Olanzapine pamoate LAI

ZYPREXA RELPREVV

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What it isEvery-two-to-four-week intramuscular olanzapine pamoate for schizophrenia — the only long-acting olanzapine.

Why this oneIt brings olanzapine’s efficacy to patients who respond to the molecule but cannot sustain oral adherence.

What limits itPost-injection delirium/sedation syndrome is the defining hazard: a REMS program requires administration at a registered facility with three hours of observation after every dose.

FDA label

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BOXED WARNING Post-injection delirium/sedation syndrome — patients at risk of severe sedation (incl. coma) and/or delirium after each injection; observe ≥3 h in a certified healthcare setting with emergency response access; available only through the ZYPREXA RELPREVV REMS. Increased mortality in elderly patients with dementia-related psychosis (not approved for that use).

FDA dosing	Population	Start	Target	Max
Schizophrenia	Adults	First 8 weeks (per target oral olanzapine dose): 210 mg/2 wk or 300 mg/2 wk or 405 mg/4 wk	Maintenance after 8 wk: 150 mg/2 wk, 210 mg/2 wk, 300 mg/2 wk, or 300 mg/4 wk	405 mg/4 wk or 300 mg/2 wk (higher doses not evaluated)

Renal Undefined

Hepatic Undefined

Administered every 2 to 4 weeks

Instructions

Deep IM gluteal injection only; do not administer IV or SC
Establish tolerability with oral olanzapine before initiating
Observe patient at the healthcare setting ≥3 h after each injection (REMS)
Aspirate before injecting; do not massage the injection site

Cautions

Post-injection delirium/sedation syndrome
Increased mortality and cerebrovascular events in elderly with dementia-related psychosis
Suicide risk in schizophrenia
Neuroleptic malignant syndrome
DRESS
Metabolic changes (hyperglycemia/diabetes, dyslipidemia, weight gain)
Tardive dyskinesia
Orthostatic hypotension

Adverse reactions

Headache
Sedation/somnolence
Weight gain
Cough
Diarrhea
Back pain
Nausea
Dry mouth
Increased appetite
Vomiting

Pregnancy Third-trimester exposure risks neonatal extrapyramidal and/or withdrawal symptoms; epidemiologic data have not established a drug-associated risk of major birth defects

Lactation Present in human milk; reports of excess sedation, irritability, poor feeding, and extrapyramidal symptoms in exposed infants

⚠ BOXED WARNING