Save on LYBALVI
A long copper-colored bar

NOW
AVAILABLE

A short copper-colored bar

LYBALVI® is an oral tablet taken once daily with or without food

LYBALVI Initiation In Patients Using Opioids

  • LYBALVI is contraindicated in patients using opioids or undergoing acute opioid withdrawal
  • In patients who use opioids, delay initiation of LYBALVI for a minimum of 7 days after last use of short-acting opioids and 14 days after last use of long-acting opioids

Opioid use warning

LYBALVI is contraindicated in patients using opioids or undergoing acute opioid withdrawal1

Precipitation of severe opioid withdrawal in patients who are physiologically dependent on opioids1

  • Prior to initiating LYBALVI, there should be at least a 7-day opioid-free interval from last use of short-acting opioids, and at least a 14-day opioid-free interval from the last use of long-acting opioids
    • Explain the risks associated with precipitated withdrawal and the importance of giving an accurate account of last opioid use to patients and caregivers

Samidorphan, a component of LYBALVI, can precipitate severe opioid withdrawal in patients who are physiologically dependent on opioids1

  • Administration may result in withdrawal syndrome severe enough to require hospitalization

Vulnerability to life-threatening opioid overdose1

  • Patients attempting to overcome LYBALVI’s opioid blockade with high or repeated doses of exogenous opioids could lead to life-threatening or fatal opioid intoxication (eg, respiratory arrest, circulatory collapse)
    • Inform patients of the potential consequences of trying to overcome the opioid blockade and the serious risks of taking opioids concurrently with LYBALVI or while transitioning off LYBALVI
  • Patients with a history of chronic opioid use prior to treatment with LYBALVI may have decreased tolerance to opioids if LYBALVI therapy is interrupted or discontinued
    • Advise patients that this decreased tolerance may increase the risk of opioid overdose if opioids are resumed at previously tolerated dosages

In emergency situations, when an opioid is required, discontinue LYBALVI.1

Please see LYBALVI Prescribing Information for additional details on LYBALVI use and opioids.

LYBALVI Care Support provides patient support to help patients access treatment

LYBALVI Care Support offers these services:

A small icon that shows an access support representative wearing a telephone headset
Patient Access Support

LYBALVI Care Support provides general coverage information and can conduct a benefit investigation, including a written summary of benefits, usually within 24 hours for enrolled patients.

A small icon consisting of a hand cupping a heart to indicate patient care in a patient assistance program
Patient Assistance Program (PAP)

Provides qualifying uninsured patients who meet PAP eligibility requirements access to LYBALVI treatment at no charge for up to 12 months. Certain restrictions apply.

Patient Assistance Program Eligibility

For more information call 1-844-LYBALVI (1-844-592-2584), Monday through Friday 9 AM to 8 PM ET.

Further resources

A small icon consisting of a clipboard that contains a checklist
Prior Authorization & Appeals Information

One option for supporting your patient's coverage request
is through CoverMyMeds®. If prior authorization or an appeal is required, CoverMyMeds offers electronic plan-specific prior authorization submission. CoverMyMeds also has live agents to provide plan-specific prior authorization requirements and forms. CoverMyMeds is a third-party platform not created by Alkermes.

Checklist for Letters of Medical Necessity and Appeal Medicare Appeals and Exceptions Process Brochure
Icon image of a padlock with the lock unlocked
LYBALVI Access Resources for Healthcare Professionals

Find out more information about the various services and resources available to help support access for LYBALVI
patients.

Supporting Your Patients' Access to LYBALVI® Treatment Brochure Access Support Q&A: A Guide for Healthcare Professionals

Request to meet with a sales representative and register today for LYBALVI updates

Request-a-Rep

  • Request an appointment with a LYBALVI sales representative
    • Virtual appointments are available

Get Updates Delivered to Your Inbox

  • Receive email updates about LYBALVI

Request-a-Rep

Virtual appointments are available.

*Required

 

Request-a-Rep

Thank you for submitting a request. Your LYBALVI Sales Representative will follow up with you directly. Also, be sure to check your inbox for more information about LYBALVI.

Get Updates Delivered to Your Inbox

*Required

 

Get Updates Delivered to Your Inbox

Thank you for signing up for updates about LYBALVI. Be sure to check your inbox for updates!

Resources for Patients and Caregivers

LYBALVI® Co-pay Savings Program

Commercially insured eligible patients

$0 for your first 3 fills of LYBALVI*

After the first 3 fills, each refill may cost as little as $20 with a maximum savings of $450 per 30-day supply.*

Tap the button below to do one of the following:

  • Download your co-pay savings card
  • Activate your co-pay savings card
  • Replace your co-pay savings card
Program Terms and Conditions and Privacy Policy.
Image of the Co-pay Savings card for LYBALVI® (olanzapine and samidorphan). Register to learn how commercially insured eligible patients may be able to save on their LYBALVI prescription. Program terms and conditions apply.
For illustration purposes only

*Maximum savings limit applies; patients’ out-of-pocket expenses may vary. Maximum 30-day supply per fill for the first 3 fills. Beginning at fill 4, a maximum savings of $450 per 30-day supply will be provided towards the cost of the LYBALVI prescription. Health plan requirements for a prior authorization and/or step therapies must be attempted prior to using this co-pay offer. Patient must be 18 years of age or older and have a prescription for LYBALVI. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Offer not valid for cash paying patients. Please see full Program Terms and Conditions.

LYBALVI® Co-pay Savings Program

If you have commercial insurance and are eligible for the LYBALVI® Co-pay Savings Program, you can get the co-pay savings card, which makes you eligible to pay $0 for your first 3 fills of LYBALVI. After 3 fills, each refill may cost as little as $20, with a maximum savings of $450 per 30-day supply.*

Click the button below to do one of the following:

Program Terms and Conditions and Privacy Policy.

*Maximum savings limit applies; patients’ out-of-pocket expenses may vary. Maximum 30-day supply per fill for the first 3 fills. Beginning at fill 4, a maximum savings of $450 per 30-day supply will be provided towards the cost of the LYBALVI prescription. Health plan requirements for a prior authorization and/or step therapies must be attempted prior to using this co-pay offer. Patient must be 18 years of age or older and have a prescription for LYBALVI. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Offer not valid for cash paying patients. Please see full Program Terms and Conditions.

Patient/Caregiver Sign Up

LYBALVI Co-pay Savings Card

Start by entering your date of birth. If you are a parent, legal guardian, or family member of an adult living with schizophrenia or bipolar I disorder, you can complete on their behalf. Make sure to use their birthday.

*Required

The following information is required to confirm eligibility for the LYBALVI® Co-Pay Savings Program. Please review the Program Terms and Conditions and Privacy Policy before downloading this card.

By checking this box, I certify that:

Not eligible for the co-pay savings program but interested to learn more about LYBALVI?

*Maximum savings limit applies; patients’ out-of-pocket expenses may vary. Maximum 30-day supply per fill for the first 3 fills. Beginning at fill 4, a maximum savings of $450 per 30-day supply will be provided towards the cost of the LYBALVI prescription. Health plan requirements for a prior authorization and/or step therapies must be attempted prior to using this co-pay offer. Patient must be 18 years of age or older and have a prescription for LYBALVI. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Offer not valid for cash paying patients. Please see full Program Terms and Conditions.

Patient/Caregiver Sign Up

Because you are not at least 18 years of age you are not eligible for the LYBALVI Co-pay Savings Program at this time.

Patient/Caregiver Sign Up

Because you do not meet the insurance requirement you are not eligible for the LYBALVI Co-pay Savings Program at this time.

Patient/Caregiver Sign Up

Your co-pay savings card has been displayed in your browser and a copy of your co-pay savings card was sent to you via and text. Directions to add the co-pay savings card to Apple Wallet™ or Google Pay™ in your mobile device will be provided. Your co-pay savings card is now ready to use.
How to use your co-pay savings card

Show the co-pay savings card to the pharmacist along with your LYBALVI prescription to pay as little as $0 for the first 3 fills. After the first 3 fills, each refill may cost as little as $20 with a maximum savings of $450 per 30-day supply.*

If you have any questions or concerns about the LYBALVI® Co-pay Savings Program, call 1-855-820-9624.

View Program Terms and Conditions and Privacy Policy.

*Maximum savings limit applies; patients’ out-of-pocket expenses may vary. Maximum 30-day supply per fill for the first 3 fills. Beginning at fill 4, a maximum savings of $450 per 30-day supply will be provided towards the cost of the LYBALVI prescription. Health plan requirements for a prior authorization and/or step therapies must be attempted prior to using this co-pay offer. Patient must be 18 years of age or older and have a prescription for LYBALVI. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Offer not valid for cash paying patients. Please see full Program Terms and Conditions.

Patient/Caregiver Sign Up

Activate Co-pay Savings Card

Start by entering your date of birth. If you are a parent, legal guardian, or family member of an adult living with schizophrenia or bipolar I disorder, you can complete on their behalf. Make sure to use their birthday.

*Required

The following information is required to confirm eligibility for the LYBALVI® Co-Pay Savings Program. Please review the Program Terms and Conditions and Privacy Policy before downloading this card.

By checking this box, I certify that:

Not eligible for the co-pay savings program but interested to learn more about LYBALVI?

*Maximum savings limit applies; patients’ out-of-pocket expenses may vary. Maximum 30-day supply per fill for the first 3 fills. Beginning at fill 4, a maximum savings of $450 per 30-day supply will be provided towards the cost of the LYBALVI prescription. Health plan requirements for a prior authorization and/or step therapies must be attempted prior to using this co-pay offer. Patient must be 18 years of age or older and have a prescription for LYBALVI. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Offer not valid for cash paying patients. Please see full Program Terms and Conditions.

Patient/Caregiver Sign Up

Because you are not at least 18 years of age you are not eligible for the LYBALVI Co-pay Savings Program at this time.

Patient/Caregiver Sign Up

Because you do not meet the insurance requirement you are not eligible for the LYBALVI Co-pay Savings Program at this time.

Patient/Caregiver Sign Up

Your co-pay savings card has been displayed in your browser and a copy of your co-pay savings card was sent to you via and text. Directions to add the co-pay savings card to Apple Wallet™ or Google Pay™ in your mobile device will be provided. Your co-pay savings card is now ready to use.
How to use your co-pay savings card

Show the co-pay savings card to the pharmacist along with your LYBALVI prescription to pay as little as $0 for the first 3 fills. After the first 3 fills, each refill may cost as little as $20 with a maximum savings of $450 per 30-day supply.*

If you have any questions or concerns about the LYBALVI® Co-pay Savings Program, call 1-855-820-9624.

View Program Terms and Conditions and Privacy Policy.

*Maximum savings limit applies; patients’ out-of-pocket expenses may vary. Maximum 30-day supply per fill for the first 3 fills. Beginning at fill 4, a maximum savings of $450 per 30-day supply will be provided towards the cost of the LYBALVI prescription. Health plan requirements for a prior authorization and/or step therapies must be attempted prior to using this co-pay offer. Patient must be 18 years of age or older and have a prescription for LYBALVI. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Offer not valid for cash paying patients. Please see full Program Terms and Conditions.

Patient/Caregiver Sign Up

Replace a LYBALVI Co-pay Savings Card

Please enter your date of birth, ZIP code, and the phone number you used to sign up for the program to download a duplicate of your LYBALVI Co-pay Savings Card. Show the co-pay savings card to your pharmacist, along with your prescription.

*Required

 

You will be able to download and print your co-pay savings card after you complete the form.

Optional: I would like to receive my co-pay savings card via:

*Maximum savings limit applies; patients’ out-of-pocket expenses may vary. Maximum 30-day supply per fill for the first 3 fills. Beginning at fill 4, a maximum savings of $450 per 30-day supply will be provided towards the cost of the LYBALVI prescription. Health plan requirements for a prior authorization and/or step therapies must be attempted prior to using this co-pay offer. Patient must be 18 years of age or older and have a prescription for LYBALVI. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Offer not valid for cash paying patients. Please see full Program Terms and Conditions.

Patient/Caregiver Sign Up

Your co-pay savings card has been displayed in your browser and a copy of your co-pay savings card was sent to you via and text. Directions to add the co-pay savings card to Apple Wallet™ or Google Pay™ in your mobile device will be provided. Your co-pay savings card is now ready to use.
How to use your co-pay savings card

Show the co-pay savings card to the pharmacist along with your LYBALVI prescription to pay as little as $0 for the first 3 fills. After the first 3 fills, each refill may cost as little as $20 with a maximum savings of $450 per 30-day supply.*

If you have any questions or concerns about the LYBALVI® Co-pay Savings Program, call 1-855-820-9624.

View Program Terms and Conditions and Privacy Policy.

*Maximum savings limit applies; patients’ out-of-pocket expenses may vary. Maximum 30-day supply per fill for the first 3 fills. Beginning at fill 4, a maximum savings of $450 per 30-day supply will be provided towards the cost of the LYBALVI prescription. Health plan requirements for a prior authorization and/or step therapies must be attempted prior to using this co-pay offer. Patient must be 18 years of age or older and have a prescription for LYBALVI. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Offer not valid for cash paying patients. Please see full Program Terms and Conditions.

*Required

Thank you for signing up for updates about LYBALVI.

Patient Safety Card

Always carry the Patient Safety Card with you while being treated with LYBALVI. This card is intended to inform healthcare providers that you are taking LYBALVI, so it’s important to show it when you visit a doctor or go to the emergency room for treatment.

Image of a patient safety card for LYBALVI® (olanzapine and samidorphan), which can be used to notify emergency personnel that the patient is taking LYBALVI and should not be administered an opioid for pain relief
For illustration purposes only

Reference: LYBALVI [prescribing information]. Waltham, MA: Alkermes, Inc.; 2021.

 

Indications and Important Safety Information  

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.

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.

 

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.

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.

Please see full Prescribing Information, including Boxed Warning, and Medication Guide.