Indications: LYBALVI® is used in adults to treat schizophrenia. LYBALVI is also used in adults to treat manic or mixed episodes that happen with bipolar 1 disorder, either alone for short-term (acute) or maintenance treatment or in combination with valproate or lithium.

LYBALVI (olanzapine and samidorphan) is a proven treatment for schizophrenia

LYBALVI combines olanzapine, a proven antipsychotic, with another active ingredient, samidorphan.

In a clinical study, LYBALVI reduced the symptoms of schizophrenia in adults compared to those taking a placebo (“sugar pill”).

The effectiveness of LYBALVI was measured in a clinical study using standard surveys. One survey, the Positive and Negative Syndrome Scale (PANSS), was used to measure and assess the severity of symptoms in schizophrenia.

  • Delusions
  • Conceptual disorganization
  • Hallucinatory behavior
  • Excitement
  • Grandiosity
  • Suspiciousness
  • Hostility
  • Blunted affect
  • Emotional withdrawal
  • Poor rapport
  • Passive-apathetic social withdrawal
  • Difficulty in abstract thinking
  • Lack of spontaneity and flow of conversation
  • Stereotyped thinking
  • Somatic concern
  • Anxiety
  • Guilt feelings
  • Tension
  • Mannerisms and posturing
  • Depression
  • Motor retardation
  • Uncooperativeness
  • Unusual thought content
  • Disorientation
  • Poor attention
  • Lack of judgement and insight
  • Disturbance of volition
  • Poor impulse control
  • Preoccupation
  • Active social avoidance

An improvement in PANSS score may be the result of improvement in some symptoms, but not others. LYBALVI has not been shown to improve any symptom individually. Talk to your doctor about any symptoms you are experiencing.

Less weight gain than with olanzapine

In a study of adults living with schizophrenia, patients gained less weight with LYBALVI than with olanzapinea

At 24 weeks in the study, adults who received LYBALVI gained less weight on average than adults who received olanzapine.

  • LYBALVI patients gained just over 4% of their weight, and olanzapine patients gained almost 7% of their weight
  • 18% of LYBALVI patients gained 10% or more of their body weight, while 30% of olanzapine patients gained 10% or more of their body weight

aThe effect of LYBALVI on body weight was studied in a 24-week study that included 538 patients with schizophrenia. 266 patients received LYBALVI, and 272 patients received olanzapine. Patients with diabetes mellitus were excluded. 36% of patients receiving either LYBALVI or olanzapine stopped taking the study drug before the end of the study. Because patients taking olanzapine were not specifically studied, the weight effect of switching from olanzapine to LYBALVI is unknown.

Percent weight gained
at 24 weeks

Comparison of percentages of weight gained by olanzapine patients and LYBALVI® (olanzapine and samidorphan) patients in a 24-week study

Percentage of people who gained 10%
or more of their body weight at 24 weeks

Bar graph that shows the percentages of olanzapine patients and LYBALVI® (olanzapine and samidorphan) patients who gained at least 10% of their body weight in a 24-week study

In this study, weight gain was reported as a side effect in 25% of patients taking LYBALVI and 36% of patients taking olanzapine.

In a separate 4-week study of people with schizophrenia that studied LYBALVI and placebo (sugar pill):

  • 19% of patients taking LYBALVI reported weight gain as a side effect compared to 3% of patients taking placebo
    • LYBALVI patients gained an average of about 7 pounds, while placebo patients gained an average of about a half a pound
    • 26% of patients treated with LYBALVI and 5% of patients treated with placebo gained 7% or more of their body weight

LYBALVI may cause serious side effects, including problems with your metabolism, such as high blood sugar (hyperglycemia). Increases in blood sugar can happen in some people who take LYBALVI. Extremely high blood sugar can lead to a coma or death. Your healthcare provider should check your blood sugar before you start receiving LYBALVI and during your treatment.

Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with LYBALVI: 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.

LYBALVI may also cause 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. You and your healthcare provider should check your weight regularly.

The most common side effects of LYBALVI when used to treat people with schizophrenia include:

  • weight gain
  • dry mouth
  • sleepiness
  • headache

These are not all of 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.

Keep the conversation going
with your doctor

Discussion Guide

At your next appointment, have a conversation
with your doctor about LYBALVI.

Download Guide
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What's next?

Starting LYBALVI
View Site for Bipolar 1 in Adults

Important Safety Information and Indications

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 people with dementia-related psychosis.

Do not take LYBALVI if you are taking opioids or are experiencing acute opioid withdrawal.

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.
  • 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 to treat people with schizophrenia include:
  • weight gain
  • dry mouth
  • sleepiness
  • headache
The most common side effects of LYBALVI when used alone to treat people with mixed or manic episodes that happen with bipolar I 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 I 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
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.
    • Drink plenty of water.
Before taking LYBALVI, tell your healthcare provider about all of your medical conditions, including if you:
  • have or had heart problems or a stroke
  • use or abuse street (illegal) drugs
  • have or had low or high blood pressure
  • have kidney problems
  • have diabetes or high blood sugar or a family history of diabetes or high blood sugar
  • have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides or low levels of HDL cholesterol
  • have or had a low white blood cell count
  • have problems swallowing
  • have or had seizures (convulsions)
  • have or had problems with urination or prostate problems
  • have or had breast cancer
  • have or had constipation or a bowel obstruction
  • have or had high prolactin levels
  • are pregnant or plan to become pregnant. Talk to your healthcare provider about the risks to you and your unborn or newborn baby if you take LYBALVI during pregnancy.
  • are breastfeeding or plan to breastfeed. LYBALVI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with LYBALVI.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

LYBALVI and other medicines may affect each other causing possible serious side effects.

LYBALVI may affect the way other medicines work, and other medicines may affect how LYBALVI works.

Especially tell your healthcare provider if you:
  • take opioids or have stopped taking opioids in the past 14 days
  • take or plan to take other olanzapine containing medicines

Your healthcare provider can tell you if it is safe to take LYBALVI with your other medicines. Do not start or stop any medicines while taking LYBALVI without first talking to your healthcare provider.

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.

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.

Indications

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

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

It is not known if LYBALVI is safe or effective in children.