Invega Hafyera^®

Schizophrenia in adults after they have been adequately treated with:

• INVEGA SUSTENNA® for at least 4 months;
• INVEGA TRINZA® for at least one 3-month cycle.³

Initiation Regimen Required for Schizophrenia

Yes³

Oral Supplementation Required During Initiation for Schizophrenia

No³

Initiation Regimen for Schizophrenia

Initial INVEGA HAFYERA dose is based on previous INVEGA SUSTENNA or INVEGA TRINZA dose.³

Initiate INVEGA HAFYERA when the next INVEGA SUSTENNA or INVEGA TRINZA dose is scheduled.³

100 mg INVEGA SUSTENNA --> initiate INVEGA HAFYERA at 700 mg
150 mg INVEGA SUSTENNA --> initiate INVEGA HAFYERA at 1000 mg
350 mg INVEGA TRINZA --> initiate INVEGA HAFYERA at 700 mg
525 mg INVEGA TRINZA --> initiate INVEGA HAFYERA at 1000 mg³

Notes:
INVEGA HAFYERA may be administered up to 7 days before or after the monthly time point of the next scheduled INVEGA SUSTENNA dose.

INVEGA HAFYERA may be administerd up to 14 days before or after the 3-monthly time point of the next scheduled INVEGA TRINZA dose.³

Disease States

Schizophrenia in adults after they have been adequately treated with:

• INVEGA SUSTENNA® for at least 4 months;
• INVEGA TRINZA® for at least one 3-month cycle.³

Reconstitution Required

No³

How Supplied

Prefilled syringe³

Preparation Instructions

INVEGA HAFYERA is a highly concentrated product and requires specific steps to resuspend. Proper shaking can reduce the likelihood for an incomplete injection and storing the carton in a horizontal position improves the ability to resuspend this product. Shake the syringe containing INVEGA HAFYERA very fast for at least 15 seconds. Rest briefly, then shake again for another 15 seconds. To ensure complete resuspension, shake syringe with short, very fast up and down motion and with a loose wrist. A properly resuspended product will be uniform, thick, and milky white.³

Note: INVEGA HAFYERA requires longer and faster shaking than INVEGA SUSTENNA.³

Requirements Once Prepared or Reconstituted

If more than 5 minutes pass after initial shaking before injection, shake very fast again for at least 30 seconds to resuspend the medication.³

Number of Dosing Options Available

2³

Preparation Kits Available

Single-dose, prefilled syringe kit

• 700 mg (3.5 mL)
• 1000 mg (5.0 mL)

Dose Strengths

• 1092 mg (equivalent to 700 mg paliperidone)
• 1560 mg (equivalent to 1000 mg paliperidone)³

Equivalencies

INVEGA HAFYERA (paliperidone palmitate) doses hydrolyze to the following amounts of the active moiety (paliperidone):³

• 1092 mg INVEGA HAFYERA = 700 mg active moiety (paliperidone)
• 1560 mg INVEGA HAFYERA = 1000 mg active moiety (paliperidone)

Maintenance Dose for Schizophrenia

1092 mg - 1560 mg Q6M³

• Q6M³

3.5 mL (1092 mg dose) - 5 mL (1560 mg dose):³

• 3.5 mL (1092 mg dose)
• 5 mL (1560 mg dose)³

Needle Lengths

1.5³

Needle Gauges

20³

Injection Site(s)

IM (gluteal only)³

Deltoid Administration (Needle Gauge & Length)

n/a

Gluteal Administration (Needle Gauge & Length)

20 gauge, 1.5-inch safety needle³

Subcutaneous Administration (Needle Gauge & Length)

n/a

How Supplied

Prefilled syringe³

Preparation Kits Available

Single-dose, prefilled syringe kit

• 1092 mg
• 1560 mg³

Kit Contents

1 single-dose, prefilled syringe containing INVEGA HAFYERA aqueous suspension
+
1 thin-walled safety needle for drug administration³
+
tip cap
+
plunger rod
+
backstop

Kit Storage (Refrigeration Required)

No³

Kit Storage (Specific Temperature Requirements)

Store below 25°C

Kit Storage (Excursions Permitted)

Not stated in PI

Kit Storage (Protect from Light)

Not stated in PI

Kit Storage (Other Requirements)

Store in a horizontal position. See arrows on product carton for proper orientation.

Temperature Requirements for Drug Preparation

Room Temperature³

Preparation Instructions

INVEGA HAFYERA is a highly concentrated product and requires specific steps to resuspend. Proper shaking can reduce the likelihood for an incomplete injection and storing the carton in a horizontal position improves the ability to resuspend this product. Shake the syringe containing INVEGA HAFYERA very fast for at least 15 seconds. Rest briefly, then shake again for another 15 seconds. To ensure complete resuspension, shake syringe with short, very fast up and down motion and with a loose wrist. A properly resuspended product will be uniform, thick, and milky white.³

Note: INVEGA HAFYERA requires longer and faster shaking than INVEGA SUSTENNA.³

Requirements Once Prepared or Reconstituted

If more than 5 minutes pass after initial shaking before injection, shake very fast again for at least 30 seconds to resuspend the medication.³