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Effective Date: April 1, 2025

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Important Safety
Information &
Indication

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. WELTRUZA is not approved for the treatment of patients with dementia-related psychosis.

Indication

WELTRUZA (olanzapine) for extended release injectable suspension is indicated for the treatment of schizophrenia in adults

WARNINGS AND PRECAUTIONS

Cerebrovascular Adverse Reactions: In trials of elderly patients with dementia-related psychosis, there was a significantly higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, in patients treated with olanzapine compared to placebo. WELTRUZA is not approved for the treatment of dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status including delirium, and autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additionalsigns may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. If NMS is suspected, immediately discontinue WELTRUZA and provide symptomatic treatment and monitoring.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): has been reported with exposure to olanzapine. DRESS may present with a cutaneous reaction, eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. DRESS is sometimes fatal. Discontinue WELTRUZA if DRESS is suspected.
Post-Injection Delirium/Sedation Syndrome (PDSS): Post-Injection Delirium/Sedation Syndrome (PDSS) is associated with signs and symptoms consistent with olanzapine overdose and is presumed to occur following an uncontrolled release of olanzapine into the bloodstream following administration of the long-acting olanzapine pamoate intramuscular (IM) product. WELTRUZA utilizes an olanzapine base in a long-acting polymer formulation for subcutaneous injection to prevent an uncontrolled release of olanzapine. In premarketing trials of WELTRUZA, there were no suspected or confirmed cases of PDSS. Because the exact mechanism by which olanzapine can be unintentionally introduced into the bloodstream following long-acting olanzapine pamoate IM injections is not known, healthcare professionals should consider this information, in the event a patient experiences the signs and symptoms of olanzapine overdose.
Metabolic Changes: metabolic changes including hyperglycemia, dyslipidemia, and weight gain. Metabolic changes may be associated with increased cardiovascular/cerebrovascular risk. Olanzapine’s specific metabolic profile is presented below..
Hyperglycemia and Diabetes Mellitus (DM), in some cases extreme and associated with ketoacidosis, hyperosmolar coma, or death, have been reported in patients treated with atypical antipsychotics, including olanzapine. While relative risk estimates are inconsistent, the association between atypical antipsychotics and increase in glucose levels appears to fall on a continuum, and olanzapine appears to have a greater association compared with some other atypical antipsychotics. Physicians should consider the risks and benefits when prescribing OLANZAPINE to patients with an established diagnosis of DM or with a borderline increase in blood glucose levels. Patients taking OLANZAPINE should be monitoredregularly for worsening of glucose control. Patients starting treatment with OLANZAPINE should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of OLANZAPINE.
Dyslipidemia: Undesirable alterations in lipids have been observed with olanzapine use. Clinical monitoring, including baseline and periodic follow-up lipid evaluations in patients using OLANZAPINE, is recommended. Clinically significant, and sometimes very high (³500 mg/dL), elevations in triglyceride levels have been observed with olanzapine use.
Weight Gain: Potential consequences of weight gain should be considered prior to starting OLANZAPINE. Patients receiving OLANZAPINE should receive regular monitoring of weight.
Tardive Dyskinesia (TD): As with all antipsychotic medications, prescribing should be consistent with the need to minimize the risk of TD. The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses or may even arise after discontinuation of treatment. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.
Orthostatic Hypotension and Syncope: WELTRUZA may induce orthostatic hypotension associated with dizziness, tachycardia, bradycardia, and in some patients, syncope, probably reflecting its α1 -adrenergic antagonistic properties. Olanzapine should be used with particular caution in patients with known cardiovascular disease cerebrovascular disease, and conditions which would predispose patients to hypotension.
Falls: WELTRUZA may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.
Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotics, including olanzapine. Patients with a history of a clinically significant low white blood cell (WBC) count or drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of WELTRUZAshould be considered at the first sign of a clinically significant decline in WBCs in the absence of other causative factors. Patients with severe neutropenia (absolute neutrophil count <1000 mm3) should discontinue WELTRUZA and have their WBC counts checked until recovery.
Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Antipsychotic drugs, including WELTRUZA, should be used cautiously in patients at risk for aspiration.
Seizures: Like other antipsychotic drugs, WELTRUZA may cause seizures. This risk is greatest in patients with a history of seizures or with conditions that lower the seizure threshold and WELTRUZA should be used cautiously. Conditions that lower the seizure threshold may be more prevalent in older patients.
Potential for Cognitive and Motor Impairment: WELTRUZA has the potential to impair judgment, thinking, and motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that WELTRUZA does not affect them adversely.
Body Temperature Dysregulation may occur with antipsychotic agents. Appropriate care is advised when prescribing WELTRUZA for patients who will be experiencing conditions that may contribute to elevation in core body temperature (e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, being subject to dehydration).
Anticholinergic Effects: Olanzapine exhibits in vitro muscarinic receptor affinity. In premarketing clinical trials, olanzapine was associated with constipation, dry mouth, and tachycardia, all adverse reactions possibly related to cholinergic antagonism. WELTRUZA should be used with caution in patients with a current diagnosis or prior history of urinary retention, clinically significant prostatic hypertrophy, constipation, or a history of paralytic ileus or related conditions. In postmarketing experience, the risk for severe adverse reactions (including fatalities) was increased with concomitant use of anticholinergic medications.
Hyperprolactinemia: As with other drugs that antagonize dopamine receptors, OLANZAPINE elevates prolactin levels, and the elevation persists during chronic administration. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.

ADVERSE EVENTS

Most common adverse reactions (≥5% in at least one of the treatment groups and greater than placebo) associated with WELTRUZA treatment: Weight increased, Somnolence, Headache, Constipation and Injection Site Reactions (induration, pain, erythema, pruritus, swelling).

DRUG INTERACTIONS

Diazepam: may potentiate orthostatic hypotension
Alcohol: may potentiate orthostatic hypotension
Carbamazepine: increased clearance of olanzapine
Fluvoxamine: may increase olanzapine levels
Olanzapine and fluoxetine in combination: also refer to the Drug Interactions section of the package insert for Symbyax
CNS acting drugs: caution should be used when used in combination with other centrally acting drugs and alcohol
Antihypertensive agents: enhanced antihypertensive effect
Levodopa and dopamine agonists: may antagonize levodopa/dopamine agonists
Other concomitant drug therapy: when using olanzapine in combination with lithium or valproate, refer to the Drug Interactions sections of the package insert for those products

USE IN SPECIFIC POPULATIONS

Pregnancy: Use only if potential benefit justifies the potential risk to the fetus. May cause extrapyramidal symptoms (EPS) and/or withdrawal symptoms in neonates with third-trimester exposure. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including OLANZAPINE, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
Lactation: WELRUZA is present in human milk. Infants should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements).
Fertility: WELTRUZA may cause a reversible reduction in fertility in females.
Pediatric Use: Safety and effectiveness of olanzapine in patients younger than 13 years have not been established.

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