Pronunciation:

oh-LAN-za-peen

Brand Names:

• ZyPREXA IntraMuscular
• ZyPREXA Relprevv

Dosage Forms:

• Powder for Solution
• Powder for Suspension, Extended Release

Warnings:

Risk of death is increased in elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .

Patients are at risk for severe sedation (including coma) or delirium after each injection and must be observed for at least 3 hours in a registered facility with ready access to emergency response services. Because of this risk, olanzapine pamoate is available only through a restricted distribution program called olanzapine pamoate Patient Care Program and requires prescriber, healthcare facility, patient, and pharmacy enrollment. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine pamoate is not approved for the treatment of patients with dementia-related psychosis .

Classifications:

Therapeutic—

Antipsychotic

Chemical—

Thienobenzodiazepine

Uses of This Medicine:

Olanzapine injection is used to treat agitation that occurs with schizophrenia and bipolar mania. This medicine should not be used to treat behavioral problems in older adult patients who have dementia or Alzheimer's disease.

Zyprexa® IntraMuscular injection is to be given only by or under the direct supervision of a doctor.

Zyprexa® Relprevv™ is available only under a special restricted distribution program called Zyprexa® Relprevv™ patient care program.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of olanzapine injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olanzapine injection in the elderly. However, elderly patients are more likely to have dementia or age-related liver, kidney, or heart problems, which may require caution or an adjustment in the dose for patients receiving olanzapine injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Levoketoconazole
• Levomethadyl
• Metoclopramide
• Pimozide
• Piperaquine
• Potassium Citrate
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Acepromazine
• Adagrasib
• Alfentanil
• Alfuzosin
• Alprazolam
• Amantadine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amobarbital
• Anagrelide
• Anileridine
• Apalutamide
• Apomorphine
• Apomorphine Hydrochloride
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Baclofen
• Bedaquiline
• Benperidol
• Benzhydrocodone
• Bromazepam
• Bromocriptine Mesylate
• Buprenorphine
• Bupropion
• Buserelin
• Buspirone
• Butabarbital
• Butorphanol
• Cabergoline
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Capmatinib
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chloroquine
• Chlorpromazine
• Chlorzoxazone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clofazimine
• Clomipramine
• Clonazepam
• Clorazepate
• Clothiapine
• Clozapine
• Cobicistat
• Codeine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Daridorexant
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Enflurane
• Enoxacin
• Entrectinib
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etrasimod
• Famotidine
• Felbamate
• Fenoldopam Mesylate
• Fentanyl
• Fexinidazole
• Fingolimod
• Flecainide
• Flibanserin
• Fluconazole
• Flunitrazepam
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fospropofol
• Fostemsavir
• Gabapentin
• Gabapentin Enacarbil
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gonadorelin
• Goserelin
• Granisetron
• Halazepam
• Halofantrine
• Haloperidol
• Halothane
• Hexobarbital
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Isoflurane
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lapatinib
• Lefamulin
• Lemborexant
• Lenvatinib
• LetibotulinumtoxinA-wlbg
• Leuprolide
• Levocetirizine
• Levodopa
• Levofloxacin
• Levorphanol
• Lithium
• Lofexidine
• Lorazepam
• Loxapine
• Lumacaftor
• Lumefantrine
• Macimorelin
• Magnesium Oxybate
• Meclizine
• Mefloquine
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methacholine
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metronidazole
• Midazolam
• Mifepristone
• Mirtazapine
• Mitotane
• Mizolastine
• Mobocertinib
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nalbuphine
• Nelfinavir
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Norfloxacin
• Octreotide
• Ofloxacin
• Oliceridine
• Omeprazole
• Ondansetron
• Opium
• Opium Alkaloids
• Orphenadrine
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxazepam
• Oxycodone
• Oxymorphone
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaveretum
• Papaverine
• Paregoric
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pipamperone
• Piperacetazine
• Pipotiazine
• Piritramide
• Pitolisant
• Pixantrone
• Ponesimod
• Posaconazole
• Potassium Oxybate
• Pramipexole Dihydrochloride
• Prazepam
• Pregabalin
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promazine
• Promethazine
• Propafenone
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ramelteon
• Ranolazine
• Relugolix
• Remifentanil
• Remimazolam
• Remoxipride
• Revefenacin
• Ribociclib
• Rifampin
• Risperidone
• Ritonavir
• Ropeginterferon Alfa-2b-njft
• Ropinirole Hydrochloride
• Rotigotine
• Scopolamine
• Secobarbital
• Secretin Human
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Oxybate
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sufentanil
• Sulpiride
• Sultopride
• Sunitinib
• Suvorexant
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Temazepam
• Tetrabenazine
• Thiethylperazine
• Thiopental
• Thiopropazate
• Tilidine
• Tiotropium
• Tizanidine
• Tolonium Chloride
• Tolterodine
• Topiramate
• Toremifene
• Tramadol
• Trazodone
• Triazolam
• Triclabendazole
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Viloxazine
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zaleplon
• Zolpidem
• Zopiclone
• Zotepine
• Zuclopenthixol
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amprenavir
• Betel Nut
• Fosamprenavir
• Valproic Acid

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Tobacco

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood vessel disease or circulation problems or
• Dehydration or
• Heart attack or stroke, history of or
• Heart disease or
• Heart failure or
• Heart rhythm problems or
• Hypotension (low blood pressure) or
• Hypovolemia (low blood volume)—May cause side effects to become worse.

• Breast cancer, prolactin-dependent or
• Glaucoma, narrow-angle or
• Hyperlipidemia (high cholesterol or fat in the blood) or
• Hyperprolactinemia (high prolactin in the blood) or
• Liver disease or
• Paralytic ileus (severe intestinal problem), or history of or
• Prostatic hypertrophy (enlarged prostate), or history of or
• Seizures, history of or
• Urinary retention (problems with passing urine), or history of—Use with caution. This medicine may make these conditions worse.

• Diabetes or
• Hyperglycemia (high blood sugar)—This medicine may raise your blood sugar levels.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a clinic, community health center, or hospital. This medicine is given as a shot into a muscle.

Your doctor may give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Tell your doctor if you smoke tobacco. You might need a different amount of this medicine if you smoke.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are receiving this medicine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.

Olanzapine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.

This medicine may cause a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). Call your doctor right away if you have a rash, red, swollen skin, fever, chills, cough, trouble breathing, swollen glands, or unusual bleeding, bruising, or weakness after receiving this medicine.

This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

This medicine may increase your weight. Your doctor may need to check your weight regularly during treatment with this medicine.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

Check with your doctor right away if you have difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Olanzapine injection may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision, which may lead to falls, fractures, or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may cause post-injection delirium/sedation syndrome. Tell your doctor right away if you have dizziness, drowsiness, sleepiness, seizures, or confusion as to time, place, or person after receiving the injection.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and can not cool down.

Avoid drinking alcohol while you are receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

change in vision

change in walking and balance

clumsiness or unsteadiness

difficulty with speaking

difficulty with swallowing

drooling

impaired vision

inability to sit still

loss of balance control

mask-like face

muscle trembling, jerking, or stiffness

need to keep moving

rapid weight gain

restlessness

shakiness in the legs, arms, hands, or feet

shuffling walk

slowed movements

slurred speech

stiffness of the arms and legs

tic-like (jerky) movements of the head, face, mouth, and neck

tingling of the hands or feet

trembling or shaking of the fingers, hands, or feet

twisting movements of the body

uncontrolled movements, especially of the face, neck, and back

unusual weight gain or loss

Less common

Bladder pain

bloody or cloudy urine

bruising

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain

difficult or labored breathing

difficult, burning, or painful urination

dizziness

excessive muscle tone

frequent urge to urinate

headache

inability to move the eyes

increased blinking or spasms of the eyelid

itching of the vagina or genital area

lack of coordination

large, flat, blue, or purplish patches in the skin

loss of bladder control

loss of memory

lower back or side pain

muscle tension or tightness

nervousness

pain, redness, and swelling at the injection site

pounding in the ears

problems with memory

rhythmic movement of the muscles

slow, fast, pounding, or irregular heartbeat or pulse

speaking is less clear than usual

sticking out the tongue

thick, white vaginal discharge with no odor or with a mild odor

tightness in the chest

trouble with breathing, speaking, or swallowing

twitching

uncontrolled twisting movements of the neck, trunk, arms, or legs

unusual or incomplete body or facial movements

weakness of the arms and legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

back pain

belching

change in personality

difficulty having a bowel movement (stool)

discouragement

feeling sad or empty

fever

heartburn

increased appetite

increased cough

indigestion

lack of appetite

lack or loss of strength

loss of interest or pleasure

runny nose

sneezing

stomach discomfort, upset, or pain

stuffy nose

thirst

trouble sleeping

trouble with concentrating

watering of the mouth

weight gain

Less common

Body aches or pain

chills

cold sweats

congestion

cough

dry skin

dryness or soreness of the throat

false or unusual sense of well-being

heavy menstrual bleeding

hoarseness

joint pain

lack of feeling or emotion

leg cramps

pain in the arms or legs

sweating

tender, swollen glands in the neck

uncaring feelings

voice change

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.