Olanzapine (oh-LAN-za-peen), Samidorphan (sam-i-DOR-fan)

Treats schizophrenia or bipolar disorder (manic-depressive illness).

Brand Name(s):

Lybalvi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not crush, break, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are also using opioid medicines. Wait at least 7 days after you stopped taking short-acting opioids and at least 14 days after you stopped taking long-acting opioids before you start this medicine. Do not start taking opioid medicines for at least 5 days after treatment with this medicine.
• Some medicines can affect how olanzapine/samidorphan works. Tell your doctor if you are using carbamazepine, diazepam, itraconazole, levodopa, or rifampin.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or planning to become pregnant. This medicine may cause unwanted effects to newborn babies if used during the later part of pregnancy.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, dementia, diabetes, seizures, breast cancer, prostate problems, problems with passing urine, stomach or bowel problems (including blockage), trouble swallowing, or a history of alcohol or drug abuse or dependence. Tell your doctor if you have any kind of blood vessel or heart problems, including low or high blood pressure, heart failure, heart rhythm problems, high cholesterol, or a history of heart attack or stroke.
• This medicine may cause the following problems:
  • Increased risk of stroke
  • Increased risk of opioid overdose, when used with opioid (narcotic) medicine
  • Neuroleptic malignant syndrome (a nerve and muscle problem)
  • Serious skin reaction, including drug reaction with eosinophilia and systemic symptoms (DRESS)
  • High blood sugar, cholesterol, or triglyceride levels
  • Tardive dyskinesia (a muscle problem that may become permanent)
  • High prolactin levels
• This medicine may make you dizzy or drowsy, or may cause trouble with thinking or controlling body movement, which may lead to falls, fractures or other injuries. Do not drive or do anything that could be dangerous until you know how this medicine affects you. You may also feel lightheaded when getting up suddenly from a lying or sitting position, so stand up slowly.
• This medicine may make it more difficult for your body to cool down. Be careful to not become overheated during exercise or hot weather, because you could have heat stroke.
• This medicine lowers the number of white blood cells. This weakens your immune system, so you may get infections more easily. Wash your hands often. Avoid people who are sick.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Feeling very thirsty or hungry, change in how much or how often you urinate
• Fever, chills, cough, sore throat, body aches
• Jerky muscle movement you cannot control (often in your face, tongue, or jaw)
• Lightheadedness, dizziness, fainting
• Muscle pain, tenderness, or weakness
• Numbness or weakness in your arm or leg, or on one side of your body, problems with memory or speech
• Seizures or tremors
• Sweating, confusion, uneven heartbeat, muscle stiffness
• Swollen breasts, or liquid discharge from your nipples (men or women)
• Trouble breathing or swallowing
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Constipation, upset stomach
• Dry mouth
• Headache, tiredness
• Sleepiness or unusual drowsiness
• Weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor

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