Lybalvi (olanzapine/samidorphan)

Lybalvi generic

Lybalvi is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Lybalvi side effects

Lybalvi can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Lybalvi. These lists do not include all possible side effects.

For more information about the possible side effects of Lybalvi, talk with your doctor or pharmacist. They can give you tips on managing any side effects that may concern or bother you.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Lybalvi, you can do so through MedWatch.

Mild side effects

Mild side effects* of Lybalvi can include:

• sleepiness
• dry mouth
• headache
• constipation
• increased appetite
• dizziness
• tremor (shaking)
• weakness
• indigestion
• back pain
• speech difficulties
• increased saliva
• amnesia (memory loss)
• difficulty swallowing
• numbness or tingling of your arms or legs
• high cholesterol
• weight gain†

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or do not go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Lybalvi. To learn about other mild side effects, talk with your doctor or pharmacist or view Lybalvi’s prescribing information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Lybalvi are not common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Drug reaction with eosinophilia and systemic symptoms (DRESS), which is a reaction that can occur after taking certain medications. Symptoms can include:
  • fever
  • rash
  • swollen lymph nodes
• Hyperglycemia (high blood sugar) or diabetes. Symptoms can include:
  • feeling thirsty
  • confusion
  • blurry vision
• Orthostatic hypotension (dizziness when changing positions) or fainting. Symptoms can include:
  • dizziness
  • blurry vision
  • lightheadedness
• Changes in blood cell levels, such as low white blood cells. Symptoms can include:
  • fever
  • chills
  • sore throat
• Seizures. Symptoms can include:
  • stiffening of your body
  • jerking motions
  • losing consciousness
• High prolactin levels (a hormone made in your brain). Symptoms can include:
  • changes in menstrual cycle
  • milky discharge (when you are not pregnant or breastfeeding)
  • headache
• Tardive dyskinesia (uncontrolled muscle movements). Symptoms can include:
  • smacking or pursing your lips
  • sticking out your tongue
  • blinking excessively
• Increased risk of death in older people with dementia-related psychosis.*
• Allergic reaction.†
• Neuroleptic malignant syndrome (NMS).†

* Lybalvi has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA.
† For more information about this side effect, see “Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause. To find out how often side effects occurred in clinical trials, see Lybalvi’s prescribing information.

Note: In addition to the information above and below, you can refer to this article about Lybalvi’s side effects.

Weight gain

You may experience weight gain while you are taking Lybalvi. In clinical trials, this side effect was common.

Many antipsychotic medications (including Lybalvi) can increase your risk of weight gain. However, it is important to note that people taking Lybalvi in a trial for schizophrenia experienced less weight gain than people taking olanzapine alone. (Olanzapine is one of Lybalvi’s active ingredients.)

What you can do

Before you start taking Lybalvi, your doctor will check your body weight. They will then monitor your weight throughout your treatment with Lybalvi.

If you notice that you are gaining weight while taking Lybalvi, talk with your doctor. They may recommend a change in your diet or exercise routine that can help limit your weight gain.

Neuroleptic malignant syndrome

Although rare, it is possible to develop neuroleptic malignant syndrome (NMS) while you are taking Lybalvi. This condition is due to a negative reaction to drugs used to treat mental health conditions.

You should be aware of the possible symptoms of NMS while you are taking Lybalvi. You should see your doctor right away if you notice that you’re developing any symptoms, such as:

• fever
• confusion
• sweating
• muscle stiffness
• changes in your heart rate, pulse, or blood pressure
• changes in your breathing

What you can do

If you develop symptoms of NMS, it’s important to call your doctor or go to the hospital right away. Even though it is rare, NMS can be life threatening. If you develop NMS, your doctor will treat your condition and recommend that you stop taking Lybalvi.

Increased risk of death in older people with dementia-related psychosis

Lybalvi has a boxed warning about an increased risk of death in older people with psychosis that is related to dementia. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). These warnings alert doctors and patients about drug effects that may be dangerous.

Antipsychotic drugs, such as Lybalvi, may increase the risk of death in older people. Specifically, older people with psychosis that is related to dementia (a condition involving memory loss). With psychosis, you lose touch with reality and may hear or see things that are not really there. You may also have hallucinations or delusions.

Lybalvi can increase the risk of death in this group of people. In studies of olanzapine, death occurred from different causes, such as heart problems or infections like pneumonia.

Stroke also occurred in older people with dementia-related psychosis who took olanzapine in clinical trials. Stroke can be fatal for some people. Possible symptoms of stroke include:

• confusion
• trouble speaking, seeing, or walking
• headache
• weakness on one side of the body, usually in your face, arm, or leg

What you can do

Lybalvi is not approved for use in people with dementia-related psychosis. Your doctor can recommend different treatment options that are more appropriate.

If you experience symptoms of stroke, be sure to call 911 or your local emergency number right away.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Lybalvi. This side effect wasn’t reported in clinical trials of Lybalvi. However, allergic reaction has been reported since the drug became available for use.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have an allergic reaction to Lybalvi, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Lybalvi cost

As with all medications, the cost of Lybalvi can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Lybalvi. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor, pharmacist, or insurance company.

Before approving coverage for Lybalvi, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you will need to get prior authorization for Lybalvi, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Lybalvi, or if you need help understanding your insurance coverage, help is available.

Lybalvi’s manufacturer offers a co-pay savings card you may use if you have insurance. For more information and to find out if you’re eligible for support, call 855-820-9624 or visit the manufacturer’s website. You can also ask your doctor for more information.

You can visit Optum Perks for price estimates of Lybalvi. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.

To learn more about saving money on prescriptions, check out this article.

Mail-order pharmacies

Lybalvi may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Lybalvi, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor, pharmacist, or insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you do not have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Lybalvi is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

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Retail price refers to the manufacturer’s published list price and is up to date as of 3/2023. Retail and discounted prices are U.S.-only and can vary based on region and pharmacy. We cannot guarantee that the discounted price listed here will exactly match the price at your pharmacy. Please contact your pharmacy for the exact price.

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Lybalvi dosage

The Lybalvi dosage your doctor prescribes will depend on several factors. These include:

• the type of condition you are taking Lybalvi to treat
• other medications that you are taking with Lybalvi
• side effects that you have from the medication

Typically, your doctor will start you on a low dosage. Then they will adjust it over time to reach the amount that is right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Lybalvi contains the active ingredients olanzapine and samidorphan. It comes as a tablet that you swallow. And it is available in the following strengths:

• 5 milligrams (mg) olanzapine/10 mg samidorphan
• 10 mg olanzapine/10 mg samidorphan
• 15 mg olanzapine/10 mg samidorphan
• 20 mg olanzapine/10 mg samidorphan

Dosage for schizophrenia

For the treatment of schizophrenia in adults, your doctor will usually start your treatment with a dose of 5 mg/10 mg (5 mg of olanzapine and 10 mg of samidorphan) or 10 mg/10 mg once per day.

After a week of treatment, your doctor may increase your dose until your schizophrenia symptoms have decreased. The maximum recommended dose of Lybalvi to treat schizophrenia is 20 mg/10 mg once per day.

Dosage for bipolar I disorder

Your dosage of Lybalvi for bipolar I disorder depends on whether you are taking the drug alone or in combination with other medications.

Lybalvi used alone

Your doctor may prescribe Lybalvi alone for short-term use during mixed or manic episodes of bipolar I disorder. The starting dosage for this condition is typically 10 mg/10 mg or 15 mg/10 mg once per day. Your doctor may adjust your dose every 24 hours until you reach the right amount of medication for you.

The maximum recommended dosage of Lybalvi for bipolar I disorder is 20 mg/10 mg once per day.

Once the symptoms of your condition have eased, your doctor may have you keep taking Lybalvi long term.

Lybalvi used with lithium or valproate

Your doctor may recommend taking Lybalvi in combination with lithium (Lithobid) or valproate to treat bipolar I disorder. In this case, you will likely begin by taking a dose of 10 mg/10 mg once per day. Then, your doctor may increase your dose each week based on how well the medication is working for you.

The maximum recommended dosage of Lybalvi when you take it with lithium or valproate for bipolar I disorder is 20 mg/10 mg once per day.

Lybalvi used as maintenance monotherapy

Lybalvi can also be used as maintenance monotherapy to treat bipolar I disorder. Maintenance monotherapy means taking the drug alone as a long-term treatment option. In this case, your doctor may recommend a dose of any of the following strengths, taken once per day:

• 5 mg/10 mg
• 10 mg/10 mg
• 15 mg/10 mg
• 20 mg/10 mg

What if I miss a dose?

If you miss your dose of Lybalvi, talk with your doctor or pharmacist. Depending on how long it has been since your missed your dose, they can help you determine when to take your next dose.

Sometimes, your doctor may recommend taking your missed dose as soon as you remember. But, if it’s almost time for your next dose, they may recommend skipping your missed dose and taking your next dose at your regular time.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Will I need to use this drug long term?

Lybalvi may be used as a short-term or long-term treatment. For schizophrenia, you’ll likely take Lybalvi long term. However, for manic or mixed episodes of bipolar I disorder, you may take the drug short or long term. If you and your doctor determine that Lybalvi is safe and effective for you, you will likely take it long term.

Note: In addition to the information in the above sections, you can refer to this article about Lybalvi’s dosage.

How Lybalvi works

Lybalvi is approved to treat schizophrenia and bipolar I disorder in adults. It contains two active drugs: olanzapine and samidorphan.

The exact mechanism of action (how a drug works) for treating schizophrenia or bipolar I disorder is unknown. However, it’s thought that olanzapine may block dopamine and serotonin (hormones in your brain) from having an effect. This may help balance your mood, which can decrease symptoms of schizophrenia or bipolar I disorder.

Lybalvi also contains the drug samidorphan, which is an opioid antagonist. This drug was added to olanzapine to decrease the weight gain* that olanzapine may cause. Although weight gain is still a possible side effect of Lybalvi, people who took Lybalvi reported less weight gain than those who took olanzapine alone.

* For more information about this side effect, see “Side effect details” in the “Lybalvi side effects” section above.

How long does it take to work?

Lybalvi begins working as soon as you take your first dose of medication. However, it can take up to 7 days for the drug to reach a consistent amount in your body. So, it may take some time for you to notice a difference in your mood.

Common questions about Lybalvi

Here are answers to some frequently asked questions about Lybalvi.

Is Lybalvi a controlled substance?

No, Lybalvi is not a controlled substance. A controlled substance is a drug that the government monitors. Monitored drugs include those that can cause dependence or where there is a possibility that a person may misuse them. Misusing a medication means using it differently from how a doctor prescribed it.

Lybalvi contains a drug called samidorphan. This drug is an opioid antagonist, which means that it blocks opioids from working. However, in Lybalvi, samidorphan is used to decrease weight gain* that can occur from the medication. Lybalvi does not contain any opioid drug. Opioids are controlled substances because they can lead to dependence and misuse.

It is important to note that you should not take Lybalvi if you are taking opioid medications. Since samidorphan works to block the opioid receptor (where opioids work), taking this medication within 7 days of a short-acting opioid or 14 days of a long-acting opioid may cause withdrawal symptoms. Withdrawal may be serious and can even cause hospitalization.

If you have additional questions about Lybalvi, talk with your doctor or pharmacist.

* For more information about this side effect, see “Side effect details” in the “Lybalvi side effects” section above.

What activities should I avoid while taking Lybalvi?

Due to the risk of certain side effects with Lybalvi, you should not drive a car or operate other machinery until you know how your body reacts to Lybalvi treatment. Lybalvi can cause sleepiness, dizziness, or tremors. It can also cause more serious side effects, such as fainting or seizures. These potential side effects can affect your ability to drive or operate machinery safely.

Also, becoming overheated or dehydrated during your treatment with Lybalvi can increase your risk of orthostatic hypotension or fainting. Strategies to avoid overheating or dehydration include:

• avoiding over-exercising
• staying in a cool area, out of the sun
• not wearing heavy clothes or layers of clothes
• staying hydrated
• avoid consuming alcohol

If you have additional questions about what activities to avoid during your treatment with Lybalvi, talk with your doctor.

Can Lybalvi cause any changes in my personality?

Lybalvi is not known to cause changes in your personality. No changes in personality were reported as a side effect in clinical trials. However, this medication does work to stabilize your mood. So, you may notice that your mood and behavior are more manageable while you’re taking Lybalvi. You may not experience symptoms of schizophrenia or bipolar I disorder as often as usual.

If you are concerned about personality changes during Lybalvi treatment, talk with your doctor. They can help determine if Lybalvi may be a good treatment option for you.

Lybalvi uses

The Food and Drug Administration (FDA) approves prescription drugs, such as Lybalvi, to treat certain conditions.

Doctors prescribe Lybalvi to treat adults with schizophrenia and bipolar I disorder, which are mental health conditions. You can learn more about mental health by visiting our mental health hub.

Lybalvi for schizophrenia

One indication, or approved use, of Lybalvi is to treat schizophrenia in adults. Schizophrenia is a mental health condition that can cause problems with perception. Symptoms may include hallucinations, trouble making sense of your thoughts, and believing things that are not true.

Effectiveness for schizophrenia

Lybalvi is an effective treatment option for people with schizophrenia. The American Psychiatric Association guidelines include olanzapine (one of the drugs in Lybalvi) as a recommended treatment option for schizophrenia. However, since Lybalvi was recently approved (in 2021), the drug has not been added to the guidelines yet. For information on how Lybalvi performed in clinical trials, see the drug’s prescribing information.

Lybalvi for bipolar I disorder

Lybalvi is also approved to treat bipolar I disorder in adults. Bipolar I disorder is a mental health condition that can cause manic and depressive episodes to occur.

Symptoms of manic episodes may include increased energy or extreme levels of confidence. Symptoms of depression may include feeling sad or lonely or not wanting to participate in activities you usually enjoy. For details about bipolar 1 disorder, you can refer to our bipolar disorder hub.

Lybalvi can be used to treat manic or mixed (both manic and depressed) episodes. In this case, the drug can be used alone as a short-term or long-term treatment option. In addition, people with bipolar I disorder can take Lybalvi in combination with lithium (Lithobid) or valproate.

Effectiveness for bipolar I disorder

Lybalvi is an effective treatment option for people with bipolar I disorder. Olanzapine (one of the drugs in Lybalvi) is recommended in guidelines for treating bipolar I disorder. However, since Lybalvi was recently approved, the drug has not been added to the guidelines yet. For information on how Lybalvi performed in clinical trials, see the drug’s prescribing information.

Lybalvi and children

Lybalvi is not approved for use in children at this time. It is unknown if the drug may be a safe or effective treatment option for children with schizophrenia or bipolar I disorder.

Alternatives to Lybalvi

Other drugs that can treat your condition are available. Some may be a better fit for you than others. If you’re interested in finding an alternative to Lybalvi, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Doctors prescribe some of the drugs listed here off-label to treat these specific conditions. Off-label drug use is when a doctor prescribes a drug that’s approved by the Food and Drug Administration (FDA) ]for a purpose other than what it’s approved for.

Alternatives for schizophrenia

Examples of other drugs that may treat schizophrenia include:

• aripiprazole (Abilify)
• cariprazine (Vraylar)
• lurasidone (Latuda)
• risperidone (Risperdal)
• olanzapine (Zyprexa)
• haloperidol (Haldol)
• paliperidone (Invega)

Alternatives for bipolar I disorder

Examples of other drugs that may treat bipolar I disorder include:

• lithium (Lithobid)
• valproate
• carbamazepine (Tegretol)
• lamotrigine (Lamictal)
• quetiapine (Seroquel)
• olanzapine (Zyprexa)
• fluoxetine (Prozac)
• escitalopram (Lexapro)
• paroxetine (Paxil)

Lybalvi interactions

Lybalvi can interact with several other medications. It is not known to interact with food but may interact with certain supplements.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Lybalvi and other medications

Below is a list of medications that can interact with Lybalvi. This list does not contain all drugs that may interact with Lybalvi.

Before taking Lybalvi, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Drugs you should not take with Lybalvi:

• Opioids. Some people take these medications to treat pain. Lybalvi can cause opioid withdrawal to occur or may worsen existing opioid withdrawal. Examples include:
  • oxycodone (Roxicodone)
  • hydromorphone (Dilaudid)
  • morphine ER (MS Contin)
  • methadone (Methadose)

Types of drugs that can interact with Lybalvi include:

• Strong CYP3A4 inducers. These drugs affect a protein in your body called CYP3A4. Taking Lybalvi with these drugs may make Lybalvi less effective. Examples of these medications include:
  • carbamazepine (Tegretol)
  • phenytoin (Dilantin)
  • rifampin (Rimactane)
• Strong CYP1A2 blockers. These medications block a protein called CYP1A2 from working in your body, which can increase your risk of side effects from Lybalvi. Examples of these drugs include:
  • ciprofloxacin (Cipro)
  • fluvoxamine (Luvox)
  • omeprazole (Prilosec)
• CYP1A2 inducers. These drugs affect a protein in your body called CYP1A2. Taking Lybalvi with these drugs may make Lybalvi less effective. Examples of these medications include:
  • phenytoin (Dilantin)
  • ritonavir (Norvir)
  • rifampin (Rimactane)
• Diazepam or other drugs that affect your central nervous system. Taking these drugs with Lybalvi may cause an increased risk of orthostatic hypotension. Examples of these medications include:
  • diazepam (Valium)
  • alprazolam (Xanax)
  • clonazepam (Klonopin)
• Anticholinergic drugs. Taking these drugs in combination with Lybalvi can increase your risk of side effects, including digestive problems. Examples of these medications include:
  • benztropine
  • aclidinium (Tudorza Pressair)
  • amitriptyline
• Certain blood pressure medications. Lybalvi can make these drugs lower your blood pressure even more. Examples of these medications include:
  • lisinopril (Zestril)
  • losartan (Cozaar)
  • metoprolol (Toprol XL, Lopressor)
• Levodopa or other drugs that affect dopamine (a type of brain chemical). Lybalvi can block these drugs from working. Examples of these medications include:
  • levodopa (Inbrija)
  • ropinirole
  • pramipexole (Mirapex ER)

Lybalvi and herbs and supplements

Lybalvi may interact with an herbal supplement called St. John’s Wort. St. John’s Wort affects a protein in your body called CYP3A4 and causes it to work faster than usual. Taking Libalvi with St. John’s Wort may make Lybalvi less effective.

Be sure to talk with your doctor or pharmacist before using any herbs or supplements while taking Lybalvi.

Lybalvi and foods

You should avoid drinking alcohol while you’re taking Lybalvi. Alcohol can increase your risk of orthostatic hypotension, which may cause you to faint or become dizzy. For more information on this risk, see the “Lybalvi and alcohol” section below.

Lybalvi and smoking

If you smoke, be sure to let your doctor know before starting Lybalvi. Smoking may cause your body to get rid of Lybalvi faster than usual. This can make Lybalvi less effective. Be sure to talk with your doctor about the best dosage of Lybalvi and the best treatment plan for you.

Lybalvi use with other drugs

In some cases, your doctor may recommend that you take Lybalvi in combination with other medications to treat your condition. According to recommendations, some people with bipolar I disorder should take Lybalvi in combination with lithium (Lithobid) or valproate.

If you are interested in taking Lybalvi along with other medications for your schizophrenia or bipolar I disorder, talk with your doctor. They can help determine the best treatment plan for you.

Lybalvi and alcohol

You should avoid drinking alcohol while taking Lybalvi. Alcohol can increase your risk of side effects such as orthostatic hypotension, which may cause you to faint or become dizzy. Due to this risk, it’s recommended to avoid drinking alcohol or be very careful while drinking alcohol if you’re taking Lybalvi.

If you drink alcohol, talk with your doctor about how much alcohol, if any, is safe for you to drink during your treatment with Lybalvi.

How to take Lybalvi

You should take Lybalvi according to the instructions your doctor gives you.

When to take

You should take Lybalvi once per day, at about the same time each day.

To help make sure that you do not miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Accessible labels and containers

Some pharmacies offer labels that have large print, braille, or a code you scan with a smartphone to convert text to speech. If your local pharmacy does not have these options, your doctor or pharmacist may be able to direct you to one that does.

If you have difficulty opening medication bottles, ask your pharmacist if they can put Lybalvi in an easy-open container. They also may be able to recommend tools that can make it simpler to open lids.

Taking Lybalvi with food

You can take Lybalvi with or without food.

Can Lybalvi be crushed, split, or chewed?

No, you should swallow Labalvi tablets whole. You should not crush, split, or chew Lybalvi.

Lybalvi and pregnancy

It’s not known if Lybalvi is safe to take during pregnancy.

Taking Lybalvi during the third trimester of pregnancy can increase the risk of withdrawal symptoms or extrapyramidal symptoms (movements you cannot control), such as agitation, tremor, or sleepiness, occurring in a newborn.

Studies of people taking olanzapine, one of the drugs in Lybalvi, do not show an increased risk of congenital anomalies (commonly known as birth defects). But, it is unknown what effects samidorphan or the combination of olanzapine and samidorphan (Lybalvi) may have on a fetus.

In animal studies, high doses of Lybalvi did cause developmental problems to occur in a fetus. However, animal studies do not always indicate what may happen in humans.

It is also important to note that there are possible risks to pregnant people with untreated bipolar I disorder or schizophrenia during pregnancy. Untreated bipolar I disorder or schizophrenia may increase the risk of worsening symptoms, hospitalization, or even suicide.

If you’re pregnant or planning to become pregnant, talk with your doctor about the best treatment plan for your bipolar I disorder or schizophrenia.

Pregnancy registry for Lybalvi

If you take Lybalvi during pregnancy, you might consider joining the drug’s pregnancy registry. A pregnancy registry collects information about any effects that a drug may have on pregnancy. Researchers then study the information to determine whether the drug is a safe option for use during pregnancy.

If you’d like to know more about this pregnancy registry or want to enroll in it, visit the registry website or call 866-961-2388.

Lybalvi and fertility

It is possible that Lybalvi can temporarily decrease fertility in females.* This is because the drug can increase prolactin levels. However, your fertility should return to normal when you stop taking Lybalvi. If you are planning to become pregnant, talk with your doctor before starting Lybalvi.

Lybalvi did not seem to affect male* fertility.

* Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.

Lybalvi and birth control

It is unknown if Lybalvi is safe to take during pregnancy. If you are sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you are using Lybalvi.

For more information about taking Lybalvi during pregnancy, see the “Lybalvi and pregnancy” section above.

Lybalvi and breastfeeding

Breastfeeding while taking Lybalvi may expose your baby to Lybalvi. Olanzapine, one of the drugs in Lybalvi, does pass into breast milk. It’s unknown if samidorphan (the other drug in Lybalvi) passes into breast milk.

Babies exposed to olanzapine from breastfeeding may have side effects such as sleepiness, irritability, or difficulty feeding. They may also have extrapyramidal symptoms (movements you cannot control), including tremors or uncontrolled muscle movements. Babies exposed to Lybalvi through breastfeeding will likely require monitoring for these symptoms.

If you are breastfeeding or planning to breastfeed, talk with your doctor before taking Lybalvi. They can discuss the risks and benefits of taking this drug while you are breastfeeding.

Lybalvi precautions

This drug comes with several precautions.

FDA warning: Increased risk of death in older people with dementia-related psychosis

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Lybalvi has a boxed warning for an increased risk of death in older people who also have psychosis that’s related to dementia (a condition involving memory loss). This warning applies to all antipsychotic medications, including Lybalvi. Due to this risk, your doctor will likely not prescribe Lybalvi if you have dementia-related psychosis. For more information, see the “Lybalvi side effects” section above.

Other precautions

Before taking Lybalvi, talk with your doctor about your health history. Lybalvi may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• Heart problems or history of stroke. If you have a history of heart problems or have had a stroke, your doctor may recommend a different medication for you. This is because Lybalvi may increase your risk of heart problems or stroke.
• High or low blood pressure. Tell your doctor if you have any blood pressure problems, including high or low blood pressure. Lybalvi may affect your blood pressure and can worsen existing blood pressure problems. Your doctor may monitor your blood pressure levels more often throughout your treatment with Lybalvi.
• Kidney problems. If you have a serious kidney problem, tell your doctor before starting treatment with Lybalvi. Your kidneys work to break down this drug in your body. If your kidneys are not functioning properly, you may get too much Lybalvi. Your doctor will be able to help you determine if this medication is safe for you to take with your kidney problems.
• Diabetes. If you have diabetes, tell your doctor before you start taking Lybalvi. This medication may increase your blood sugar levels even more, which can worsen your diabetes symptoms. If you have diabetes, your doctor may recommend monitoring your blood sugar levels more often.
• High cholesterol or triglycerides. Lybalvi may lead to high cholesterol or high triglyceride levels. If you already have high cholesterol or high triglycerides, taking Lybalvi may worsen your condition. Your doctor may monitor your cholesterol or triglyceride levels more often throughout treatment with Lybalvi.
• Low white blood cell levels. It is possible for Lybalvi to cause low levels of white blood cells. If you already have low levels of white blood cells, taking Lybalvi may worsen your condition, such as increasing your risk of infection. Talk with your doctor to see if Lybalvi is a safe option for you.
• High prolactin levels. Lybalvi can increase your prolactin levels. If you already have high prolactin levels, taking this medication may worsen your symptoms. Talk with your doctor to see if this medication may be a safe treatment option for you.
• Breast cancer. Certain types of breast cancer may be sensitive to a hormone called prolactin. Lybalvi can increase the amount of prolactin in your body. If you have breast cancer or have a history of breast cancer, your doctor may recommend avoiding this medication. Talk with your doctor to see if Lybalvi may be a safe treatment option for you.
• Difficulty swallowing. Lybalvi may cause difficulty swallowing. If you already have difficulty swallowing, taking this medication may worsen this symptom. Your doctor can help determine if this medication may be a safe treatment option for you.
• Seizures. Lybalvi may increase your risk of seizures occurring. If you have a history of seizures or a seizure disorder, tell your doctor before taking Lybalvi.
• Urinary retention. Lybalvi may increase your risk of developing urinary retention. This may make it more difficult for you to urinate. If you have urinary retention, taking Lybalvi may worsen your symptoms. Talk with your doctor to see if this medication is a good treatment option for you.
• Prostate problems. If you have certain prostate problems, such as enlarged prostate, taking Lybalvi may worsen the symptoms of your condition. Talk with your doctor to see if this medication is safe for you to take along with your existing prostate problems.
• Digestive problems. Lybalvi can increase your risk of digestive problems, such as constipation or paralytic ileus. If you already have digestive problems, taking this medication may worsen your condition. Talk with your doctor to see if Lybalvi may be a good treatment option for you.
• Allergic reaction. If you’ve had an allergic reaction to Lybalvi or any of its ingredients, your doctor will likely not prescribe Lybalvi. Ask your doctor what other medications are better options for you.
• Pregnancy. It is unknown if Lybalvi is safe to take during pregnancy. For more information, see the “Lybalvi and pregnancy” section above.
• Breastfeeding. It is unknown if Lybalvi is safe to take while breastfeeding. Lybalvi is present in breast milk. For more information, see the “Lybalvi and breastfeeding” section above.

Note: For more information about the potential negative effects of Lybalvi, see the “Lybalvi side effects” section above.

Lybalvi overdose

Taking more than the recommended dosage of Lybalvi can lead to serious side effects.

Do not take more Lybalvi than your doctor recommends.

Overdose symptoms

Symptoms of an overdose can include:

• agitation or aggression
• increased heart rate
• loss of consciousness
• difficulty talking
• heart problems
• changes in blood pressure

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.