INVEGA HAFYERA

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

1 INDICATIONS AND USAGE

INVEGA HAFYERA, an every-six-month injection, is indicated for the treatment of schizophrenia in adults after they have been adequately treated with:

• A once-a-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA SUSTENNA) for at least four months, or
• An every-three-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA TRINZA) for at least one three-month cycle.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Information

• INVEGA HAFYERA must be administered as a gluteal intramuscular injection by a healthcare professional once every 6 months. Do not administer by any other route [see Dosage and Administration (2.4, 2.5)].
• Initiate INVEGA HAFYERA only after adequate treatment has been established with either:
  • A once-a-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA SUSTENNA), referred to as PP1M, once monthly for at least four months; or
  • An every-three-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA TRINZA), referred to as PP3M, once every three months for at least one three-month injection cycle.
• See Prescribing Information of the PP1M and PP3M products for the recommended dosage of these products.

2.2 Recommended Dosage for INVEGA HAFYERA

Switching to INVEGA HAFYERA from a PP1M Product

The recommended initial INVEGA HAFYERA dose is based on the previous PP1M dose (see Table 1). Initiate INVEGA HAFYERA when the next PP1M dose is scheduled. INVEGA HAFYERA may be administered up to 1 week before or 1 week after the next scheduled PP1M dose. When switching from PP1M to INVEGA HAFYERA, the two injection cycles immediately preceding the switch should be the same dosage strength before starting INVEGA HAFYERA.

Table 1. Initial INVEGA HAFYERA Dose for Adult Patients Switching from a PP1M * Product

Last Dose of PP1M †	Initial Dose of INVEGA HAFYERA
* PP1M: Once-a-month paliperidone palmitate extended-release injectable suspension † There are no equivalent doses of INVEGA HAFYERA for 39 mg, 78 mg, or 117 mg doses of a PP1M product, which were not studied [see Clinical Studies (14)].
156 mg	1,092 mg
234 mg	1,560 mg

Switching to INVEGA HAFYERA from a PP3M Product

The recommended initial INVEGA HAFYERA dose is based on the previous PP3M dose (see Table 2). Initiate INVEGA HAFYERA when the next PP3M dose is scheduled. INVEGA HAFYERA may be administered up to 2 weeks before or 2 weeks after the next scheduled PP3M dose.

Table 2. Initial INVEGA HAFYERA Dose for Adult Patients Switching from a PP3M * Product

Last Dose of PP3M †	Initial Dose of INVEGA HAFYERA
* PP3M: Every-three-month paliperidone palmitate extended-release injectable suspension † There are no equivalent doses of INVEGA HAFYERA for the 273 mg or 410 mg doses of a PP3M product, which were not studied [see Clinical Studies (14)].
546 mg	1,092 mg
819 mg	1,560 mg

Dosing Interval and Dosage Adjustments of INVEGA HAFYERA

Following the initial dose, administer INVEGA HAFYERA once every 6 months.

If needed, dosage adjustment can be made every 6 months between the dose of 1,092 mg to 1,560 mg based on individual response and tolerability. Because of the potential longer duration of INVEGA HAFYERA, 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

To avoid a missed dose, patients may be given the injection up to 2 weeks before or 3 weeks after the scheduled 6-month dose.

Missed Dose

If a dose of INVEGA HAFYERA is missed, re-initiate with a PP1M product using the re-initiation regimens described in Tables 3 and 4.

More than 6 Months and 3 Weeks, up to but Less than 8 Months Since Last Dose

If more than 6 months and 3 weeks but less than 8 months have elapsed since the last dose of INVEGA HAFYERA, do not administer the next dose of INVEGA HAFYERA. Instead, use the re-initiation regimen shown in Table 3:

Table 3. Re-initiation Regimen for Missed Dose (more than 6 months and 3 weeks, but less than 8 months since last dose)

Last Dose of INVEGA HAFYERA	Administer PP1M Product * into deltoid muscle	Administer INVEGA HAFYERA into gluteal muscle
	Day 1	1 month after Day 1
* PP1M: Once-a-month paliperidone palmitate extended-release injectable suspension
1,092 mg	156 mg	1,092 mg
1,560 mg	234 mg	1,560 mg

8 Months Up to and including 11 Months Since Last Dose

If 8 months but up to and including 11 months have elapsed since the last dose of INVEGA HAFYERA, do not administer the next dose of INVEGA HAFYERA. Instead, use the re-initiation regimen shown in Table 4:

Table 4. Re-initiation Regimen for Missed Dose (8 months up to and including 11 months since last dose)

Last dose of INVEGA HAFYERA	Administer PP1M Product * into deltoid muscle		Administer INVEGA HAFYERA into gluteal muscle
	Day 1	Day 8	1 month after Day 8
* PP1M: Once-a-month paliperidone palmitate extended-release injectable suspension
1,092 mg	156 mg	156 mg	1,092 mg
1,560 mg	156 mg	156 mg	1,560 mg

More than 11 Months Since Last Dose

If more than 11 months have elapsed since the last dose of INVEGA HAFYERA, re-initiate treatment with a PP1M product as described in the prescribing information for that product. INVEGA HAFYERA can then be resumed after the patient has been adequately treated with a PP1M product for at least 4 months.