ZYPREXA RELPREVV- olanzapine pamoate   
Eli Lilly and Company

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Medication Guide

ZYPREXA® RELPREVV™ (zy-PREX-a REL-prev)

(olanzapine)

For Extended Release Injectable Suspension

Read the Medication Guide that comes with ZYPREXA RELPREVV before you start taking it and each time before you get an injection. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Talk with your doctor if there is something you do not understand or you want to learn more about ZYPREXA RELPREVV.

What is the most important information I should know about ZYPREXA RELPREVV?

Before you receive ZYPREXA RELPREVV treatment you must:

ZYPREXA RELPREVV may cause serious side effects, including:

  1. Post-injection Delirium Sedation Syndrome (PDSS).
  2. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis).
  3. High blood sugar (hyperglycemia).
  4. High fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers age 13 to 17.
  5. Weight gain, especially in teenagers age 13 to 17.

These serious side effects are described below.

  1. Post-injection Delirium Sedation Syndrome (PDSS). PDSS is a serious problem that can happen after you get a ZYPREXA RELPREVV injection if the medicine gets in your blood too fast. This problem usually happens within 3 hours after you receive ZYPREXA RELPREVV. If the medicine gets in your blood too fast, you may have some of the following symptoms:
    • feel more sleepy than usual
    • feel dizzy
    • feel confused or disoriented
    • trouble talking or walking
    • muscles feel stiff or shaking
    • feel weak
    • feel grouchy or angry
    • feel nervous or anxious
    • higher blood pressure
    • seizures (convulsions)
    • pass out (become unconscious or coma)

    You will need to stay at the clinic where you receive the injection for at least 3 hours so your doctor can make sure you do not have symptoms of PDSS. When you leave the clinic someone must be with you. If you have symptoms of PDSS after you leave the clinic, get medical help or go to an emergency room right away.

  2. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). ZYPREXA RELPREVV is not approved for treating psychosis in elderly people with dementia.
  3. High blood sugar (hyperglycemia). High blood sugar can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to:
    • a build up of acid in your blood due to ketones (ketoacidosis)
    • coma
    • death

    Your doctor should do tests to check your blood sugar before you start taking ZYPREXA RELPREVV and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when ZYPREXA RELPREVV is stopped. People with diabetes and some people who did not have diabetes before taking ZYPREXA RELPREVV need to take medicine for high blood sugar even after they stop taking ZYPREXA RELPREVV.

    If you have diabetes, follow your doctor's instructions about how often to check your blood sugar while taking ZYPREXA RELPREVV.

    Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking ZYPREXA RELPREVV:

    • feel very thirsty
    • need to urinate more than usual
    • feel very hungry
    • feel weak or tired
    • feel sick to your stomach
    • feel confused or your breath smells fruity
  4. High fat levels in your blood (cholesterol and triglycerides). High fat levels may happen in people treated with ZYPREXA RELPREVV, especially in teenagers (13 to 17 years old). ZYPREXA RELPREVV is not approved in patients less than 18 years old. You may not have any symptoms, so your doctor should do blood tests to check your cholesterol and triglyceride levels before you start taking ZYPREXA RELPREVV and during treatment.
  5. Weight gain. Weight gain is very common in people who take ZYPREXA RELPREVV. Teenagers (13 to 17 years old) are more likely to gain weight and to gain more weight than adults. ZYPREXA RELPREVV is not approved in patients less than 18 years old. Some people may gain a lot of weight while taking ZYPREXA RELPREVV, so you and your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.

What is ZYPREXA RELPREVV?

ZYPREXA RELPREVV is a long-acting prescription medicine given by injection and used to treat schizophrenia in adults. The symptoms of schizophrenia include:

Some of your symptoms of schizophrenia may improve with treatment with ZYPREXA RELPREVV. If you do not think you are getting better, call your doctor.

It is not known if ZYPREXA RELPREVV is safe and effective in children under 18 years of age.

What should I tell my doctor before taking ZYPREXA RELPREVV?

ZYPREXA RELPREVV may not be right for you. Before starting ZYPREXA RELPREVV, tell your doctor if you have or had:

Tell your doctor if you exercise a lot or are in hot places often.

The symptoms of schizophrenia may include thoughts of suicide or of hurting yourself or others. If you have these thoughts at any time, tell your doctor or go to an emergency room right away.

Tell your doctor about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. ZYPREXA RELPREVV and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Your doctor can tell you if it is safe to take ZYPREXA RELPREVV with your other medicines. Do not start or stop any medicine while taking ZYPREXA RELPREVV without talking to your doctor first.

How should I receive ZYPREXA RELPREVV?

What should I avoid while receiving ZYPREXA RELPREVV?

What are the possible side effects of ZYPREXA RELPREVV?

Serious side effects may happen when you take ZYPREXA RELPREVV, including:

Common side effects of ZYPREXA RELPREVV include: headache, sleepiness or drowsiness, weight gain, dry mouth, diarrhea, nausea, common cold, eating more (increased appetite), vomiting, cough, back pain, or pain at the injection site.

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects with ZYPREXA RELPREVV. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about ZYPREXA RELPREVV

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

This Medication Guide summarizes the most important information about ZYPREXA RELPREVV. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ZYPREXA RELPREVV that was written for healthcare professionals. For more information about ZYPREXA RELPREVV call 1-800-Lilly-Rx (1-800-545-5979) or visit www.zyprexarelprevv.com.

What are the ingredients in ZYPREXA RELPREVV?

Active ingredient: olanzapine

Inactive ingredients: carboxymethylcellulose sodium, mannitol, polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Medication Guide revised August 3, 2012

Marketed by: Lilly USA, LLC

Indianapolis, IN 46285, USA

www.zyprexarelprevv.com

Copyright © 2009, 2012, Eli Lilly and Company. All rights reserved.

PV 5942 AMP

Revised: 10/2014
 
Eli Lilly and Company