OlanzapineFor Injection
- “AP” Rated to Zyprexa®*1
- Preservative free
- Vial closure is not made with natural rubber latex
| Pack NDC# | Strength | Supplied As | Shelf Pack | Vial Opening Size | Product Info | Availability | ||
|---|---|---|---|---|---|---|---|---|
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Strength:
10 mg/Vial Supplied As:Single Use Vial NDC#: 0517-0955-01 |
0517-0955-01 |
10 mg/Vial |
Single Use Vial |
1 | 13 mm | Product Label Full Prescribing Information Safety Data Sheet | Limited Availability | |
Product Label Full Prescribing Information Safety Data Sheet Wholesaler Numbers
Case Information
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*Zyprexa is a registered trademark of Eli Lilly and Company
1Approved Drug Products with Therapeutic Equivalence Evaluations.
https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?
Appl_Type=A&Appl_No=201741 Accessed May 30 2018.
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This is a boxed warning product. Please see below for Important Safety Information, including BOXED WARNING.
Powder, for Solution for Intramuscular UseINDICATIONS AND USAGEAgitation Associated with Schizophrenia and Bipolar I ManiaOlanzapine for injection is indicated for the treatment of acute agitation associated with schizophrenia and bipolar I mania.IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
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. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine for injection is not approved for the treatment of patients with dementia-related psychosis.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine for injection is not approved for the treatment of patients with dementia-related psychosis.
CONTRAINDICATIONSNone with olanzapine monotherapy.WARNINGS AND PRECAUTIONSElderly Patients with Dementia-Related Psychosis
Increased Mortality — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine for injection is not approved for the treatment of patients with dementia-related psychosis.In placebo-controlled clinical trials of elderly patients with dementia-related psychosis, the incidence of death in olanzapine-treated patients was significantly greater than placebo-treated patients (3.5% vs. 1.5%, respectively).Cerebrovascular Adverse Events, Including Stroke — Cerebrovascular adverse events, including fatalities, were reported in patients in trials of olanzapine in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with olanzapine compared to patients treated with placebo. Olanzapine is not approved for the treatment of patients with dementia-related psychosis.Suicide
The possibility of a suicide attempt is inherent in schizophrenia and in bipolar I disorder, and close supervision of high-risk patients should accompany drug therapy. Prescriptions for olanzapine should be written for the smallest quantity consistent with good patient management, in order to reduce the risk of overdose.Neuroleptic Malignant Syndrome (NMS)
A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome has been reported in association with administration of antipsychotic drugs, including olanzapine.The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available.If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. Recurrences of NMS have been reported.Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with olanzapine exposure. 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.Metabolic Changes
Atypical antipsychotic drugs have been associated with metabolic changes including hyperglycemia, dyslipidemia, and weight gain. Metabolic changes may be associated with increased cardiovascular/cerebrovascular risk.Hyperglycemia and Diabetes Mellitus
Physicians should consider the risks and benefits when prescribing olanzapine to patients with an established diagnosis of diabetes mellitus, or having borderline increased blood glucose level. Patients taking olanzapine should be monitored regularly 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.Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.Dyslipidemia
Undesirable alterations in lipids have been observed with olanzapine use. Clinical monitoring of lipids is recommended.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
A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs.Orthostatic Hypotension
Olanzapine may induce orthostatic hypotension.Leukopenia, Neutropenia, and Agranulocytosis
Class Effect — in clinical trial and/or postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including olanzapine. Agranulocytosis has also been reported.Dysphagia
Esophageal dysmotility and aspiration have been associated with antipsychotic drug use.Seizures
Olanzapine should be used cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold.Potential for Cognitive and Motor Impairment
Somnolence was a commonly reported adverse reaction associated with olanzapine treatment, occurring at an incidence of 26% in olanzapine patients compared to 15% in placebo patients.Body Temperature Regulation
Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing olanzapine for patients who will be experiencing conditions which may contribute to an elevation in core body temperature.Use in Patients with Concomitant Illness
Clinical experience with olanzapine in patients with certain concomitant systemic illnesses is limited.Hyperprolactinemia
Olanzapine elevates prolactin levels, and the elevation persists during chronic administration.Use in Combination with Lithium or Valproate
When using olanzapine for injection in combination with lithium or valproate, refer to the package inserts for lithium or valproate.ADVERSE REACTIONS
Adverse Reactions occurring in ≥1% of patients: asthenia, hypotension, postural hypotension, somnolence, dizziness, tremor. Other adverse reactions include, but are not limited to, injection site pain, syncope, nausea and creatine phosphokinase increased and extrapyramidal symptoms.POST-MARKETING EXPERIENCE
Adverse reactions reported since market introduction that were temporally (but not necessarily causally) related to olanzapine therapy include the following: allergic reaction, cholestatic or mixed liver injury, diabetic coma, diabetic ketoacidosis, discontinuation reaction, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), hepatitis, jaundice, neutropenia, pancreatitis, priapism, rash, rhabdomyolysis and venous thromboembolic events have been reported. Random cholesterol levels ≥240 mg/dL and triglyceride levels ≥1000 mg/dL have been reported.DRUG INTERACTIONS
The risks of using olanzapine in combination with other drugs have not been extensively evaluated in systematic studies.Potential for Other Drugs to Affect Olanzapine
Diazepam; Cimetidine and Antacids; Inducers of CYP1A2; Alcohol; Inhibitors of CYP1A2; Inhibitors of CYP2D6; Warfarin; Inducers of CYP1A2 or Glucuronyl Transferase; Charcoal.Potential for Olanzapine to Affect Other Drugs
CNS Acting Drugs; Antihypertensive Agents; Levodopa and Dopamine Agonists; Lorazepam (IM ); Lithium; Valproate.USE IN SPECIFIC POPULATIONS
Pregnancy
Teratogenic Effects — Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Non-Teratogenic Effects — Neonates exposed to antipsychotic drugs (including olanzapine for injection) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.Labor and Delivery
The effect of olanzapine on labor and delivery in humans is unknown.Nursing Mothers
In a study in lactating, healthy women, olanzapine was excreted in breast milk. Mean infant dose at steady state was estimated to be 1.8% of the maternal olanzapine dose. It is recommended that women receiving olanzapine should not breast-feed.Pediatric Use
Adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic aminotransferase levels. Safety and effectiveness of olanzapine for injection in children <13 years of age have not been established.Geriatric Use
Elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death compared to placebo. In placebo-controlled studies of olanzapine in elderly patients with dementia-related psychosis, there was a higher incidence of cerebrovascular adverse events in patients treated with olanzapine. The presence of factors that might decrease pharmacokinetic clearance or increase the pharmacodynamic response to olanzapine should lead to consideration of a lower starting dose for any geriatric patient.For additional Safety Information, please see Full Prescribing Information.You are encouraged to report Adverse Drug Events (ADEs) to American Regent Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/MedWatch or calling 1-800-FDA-1088.
Increased Mortality — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine for injection is not approved for the treatment of patients with dementia-related psychosis.In placebo-controlled clinical trials of elderly patients with dementia-related psychosis, the incidence of death in olanzapine-treated patients was significantly greater than placebo-treated patients (3.5% vs. 1.5%, respectively).Cerebrovascular Adverse Events, Including Stroke — Cerebrovascular adverse events, including fatalities, were reported in patients in trials of olanzapine in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with olanzapine compared to patients treated with placebo. Olanzapine is not approved for the treatment of patients with dementia-related psychosis.Suicide
The possibility of a suicide attempt is inherent in schizophrenia and in bipolar I disorder, and close supervision of high-risk patients should accompany drug therapy. Prescriptions for olanzapine should be written for the smallest quantity consistent with good patient management, in order to reduce the risk of overdose.Neuroleptic Malignant Syndrome (NMS)
A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome has been reported in association with administration of antipsychotic drugs, including olanzapine.The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available.If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. Recurrences of NMS have been reported.Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with olanzapine exposure. 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.Metabolic Changes
Atypical antipsychotic drugs have been associated with metabolic changes including hyperglycemia, dyslipidemia, and weight gain. Metabolic changes may be associated with increased cardiovascular/cerebrovascular risk.Hyperglycemia and Diabetes Mellitus
Physicians should consider the risks and benefits when prescribing olanzapine to patients with an established diagnosis of diabetes mellitus, or having borderline increased blood glucose level. Patients taking olanzapine should be monitored regularly 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.Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.Dyslipidemia
Undesirable alterations in lipids have been observed with olanzapine use. Clinical monitoring of lipids is recommended.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
A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs.Orthostatic Hypotension
Olanzapine may induce orthostatic hypotension.Leukopenia, Neutropenia, and Agranulocytosis
Class Effect — in clinical trial and/or postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including olanzapine. Agranulocytosis has also been reported.Dysphagia
Esophageal dysmotility and aspiration have been associated with antipsychotic drug use.Seizures
Olanzapine should be used cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold.Potential for Cognitive and Motor Impairment
Somnolence was a commonly reported adverse reaction associated with olanzapine treatment, occurring at an incidence of 26% in olanzapine patients compared to 15% in placebo patients.Body Temperature Regulation
Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing olanzapine for patients who will be experiencing conditions which may contribute to an elevation in core body temperature.Use in Patients with Concomitant Illness
Clinical experience with olanzapine in patients with certain concomitant systemic illnesses is limited.Hyperprolactinemia
Olanzapine elevates prolactin levels, and the elevation persists during chronic administration.Use in Combination with Lithium or Valproate
When using olanzapine for injection in combination with lithium or valproate, refer to the package inserts for lithium or valproate.ADVERSE REACTIONS
Adverse Reactions occurring in ≥1% of patients: asthenia, hypotension, postural hypotension, somnolence, dizziness, tremor. Other adverse reactions include, but are not limited to, injection site pain, syncope, nausea and creatine phosphokinase increased and extrapyramidal symptoms.POST-MARKETING EXPERIENCE
Adverse reactions reported since market introduction that were temporally (but not necessarily causally) related to olanzapine therapy include the following: allergic reaction, cholestatic or mixed liver injury, diabetic coma, diabetic ketoacidosis, discontinuation reaction, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), hepatitis, jaundice, neutropenia, pancreatitis, priapism, rash, rhabdomyolysis and venous thromboembolic events have been reported. Random cholesterol levels ≥240 mg/dL and triglyceride levels ≥1000 mg/dL have been reported.DRUG INTERACTIONS
The risks of using olanzapine in combination with other drugs have not been extensively evaluated in systematic studies.Potential for Other Drugs to Affect Olanzapine
Diazepam; Cimetidine and Antacids; Inducers of CYP1A2; Alcohol; Inhibitors of CYP1A2; Inhibitors of CYP2D6; Warfarin; Inducers of CYP1A2 or Glucuronyl Transferase; Charcoal.Potential for Olanzapine to Affect Other Drugs
CNS Acting Drugs; Antihypertensive Agents; Levodopa and Dopamine Agonists; Lorazepam (IM ); Lithium; Valproate.USE IN SPECIFIC POPULATIONS
Pregnancy
Teratogenic Effects — Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Non-Teratogenic Effects — Neonates exposed to antipsychotic drugs (including olanzapine for injection) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.Labor and Delivery
The effect of olanzapine on labor and delivery in humans is unknown.Nursing Mothers
In a study in lactating, healthy women, olanzapine was excreted in breast milk. Mean infant dose at steady state was estimated to be 1.8% of the maternal olanzapine dose. It is recommended that women receiving olanzapine should not breast-feed.Pediatric Use
Adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic aminotransferase levels. Safety and effectiveness of olanzapine for injection in children <13 years of age have not been established.Geriatric Use
Elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death compared to placebo. In placebo-controlled studies of olanzapine in elderly patients with dementia-related psychosis, there was a higher incidence of cerebrovascular adverse events in patients treated with olanzapine. The presence of factors that might decrease pharmacokinetic clearance or increase the pharmacodynamic response to olanzapine should lead to consideration of a lower starting dose for any geriatric patient.For additional Safety Information, please see Full Prescribing Information.You are encouraged to report Adverse Drug Events (ADEs) to American Regent Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/MedWatch or calling 1-800-FDA-1088.
REF-1542 5/2020