Erzofri

• Schizophrenia in adults¹⁵
• Schizoaffective disorder in adults¹⁵

Initiation Regimen Required for Schizophrenia

Yes¹⁵

Oral Supplementation Required During Initiation for Schizophrenia

No¹⁵

Initiation Regimen for Schizophrenia

351 mg IM (deltoid) on day 1¹⁵

Disease States

• Schizophrenia in adults¹⁵
• Schizoaffective disorder in adults¹⁵

Reconstitution Required

No¹⁵

How Supplied

Aqueous suspension¹⁵

Preparation Instructions

Shake the syringe containing Erzofri for a minimum of 10 seconds to ensure a homogenous suspension.¹⁵

Requirements Once Prepared or Reconstituted

None stated in the PI

Number of Dosing Options Available

6¹⁵

Preparation Kits Available

Single-dose, pre-filled syringe kit

• 39 mg
• 78 mg
• 117 mg
• 156 mg
• 234 mg
• 351 mg¹⁵

Dose Strengths

• 39 mg (equivalent to 25 mg paliperidone)
• 78 mg (equivalent to 50 mg paliperidone)
• 117 mg (equivalent to 75 mg paliperidone)
• 156 mg (equivalent to 100 mg paliperidone)
• 234 mg (equivalent to 150 mg paliperidone)
• 351 mg (equivalent to 225 mg paliperidone)¹⁵

Equivalencies

Doses of Erzofri maintenance doses that produce similar steady-state paliperidone exposure:

• 3 mg PO paliperidone extended-release QD = 39-78 mg Erzofri Q1M
• 6 mg PO paliperidone extended-release QD = 117 mg Erzofri Q1M
• 9 mg PO paliperidone extended-release QD = 156 mg Erzofri Q1M
• 12 mg PO paliperidone extended-release QD = 234 mg Erzofri Q1M¹⁵

Erzofri (paliperidone palmitate) doses hydrolyze to the following amounts of the active moiety (paliperidone):

• 39 mg Erzofri = 25 mg active moiety (paliperidone)
• 78 mg Erzofri = 50 mg active moiety (paliperidone)
• 117 mg Erzofri = 75 mg active moiety (paliperidone)
• 156 mg Erzofri = 100 mg active moiety (paliperidone)
• 234 mg Erzofri = 150 mg active moiety (paliperidone)
• 351 mg Erzofri = 225 mg active moiety (paliperidone)¹⁵

Maintenance Dose for Schizophrenia

39 mg - 234 mg Q1M (recommended maintenance dose is 117 mg Q1M)¹⁵

• Q1M¹⁵

0.25 mL (39 mg dose) - 2.25 mL (351 mg dose)¹⁵

• 0.25 mL (39 mg dose)
• 0.5 mL (78 mg dose)
• 0.75 mL (117 mg dose)
• 1.0 mL (156 mg dose)
• 1.5 mL (234 mg dose)
• 2.25 mL (351 mg dose)¹⁵

Needle Lengths

1, 1.5¹⁵

Needle Gauges

22, 23¹⁵

Injection Site(s)

IM (deltoid or gluteal)¹⁵

Deltoid Administration (Needle Gauge & Length)

• 23-gauge / 1-inch (patients weighing <90kg)
• 22-gauge / 1.5-inch (patients weighing >=90kg)¹⁵

Gluteal Administration (Needle Gauge & Length)

22-gauge / 1.5-inch (any patient, regardless of weight)¹⁵

Subcutaneous Administration (Needle Gauge & Length)

n/a

How Supplied

Aqueous suspension¹⁵

Preparation Kits Available

Single-dose, pre-filled syringe kit

• 39 mg
• 78 mg
• 117 mg
• 156 mg
• 234 mg
• 351 mg¹⁵

Kit Contents

1 single-dose, pre-filled syringe containing Erzofri aqueous suspension
+
2 safety needles to choose from for drug administration¹⁵

Kit Storage (Refrigeration Required)

No¹⁵

Kit Storage (Specific Temperature Requirements)

Store pre-filled syringe kit at room temperature (68F-77F; 20C-25C)¹⁵

Kit Storage (Excursions Permitted)

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

Kit Storage (Protect from Light)

Not stated in PI

Kit Storage (Other Requirements)

n/a

Temperature Requirements for Drug Preparation

Room Temperature¹⁵

Preparation Instructions

Shake the syringe containing Erzofri for a minimum of 10 seconds to ensure a homogenous suspension.¹⁵

Requirements Once Prepared or Reconstituted

None stated in the PI