ZYPREXA RELPREVV (olanzapine pamoate)
ZYPREXA RELPREVV is a long-acting atypical antipsychotic administered via intramuscular injection for the treatment of schizophrenia in adults. The medication is available only through a restricted distribution program known as the ZYPREXA RELPREVV Patient Care Program. Under this program, the drug must not be dispensed directly to patients, and all involved parties—including the prescriber, healthcare facility, pharmacy, and patient—must be enrolled to facilitate treatment.
How ZYPREXA RELPREVV Works
The precise mechanism of action for olanzapine in treating schizophrenia remains unclear. Its clinical efficacy is believed to be mediated through a combination of antagonistic effects on specific neurotransmitter receptors. Specifically, the drug acts as an antagonist at both dopamine and serotonin type 2 (5HT2) receptors.
Details
- Status
- Prescription
- First Approved
- 2009-12-11
- Routes
- INTRAMUSCULAR
- Dosage Forms
- SUSPENSION, EXTENDED RELEASE
ZYPREXA RELPREVV Approval History
What ZYPREXA RELPREVV Treats
1 indicationsZYPREXA RELPREVV is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schizophrenia
ZYPREXA RELPREVV Boxed Warning
POST-INJECTION DELIRIUM/SEDATION SYNDROME and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS WARNING: POST-INJECTION DELIRIUM/SEDATION SYNDROME and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Patients are at risk for severe sedation (including coma) and/or delirium after each injection and must be observed for at least 3 hours in a registered facility with ready access to emergency r...
WARNING: POST-INJECTION DELIRIUM/SEDATION SYNDROME and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS WARNING: POST-INJECTION DELIRIUM/SEDATION SYNDROME and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Patients are at risk for severe sedation (including coma) and/or delirium after each injection and must be observed for at least 3 hours in a registered facility with ready access to emergency response services. 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. ( 2.1 , 5.1 , 5.2 , 10.2 , 17 ) Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ZYPREXA RELPREVV is not approved for the treatment of patients with dementia-related psychosis. ( 5.3 , 8.5 , 17 ) Post-Injection Delirium/Sedation Syndrome — Adverse events with signs and symptoms consistent with olanzapine overdose, in particular, sedation (including coma) and/or delirium, have been reported following injections of ZYPREXA RELPREVV. 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 [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.1 , 5.2 ), Overdosage ( 10.2 ), and Patient Counseling Information ( 17 )] . Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly patients with dementia-related psychosis trea
ZYPREXA RELPREVV Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZYPREXA RELPREVV FDA Label Details
Indications & Usage
FDA Label (PDF)ZYPREXA RELPREVV is indicated for the treatment of Schizophrenia.
WARNING: POST-INJECTION DELIRIUM/SEDATION SYNDROME and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS WARNING: POST-INJECTION DELIRIUM/SEDATION SYNDROME and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.