Invega Hafyera^®

Schizophrenia in adults after they have been adequately treated with:

• A once-a-month paliperidone palmitate extended-release injectable suspension for at least 4 months;
• INVEGA TRINZA® for at least one 3-month cycle.⁶

Initiation Regimen Required for Schizophrenia

Yes⁶

Oral Supplementation Required During Initiation for Schizophrenia

No⁶

Initiation Regimen for Schizophrenia

Initial INVEGA HAFYERA dose is based on previous INVEGA SUSTENNA or INVEGA TRINZA dose.⁶
Initiate INVEGA HAFYERA when the next INVEGA SUSTENNA or INVEGA TRINZA dose is scheduled.⁶
156 mg INVEGA SUSTENNA --> initiate INVEGA HAFYERA at 1092 mg
234 mg INVEGA SUSTENNA --> initiate INVEGA HAFYERA at 1560 mg
546 mg INVEGA TRINZA --> initiate INVEGA HAFYERA at 1092 mg
819 mg INVEGA TRINZA --> initiate INVEGA HAFYERA at 1560 mg⁶
Notes:
There are no equivalent doses of INVEGA HAFYERA for the lower doses of INVEGA SUSTENNA (39 mg, 78 mg, or 117 mg).

There are no equivalent doses of INVEGA HAFYERA for the lower doses of INVEGA TRINZA (273 mg or 410 mg).⁶

Disease States

Schizophrenia in adults after they have been adequately treated with:

• A once-a-month paliperidone palmitate extended-release injectable suspension for at least 4 months;
• INVEGA TRINZA® for at least one 3-month cycle.⁶

Reconstitution Required

No⁶

How Supplied

Aqueous suspension⁶

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.⁶

Note: INVEGA HAFYERA requires longer and faster shaking than INVEGA SUSTENNA.⁶

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.⁶

Number of Dosing Options Available

2⁶

Preparation Kits Available

Single-dose, prefilled syringe kit

• 1092 mg
• 1560 mg⁶

Dose Strengths

• 1092 mg (equivalent to 700 mg paliperidone)
• 1560 mg (equivalent to 1000 mg paliperidone)⁶

Equivalencies

INVEGA HAFYERA (paliperidone palmitate) doses hydrolyze to the following amounts of the active moiety (paliperidone):⁶

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

INVEGA HAFYERA doses administered Q6M result in total paliperidone exposures that correspond to the following INVEGA SUSTENNA doses administered Q1M:⁶

• 1092 mg INVEGA HAFYERA Q6M = 156 mg INVEGA SUSTENNA Q1M
• 1560 mg INVEGA HAFYERA Q6M = 234 mg INVEGA SUSTENNA Q1M

INVEGA HAFYERA doses administered Q6M result in total paliperidone exposures that correspond to the following INVEGA TRINZA doses administered Q3M:⁶

• 1092 mg INVEGA HAFYERA Q6M = 546 mg INVEGA TRINZA Q3M
• 1560 mg INVEGA HAFYERA Q6M = 819 mg INVEGA TRINZA Q3M

Maintenance Dose for Schizophrenia

1092 mg - 1560 mg Q6M⁶

• Q6M⁶

3.5 mL (1092 mg dose) - 5 mL (1560 mg dose):⁶

• 3.5 mL (1092 mg dose)
• 5 mL (1560 mg dose)⁶

Needle Lengths

1.5⁶

Needle Gauges

20⁶

Injection Site(s)

IM (gluteal only)⁶

Deltoid Administration (Needle Gauge & Length)

n/a

Gluteal Administration (Needle Gauge & Length)

20 gauge, 1.5-inch safety needle⁶

Subcutaneous Administration (Needle Gauge & Length)

n/a

How Supplied

Aqueous suspension⁶

Preparation Kits Available

Single-dose, prefilled syringe kit

• 1092 mg
• 1560 mg⁶

Kit Contents

1 single-dose, prefilled syringe containing INVEGA HAFYERA aqueous suspension
+
1 thin-walled safety needle for drug administration⁶

Kit Storage (Refrigeration Required)

No⁶

Kit Storage (Specific Temperature Requirements)

Store prefilled syringe kit at room temperature (68°F to 77°F; 20°C to 25°C).⁶

Kit Storage (Excursions Permitted)

Excursions permitted between 59°F and 86°F (15°C and 30°C).⁶

Kit Storage (Protect from Light)

Not stated in PI

Kit Storage (Other Requirements)

Ship and store in a horizontal position. See arrows on product carton for proper orientation.⁶

Storing the carton in a horizontal position improves the ability to resuspend this product.⁶

Temperature Requirements for Drug Preparation

Room Temperature⁶

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.⁶

Note: INVEGA HAFYERA requires longer and faster shaking than INVEGA SUSTENNA.⁶

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.⁶