Zyprexa Tablets 5 mg

ZYPREXA RELPREVV is available only through a restricted distribution program [see Warnings and Precautions ( 5.2 )] . ZYPREXA RELPREVV must not be dispensed directly to a patient. For a patient to receive treatment, the prescriber, healthcare setting, patient, and pharmacy must all be enrolled in the ZYPREXA RELPREVV REMS. To enroll, call 1-877-772-9390. ZYPREXA ® RELPREVV™ is a long-acting atypical antipsychotic for intramuscular injection indicated for the treatment of schizophrenia. ( 1.1 ) Efficacy was established in two clinical trials in patients with schizophrenia: one 8-week trial in adults and one maintenance trial in adults. …

• 150 mg/2 wks, 300 mg/4 wks, 210 mg/2 wks, 405 mg/4 wks, or 300 mg/2 wks
• See Table 1 for dosing recommendations
• ZYPREXA RELPREVV is intended for deep intramuscular gluteal injection only
• Do not administer intravenously or subcutaneously
• Be aware that there are two ZYPREXA intramuscular formulations with different dosing schedules
• ZYPREXA IntraMuscular (10 mg/vial) is a short-acting formulation and should not be confused with ZYPREXA RELPREVV
• Establish tolerability with oral olanzapine prior to initiating treatment
• ZYPREXA RELPREVV doses above 405 mg every 4 weeks or 300 mg every 2 weeks have not been evaluated in clinical trials
• Use in specific populations (including renal and hepatic impaired, and pediatric population) has not been studied
• Must be suspended using only the diluent for ZYPREXA RELPREVV provided in the convenience kit
• Dosage ZYPREXA RELPREVV is intended for deep intramuscular gluteal injection only and should not be administered intravenously or subcutaneously
• Be aware that there are two ZYPREXA intramuscular formulations with different dosing schedules
• ZYPREXA IntraMuscular (10 mg/vial) is a short-acting formulation and should not be confused with ZYPREXA RELPREVV
• Refer to the package insert for ZYPREXA IntraMuscular for more information about that product

ZYPREXA RELPREVV is a powder for suspension for intramuscular use only. ZYPREXA RELPREVV is present as a yellow solid in a glass vial equivalent to 210, 300, or 405 mg olanzapine single-dose per vial. The diluent is a clear, colorless to slightly yellow solution in a glass vial [see Description ( 11 ) and How Supplied/Storage and Handling ( 16 )] . …

• Safety and effectiveness of ZYPREXA RELPREVV in children and adolescent patients have not been established [see Warnings and Precautions ]
• Compared to patients from adult clinical trials, adolescents treated with oral ZYPREXA were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic aminotransferase levels

Clinical studies of ZYPREXA RELPREVV did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In the premarketing clinical studies with oral olanzapine, there was no indication of any different tolerability of olanzapine in elderly patients compared to younger patients with schizophrenia. …

• Advise the patient to read the FDA-approved patient labeling ( Medication Guide )
• Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking ZYPREXA RELPREVV
• Patients should be advised to call their doctor if they do not think they are getting better or have concerns about their condition
• Post-Injection Delirium/Sedation Syndrome During premarketing clinical studies, reactions that presented with signs and symptoms consistent with olanzapine overdose have been reported in patients following an injection of ZYPREXA RELPREVV
• It is mandatory that patients be enrolled in the ZYPREXA RELPREVV REMS to receive ZYPREXA RELPREVV treatment. …

• None
• None

CNS Acting Drugs: Caution should be used when used in combination with other centrally acting drugs and alcohol. ( 7.2 ) Antihypertensive Agents: Enhanced antihypertensive effect. ( 7.2 ) Levodopa and Dopamine Agonists: May antagonize levodopa/dopamine agonists. ( 7.2 ) Diazepam: May potentiate orthostatic hypotension. ( 7.1 , 7.2 ) Alcohol: May potentiate orthostatic hypotension. ( 7.1 ) Carbamazepine: Increased clearance of olanzapine. ( 7.1 ) Fluvoxamine: May increase olanzapine levels. …

Elderly Patients with Dementia-Related Psychosis: Increased risk of death and increased incidence of cerebrovascular adverse events (e.g. stroke, transient ischemic attack). ( 5.3 ) Suicide: The possibility of a suicide attempt is inherent in schizophrenia, and close supervision of high-risk patients should accompany drug therapy. ( 5.4 ) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. ( 5.5 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue if DRESS is suspected. ( 5.6 ) Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes including hyperglycemia, dyslipidemia, and weight gain. …

Most common adverse reactions (≥5% in at least one of the treatment groups and greater than placebo) associated with ZYPREXA RELPREVV treatment: headache, sedation, weight gain, cough, diarrhea, back pain, nausea, somnolence, dry mouth, nasopharyngitis, increased appetite, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact the Safety Call Center at 1-866-770-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or p …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including ZYPREXA RELPREVV, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. …

10.1 Human Experience During premarketing clinical studies of ZYPREXA RELPREVV, adverse reactions that presented with signs and symptoms consistent with olanzapine overdose, in particular, sedation (including coma) and/or delirium, were reported in patients following an injection of ZYPREXA RELPREVV [see Boxed Warning and Dosage and Administration ( 2.1 )] . These reactions occurred in

9.3 Dependence In studies prospectively designed to assess abuse and dependence potential, olanzapine was shown to have acute depressive CNS effects but little or no potential of abuse or physical dependence in rats administered oral doses up to 15 times the daily oral MRHD (20 mg) and rhesus monkeys administered oral doses up to 8 times the daily oral MRHD based on mg/m 2 body surface area. …

ZYPREXA RELPREVV should be stored at room temperature not to exceed 30°C (86°F). When the drug product is suspended in the solution for ZYPREXA RELPREVV, it may be held at room temperature for 24 hours. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.