FDA Approves Zyprexa Relprevv (olanzapine)
The U.S. Food and Drug Administration (FDA) has approved Zyprexa Relprevv (olanzapine) For Extended Release Injectable Suspension for the treatment of schizophrenia in adults. Zyprexa Relprevv, a long-acting intramuscular injection, sustains the delivery of olanzapine for up to four weeks.
Generic Name: olanzapine
Date of Approval: December 11, 2009
Company: Eli Lilly and Company
Read the Medication Guide that comes with Zyprexa Relprevv before you start taking it and each timebefore 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.
To receive Zyprexa Relprevv you have to:
Serious side effects may happen when you take Zyprexa Relprevv, including:
Post-injection Delirium Sedation Syndrome (PDSS): 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:
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 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 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 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:
High cholesterol and triglyceride levels in the blood (fat in the blood) may happen in people treated with Zyprexa Relprevv, especially in teenagers (13-17 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.
Increase in weight (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 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 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, talk with your doctor about the possible long-term risks of teenagers taking Zyprexa Relprevv.