"The US Food and Drug Administration (FDA) has approved a quarterly injection form of paliperidone (Invega Trinza, Janssen Pharmaceuticals) for schizophrenia, the company announced today.
Janssen Pharmaceuticals already markets a "...
(olanzapine) for Extended Release Injectable Suspension
Read the Medication Guide that comes with ZYPREXA RELPREVV before you start taking it andeach time before you get an injection. There may be new information. This Medication Guide doesnot take the place of talking to your doctor about your medical condition or treatment. Talk with yourdoctor if there is something you do not understand or you want to learn more about ZYPREXARELPREVV.
What is the most important information I should know about ZYPREXA RELPREVV?
Before you receive ZYPREXA RELPREVV treatment you must:
- understand the risks and benefits of ZYPREXA RELPREVV treatment. Your doctor will talk to you about the risks and benefits of ZYPREXA RELPREVV treatment.
- register in the ZYPREXA RELPREVV Patient Care Program. You must agree to the rulesof the ZYPREXA RELPREVV Patient Care Program before you register.
ZYPREXA RELPREVV may cause serious side effects, including:
- Post-injection Delirium Sedation Syndrome (PDSS).
- Increased risk of death in elderly people who are confused, have memory loss and havelost touch with reality (dementia-related psychosis).
- High blood sugar (hyperglycemia).
- High fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers age 13 to 17.
- Weight gain, especially in teenagers age 13 to 17.
These serious side effects are described below.
- Post-injection Delirium Sedation Syndrome (PDSS). PDSS is a serious problem that canhappen 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 yourdoctor can make sure you do not have symptoms of PDSS. When you leave the clinicsomeone must be with you. If you have symptoms of PDSS after you leave the clinic, getmedical help or go to an emergency room right away.
- Increased risk of death in elderly people who are confused, have memory loss and havelost touch with reality (dementia-related psychosis). ZYPREXA RELPREVV is not approved for treating psychosis in elderly people with dementia.
- High blood sugar (hyperglycemia). High blood sugar can happen if you have diabetes alreadyor if you have never had diabetes. High blood sugar could lead to:
- a build up of acid in your blood due to ketones (ketoacidosis)
Your doctor should do tests to check your blood sugar before you start taking ZYPREXA RELPREVVand during treatment. In people who do not have diabetes, sometimes high blood sugar goes awaywhen 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 afterthey stop taking ZYPREXA RELPREVV.
If you have diabetes, follow your doctor’s instructions about how often to check your blood sugarwhile taking ZYPREXA RELPREVV.
Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) whiletaking 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 triglycerides). High fat levels may happen in people treated with ZYPREXA RELPREVV, especially in teenagers (13 to 17 years old). ZYPREXARELPREVV is not approved in patients less than 18 years old. You may not have any symptoms, soyour doctor should do blood tests to check your cholesterol and triglyceride levels before you starttaking ZYPREXA RELPREVV and during treatment.
- 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 weightregularly. 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 treatschizophrenia in adults. The symptoms of schizophrenia include:
- hearing voices
- seeing things that are not there
- having beliefs that are not true
- being suspicious or withdrawn
Some of your symptoms of schizophrenia may improve with treatment with ZYPREXA RELPREVV. Ifyou 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 yourdoctor if you have or had:
- heart problems
- 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 will harmyour unborn baby.
- are breast-feeding or plan to breast-feed. ZYPREXA RELPREVV can pass into your breastmilk and may harm your baby. You should not breast-feed while taking ZYPREXARELPREVV. Talk to your doctor about the best way to feed your baby if you take ZYPREXARELPREVV.
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 mayinteract with each other and may not work as well, or cause possible serious side effects. Your doctorcan 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?
- ZYPREXA RELPREVV will be injected into the muscle in your buttock (gluteus) by your doctoror nurse at the clinic.
- After receiving ZYPREXA RELPREVV, you will need to stay at the clinic for at least 3 hours.
- When you leave the clinic, someone must be with you.
- Call your doctor if you do not think you are getting better or have any concerns about yourcondition while taking ZYPREXA RELPREVV.
What should I avoid while receiving ZYPREXA RELPREVV?
- 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 dangerousactivities until you know how ZYPREXA RELPREVV affects you. You should not drive oroperate heavy machinery for the rest of the day after each injection.
- Avoid drinking alcohol while taking ZYPREXA RELPREVV. Drinking alcohol while you take ZYPREXA RELPREVV may make you sleepier than if you take ZYPREXA RELPREVV alone.
What are the possible side effects of ZYPREXA RELPREVV?
Serious side effects may happen when you take ZYPREXA RELPREVV, including:
- See “What is the most important information I should know about ZYPREXARELPREVV?”, which describes the risk of post-injection delirium sedation syndrome(PDSS), increased risk of death in elderly people with dementia-related psychosis andthe 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 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. NMScan 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
- changes in your breathing, heartbeat, and blood pressure
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): DRESS can occur with ZYPREXA RELPREVV. Features of DRESS may include rash, fever, swollen glands and other internal organ involvement such as liver, kidney, lung and heart. DRESS is sometimesfatal; therefore, tell your doctor immediately if you experience any of these signs.
- Tardive Dyskinesia: This condition causes body movements that keep happening and thatyou can not 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 can not control.
- Decreased blood pressure when you change positions, with symptoms of dizziness,fast or slow heartbeat, 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.
- 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 toavoid 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 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, askyour doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at1-800-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. Ifyou would like more information, talk with your doctor. You can ask your doctor or pharmacist forinformation about ZYPREXA RELPREVV that was written for healthcare professionals. For moreinformation about ZYPREXA RELPREVV call 1-800-Lilly-Rx (1-800-545-5979) or visitwww.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: 3/21/2017
This monograph has been modified to include the generic and brand name in many instances.
Additional Zyprexa Relprevv Information
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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