ZYPREXA RELPREVV Is a Long-Acting Medicine Used to Treat Schizophrenia in Adults

Important Safety Information about ZYPREXA^® RELPREVV™ (olanzapine) For Extended Release Injectable Suspension

Please read the Medication Guide that comes with ZYPREXA RELPREVV before you start taking it and each time you get an injection

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

• Post-injection Delirium Sedation Syndrome (PDSS): Patients are at risk for severe drowsiness (including unconsciousness or coma) and/or confusion and disorientation after each injection and must stay at the doctor’s office or clinic for at least 3 hours after the injection is given. ZYPREXA RELPREVV is only prescribed by doctors who are enrolled in the ZYPREXA RELPREVV Patient Care Program to patients who are also enrolled.
• Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis): Medicines like ZYPREXA RELPREVV 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 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 if you have never had diabetes. This could lead to ketoacidosis (build up of acid in the blood due to ketones), coma, or 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.

• High fat levels in your blood (cholesterol and trigylcerides). High fat levels in your blood may happen in people treated with ZYPREXA RELPREVV, especially in teenagers (13-17 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.
• Weight gain. Weight gain is very common in people who take ZYPREXA RELPREVV. Teenagers (13-17 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 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.
• Strokes and “mini-strokes” called transient ischemic attacks (TIAs). These are more common in elderly people with dementia-related psychosis (elderly people who have lost touch with reality due to confusion and memory loss). ZYPREXA RELPREVV is not approved for these patients.
• Suicide. 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.
• Neuroleptic malignant syndrome (NMS). NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including ZYPREXA RELPREVV. NMS can cause death and must be treated in a hospital. The symptoms include high fever; excessive sweating; rigid muscles; confusion; and changes in breathing, heartbeat, and blood pressure. Call your doctor right away if you become severely ill and have any of these symptoms.
• Tardive dyskinesia. This condition causes body movements that keep happening and that you cannot control. These movements usually affect the face and tongue. Tardive dyskinesia may not go away, even if you stop taking ZYPREXA RELPREVV. It may also start after you stop taking ZYPREXA RELPREVV. Tell your doctor if you get any body movements that you cannot control.
• Decreased blood pressure when you change position, with symptoms of dizziness, fast or slow heartbeat, or fainting.
• Decreases in white blood cells (infection fighting cells) have been reported in some patients taking antipsychotic agents, including ZYPREXA (olanzapine). Patients with a history of a significant decrease in white blood cell (WBC) count or who have experienced a low WBC count due to drug therapy should have their blood tested and monitored during the first few months of therapy.
• Trouble swallowing, that can cause food or liquid to get into your lungs.
• Seizures. Tell your doctor if you have a history of seizures, or if you have a seizure during treatment with ZYPREXA RELPREVV.
• 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 some or all of these symptoms of dehydration: sweating too much or not at all, dry mouth, feeling very hot, feeling thirsty, not able to produce urine.
• Increases in prolactin (a naturally occurring hormone in the body) have been reported in some patients taking ZYPREXA RELPREVV and other medications like it, and these increases can continue while taking the medication. Some patients who have taken medications that increase prolactin have reported milk production from the breasts, stopping of menstrual periods, enlargement of the breasts in men, and impotence
• 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. You should not drive or operate heavy machinery for the rest of the day after each injection.

What are the common possible side effects of ZYPREXA RELPREVV?

This is not a complete list of possible side effects. If you have questions or if you have any side effects that concern you, talk with your doctor and/or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What should I tell my doctor before taking ZYPREXA RELPREVV?

Tell your doctor if you are taking, or plan to take, any prescription or over-the-counter drugs including 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. Do not start or stop any medicine while taking ZYPREXA RELPREVV without talking to your doctor first.

ZYPREXA RELPREVV may not be right for you. Before starting ZYPREXA RELPREVV, 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, or any other medical condition. Also tell your doctor if you are pregnant or plan to become pregnant (it is not known if ZYPREXA RELPREVV will harm your unborn baby), or if you are breast-feeding or plan to breast-feed (ZYPREXA RELPREVV can pass into your breast milk and may harm your baby. You should not breast-feed while taking ZYPREXA RELPREVV. Talk to your doctor about the best way to feed your baby if you take ZYPREXA RELPREVV.).

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

What other important information should I know about ZYPREXA RELPREVV?

ZYPREXA RELPREVV will be injected into your buttock (gluteus) by your healthcare provider at their office. After each injection, you need to stay at your healthcare provider’s office for at least 3 hours. When you leave the clinic, someone must be with you. You should not drive or operate heavy machinery for the rest of the day after receiving ZYPREXA RELPREVV.

If you have symptoms of post-injection delirium/sedation syndrome (PDSS), you need to get medical help or be taken to an emergency room right away. PDSS is a serious reaction that can happen after you get a ZYPREXA RELPREVV injection if the medicine gets in your blood too fast. If this happens, you may have some of these symptoms: feeling more sleepy than usual, feeling dizzy, feeling confused or disoriented, trouble talking or walking, muscles feeling stiff or shaking, feeling weak, feeling grouchy or angry, feeling nervous or anxious, higher blood pressure, seizures, passing out (becoming unconscious or coma).

Avoid the use of alcohol while taking ZYPREXA RELPREVV.

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

If you have any questions or concerns, or if you want to report any problems with the use of ZYPREXA RELPREVV, contact your doctor, pharmacist, or other healthcare provider. For more information, talk with your doctor or visit www.ZYPREXARELPREVV.com or call 1-800-LillyRx.

For more safety information, please see the Full Prescribing Information including Medication Guide.

OD Con ISI 31AUG2012

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For more information about ZYPREXA RELPREVV, contact your doctor or other healthcare professional.