LYBALVI is a prescription medicine which contains 2 medicines (olanzapine and samidorphan) used in adults:

• alone for short-term (acute) or maintenance treatment of manic or mixed episodes that happen with bipolar 1
• in combination with valproate or lithium to treat manic or mixed episodes that happen with bipolar 1

It is not known if LYBALVI is safe or effective in children. Learn more about LYBALVI >

LYBALVI may cause serious side effects, including increased risk of death in elderly people with dementia-related psychosis. LYBALVI increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). LYBALVI is not approved for the treatment of patients with dementia-related psychosis.

Do not take LYBALVI if you are taking opioids or are experiencing acute opioid withdrawal.
See What are the possible side effects of LYBALVI? > and LYBALVI and opioid use >

Take LYBALVI exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking LYBALVI without first talking to your healthcare provider. LYBALVI can be taken with or without food. Swallow LYBALVI tablets whole. Do not split or combine tablets, or take more than 1 daily.

Do not drive a car, operate machinery, or do other dangerous activities until you know how LYBALVI affects you. LYBALVI may make you feel drowsy.

Avoid drinking alcohol during treatment with LYBALVI.

Avoid getting over-heated or dehydrated. Do not exercise too much. In hot weather, stay inside in a cool place, if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Be sure to drink plenty of water.

LYBALVI may cause serious side effects, including:

• Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.
• Opioid withdrawal. Do not take LYBALVI for at least 7 days after you stopped taking short-acting opioids and for at least 14 days after you stopped taking long-acting opioids. One of the medicines in LYBALVI (samidorphan) can cause opioid withdrawal that may be severe and cause hospitalization in people who are physically dependent on opioids. Talk to your healthcare provider if you have questions about the type of opioid you take.
• Risk of life-threatening opioid overdose. You should not start taking opioids for at least 5 days after you stop treatment with LYBALVI. One of the medicines in LYBALVI (samidorphan) can increase your chance of having an opioid overdose that can cause death if you take opioids during treatment or within 5 days after stopping treatment with LYBALVI.
• You can accidentally overdose in 2 ways:
• • LYBALVI blocks the effects of opioids, such as heroin, methadone, or opioid pain medicines. Do not take large amounts of opioids to try to overcome the opioid-blocking effects of LYBALVI. This can lead to serious injury, coma, or death.
  • After you take LYBALVI, its blocking effect slowly decreases and completely goes away over time. You may be more sensitive to the effects of opioids. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment with LYBALVI can lead to overdose or death.
  • It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.
  • You or someone close to you should get emergency medical help right away if you:
  • have trouble breathing
  • become very drowsy with slowed breathing
  • have slow, shallow breathing (little chest movement with breathing)
  • feel faint, very dizzy, confused, or have unusual symptoms
  • Tell your healthcare provider if you are taking LYBALVI before a medical procedure or surgery.
• Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:
  • high fever
  • stiff muscles
  • confusion
  • sweating
  • changes in your breathing, pulse, heart rate, and blood pressure
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): One of the medicines in LYBALVI (olanzapine) can cause DRESS, which can cause death. Tell your healthcare provider right away if you develop any of the following symptoms of DRESS, including:
  • rash
  • swollen glands
  • liver problems
  • heart problems
  • fever
  • kidney problems
  • lung problems
• Problems with your metabolism such as:
  • high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take LYBALVI. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start and regularly during treatment with LYBALVI.
  • Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with LYBALVI:
  • • feel very thirsty
    • feel very hungry
    • feel sick to your stomach
    • need to urinate more than usual
    • feel weak or tired
    • feel confused, or your breath smells fruity
  • increased fat levels (cholesterol and triglycerides) in your blood. Your healthcare provider should check the fat levels in your blood before you start and regularly during treatment with LYBALVI.
  • weight gain. You and your healthcare provider should check your weight before you start and often during treatment with LYBALVI.
• Uncontrolled body movements (tardive dyskinesia). LYBALVI may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking LYBALVI. Tardive dyskinesia may also start after you stop taking LYBALVI.
• Decreased blood pressure (orthostatic hypotension) and fainting. You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
• Falls. LYBALVI may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills, which may lead to falls that can cause fractures or other injuries.
• Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with LYBALVI.
• Difficulty swallowing that can cause food or liquid to get into your lungs.
• Seizures (convulsions).
• Problems controlling your body temperature so that you feel too warm. See "What should I avoid while taking LYBALVI?"
• Increased prolactin levels in your blood. Your healthcare provider may do blood tests to check your prolactin levels during treatment with LYBALVI.
• The most common side effects of LYBALVI when used alone to treat people with mixed or manic episodes that happen with bipolar 1 disorder include:
• weakness
• constipation
• sleepiness
• shaking
• dry mouth
• increased appetite
• dizziness
• The most common side effects of LYBALVI when used in combination with lithium or valproate to treat people with mixed or manic episodes that happen with bipolar 1 disorder include:
• dry mouth
• increased appetite
• back pain
• problems speaking
• memory problems
• weight gain
• dizziness
• constipation
• mouth watering
• numbness and tingling in your arm and legs

These are not all the possible side effects of LYBALVI.

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

Tell your healthcare provider if you take a urine drug screening test because LYBALVI may affect your test results. Tell those giving the drug screening test that you are taking LYBALVI.

The list price, also known as the Wholesale Acquisition Cost (WAC),^a of LYBALVI is $1,599.20 for a 30-day supply, but most patients may pay less with their prescription drug plan.

You may be able to save on your prescription with the LYBALVI Co-pay Savings Program if you have commercial insurance. Learn more >

^aThe WAC is the published list price to wholesalers and distributors. The WAC does not necessarily represent actual transaction costs and does not include discounts, rebates, deductions or applicable taxes, if any. The above reflects the WAC as of July 2024.

The LYBALVI Co-pay Savings Program can help you save on the costs of your treatment. If you’re commercially insured, you may be eligible to save on out-of-pocket costs for LYBALVI. If you’re eligible, you could pay as little as $0 for your first 3 prescriptions. Learn about the Co-pay Savings Program >

Different types of insurance cover LYBALVI, including commercial insurance, Medicare Part D, and Medicaid. Coverage varies based on your specific insurance. Please talk to your healthcare provider for more details.

Bipolar 1, a type of bipolar disorder, is a lifelong condition that affects the brain. Bipolar 1 can cause extreme changes in thoughts, moods, and energy levels. Learn more about living with bipolar 1 >

The exact cause of bipolar 1 is not known, but research suggests it could be caused by a combination of factors. One theory says bipolar 1 could be caused when certain chemicals in the brain, called neurotransmitters, get out of balance. Bipolar 1 is also known to run in families, so it is believed that certain genetic factors can make some people more likely to have bipolar 1 than others. Learn more about living with bipolar 1 >

It is estimated that 1% of adults in the United States live with a bipolar 1 diagnosis.

A manic episode is one type of way bipolar 1 can cause changes to your thoughts, mood, or energy levels, which can last from days to weeks.

Manic episodes can be recognized by symptoms such as:

• Extreme moods
• Intense feelings of highs or lows
• Overwhelming feelings that drive behavior
• Decreased need for sleep
• Racing thoughts
• Talking really fast
• Feeling overconfident
• Acting impulsively

A mixed episode means having both high and low symptoms at the same time. For example, you may feel overly excited but also sad.

Individuals with bipolar 1 often report that these are the most difficult episodes to cope with as they can be highly unpredictable and confusing to process. Feelings and emotions that swing extremely high and low might not just be a depressive episode. It could be a mixed episode, which LYBALVI may help manage.

Bipolar 1 is seen more often in people with a sibling or parent (a first-degree relative) who has the condition. Research is being done to try to determine the genes that may be linked to bipolar 1.

Bipolar 1 is a chronic condition, and there is no cure. Even though it is a lifelong condition, many people are able to manage the symptoms with prescription treatment.

Talk with your doctor if you have any questions about LYBALVI. You can also sign up to receive updates and information from Alkermes about LYBALVI. If you have questions, call 1-844-592-2584 to speak with a LYBALVI representative, Monday through Friday, 9 AM to 8 PM ET.

Before starting LYBALVI, talk with your doctor about any medical conditions you have and any medicines you take or recently have taken.

Mental health conditions and the medicines used to treat them can affect your health. Additionally, people who live with bipolar 1 may have other health conditions, such as certain respiratory diseases, infectious diseases, or cardiovascular diseases. Therefore, it’s important to talk to your healthcare provider about your overall health.

Talk to your healthcare provider about staying active, eating healthy foods, getting enough sleep, and avoiding alcohol use, smoking, or drug use.

Mental health professionals and people living with mental illness report that keeping a journal may be helpful.

Download a journal now >