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Overview: Lybalvi is an oral tablet that is used to treat schizophrenia or bipolar disorder. Common side effects include weight gain, sleepiness, dry mouth, constipation, and headache. Lybalvi can also affect your alertness or coordination. Lybalvi interacts with opioid medicines, which are used to treat certain types of pain. You should not take Lybalvi if you are taking or have recently taken an opioid. You should also not start an opioid too soon after stopping Lybalvi.  It is important to talk with your health care provider before starting or stopping any medicines while you are taking Lybalvi.

Uses

What is Lybalvi used for?

Lybalvi (olanzapine/samidorphan) is commonly used for the following mental health conditions.

Learn more about Lybalvi for schizophrenia and bipolar disorder.

Lybalvi may also be used for other conditions as determined by your health care provider.

How does Lybalvi work (mechanism of action)?

Lybalvi is a combination of two medicines, olanzapine and samidorphan. Olanzapine belongs to a group of medicines called second-generation (atypical) antipsychotics. It is thought to work by balancing brain chemicals called serotonin and dopamine. These chemicals are known to affect thoughts and mood. Samidorphan may work by blocking opioid receptors. Opioids are medicines used to treat certain types of pain. By blocking opioid receptors, samidorphan may limit the weight gain that can sometimes happen with olanzapine.

How is Lybalvi supplied (dosage forms)?

Brands and other names

  • Lybalvi

Dosage forms and strengths

  • 5 mg/10 mg oral tablets
  • 10 mg/10 mg oral tablets
  • 15 mg/10 mg oral tablets
  • 20 mg/10 mg oral tablets

How should I store Lybalvi?

Lybalvi should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Protect from moisture.

Side Effects

What are the most common side effects of Lybalvi?

The most common side effects of Lybalvi are listed below. These side effects may vary depending on the condition being treated. Tell your health care provider if you have any of these side effects that bother you.

  • Weight gain
  • Drowsiness
  • Dry mouth
  • Headache
  • Feeling unusually weak or tired
  • Constipation
  • Increased appetite
  • Dizziness
  • Tremor
  • Upset stomach
  • Back pain
  • Trouble speaking
  • More saliva than usual
  • Memory problems
  • Numbness, tingling, or burning in your arms, feet, or face

There may be other side effects of Lybalvi that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Lybalvi?

While less common, the most serious side effects of Lybalvi are described below, along with what to do if they happen.

Severe Allergic Reactions. Lybalvi may cause allergic reactions,  including a serious specific type of allergic reaction called DRESS. DRESS stands for drug reaction with eosinophilia and systemic symptoms. It is also sometimes called multi-organ hypersensitivity. This is a reaction that can affect multiple parts of the body including your liver, kidneys, and heart. Stop taking Lybalvi and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, throat, feet, ankles, or legs
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Dark-colored pee
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Metabolism Changes. Lybalvi can cause high blood sugar levels or diabetes, high cholesterol levels, and weight gain. Keep all appointments with your health care provider to check your blood work and weight. Call your health care provider if you gain weight or develop the following symptoms of high blood sugar.

  • Thirsty more than usual
  • Peeing more than usual
  • Increase in hunger
  • Tiredness
  • Feeling sick to your stomach
  • Confusion
  • Your breath smelling fruity

Uncontrolled Movements. Lybalvi can cause some people to have movements that they cannot control.  This condition, called tardive dyskinesia (TD), can cause jerky movements of the face, tongue, or body.  TD can be permanent. Call your health care provider right away if you have any of the following symptoms of TD.

  • Tongue sticking out
  • Lip smacking or puckering
  • Grimacing
  • Rapid eye blinking
  • Jerking or twisting motion of the arms, legs, or trunk

Low Blood Pressure Upon Standing (Orthostatic Hypotension) and Falls. Lybalvi may cause a sudden drop in blood pressure when standing up from a seated or lying position. Some people faint or even fall when this happens. To help prevent this, be careful not to get up too quickly. If you feel dizzy, sit or lie down right away until the dizziness stops, then take your time getting up again. Tell your health care provider right away if you have any of the following symptoms of orthostatic hypotension.

  • Dizziness, feeling lightheaded, or fainting upon standing
  • Blurred vision
  • Confusion
  • Feeling weak

Blood Disorders. Lybalvi can cause blood disorders, such as low white blood cell levels (leukopenia,  neutropenia, or agranulocytosis). Keep all appointments with your health care provider to check your blood work. Stop taking Lybalvi and get help right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

Neuroleptic Malignant Syndrome (NMS). Antipsychotic medicines, like Lybalvi, may cause a rare but serious condition called neuroleptic malignant syndrome. NMS can lead to death. Stop taking Lybalvi and contact your health care provider right away if you have any of the following symptoms.

  • High fever
  • Muscle stiffness or rigidity, where it is hard to move
  • Confusion 
  • Changes in your breathing or heart rate
  • Increased sweating

High Prolactin Level (Hyperprolactinemia). Lybalvi may cause an increased level of the hormone prolactin in your blood. High levels of prolactin could lead to fertility or bone problems. Contact your health care provider if you have any of the following symptoms.

  • Vaginal dryness
  • Irregular or no periods
  • Production of breastmilk when not pregnant or nursing
  • Inability to get or keep an erection
  • Enlarged breast size (gynecomastia)
  • Decreased muscle and body hair

Seizures. Some people who have taken Lybalvi have reported having seizures. There are many different types of seizures and some of them are not easy to recognize. Stop taking Lybalvi and call your health care provider if you have any of the following signs that a seizure is happening or could happen.

  • Muscle twitching, jerking, spasms, tremors, or other uncontrolled movements
  • Stiffening of your arms and legs
  • Feeling anxious, nervous, confused, or a sense of dread
  • Feeling dizzy or lightheaded
  • Falling or losing consciousness

Decreased Alertness or Coordination. Lybalvi can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Lybalvi affects you.

Trouble Swallowing. Lybalvi can cause trouble swallowing (dysphagia), which can increase your risk of choking while eating or drinking. Eat small amounts of food, and chew your food well. Get emergency help if you are choking or have food stuck in your esophagus that is not passing.

Body Temperature Regulation. Lybalvi can affect your ability to regulate your body temperature. This could make you become very hot, especially in hot weather or after exercising a lot. You should drink water and avoid overheating and dehydration. Call your health care provider right away if you are severely ill and have the following symptoms of dehydration.

  • Excessive or no sweating
  • Dry mouth
  • Feeling very hot
  • Feeling thirsty 
  • Not able to pee

Warnings & Precautions

Who should not use Lybalvi?

Allergies to Ingredients. People who are allergic to any of the following should not take Lybalvi.

  • Lybalvi
  • Olanzapine
  • Samidorphan
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Lybalvi.

Drug Interactions. Lybalvi should not be taken while you are using certain other medicines. Before taking Lybalvi, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. Do not start or stop taking any medicines without asking your health care provider first. See the Interactions section for more details.

Opioid Withdrawal. You should not take Lybalvi if you are currently having opioid withdrawal. This can happen when you stop taking an opioid after your body has come to rely on it. Tell your health care provider if you have recently stopped taking an opioid. Talk with your health care provider about when it is safe to start Lybalvi after stopping an opioid. 

What should I know about Lybalvi before using it?

Do not take Lybalvi unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Lybalvi with other people, even if they have the same condition as you. It may harm them.

Keep Lybalvi out of the reach of children.

Do not chew, cut, or crush Lybalvi. 

You should not take Lybalvi if you take or have recently stopped taking an opioid, because it may put you at risk for opioid withdrawal. You also should not start taking an opioid medicine too soon after stopping Lybalvi. This could put you at risk for opioid overdose. Tell all of your health care providers about all of the medicines you take, especially before starting or changing any medicines for pain.

Because Lybalvi can make it hard for you to regulate your body temperature, try to avoid becoming too hot or dehydrated. Drink plenty of water, limit your exposure to the heat and sun, do not overexercise, and wear light and breathable clothing.

People who are 65 or older can be at greater risk for some side effects from Lybalvi. Talk to your health care provider about your risks if you are in this age group.

Lybalvi may cause a false positive urine test for opioids. If you are having a urine drug test, tell the person who is running the test that you are taking Lybalvi.

If you can become pregnant, taking Lybalvi may make this more difficult. These effects likely go away after you stop taking Lybalvi. Talk to your health care provider if you have any concerns.

What should I tell my health care provider before using Lybalvi?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Lybalvi is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.

Psychosis Related to Dementia. There is a higher risk of death, stroke, or ministroke in older adults who take Lybalvi or another antipsychotic and have memory loss or psychosis related to dementia. Lybalvi is not approved to treat dementia-related psychosis.

Planned Surgery or Procedures. Tell all of your health care providers that you take Lybalvi before any planned procedures. Your health care provider may need to adjust your medicines before or after the procedure, especially if you need to take any medicines for pain.

Use or Misuse Any Street Drugs. Tell your health care provider if you are using any street (illegal) drugs or you have used or misused any drugs in the past. Also tell your health care provider if you are undergoing opioid withdrawal.

Pregnancy. Lybalvi taken later in pregnancy may lead to an increased risk of certain problems in your newborn. Tell your health care provider if you are or plan to become pregnant while taking Lybalvi. Your health care provider will advise you if you should take Lybalvi while you are pregnant or trying to get pregnant. If you become pregnant while taking Lybalvi, you can register with the National Pregnancy Registry for Atypical Antipsychotics by calling 866-961-2388 or at womensmentalhealth.org/research/pregnancyregistry. This registry collects safety information about the use of psychiatric medicines during pregnancy.

Breastfeeding. Lybalvi passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will advise you if you should take Lybalvi while breastfeeding.

How can I get more information about Lybalvi?

For more information about Lybalvi, you can visit the manufacturer’s website at www.lybalvi.com or call them at 844-592-2584.

Interactions

Does Lybalvi interact with foods or drinks?

There are no known interactions between Lybalvi and foods or drinks.

You should avoid drinking alcohol while taking Lybalvi. Drinking alcohol while taking Lybalvi could increase your risk of dizziness, sleepiness, feeling lightheaded, or fainting upon standing.

Does Lybalvi interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Lybalvi.

  • An opioid, such as codeine, fentanyl, morphine, or oxycodone, which is a medicine used to treat certain types of pain, or if you have stopped taking an opioid in the last 14 days
  • Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine used to treat seizures or nerve pain
  • Fluvoxamine (Luvox), which is a medicine used for obsessive-compulsive disorder (OCD)
  • Levodopa, which is a medicine for Parkinson’s disease
  • A dopamine agonist, such as pramipexole (Mirapex) or ropinirole (Requip), which is a medicine used for Parkinson’s disease, restless legs syndrome, and other conditions
  • A medicine for high blood pressure
  • Rifampin (Rifadin), which is a medicine used to treat an infection called tuberculosis
  • An anticholinergic medicine, which includes antihistamines and medicines used for overactive bladder, Parkinson’s disease, or stomach problems
  • A benzodiazepine, such as diazepam (Valium and others), which is a medicine used for anxiety, muscle spasms, or seizures
  • Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, and medicines for anxiety
  • Any other medicine containing olanzapine (Zyprexa and others)

Many other medicines may alter the blood levels of Lybalvi. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Lybalvi. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Lybalvi?

If you or someone else has used too much Lybalvi, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Lybalvi?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

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