Lybalvi is a prescription medicine which contains two 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 this medicine is safe or effective in children.
Lybalvi side effects
Lybalvi may cause serious side effects, including:
See Important information
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. Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment:
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.
weight gain. You and your healthcare provider should check your weight before you start and often during treatment.
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.
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.
The most common side effects when used to treat people with schizophrenia include:
weight gain
dry mouth
sleepiness
headache
The most common side effects 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 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
These are not all the possible side effects. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.
Before taking Lybalvi
You should not take this medicine if you are taking opioids or are experiencing acute opioid withdrawal. See Lybalvi side effects.
Take Lybalvi exactly as your healthcare provider tells you to take it. Do not change the dose or stop treatment without first talking to your healthcare provider.
Take Lybalvi tablets one time each day with or without food.
Swallow the tablets whole. Do not split or combine different strength tablets.
If you take too much or overdose, call your Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.
Warnings
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.
If your healthcare provider prescribes Lybalvi in combination with valproate or lithium, also read the Medication Guide that comes with those medicines.
What other drugs will affect Lybalvi
Other drugs may interact with olanzapine and samidorphan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
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