What should clinicians know about Zyprexa Relprevv (olanzapine for extended release injectable suspension)?

Zyprexa Relprevv

Indication(s)

Schizophrenia

Dosing available as prefilled syringes

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

Recommended starting and maintenance dose

Recommended dosing for Zyprexa Relprevv is based on correspondence to oral Zyprexa doses (see table below).

Drug Metabolizing Enzyme

CYP1A2, CYP2D6 

Dosing exclusions

Requires a REMS

Loading dose

Not required

Oral overlap

Not required

Establishing tolerability

Prior to initiating Zyprexa Relprevv, establish tolerability with oral olanzapine.

Storage

Room temperature not to exceed 30°C (86°F). When the drug product is suspended in the solution for Zyprexa Relprevv, it may be held at room temperature for 24 hours.

Reconstitution or mixing

Reconstitution required

Injection site

Deep intramuscular gluteal injection using a 19-gauge, 1.5-inch needle

Injection interval

Every 2 to 4 weeks 

Preparation

Lightly tap the vial to loosen powder. Withdraw the pre-determined diluent volume into the provided syringe. Inject diluent into the powder vial. Tap the vial firmly and repeatedly on a surface until no powder is visible. Shake the vial vigorously until the suspension appears smooth. If foam forms, let vial stand to allow foam to dissipate.

Administration considerations

After insertion of the needle into the muscle, aspirate for several seconds to ensure that no blood appears. If any blood is drawn into the syringe, discard the syringe and the dose and being with a new convenience kit. The injection should be performed with steady, continuous pressure. Post injection monitoring must occur for three hours and the patient must be accompanied by someone to their destination when leaving.

Timing variations

None noted

When a dose is missed

No information provided

REMS

Yes

Additional information

Zyprexa®Relprevv™ can cause serious reactions following injection called post-injection delirium sedation syndrome. Post-Injection Delirium/Sedation Syndrome signs and symptoms are consistent with olanzapine overdose, in particular, sedation (including coma) and/or delirium. The risk of post-inection delirium sedation syndrome is present with every injection, although it is a small risk. Zyprexa® Relprevv™ must be administered in a registered healthcare facility with ready access to emergency response services. After each injection, patients must be observed at the healthcare facility by a healthcare professional for at least 3 hours. Because of this risk, Zyprexa® Relprevv™ is available only through a restricted distribution program called Zyprexa® Relprevv™ Patient Care Program and requires prescriber, healthcare facility, patient, and pharmacy enrollment. Community pharmacies are eligible for administration per the REMS criteria.