See full prescribing information for complete boxed warning. Your doctor can tell you if it is safe to take zyprexa relprevv with your other medicines. Apr 23, 2019 dosing of zyprexa relprevv ranges from 1020 mg daily for schizophrenia, and 1015 mg daily for bipolar i disorder. Highlights of prescribing information metabolic changes. More than 1 million american youths take antipsychotic drugs. Intramuscular 10 mgvial is a shortacting formulation and should not be confused with zyprexa relprevv. For more information about zyprexa relprevv, contact your doctor or other healthcare professional. Refer to the package insert for zyprexa intramuscular for more information about that product. Listing a study does not mean it has been evaluated by the u. In general, clinicians can use a stepwise approach to managing missed doses of laias figure 10. Eli lilly and company application no 022173 approval date. Also refer to the adverse reactions section of the package insert for symbyax.
For more information about treatment with zyprexa velotab, read the package leaflet also part of the epar or contact your doctor or pharmacist. Refer to the prescribing information for oral aripiprazole for recommendations regarding dosage adjustments due to drug interactions, for the first 21 days when the patient is taking 21 days of oral aripiprazole concomitantly with the first dose of aristada. Please see the prescribing information and the reconstitution and administration poster. Side effects of zyprexa relprevv olanzapine extended release. Abilify maintena is a longacting aripiprazole formulation with 4week dosing intervals indicated for the treatment of schizophrenia and maintenance monotherapy of bipolar i disorder in adults. Currently receiving medication via health plan benefit and documentation supports. Elderly patients with dementiarelated psychosis treated with antipsychotic drugs are at an increased risk of death. Zyprexa relprevv, an extendedrelease injectable suspension of olanzapine, received fda approval in december 2009 for the treatment of schizophrenia in adults. A doctor may prescribe zyprexa zydis disintegrating tablets to treat schizophrenia or bipolar disorder. Zyprexa relprevv should be administered by a healthcare professional every 2 to 4 weeks by deep intramuscular gluteal injection using a. Zyprexa dosage for injectable forms shortacting zyprexa injection is used to treat agitation due to schizophrenia or bipolar disorder and is typically used in dosages ranging from 2.
Oct 23, 2019 refer to the package insert for zyprexa intramuscular for more information about that product. Zyprexa relprevv is a combination of olanzapine and pamoic acid in the form of a crystalline salt, which is insoluble in water but has very low solubility in muscle. In case of overdose, get medical help or contact a poison control center immediately. In addition, people with bipolar disorder are frequently found to have psychiatric and general medical comorbidities, such as cardiometabolic disease. Schizophrenia is a mental illness with disturbances in thinking, feelings and behaviour. The fda says it wont recommend new limits on eli lilly schizophrenia med zyprexa relprevv after almost a year of investigating the deaths of. Prior approval is required to ensure the safe, clinically appropriate and cost effective use of zyprexa relprevv while maintaining optimal therapeutic outcomes. Zyprexa is used for the treatment of psychotic conditions such as schizophrenia and bipolar disorder.
Zyprexa relprevv fda prescribing information, side effects. The potential for signs and symptoms of sedation andor delirium consistent with olanzapine overdose exists after every injection of zyprexa relprevv. Zyprexa intramuscular olanzapine injection, powder, for. Fda lets lillys longacting zyprexa off the hook in. Antipsychotics for children with adhd should be a last resort. Olanzapine, sold under the trade name zyprexa among others, is an atypical antipsychotic. Zyprexa relprevv olanzapine for extended release injectable suspension 210 mg, 300 mg, and 405 mg company. Food and drug administration, center for drug evaluation and research. Paxos prescribing pearls from your friendly neighborhood. This emedtv page offers a brief overview of this product, including some general dosing tips, available strengths, and potential side effects. Please see prescribing information for full details about the risks of zyprexa relprevv, including boxed warnings. Find patient medical information for zyprexa relprevv intramuscular on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Zyprexa relprevv can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how zyprexa relprevv affects you.
Clinical policy longacting injectable atypical antipsychotics page 3 of 5 b. Establish tolerability with oral olanzapine prior to initiating treatment. Zyprexa, zyprexa relprevv olanzapine dosing, indications. Zyprexa olanzapine tablet zyprexa zydis olanzapine tablet, orally disintegrating zyprexa intramuscular olanzapine injection, powder, for solution eli lilly and company highlights of prescribing information these highlights do not include all the information needed to use zyprexa safely and effectively. After the first abilify maintena injection, administer oral aripiprazole 10 mg to 20 mg for 14 consecutive days to achieve therapeutic aripiprazole concentrations during initiation of therapy.
Establish tolerability with oral olanzapine prior to initiating. Currently, there is no concrete guidance on how to address missed doses of olanzapine longacting injection. Olanzapine is approved in the united states by the food and drug administration fda for. Such individuals are at an increased risk of death. These highlights do not include all the information needed to. The zyprexa relprevv patient care program is a risk evaluation and mitigation strategy rems program necessary to mitigate the risk of negative outcomes associated with zyprexa relprevv postinjection deliriumsedation syndrome pdss.
Zyprexa relprevv olanzapine pamoate has a black box warning regarding use in elderly individuals with dementiarelated psychosis. It helps to correct chemical imbalances in the brain, which may cause mental illness. Zyprexa is not approved for the treatment of patients with dementiarelated psychosis. Demystifying zyprexa relprevv usage mental health clinician. Zyprexa relprevv patient care program instructions brochure. Zyprexa relprevv is present as a yellow solid in a glass vial equivalent to 210, 300, or 405 mg olanzapine per vial. Zyprexa intramuscular olanzapine injection, powder. Before starting any laia, patients should receive the oral formulation of that antipsychotic to establish tolerability. Zyprexa intramuscular for more information about that product. You should not drive or operate heavy machinery for the rest of the day after each injection. These highlights do not include all the information needed. Agitation with schizophrenia and bipolari maniaadults somnolence. Zyprexa is not approved for the treatment of patients with dementiarelated psychosis 5. Approved drug products with therapeutic equivalence evaluations.
The treatment plan includes concomitant oral aripiprazole for 14 days with the next administered injection if one of the following. The maximum dose is 20 mg daily for both schizophrenia and bipolar i disorder. Secondgeneration longacting injectable antipsychotics. Highlights of prescribing information these highlights. Zyprexa relprevv is given as an injection into a large muscle in the buttocks where it is slowly released over 2 to 4 weeks. Zyprexa relprevv olanzapine is an atypical antipsychotic prescribed to treat schizophrenia and acute manic episodes associate with bipolar disorder. Side effects of zyprexa relprevv olanzapine extended.
The european commission granted a marketing authorisation valid throughout the european union for zyprexa velotab on 3 february 2000. When using zyprexa and fluoxetine in combination, also refer to the boxed warning section of the package insert for symbyax. Bipolar disorder has a lifelong effect on patients overall health status, healthrelated quality of life, and functioning. Ask your doctor or nurse if you have any questions about why zyprexa relprevv has been. Zyprexa relprevv authorization guidelines continuity of care will be allowed for the following conditions. Your doctor may have prescribed zyprexa relprevv for another reason. You need to login to view this content please login in order to access this content.
Do not start or stop any medicine while taking zyprexa relprevv without talking to your doctor first. Zyprexa relprevv may interact with blood pressure medications, alprazolam, diazepam, clonazepam, lorazepam, temazepam, or oral olanzapine. This injection should only be given by a doctor or nurse. Oct 22, 2019 zyprexa relprevv and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Zyprexa relprevv should be administered by a healthcare professional every 2 to 4 weeks by deep intramuscular gluteal injection using a 19gauge, 1. Zyprexa relprevv belongs to a group of medicines called antipsychotics. Members 18 years or older started on an atypical antipsychotic during a recent hospitalization will receive a 90 day approval requests for continued use.
Zyprexa relprevv is used to treat symptoms of schizophrenia. Administer 21 consecutive days of oral aripiprazole. When injected into the gluteal muscle, the salt then dissolves slowly at the site of the injection. Zyprexa relprevv or to any of the ingredients listed at the end of this leaflet see. Abilify is not approved for the treatment of patients with dementiarelated psychosis. Saphris 5 mg tablets, black cherry flavor, are round, white to offwhite sublingual tablets, with 5 on one side within a circle. Zyprexa is not approved for the treatment of patients with dementiarelated when using zyprexa and fluoxetine in combination, also refer to the boxed warning section of the package insert for symbyax. Do not administer intravascularly or subcutaneously. Do not take zyprexa, zyprexa relprevv, or zyprexa zydis if you are allergic to olanzapine or any ingredients contained in this drug. Zyprexa relprevv is a longacting atypical antipsychotic used in the treatment of schizophrenia. Tolerability with oral zyprexa olanzapine must be established prior to initiating treatment with zyprexa relprevv 1. Due to the halflife of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability. First, establish the number of laia doses the patient had received prior to the last dose, and whether these injections were administered on schedule. Approved risk evaluation and mitigation strategies rems.
The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering. Zyprexa relprevv fda prescribing information, side. In the past decade, physicians have been more likely to prescribe antipsychotic medications to children, and especially adolescents, than ever before. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and.
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