Invega Sustenna^®

• Schizophrenia in adults⁴
• Schizoaffective disorder in adults⁴

Initiation Regimen Required for Schizophrenia

Yes⁴

Oral Supplementation Required During Initiation for Schizophrenia

No⁴

Initiation Regimen for Schizophrenia

234 mg IM (deltoid) on day 1
156 mg IM (deltoid) on day 8⁴

Disease States

• Schizophrenia in adults⁴
• Schizoaffective disorder in adults⁴

Reconstitution Required

No⁴

How Supplied

Aqueous suspension⁴

Preparation Instructions

Shake the syringe containing INVEGA SUSTENNA for a minimum of 10 seconds to ensure a homogenous suspension.⁴

Requirements Once Prepared or Reconstituted

None stated in the PI

Number of Dosing Options Available

5⁴

Preparation Kits Available

Single-dose, prefilled syringe kit

• 39 mg
• 78 mg
• 117 mg
• 156 mg
• 234 mg⁴

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)⁴

Equivalencies

Doses of INVEGA extended-release tablets and INVEGA SUSTENNA maintenance doses that produce similar steady-state paliperidone exposure:

• 3 mg PO INVEGA QD = 39-78 mg INVEGA SUSTENNA Q1M
• 6 mg PO INVEGA QD = 117 mg INVEGA SUSTENNA Q1M
• 9 mg PO INVEGA QD = 156 mg INVEGA SUSTENNA Q1M
• 12 mg PO INVEGA QD = 234 mg INVEGA SUSTENNA Q1M⁴

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

• 39 mg INVEGA SUSTENNA = 25 mg active moiety (paliperidone)
• 78 mg INVEGA SUSTENNA = 50 mg active moiety (paliperidone)
• 117 mg INVEGA SUSTENNA = 75 mg active moiety (paliperidone)
• 156 mg INVEGA SUSTENNA = 100 mg active moiety (paliperidone)
• 234 mg INVEGA SUSTENNA = 150 mg active moiety (paliperidone)⁴

Maintenance Dose for Schizophrenia

39 mg - 234 mg Q1M
(recommended maintenance dose is 117 mg Q1M)⁴

• Q1M⁴

0.25 mL (39 mg dose) - 1.5 mL (234 mg dose):⁴

• 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)⁴

Needle Lengths

1, 1.5⁴

Needle Gauges

22, 23⁴

Injection Site(s)

IM (deltoid or gluteal)⁴

Deltoid Administration (Needle Gauge & Length)

For patients weighing less than 90 kg, the 1-inch, 23 gauge needle is recommended
For patients weighing 90 kg or more, the 1.5-inch, 22 gauge needle is recommended⁴

Gluteal Administration (Needle Gauge & Length)

The recommended needle size for administration into the gluteal muscle is the 1.5-inch, 22 gauge needle regardless of patient weight⁴

Subcutaneous Administration (Needle Gauge & Length)

n/a

How Supplied

Aqueous suspension⁴

Preparation Kits Available

Single-dose, prefilled syringe kit

• 39 mg
• 78 mg
• 117 mg
• 156 mg
• 234 mg⁴

Kit Contents

1 single-dose, prefilled syringe containing INVEGA SUSTENNA aqueous suspension
+
2 safety needles to choose from for drug administration⁴

Kit Storage (Refrigeration Required)

No⁴

Kit Storage (Specific Temperature Requirements)

Store prefilled syringe kit at room temperature (77°F; 25°C).⁴

Kit Storage (Excursions Permitted)

Excursions permitted between 59°F and 86°F (15°C and 30°C).⁴

Kit Storage (Protect from Light)

Not stated in PI

Kit Storage (Other Requirements)

Not stated in PI

Temperature Requirements for Drug Preparation

Room Temperature⁴

Preparation Instructions

Shake the syringe containing INVEGA SUSTENNA for a minimum of 10 seconds to ensure a homogenous suspension.⁴

Requirements Once Prepared or Reconstituted

None stated in the PI