Invega Hafyera Dosage/Direction for Use

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 Instructions for Preparation and Administration under Cautions for Usage].
Initiate INVEGA HAFYERA only after adequate treatment has been established with either: A once-a-month paliperidone palmitate prolonged-release suspension for injection (e.g., INVEGA SUSTENNA), referred to as PP1M, once monthly for at least four months, or; An every-three-month paliperidone palmitate prolonged-release suspension for injection (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.
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. (See Table 1.)

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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. (See Table 2.)

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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 700 mg to 1,000 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 Pharmacology: Pharmacokinetics under Actions].
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: See Table 3.

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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: See Table 4.

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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.