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Zyprexa Relprevv

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Zyprexa Relprevv

PATIENT INFORMATION

Medication Guide

ZYPREXA® RELPREVV™
(zy-PREX-a REL-prev)
(olanzapine) For Extended Release Injectable Suspension

Read the Medication Guide that comes with ZYPREXA RELPREVV (olanzapine extended release injectable suspension) 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 (olanzapine extended release injectable suspension) .

What is the most important information I should know about ZYPREXA RELPREVV (olanzapine extended release injectable suspension) ?

To receive ZYPREXA RELPREVV (olanzapine extended release injectable suspension) you have to:

  • talk to your doctor to understand the benefits and risks of ZYPREXA RELPREVV (olanzapine extended release injectable suspension)
  • register in and agree to the rules of the ZYPREXA RELPREVV (olanzapine extended release injectable suspension) Patient Care Program

Serious side effects may happen when you take ZYPREXA RELPREVV (olanzapine extended release injectable suspension) , including:

Post-injection Delirium Sedation Syndrome (PDSS): PDSS is a serious reaction that can happen after you get a ZYPREXA RELPREVV (olanzapine extended release injectable suspension) injection if the medicine gets in your blood too fast. If this happens, you may have some of these 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
  • pass out (become unconscious or coma)

If you have symptoms of PDSS, you need to get medical help or be taken to an emergency room right away.

Increased risk of death in elderly patients with dementia-related psychosis: Medicines like ZYPREXA RELPREVV (olanzapine extended release injectable suspension) can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ZYPREXA RELPREVV (olanzapine extended release injectable suspension) is not approved for treating psychosis in the elderly with dementia.

High blood sugar (hyperglycemia): High blood sugar can happen if you have diabetes already or even if you have never had diabetes. In rare cases, this could lead to ketoacidosis (build up of acid in the blood due to ketones), coma, or death. Your doctor should do lab tests to check your blood sugar before you start taking ZYPREXA RELPREVV (olanzapine extended release injectable suspension) and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when ZYPREXA RELPREVV (olanzapine extended release injectable suspension) is stopped. People with diabetes and some people who did not have diabetes before taking ZYPREXA RELPREVV (olanzapine extended release injectable suspension) need to take medicine for high blood sugar even after they stop taking ZYPREXA RELPREVV (olanzapine extended release injectable suspension) .

If you have diabetes, follow your doctor's instructions about how often to check your blood sugar while taking ZYPREXA RELPREVV (olanzapine extended release injectable suspension) .

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

  • 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.

High cholesterol and triglyceride levels in the blood (fat in the blood) may happen in people treated with ZYPREXA RELPREVV (olanzapine extended release injectable suspension) , especially in teenagers (13-17 years old). ZYPREXA RELPREVV (olanzapine extended release injectable suspension) 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.

Increase in weight (weight gain): Weight gain is very common in people who take ZYPREXA RELPREVV (olanzapine extended release injectable suspension) . Teenagers (13-17 years old) are more likely to gain weight and to gain more weight than adults. ZYPREXA RELPREVV (olanzapine extended release injectable suspension) is not approved in patients less than 18 years old. Some people may gain a lot of weight while taking ZYPREXA RELPREVV (olanzapine extended release injectable suspension) , 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.

Increased risk in teenagers (13-17 years old): ZYPREXA RELPREVV (olanzapine extended release injectable suspension) is not approved in patients less than 18 years old. Possible serious risks of weight gain and increases in cholesterol and triglycerides are more common in teenagers than in adults. You and your doctor should decide if other available treatments should be used first. Before your teenager takes ZYPREXA RELPREVV (olanzapine extended release injectable suspension) , talk with your doctor about the possible long-term risks of teenagers taking ZYPREXA RELPREVV (olanzapine extended release injectable suspension) .

What is ZYPREXA RELPREVV (olanzapine extended release injectable suspension) ?

ZYPREXA RELPREVV (olanzapine extended release injectable suspension) is a long-acting prescription medicine given by injection used to treat schizophrenia in adults. The symptoms of schizophrenia include hearing voices, seeing things that are not there, having beliefs that are not true, and being suspicious or withdrawn. Treatment with ZYPREXA RELPREVV (olanzapine extended release injectable suspension) may lessen some of your symptoms of schizophrenia. If you do not think you are getting better, call your doctor.

It is not known if ZYPREXA RELPREVV (olanzapine extended release injectable suspension) is safe and works in children younger than 18 years old.

What should I tell my doctor before taking ZYPREXA RELPREVV (olanzapine extended release injectable suspension) ?

ZYPREXA RELPREVV (olanzapine extended release injectable suspension) may not be right for you. Before starting ZYPREXA RELPREVV (olanzapine extended release injectable suspension) , tell your doctor if you have or had:

  • heart problems
  • seizures
  • diabetes or high blood sugar levels (hyperglycemia)
  • high cholesterol or triglyceride levels in your blood
  • liver problems
  • low or high blood pressure
  • strokes or “mini-strokes” also called transient ischemic attacks (TIAs)
  • Alzheimer's disease
  • narrow-angle glaucoma
  • enlarged prostate in men
  • bowel obstruction
  • breast cancer
  • thoughts of suicide or hurting yourself
  • any other medical condition
  • are pregnant or plan to become pregnant. It is not known if ZYPREXA RELPREVV (olanzapine extended release injectable suspension) will harm your unborn baby.
  • are breast-feeding or plan to breast-feed. ZYPREXA RELPREVV (olanzapine extended release injectable suspension) can pass into your breast milk and may harm your baby. You should not breast-feed while taking ZYPREXA RELPREVV (olanzapine extended release injectable suspension) . Talk to your doctor about the best way to feed your baby if you take ZYPREXA RELPREVV (olanzapine extended release injectable suspension) .

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 (olanzapine extended release injectable suspension) 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 (olanzapine extended release injectable suspension) with your other medicines. Do not start or stop any medicine while taking ZYPREXA RELPREVV (olanzapine extended release injectable suspension) without talking to your doctor first.

How will I receive ZYPREXA RELPREVV (olanzapine extended release injectable suspension) ?

  • ZYPREXA RELPREVV (olanzapine extended release injectable suspension) will be injected into the muscle in your buttock (gluteus) by your doctor or nurse at the clinic.
  • After receiving ZYPREXA RELPREVV (olanzapine extended release injectable suspension) , you will need to stay at the clinic for at least 3 hours.
  • When you leave the clinic, someone must be with you.
  • You should not drive or use heavy machinery for the rest of the day after receiving ZYPREXA RELPREVV (olanzapine extended release injectable suspension) .
  • Call your doctor if you do not think you are getting better or have any concerns about your condition while taking ZYPREXA RELPREVV (olanzapine extended release injectable suspension) .

What should I avoid while taking ZYPREXA RELPREVV (olanzapine extended release injectable suspension) ?

  • ZYPREXA RELPREVV (olanzapine extended release injectable suspension) can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how ZYPREXA RELPREVV affects you. You should not drive or operate heavy machinery for the rest of the day after each injection.
  • Avoid drinking alcohol while taking ZYPREXA RELPREVV (olanzapine extended release injectable suspension) . Drinking alcohol while you take ZYPREXA RELPREVV (olanzapine extended release injectable suspension) may make you sleepier than if you take ZYPREXA RELPREVV alone.

What are the possible side effects of ZYPREXA RELPREVV (olanzapine extended release injectable suspension) ?

Serious side effects may happen when you take ZYPREXA RELPREVV (olanzapine extended release injectable suspension) , including:

  • See “What is the most important information I should know about ZYPREXA RELPREVV?”, which describes the risk of post-injection delirium sedation syndrome (PDSS), increased risk of death in elderly people with dementia-related psychosis and the risks of high blood sugar, high cholesterol and triglyceride levels, and weight gain.
  • Increased incidence of stroke or “mini-strokes” called transient ischemic attacks (TIAs) in elderly people with dementia-related psychosis(elderly people who have lost touch with reality due to confusion and memory loss). ZYPREXA RELPREVV (olanzapine extended release injectable suspension) is not approved for these patients.
  • Neuroleptic Malignant Syndrome (NMS): NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including ZYPREXA RELPREVV (olanzapine extended release injectable suspension) . NMS can cause death and must be treated in a hospital. Call your doctor right away if you become severely ill and have any of these symptoms:
    • high fever
    • excessive sweating
    • rigid muscles
    • confusion
    • changes in your breathing, heartbeat, and blood pressure.
  • Tardive Dyskinesia: This condition causes body movements that keep happening and that you can not control. These movements usually affect the face and tongue. Tardive dyskinesia may not go away, even if you stop taking ZYPREXA RELPREVV (olanzapine extended release injectable suspension) . It may also start after you stop taking ZYPREXA RELPREVV (olanzapine extended release injectable suspension) . Tell your doctor if you get any body movements that you can not control.
  • Decreased blood pressure when you change positions, with symptoms of dizziness, fast or slow heart beat, or fainting.
  • Difficulty swallowing, that can cause food or liquid to get into your lungs.
  • Seizures: Tell your doctor if you have a seizure during treatment with ZYPREXA RELPREVV (olanzapine extended release injectable suspension) .
  • Problems with control of body temperature: You could become very hot, for instance when you exercise a lot or stay in an area that is very hot. It is important for you to drink water to avoid dehydration. Call your doctor right away if you become severely ill and have any of these symptoms of dehydration:
    • sweating too much or not at all
    • dry mouth
    • feeling very hot
    • feeling thirsty
    • not able to produce urine.

Common side effects of ZYPREXA RELPREVV (olanzapine extended release injectable suspension) 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 (olanzapine extended release injectable suspension) . 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 (olanzapine extended release injectable suspension)

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 (olanzapine extended release injectable suspension) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ZYPREXA RELPREVV (olanzapine extended release injectable suspension) that was written for healthcare professionals. For more information about ZYPREXA RELPREVV (olanzapine extended release injectable suspension) 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.

Last reviewed on RxList: 8/31/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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