Zyprexa Relprevv^®

• Schizophrenia in adults⁷

Initiation Regimen Required for Schizophrenia

Yes⁷

Oral Supplementation Required During Initiation for Schizophrenia

No⁷

Initiation Regimen for Schizophrenia

Initial ZYPREXA RELPREVV dose is based on daily PO ZYPREXA dose.⁷

Initiation period is the 1st 8 weeks.⁷

10 mg QD PO ZYPREXA --> Initiate ZYPREXA RELPREVV at 210 mg Q2WK or 405 mg Q4WK for 1st 8 weeks
15 mg QD PO ZYPREXA --> Initiate ZYPREXA RELPREVV at 300 mg Q2WK for 1st 8 weeks
20 mg QD PO ZYPREXA --> Initiate ZYPREXA RELPREVV at 300 mg Q2WK for 1st 8 weeks⁷

Disease States

• Schizophrenia in adults⁷

Reconstitution Required

Yes⁷

How Supplied

Yellow powder for reconstitution
+
Diluent (clear, colorless to slightly yellow solution)⁷

Preparation Instructions

It is recommended to use gloves during reconstitution as it may irritate the skin.

Loosen the powder by lightly tapping the vial. Open the prepackaged syringe with needle attached. Withdraw the appropriate amount of diluent (see below) and then inject diluent into the powder vial. Pad a hard surface to cushion impact, and then tap the vial firmly and repeatedly on the surface until no dry powder clumps are visible. Shake the vial vigorously until the suspension appears smooth and is consistent in color and texture. The suspended product will be yellow and opaque.⁷

For the 210 mg strength vial, add 1.3 mL of diluent
For the 300 mg strength vial, add 1.8 mL of diluent
For the 405 mg strength vial, add 2.3 mL of diluent⁷

Requirements Once Prepared or Reconstituted

If the product is not used right away after reconstitution, it should be shaken vigorously to resuspend.⁷

Reconstituted ZYPREXA RELPREVV remains stable at room temperature for up to 24 hours in the vial.⁷

Number of Dosing Options Available

4⁷

Preparation Kits Available

Single-dose convenience kit

• 210 mg,
• 300 mg,
• 405 mg strength⁷

Dose Strengths

Reconstituted suspension concentration is 150 mg / mL.⁷
Doses of 150 mg, 210 mg, 300 mg, and 405 mg can be delivered by injecting the following volumes of suspended product:

• 150 mg dose --> use 1 mL
• 210 mg dose --> use 1.4 mL
• 300 mg dose --> use 2 mL
• 405 mg dose --> use 2.7 mL⁷

Equivalencies

ZYPREXA RELPREVV is supplied as olanzapine pamoate monohydrate powder for reconstitution, which is equivalent to the following doses of olanzapine:

• 483 mg olanzapine pamoate monohydrate per vial = 210 mg olanzapine dose
• 690 mg olanzapine pamoate monohydrate per vial = 300 mg olanzapine dose
• 931 mg olanzapine pamoate monohydrate per vial = 405 mg olanzapine dose⁷

Maintenance Dose for Schizophrenia

Maintenance doses of ZYPREXA RELPREVV are based on doses utilized in the initiation period (1st 8 weeks).

• 210 mg Q2WK --> 150 mg Q2WK or 300 mg Q4WK
• 405 mg Q4WK --> 150 mg Q2WK or 300 mg Q4WK
• 300 mg Q2WK --> 210 mg Q2WK, 300 mg Q2WK, or 405 mg Q4WK⁷

• Q2WK (for 150 mg - 300 mg doses)
• Q4WK (for 405 mg dose)⁷

1 mL (150 mg dose) - 2.7 mL (405 mg dose):⁷

• 1 mL (150 mg dose)
• 1.4 mL (210 mg dose)
• 2 mL (300 mg dose)
• 2.7 mL (405 mg dose)⁷

Needle Lengths

1.5⁷

Needle Gauges

19⁷

Injection Site(s)

IM (gluteal only)⁷

Deltoid Administration (Needle Gauge & Length)

n/a

Gluteal Administration (Needle Gauge & Length)

19-gauge, 1.5-inch (38 mm) hypodermic needle

For obese patients, a 2-inch (50 mm), 19-gauge or larger needle (not included in convenience kit) may be used for administration⁷

Subcutaneous Administration (Needle Gauge & Length)

n/a

How Supplied

Yellow powder for reconstitution
+
Diluent (clear, colorless to slightly yellow solution)⁷

Preparation Kits Available

Single-dose convenience kit

• 210 mg
• 300 mg
• 405 mg strength⁷

Kit Contents

1 vial of powder
+
1 vial of diluent
+
1 syringe with needle pre-attached (for withdrawing diluent and transferring it into powder vial)
+
2 safety needles (both are 19G/1.5-inch; 1 for withdrawing reconstituted product from the vial and 1 for drug administration)⁷

Kit Storage (Refrigeration Required)

No⁷

Kit Storage (Specific Temperature Requirements)

Store convenience kit at room temperature (not to exceed 86°F / 30°C).

Once reconstituted and suspended in diluent, it may be held at room temperature for 24 hours.⁷

Kit Storage (Excursions Permitted)

Not stated in PI

Kit Storage (Protect from Light)

Not stated in PI

Kit Storage (Other Requirements)

Not stated in PI

Temperature Requirements for Drug Preparation

Room Temperature⁷

Preparation Instructions

It is recommended to use gloves during reconstitution as it may irritate the skin.

Loosen the powder by lightly tapping the vial. Open the prepackaged syringe with needle attached. Withdraw the appropriate amount of diluent (see below) and then inject diluent into the powder vial. Pad a hard surface to cushion impact, and then tap the vial firmly and repeatedly on the surface until no dry powder clumps are visible. Shake the vial vigorously until the suspension appears smooth and is consistent in color and texture. The suspended product will be yellow and opaque.⁷

• For the 210 mg strength vial, add 1.3 mL of diluent
• For the 300 mg strength vial, add 1.8 mL of diluent
• For the 405 mg strength vial, add 2.3 mL of diluent⁷

Requirements Once Prepared or Reconstituted

If the product is not used right away after reconstitution, it should be shaken vigorously to resuspend.⁷

Reconstituted ZYPREXA RELPREVV remains stable at room temperature for up to 24 hours in the vial.⁷