APPROVED USE
WELTRUZA[TM] & (olanzapine) extended-release injectable suspension is a prescription medicine used in adults for the treatment of schizophrenia.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about WELTRUZA?
WELTRUZA can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss, and have lost touch with reality (dementia-related psychosis). WELTRUZA is not approved for use in patients with dementia-related psychosis.
WELTRUZA may cause serious side effects, including:
- Strokes in elderly people (cerebral problems) that can lead to death.
- Neuroleptic Malignant Syndrome (NMS). NMS is a rare but serious condition that can be life-threatening. Seek medical attention right away if you have any of these symptoms: high fever, sweating, severe muscle stiffness, confusion, irregular heartbeat, or changes in your blood pressure.
- Serious Allergic Reaction (DRESS). Features include rash, fever, and swollen glands. DRESS can affect internal organs like your liver, kidneys, lungs, and heart and can be life-threatening. Contact your healthcare provider right away if you experience any of these signs.
- Post-injection delirium/sedation syndrome (PDSS), a serious rare reaction that has been reported with another long-acting olanzapine injection (not WELTRUZA). This can happen if the medicine gets into the bloodstream too quickly. Get emergency medical help right away if you feel weak, delirious, drowsy, have muscle stiffness, or have increased blood pressure.
- Problems with your metabolism that may include high blood sugar (hyperglycemia), diabetes mellitus, changes in the fat levels in your blood (dyslipidemia), and weight gain. Extremely high blood sugar can lead to coma or death. If you have diabetes or are at risk of diabetes (e.g., obesity, family history of diabetes), your healthcare provider should check your blood sugar before you start and during treatment with WELTRUZA. Call your healthcare provider if you have symptoms of high blood sugar, including feeling very thirsty, hungry, sick to your stomach, weak or tired, or confused; needing to urinate more than usual; or your breath smells fruity.
- Uncontrolled facial or body movements (tardive dyskinesia) that may not go away, even if you stop receiving WELTRUZA.
- High levels of prolactin in the blood. WELTRUZA may cause a rise in blood levels of a hormone called prolactin that may cause side effects including missed or changed menstrual periods, problems with fertility, leakage of milk from the breasts, development of breasts in males, or problems with erection.
- Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
- Falls. Antipsychotic medicines, like WELTRUZA, may cause sleepiness, drowsiness, or dizziness when you are standing, which could increase your risk for falls and related injuries.
- Difficulty swallowing that can cause food or liquid to get into your lungs.
- Seizures (convulsions).
- Low white blood cell count, which may increase the risk of infection.
- Problems thinking clearly and moving your body. Do not drive, operate machinery, or do other dangerous activities until you know how WELTRUZA affects you.
- Problems with control of your body temperature (too high or too low). Avoid getting overheated or dehydrated.
The most common side effects of olanzapine in patients with schizophrenia include weight gain, sleepiness, headache, and constipation. Injection site reactions, such as hardening or a lump at the injection site, pain, redness, or itching, were reported with WELTRUZA.
These are not all the possible side effects with WELTRUZA. Tell your healthcare provider if you have any side effect that does not go away. For more information, ask your healthcare provider or pharmacist.
Do not drink alcohol during treatment with WELTRUZA.
Before starting WELTRUZA, tell your healthcare provider if you:
- have or have had heart problems, diabetes, high blood sugar levels, high cholesterol or triglyceride levels, or low or high blood pressure.
- have or have had seizures or epilepsy.
- have or have had liver problems.
- have or have had strokes or “mini-strokes” also called transient ischemic attacks (TIAs).
- have Alzheimer’s disease.
- have narrow-angle glaucoma.
- have an enlarged prostate in men.
- have or have had bowel obstruction.
- have or have had breast cancer.
- have or have had thoughts of suicide or hurting yourself.
- have or have had any other medical condition.
- are pregnant or plan to become pregnant. It is not known if WELTRUZA will harm your unborn baby. If you become pregnant while receiving WELTRUZA, 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 http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
- are breastfeeding or plan to breastfeed. WELTRUZA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take WELTRUZA.
- exercise a lot or are in hot places often.
Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. WELTRUZA and other medicines may affect each other.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please read the Medication Guide in the full Prescribing Information for WELTRUZA, or talk to your healthcare provider.
© 2026 Teva Neuroscience, Inc.
OLZ-40044 October 2026
