Zyprexa

Generic name: olanzapine (oral)
Brand names: ZyPREXA, ZyPREXA Zydis
Drug class: Atypical antipsychotics

Medically reviewed by  A Ras MD.

What is Zyprexa?

Zyprexa Relprevv is a long-acting prescription medicine given by injection and 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include hearing voices, seeing things that are not there, having beliefs that are not true being suspicious or withdrawn.

Zyprexa has not been approved for use in children under 13 years of age. Zyprexa in combination with fluoxetine has not been approved for use in children under 10 years of age.

The symptoms of schizophrenia include:

• hearing voices
• seeing things that are not there
• having beliefs that are not true
• being suspicious or withdrawn.

The symptoms of bipolar I disorder include:

• alternating periods of depression and high or irritable mood
• increased activity and restlessness
• racing thoughts
• talking fast
• impulsive behavior
• a decreased need for sleep.

The symptoms of treatment resistant depression include:

• decreased mood
• decreased interest
• increased guilty feelings
• decreased energy
• decreased concentration
• changes in appetite
• suicidal thoughts or behavior.

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

Description

ZYPREXA RELPREVV is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 10H-thieno[2,3-b][1,5]benzodiazepine, 2-methyl-4-(4-methyl-1-piperazinyl)-,4,4′-methylenebis[3-hydroxy-2-naphthalenecarboxylate] (1:1), monohydrate. The formula is C17H22N4S•C23H14O6•H2O, which corresponds to a molecular weight of 718.8. The chemical structure is:

ZYPREXA RELPREVV is a long-acting form of olanzapine and is intended for deep intramuscular gluteal injection only.

ZYPREXA RELPREVV includes a single-dose vial of the drug product and a vial of the sterile diluent for ZYPREXA RELPREVV.

The drug product is olanzapine pamoate monohydrate, present as a yellow solid in a glass vial equivalent to 210, 300, or 405 mg olanzapine base per vial. The diluent for ZYPREXA RELPREVV is a clear, colorless to slightly yellow solution in a glass vial and is composed of carboxymethylcellulose sodium, mannitol, polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection. The drug product is suspended in the diluent for ZYPREXA RELPREVV to a target concentration of 150 mg olanzapine per mL prior to intramuscular injection.

Mechanism of Action

The mechanism of action of olanzapine, in the listed indications is unclear. However, the efficacy of olanzapine in schizophrenia could be mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism.

What is the most important information I should know about Zyprexa?

Zyprexa may cause serious side effects, including:

1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis).
2. High blood sugar (hyperglycemia).
3. High fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers age 13 to 17 or when used in combination with fluoxetine in children age 10 to 17.
4. Weight gain, especially in teenagers age 13 to 17 or when used in combination with fluoxetine in children age 10 to 17.

These serious side effects are described below.

1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). Zyprexa is not approved for treating psychosis in elderly people with dementia.

2. 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 and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when Zyprexa is stopped. People with diabetes and some people who did not have diabetes before taking Zyprexa need to take medicine for high blood sugar even after they stop taking Zyprexa.

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

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

• 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

3. High fat levels in your blood (cholesterol and triglycerides). High fat levels may happen in people treated with Zyprexa, especially in teenagers (13 to 17 years old), or when used in combination with fluoxetine in children (10 to 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 and during treatment.

4. Weight gain. Weight gain is very common in people who take Zyprexa. Teenagers (13 to 17 years old) are more likely to gain weight and to gain more weight than adults. Children (10 to 17 years old) are also more likely to gain weight and to gain more weight than adults when Zyprexa is used in combination with fluoxetine. Some people may gain a lot of weight while taking Zyprexa, 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 should I tell my healthcare provider before taking Zyprexa?

Zyprexa may not be right for you. Before starting Zyprexa, 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
• phenylketonuria, because Zyprexa Zydis contains phenylalanine
• 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 will harm your unborn baby.
  • If you become pregnant while receiving Zyprexa, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
• are breast-feeding or plan to breast-feed. Zyprexa passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take Zyprexa.

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

The symptoms of bipolar I disorder, treatment resistant depression, or 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 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 with your other medicines. Do not start or stop any medicine while taking Zyprexa without talking to your doctor first.

How should I take Zyprexa?

• Take Zyprexa exactly as prescribed. Your doctor may need to change (adjust) the dose of Zyprexa until it is right for you.
• If you miss a dose of Zyprexa, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of Zyprexa at the same time.
• To prevent serious side effects, do not stop taking Zyprexa suddenly. If you need to stop taking Zyprexa, your doctor can tell you how to safely stop taking it.
• If you take too much Zyprexa, call your doctor or poison control center at 1-800-222-1222 right away, or get emergency treatment.
• Zyprexa can be taken with or without food.
• Zyprexa is usually taken one time each day.
• Take Zyprexa Zydis as follows:
  • Be sure that your hands are dry.
  • Open the sachet and peel back the foil on the blister. Do not push the tablet through the foil.
  • As soon as you open the blister, remove the tablet and put it into your mouth.
  • The tablet will disintegrate quickly in your saliva so that you can easily swallow it with or without drinking liquid.
• Call your doctor if you do not think you are getting better or have any concerns about your condition while taking Zyprexa.

What should I avoid while taking Zyprexa?

• Zyprexa 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 affects you.
• Avoid drinking alcohol while taking Zyprexa. Drinking alcohol while you take Zyprexa may make you sleepier than if you take Zyprexa alone.

What are the possible side effects of Zyprexa?

Serious side effects may happen when you take Zyprexa, including:

• See “What is the most important information I should know about Zyprexa?”, which describes the 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 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. 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.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): DRESS can occur with Zyprexa. DRESS is sometimes fatal; therefore, tell your doctor immediately if you experience any of these signs including:
  • rash
  • fever
  • swollen glands and other internal organ involvement such as liver, kidney, lung and heart.
• 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. It may also start after you stop taking Zyprexa. 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
  • 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.
• 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 include:

• lack of energy
• dry mouth
• increased appetite
• sleepiness
• tremor (shakes)
• having hard or infrequent stools
• dizziness
• changes in behavior
• restlessness.

Other common side effects in teenagers (13-17 years old) include:

• headache
• stomach-area (abdominal) pain
• pain in your arms or legs
• tiredness.

Teenagers experienced greater increases in prolactin, liver enzymes, and sleepiness, as compared with adults.

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. 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 the safe and effective use of Zyprexa

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Zyprexa for a condition for which it was not prescribed. Do not give Zyprexa to other people, even if they have the same condition. It may harm them.

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

How should I store Zyprexa?

• Store Zyprexa, Zyprexa Zydis and Zyprexa IntraMuscular vials (before reconstitution) at room temperature, between 68°F to 77°F (20°C to 25°C).
• Reconstituted Zyprexa IntraMuscular may be stored at a controlled room temperature of 68°F to 77°F (20°C to 25°C) for up to 1 hour (allows for excursions of between 59°F to 86°F (15°C to 30°C)). Discard any unused product.
• Keep Zyprexa and Zyprexa Zydis away from light and moisture.
• Keep Zyprexa IntraMuscular away from light and do not freeze.

Keep Zyprexa and all medicines out of the reach of children.

What are the ingredients in Zyprexa?

Active ingredient: olanzapine

Inactive ingredients:

Tablets: carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains: Titanium Dioxide, FD&C Blue No. 2 Aluminum Lake, or Synthetic Red Iron Oxide.

Zydis (orally disintegrating tablet): gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben.

Intramuscular: lactose monohydrate, tartaric acid, hydrochloric acid, sodium hydroxide.

Label

PACKAGE LABEL – ZYPREXA Relprevv 210 mg

• NDC 0002-7635-11
• ZYPREXA® Relprevv™
• (olanzapine)
• For Extended Release Injectable Suspension
• 210 mg/vial Single-Dose Vial Convenience Kit
• Medication Guide is to be dispensed to patients.
• VL7635/VL7622
• Convenience kit includes:
• Single-Dose vial of Zyprexa® Relprevv™ 210 mg/vial
• One 3-mL vial of diluent
• One 3-mL syringe with pre-attached 19-gauge, 1.5-inch Hypodermic Needle-Pro® needle with needle protection device
• Two 19-gauge, 1.5-inch Hypodermic Needle-Pro needles with needle protection device
• Hypodermic Needle-Pro is a registered trademark of Smiths Medical.
• Reconstitute each vial with 1.3 mL of enclosed diluent. The resultant solution will contain 150 mg/mL.
• Rx only
• FOR DEEP INTRAMUSCULAR GLUTEAL INJECTION ONLY.
• Dosing Frequency: Once every two weeks
• www.zyprexarelprevv.com
• Lilly

 

PACKAGE LABEL – ZYPREXA Relprevv 300 mg

• NDC 0002-7636-11
• ZYPREXA® Relprevv™
• (olanzapine)
• For Extended Release Injectable Suspension
• 300 mg/vial Single-Dose Vial Convenience Kit
• Medication Guide is to be dispensed to patients.
• VL7636/VL7622
• Convenience kit includes:
• Single-Dose vial of Zyprexa® Relprevv™ 300 mg/vial
• One 3-mL vial of diluent
• One 3-mL syringe with pre-attached 19-gauge, 1.5-inch Hypodermic Needle-Pro® needle with needle protection device
• Two 19-gauge, 1.5-inch Hypodermic Needle-Pro needles with needle protection device
• Hypodermic Needle-Pro is a registered trademark of Smiths Medical.
• Reconstitute each vial with 1.8 mL of enclosed diluent. The resultant solution will contain 150 mg/mL.
• Rx only
• FOR DEEP INTRAMUSCULAR GLUTEAL INJECTION ONLY.
• Dosing Frequency: Once every two or four weeks
• www.zyprexarelprevv.com
• Lilly

 

PACKAGE LABEL – ZYPREXA Relprevv 405 mg

• NDC 0002-7637-11
• ZYPREXA® Relprevv™
• (olanzapine)
• For Extended Release Injectable Suspension
• 405 mg/vial Single-Dose Vial Convenience Kit
• Medication Guide is to be dispensed to patients.
• VL7637/VL7622
• Convenience kit includes:
• Single-Dose vial of Zyprexa® Relprevv™ 405 mg/vial
• One 3-mL vial of diluent
• One 3-mL syringe with pre-attached 19-gauge, 1.5-inch Hypodermic Needle-Pro® needle with needle protection device
• Two 19-gauge, 1.5-inch Hypodermic Needle-Pro needles with needle protection device
• Hypodermic Needle-Pro is a registered trademark of Smiths Medical.
• Reconstitute each vial with 2.3 mL of enclosed diluent. The resultant solution will contain 150 mg/mL.
• Rx only
• FOR DEEP INTRAMUSCULAR GLUTEAL INJECTION ONLY.
• Dosing Frequency: Once every four weeks
• www.zyprexarelprevv.com
• Lilly

SRC: NLM .