Invega Hafyera™ (6-monthly paliperidone palmitate): FDA Approved for Schizophrenia

Sep 01, 2021.

Today FDA approved the first and only 6 monthly long-acting injectable for schizophrenia treatment: Invega Hafyera.

We have summarized Invega Hafyera clinical information in the following sections:

When to Initiate Invega Hafyera in Schizophrenia?
What is the starting dose?
What is the dosing-window for next dose in 6 months?
How to manage the missed dose?
What are the common adverse-events?
When is Invega Hafyera NOT recommended?

(1) When to Initiate Invega Hafyera in Schizophrenia?

Begin this long-acting injectable for the treatment of schizophrenia in adults after they have been adequately treated with either:

INVEGA SUSTENNA once a month for at least four months, or
INVEGA TRINZA every three months for at least one three-month cycle.

Initiate when the next once-a-month or every three-month paliperidone palmitate extended-release injectable suspension dose is scheduled.

(2) What is the starting dose?

This will depend on the last Invega Sustenna or Trinza dose as following:

INVEGA SUSTENNA:

Last Dose: 156 mg ===> 1,092 mg Invega Hafyera.
Last Dose: 234 mg ===> 1,560 mg Invega Hafyera.

(Note: Switching from Invega Sustenna 39 mg, 78 mg and 117 mg doses was not studied)

INVEGA TRINZA:

Last Dose: 546 mg ===> 1,092 mg Invega Hafyera.
Last Dose: 819 mg ===> 1,560 mg Invega Hafyera.

(Note: Switching from Invega Trinza 273 mg and 410 mg doses was not studied)

(3) What is the dosing-window for next dose in 6 months?

give next injection up to 2 weeks before or 3 weeks after the scheduled 6-month dose

(4) How to manage the missed dose?

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

Do not give the next dose, but do the following re-initiation schedule (Day 1 and after 1 Month) based on last dose:

LAST DOSE (1,092 mg) ==> DAY 1 (Invega Sustenna 156 mg) ==> 1 MONTH (1,092 mg)
LAST DOSE (1,560 mg) ==> DAY 1 (Invega Sustenna 234 mg) ==> 1 MONTH (1,560 mg)

(B) 8 Months Up to and including 11 Months Since Last Dose:

Do not give the next dose, but do the following re-initiation schedule based on last dose:

LAST DOSE (1,092 mg) ==> DAY 1 (Invega Sustenna 156 mg) ==> DAY 8 (Invega Sustenna 156 mg) ==> 1 MONTH (1,092 mg)
LAST DOSE (1,560 mg) ==> DAY 1 (Invega Sustenna 156 mg) ==> DAY 8 (Invega Sustenna 156 mg) ==> 1 MONTH (1,560 mg)

(C) > 11 Months Since Last Dose:

Re-initiate as a new dosing (as discussed above in “What is the Starting Dose?”

(5) What are the common adverse-events?

Upper respiratory tract infection (12%)
Injection site reaction (11%)
Weight gain (9%)
Headache (7%)
Parkinsonism (55%)

(6) When is Invega Hafyera NOT recommended?

RENAL IMPAIRMENT: mild, moderate, or severe renal impairment (creatinine clearance <90 mL/min).

Note: this is not studied in hepatic impairment.

References:

Announcement (web-link)
Package Insert (PDF)

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