Lybalvi

Generic name: Olanzapine And Samidorphan
Dosage form: tablets
Drug class: Psychotherapeutic combinations

Usage of Lybalvi

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.

    Relate drugs

    How to use Lybalvi

  • 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.

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    Popular Keywords