INVEGA TRINZA

INVEGA TRINZA- paliperidone palmitate injection, suspension, extended release
Janssen Pharmaceuticals, Inc

1 INDICATIONS AND USAGE

INVEGA TRINZA^® (paliperidone palmitate), a 3-month injection, is indicated for the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA^® (1-month paliperidone palmitate extended-release injectable suspension) for at least four months [see Dosage and Administration (2.2) and Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

2.1 Administration Instructions

INVEGA TRINZA^® should be administered once every 3 months.

Each injection must be administered only by a healthcare 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 Dosage and Administration (2.8)] .

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 Dosage and Administration (2.8)].

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^®.

2.2 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.

Table 1. INVEGA TRINZA^® Doses for Adult Patients Adequately Treated with INVEGA SUSTENNA^®

If the Last Dose of INVEGA SUSTENNA® is:	Initiate INVEGA TRINZA® at the Following Dose:
Conversion from the INVEGA SUSTENNA® 39 mg dose was not studied.
78 mg	273 mg
117 mg	410 mg
156 mg	546 mg
234 mg	819 mg

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 273 mg to 819 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 Clinical Pharmacology (12.3)].

2.3 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.

Table 2. Re-initiation Regimen After Missing 4 Months to 9 Months of INVEGA TRINZA^®

If the Last Dose of INVEGA TRINZA® was:	Administer INVEGA SUSTENNA® , two doses one week apart (into deltoid muscle)		Then administer INVEGA TRINZA® (into deltoid * or gluteal muscle)
	Day 1	Day 8	1 month after Day 8
* See Instructions for Use for deltoid injection needle selection based on body weight.
273 mg	78 mg	78 mg	273 mg
410 mg	117 mg	117 mg	410 mg
546 mg	156 mg	156 mg	546 mg
819 mg	156 mg	156 mg	819 mg

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.