LEGAL NOTICE AND TERMS OF USE

Effective Date: April 1, 2025

Teva Pharmaceuticals USA, Inc. (“Teva”) maintains this site, www.olanzapine.com (the “Site”), for your personal information, education, and communication. While you should feel free to browse the Site, please understand that your access to and use of the Site is subject to the following terms and conditions (“Terms and Conditions”) and all applicable laws. By accessing and browsing the Site, you accept, without limitation or qualification, the Terms and Conditions and acknowledge that any other agreements between you and Teva concerning the Site are superseded to the extent they conflict with these Terms and Conditions. Your use of or linking to any content on the Site, except as provided in these Terms and Conditions, is strictly prohibited.

Terms and Conditions

You should assume that everything you see or read on the Site is copyrighted and may not be used without the written permission of Teva, except as provided in these Terms and Conditions or in the text on the Site. Teva neither warrants nor represents that your use of material displayed on the Site will not infringe rights of third parties. Nothing contained on the Site should be construed as granting, by implication, estoppel, or otherwise, any license or right to use any Teva intellectual property right (including, but not limited to any patent, trademark, trade name, copyright or trade secret).
You may download material displayed on the Site for non-commercial, personal use only, provided you also retain all copyright and other proprietary notices contained in the materials or as specified on the Site. You may not, however, distribute, modify, transmit, reuse, re-post, or use the content of the Site, including the text, images, audio, and video, for public or commercial purposes.
Images of people or places displayed on the Site are either the property of, or used with permission by, Teva. The use of these images by you, or anyone else authorized by you, is prohibited unless specifically permitted by these Terms and Conditions or as provided elsewhere on the Site. Any unauthorized use of the images may violate copyright laws, trademark laws, the laws of privacy and publicity, and communications regulations and statutes. You are also advised that Teva will aggressively enforce its intellectual property rights to the fullest extent of the law, including the seeking of criminal prosecution.
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Teva has not reviewed all of the sites linked to the Site and is not responsible for the content of any off-site pages or any other sites linked to the Site. Your linking to any other off-site pages or other sites is at your own risk.
While Teva uses reasonable efforts to include accurate and up to date information in the Site, Teva makes no warranties or representations as to its accuracy. Teva shall not be held responsible for any action taken that is based on the information presented on the Site, and all users of the Site agree that access and use of the Site is at the user's own risk. Teva assumes no liability or responsibility for any errors or omissions in the content of the Site.
Your use of and browsing in the Site are at your own risk. Neither Teva nor any other party involved in creating, producing, hosting or delivering the Site is liable for any direct, incidental, consequential, indirect, or punitive damages arising out of your access to, or use of, the Site or its contents. Without limiting the foregoing, everything on the Site is provided to you "AS IS," WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. Please note that some jurisdictions may not allow the exclusion of implied warranties, so some of the above exclusions may not apply to you. Check your local laws for any restrictions or limitations regarding the exclusion of implied warranties.
You agree to indemnify, defend and hold harmless Teva, its officers, directors, employees, agents, suppliers and third party partners from and against all losses, expenses, damages and costs, including reasonable attorneys’ fees, resulting from any violation by you of these Terms and Conditions.
Teva also assumes no responsibility, and shall not be liable for, any damages to, or viruses that may infect your computer equipment or other property on account of your access to, use of, or browsing in the Site or your downloading of any materials, data, text, images, video or audio from the Site.
Any communication or material you transmit to the Site by electronic mail or otherwise, including any data, questions, comments, suggestions, or the like is, and will be treated as, non-confidential and non-proprietary. Anything you transmit or post may be used by Teva or its affiliates for any purpose, including, but not limited to, reproduction, disclosure, transmission, publication, broadcast and posting. Furthermore, Teva is free to use any ideas, concepts, know-how, or techniques contained in any communication you send to the Site for any purpose whatsoever including, but not limited to, developing, manufacturing, marketing, and selling products using such ideas, concepts, know-how, or techniques.
Teva may at any time revise these Terms and Conditions by updating this posting. You are bound by any such revisions and should therefore periodically visit this page to review the then current Terms and Conditions to which you are bound.
Teva maintains this Site as a service to the internet community. The Site has been designed to provide general information about Teva and its products. These pages are not intended to provide investment or medical advice, nor do they provide instruction on the appropriate use of products manufactured or sold by Teva or products currently under development by Teva, its affiliates, related companies, or its licensors or joint venture partners. Information on this Site regarding products approved for marketing is qualified in its entirety by reverence to the full prescribing information for such products. Users of this Site should be aware that products under development described herein have not been found safe or effective by any regulatory agency and are not approved for any use outside of clinical trials.
You agree that any action at law or in equity arising out of or relating to these Terms and Conditions or the Site shall be filed, and that venue properly lies, only in state or federal courts located in New Jersey, and you hereby consent and submit to the personal jurisdiction of such courts for the purposes of litigating any such action. Neither you nor Teva will seek to have a dispute heard as a class action, private attorney general action, or in any other proceeding in which either party acts or proposes to act in a representative capacity. If the class action waiver is found to be illegal or unenforceable as to all or some parts of a dispute, those parts will be severed and proceed in a court of law. We make no representation that Content on the Site is appropriate or available for use in any particular location. Those who choose to access the Site do so on their own initiative and are responsible for compliance with all applicable laws including any applicable local laws.
If you choose to provide us with personal information about yourself, we will handle your information according to the terms of our Privacy Notice. Our Privacy Notice is incorporated by reference into these Terms.
Contact Teva: If you have any questions about these Terms and Conditions, please write to us at the following address:

Office of General Counsel

Teva Pharmaceuticals

400 Interpace Pkwy #3

Parsippany, NJ 07054

Disclaimer

The Site was intended specifically for individuals who are U.S. residents. This content has not been approved for non-U.S. residents. The information should not be considered complete and should not be used in place of a visit, call, consultation or advice of your physician or other healthcare provider. This web site does not recommend the self-management of health problems. Information obtained through the Site is not exhaustive and does not cover all ailments, physical conditions or their treatment. Should you have any healthcare-related questions, please call or see your physician or other healthcare provider promptly. You should never disregard medical advice or delay in seeking it because of something you have read here.

VISITORS TO THE SITE ARE URGED AND ADVISED TO SEEK THE ADVICE OF A PHYSICIAN BEFORE BEGINNING ANY TREATMENT. Such individuals are specifically warned to seek professional medical advice prior to initiating any form of health treatment.

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. OLANZAPINE is not approved for the treatment of patients with dementia-related psychosis.

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. OLANZAPINE is not approved for the treatment of dementia-related psychosis.
Suicide: The possibility of a suicide attempt is inherent in schizophrenia, and close supervision of high-risk patients should accompany drug therapy.
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). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. If NMS is suspected, immediately discontinue OLANZAPINE and provide symptomatic treatment and monitoring.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): 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 if DRESS is suspected.
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. 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 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. 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 (≥500 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: OLANZAPINE may induce orthostatic hypotension associated with dizziness, tachycardia, bradycardia, and in some patients, syncope, especially during the initial dose-titration period with oral OLANZAPINE. OLANZAPINE should be used with particular caution in patients with known cardiovascular disease, with cerebrovascular disease, or who are predisposed to hypotension.
Falls: OLANZAPINE 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 OLANZAPINE should 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 OLANZAPINE and have their WBC counts checked until recovery.
Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Antipsychotic drugs, including OLANZAPINE, should be used cautiously in patients at risk for aspiration.
Seizures: OLANZAPINE should be used cautiously in patients with a history of seizures or with conditions that lower the seizure threshold, e.g., Alzheimer’s dementia. OLANZAPINE is not approved for the treatment of patients with Alzheimer disease.
Potential for Cognitive and Motor Impairment: OLANZAPINE 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 OLANZAPINE therapy does not affect them adversely.
Body Temperature Dysregulation may occur with antipsychotic agents. Appropriate care is advised when prescribing OLANZAPINE 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. OLANZAPINE 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 administration. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.

The most common treatment-emergent adverse events (incidence of ≥5% and greater than placebo) associated with oral olanzapine (vs placebo) in 6-week schizophrenia trials in adults were somnolence (26% vs 15%), dizziness (11% vs 4%), weight gain (6% vs 1%), personality disorder (COSTART term for nonaggressive objectional behavior; 8% vs 4%), constipation (9% vs 3%), akathisia (5% vs 1%), and postural hypotension (5% vs 2%).

The most common treatment-emergent adverse events (incidence of ≥5% and greater than placebo) associated with oral olanzapine (vs placebo) in 3- and 4-week bipolar I disorder (manic or mixed episodes) trials in adults were somnolence (35% vs 13%), dry mouth (22% vs 7%), dizziness (18% vs 6%), asthenia (15% vs 6%), constipation (11% vs 5%), dyspepsia (11% vs 5%), increased appetite (6% vs 3%), and tremor (6% vs 3%).

The most common treatment-emergent adverse events (incidence of ≥5% and greater than placebo) associated with oral olanzapine (vs placebo) in clinical trials of adolescents (aged 13-17 years) were sedation (44% vs 9%), weight increased (30% vs 6%), increased appetite (24% vs 6%), headache (17% vs 12%), fatigue (9% vs 4%), liver enzymes increased (8% vs 1%), dizziness (7% vs 2%), dry mouth (6% vs 0%), and pain in extremity (5% vs 1%).

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

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: OLANZAPINE is present in human milk. Infants should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements).
Fertility: OLANZAPINE may cause a reversible reduction in fertility in females.
Pediatric Use: Oral olanzapine is indicated for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents aged 13 to 17 years. The recommended starting dose for adolescents is lower than that for adults. Compared with patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin, and hepatic transaminase levels. When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential for weight gain and hyperlipidemia compared with adults. Clinicians should consider the long-term risks when prescribing to adolescents, and in many cases, this may lead them to consider prescribing other drugs first in adolescents. Medication treatment for adolescent schizophrenia and bipolar I disorder should be initiated only after a thorough diagnostic evaluation and careful consideration of the risks associated with medication treatment. Medication treatment for both adolescent schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational, and social interventions. Safety and effectiveness of olanzapine in patients younger than 13 years have not been established.

OLANZAPINE Orally Disintegrating Tablets are indicated for the treatment of schizophrenia, for acute manic and mixed episodes of bipolar I disorder, and for maintenance treatment in bipolar I disorder.

Please see the full Prescribing Information for OLANZAPINE, including Boxed WARNING.

LEGAL NOTICE AND TERMS OF USE

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