remove needle sheath: Pull the needle sheath away from the needle in a straight motion.
Do not twist the sheath, as this may loosen the needle from the syringe.
Remove air bubbles: Hold the syringe upright and tap gently to make any air bubbles rise to the top.
Remove air by pressing the plunger rod upward carefully until a drop of liquid comes out of the needle tip.
3) Inject: Inject dose: Slowly inject the entire contents of the syringe intramuscularly, deep into the selected deltoid or gluteal muscle.
Do not administer by any other route.
4) After injection: Secure needle: After the injection is complete, use the thumb or a flat surface to secure the needle in the safety device. The needle is secure when a "click" sound is heard.
Dispose properly: Dispose of the syringe and unused needle in an approved sharps container.
Thin wall safety needles are designed specifically for use with INVEGA TRINZA. Unused needle should be discarded and not saved for future use.