Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Lybalvi

Descriptions


Olanzapine and samidorphan combination is used to treat schizophrenia. It may also be used alone or with other medicines (eg, lithium or valproate) to treat mania or mixed episodes that is part of bipolar disorder (manic-depressive illness). This medicine should not be used to treat behavioral problems in older adult patients who have dementia.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of olanzapine and samidorphan combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olanzapine and samidorphan combination in the elderly. However, elderly patients are more likely to have serious unwanted effects, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Alfentanil
  • Anileridine
  • Benzhydrocodone
  • Bepridil
  • Bromopride
  • Buprenorphine
  • Butorphanol
  • Cisapride
  • Codeine
  • Diacetylmorphine
  • Difenoxin
  • Dihydrocodeine
  • Diphenoxylate
  • Dronedarone
  • Ethylmorphine
  • Fentanyl
  • Hydrocodone
  • Hydromorphone
  • Ketobemidone
  • Levoketoconazole
  • Levomethadyl
  • Levorphanol
  • Meperidine
  • Methadone
  • Metoclopramide
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Nicomorphine
  • Opium
  • Opium Alkaloids
  • Oxycodone
  • Oxymorphone
  • Papaveretum
  • Paregoric
  • Pimozide
  • Piperaquine
  • Piritramide
  • Potassium Citrate
  • Remifentanil
  • Saquinavir
  • Sparfloxacin
  • Sufentanil
  • Tapentadol
  • Terfenadine
  • Thioridazine
  • Tilidine
  • Tramadol
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abametapir
  • Acepromazine
  • Adagrasib
  • Alfentanil
  • Alfuzosin
  • Alprazolam
  • Amantadine
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amobarbital
  • Anagrelide
  • Anileridine
  • Apalutamide
  • Apomorphine
  • Apomorphine Hydrochloride
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azithromycin
  • Baclofen
  • Bedaquiline
  • Benperidol
  • Benzhydrocodone
  • Bromazepam
  • Bromocriptine Mesylate
  • Buprenorphine
  • Bupropion
  • Buserelin
  • Buspirone
  • Butabarbital
  • Butorphanol
  • Cabergoline
  • Calcium Oxybate
  • Cannabidiol
  • Cannabis
  • Capmatinib
  • Carbamazepine
  • Carbinoxamine
  • Carisoprodol
  • Carphenazine
  • Ceritinib
  • Cetirizine
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chloroquine
  • Chlorpromazine
  • Chlorzoxazone
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clobazam
  • Clofazimine
  • Clomipramine
  • Clonazepam
  • Clorazepate
  • Clothiapine
  • Clozapine
  • Cobicistat
  • Codeine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Daridorexant
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Dexmedetomidine
  • Diacetylmorphine
  • Diazepam
  • Dichloralphenazone
  • Difenoxin
  • Dihydrocodeine
  • Diphenhydramine
  • Diphenoxylate
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Doxylamine
  • Droperidol
  • Ebastine
  • Efavirenz
  • Encorafenib
  • Enflurane
  • Enoxacin
  • Entrectinib
  • Enzalutamide
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Esketamine
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Ethylmorphine
  • Etrasimod
  • Famotidine
  • Fedratinib
  • Felbamate
  • Fenoldopam Mesylate
  • Fentanyl
  • Fexinidazole
  • Fingolimod
  • Flecainide
  • Flibanserin
  • Fluconazole
  • Flunitrazepam
  • Fluoxetine
  • Fluphenazine
  • Flurazepam
  • Fluspirilene
  • Fluvoxamine
  • Formoterol
  • Foscarnet
  • Fosphenytoin
  • Fospropofol
  • Fostemsavir
  • Gabapentin
  • Gabapentin Enacarbil
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Gepirone
  • Glasdegib
  • Glucagon
  • Glycopyrrolate
  • Glycopyrronium Tosylate
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halazepam
  • Halofantrine
  • Haloperidol
  • Halothane
  • Hexobarbital
  • Histrelin
  • Hydrocodone
  • Hydromorphone
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Inotuzumab Ozogamicin
  • Isoflurane
  • Itraconazole
  • Ivabradine
  • Ivosidenib
  • Ketamine
  • Ketazolam
  • Ketobemidone
  • Ketoconazole
  • Lacosamide
  • Lapatinib
  • Lefamulin
  • Lemborexant
  • Lenvatinib
  • Leuprolide
  • Levocetirizine
  • Levodopa
  • Levofloxacin
  • Levorphanol
  • Lithium
  • Lofexidine
  • Loxapine
  • Lumacaftor
  • Lumefantrine
  • Macimorelin
  • Magnesium Oxybate
  • Mavacamten
  • Meclizine
  • Mefloquine
  • Melperone
  • Meperidine
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methacholine
  • Methadone
  • Methdilazine
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Methylene Blue
  • Metronidazole
  • Mifepristone
  • Mirtazapine
  • Mitotane
  • Mizolastine
  • Mobocertinib
  • Molindone
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Nafarelin
  • Nalbuphine
  • Naldemedine
  • Naloxegol
  • Nelfinavir
  • Nicomorphine
  • Nilotinib
  • Nitrazepam
  • Nitrous Oxide
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Omaveloxolone
  • Omeprazole
  • Ondansetron
  • Opium
  • Opium Alkaloids
  • Orphenadrine
  • Osilodrostat
  • Osimertinib
  • Oxaliplatin
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Ozanimod
  • Pacritinib
  • Paliperidone
  • Panobinostat
  • Papaveretum
  • Papaverine
  • Paregoric
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Pentazocine
  • Pentobarbital
  • Perampanel
  • Perazine
  • Periciazine
  • Perphenazine
  • Phenobarbital
  • Phenytoin
  • Pimavanserin
  • Pipamperone
  • Piperacetazine
  • Pipotiazine
  • Piritramide
  • Pitolisant
  • Pixantrone
  • Ponesimod
  • Posaconazole
  • Potassium Oxybate
  • Pramipexole Dihydrochloride
  • Prazepam
  • Pregabalin
  • Primidone
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propafenone
  • Propofol
  • Protriptyline
  • Quazepam
  • Quetiapine
  • Quinidine
  • Quinine
  • Quizartinib
  • Ramelteon
  • Ranolazine
  • Relugolix
  • Remifentanil
  • Remimazolam
  • Remoxipride
  • Revefenacin
  • Ribociclib
  • Rifampin
  • Risperidone
  • Ritonavir
  • Ropeginterferon Alfa-2b-njft
  • Ropinirole Hydrochloride
  • Rotigotine
  • Scopolamine
  • Secobarbital
  • Secretin Human
  • Selpercatinib
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Siponimod
  • Sodium Oxybate
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • St John's Wort
  • Sufentanil
  • Sulpiride
  • Sultopride
  • Sunitinib
  • Suvorexant
  • Tacrolimus
  • Tamoxifen
  • Tapentadol
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Temazepam
  • Tetrabenazine
  • Thiethylperazine
  • Thiopental
  • Thiopropazate
  • Tilidine
  • Tiotropium
  • Tizanidine
  • Tolonium Chloride
  • Tolterodine
  • Topiramate
  • Toremifene
  • Tramadol
  • Trazodone
  • Triazolam
  • Triclabendazole
  • Trifluoperazine
  • Trifluperidol
  • Triflupromazine
  • Trimeprazine
  • Trimipramine
  • Triptorelin
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vinflunine
  • Voclosporin
  • Voriconazole
  • Vorinostat
  • Zaleplon
  • Zolpidem
  • Zopiclone
  • Zotepine
  • Zuclopenthixol
  • Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amprenavir
  • Betel Nut
  • Fosamprenavir
  • Valproic Acid

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol
  • Tobacco

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol or drug abuse, or dependence, history of or
  • Blood or bone marrow problems (eg, leukopenia, neutropenia) or
  • Breast cancer, prolactin-dependent or
  • Diabetes or
  • Dyslipidemia (high cholesterol or fats in the blood) or
  • Hyperglycemia (high blood sugar) or
  • Hyperprolactinemia (high prolactin in the blood) or
  • Prostatic hypertrophy (enlarged prostate), or history of or
  • Seizures, history of or
  • Stomach or bowel problems (eg, blockage) or
  • Trouble swallowing or
  • Urinary retention (problems with passing urine), or history of—Use with caution. This medicine may make these conditions worse.
  • Blood vessel or circulation problems or
  • Dehydration or
  • Heart attack or stroke, history of or
  • Heart disease or
  • Heart failure or
  • Heart rhythm problems or
  • Hypertension (high blood pressure) or
  • Hypotension (low blood pressure) or
  • Hypovolemia (low blood volume)—May cause side effects to become worse.
  • Kidney disease, severe or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Opioid (narcotic) medicine withdrawal—Should not be used in patients with this condition.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the medication guide if you do not have one.

You may take this medicine with or without food. Swallow the tablet whole. Do not crush, break, or chew it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (tablets):
    • For treatment of schizophrenia:
      • Adults—At first, 5 to 10 milligrams (mg) olanzapine and 10 mg samidorphan once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg olanzapine and 10 mg samidorphan per day.
      • Children—Use and dose must be determined by your doctor.
    • For treatment of mania or mixed episodes with bipolar disorder (olanzapine/samidorphan alone):
      • Adults—At first, 10 to 15 milligrams (mg) olanzapine and 10 mg samidorphan once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg olanzapine and 10 mg samidorphan per day.
      • Children---Use and dose must be determined by your doctor.
    • For treatment of mania or mixed episodes with bipolar disorder (olanzapine/samidorphan with lithium or valproate):
      • Adults—At first, 10 milligrams (mg) olanzapine and 10 mg samidorphan once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg olanzapine and 10 mg samidorphan per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may increase your risk for opioid overdose. Do not use this medicine if you are also using opioid medicines. Wait at least 7 days after you stopped taking short-acting opioids and at least 14 days after you stopped taking long-acting opioids before you start this medicine. Do not start taking opioid medicines for at least 5 days after treatment with this medicine.

Tell your doctor if you are pregnant or planning to become pregnant. This medicine may cause unwanted effects to newborn babies if used during the later part of pregnancy.

Check with your doctor right away if you have difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). Call your doctor right away if you have a black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness after using this medicine.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you or your child some medicines that can lower the amount of cholesterol and fats in the blood.

This medicine may increase your weight. Your doctor may need to check your or your child's weight on a regular basis while you are using this medicine.

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for allergies or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any CNS depressants while you are taking this medicine.

Olanzapine and samidorphan may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision, which may lead to falls, fractures or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination, sore throat, sores, ulcer, or white spots in the mouth, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and can not cool down.

Check with your doctor right away if you have unexpected or excess milk flow from breasts, absent, missed, or irregular menstrual periods, stopping of menstrual bleeding, swelling of the breasts or breast soreness in both females and males, loss in sexual ability, desire, drive, or performance, decreased interest in sexual intercourse, or inability to have or keep an erection. These may be symptoms of high prolactin levels in the body (eg, galactorrhea, amenorrhea, gynecomastia, and impotence).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

  1. Black, tarry stools
  2. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  3. chills
  4. cough
  5. difficulty in speaking
  6. dizziness
  7. fever
  8. headache
  9. inability to sit still
  10. lack or loss of strength
  11. loss of memory
  12. lower back or side pain
  13. need to keep moving
  14. nosebleeds
  15. numbness or tingling in the face, arms, or legs
  16. pale skin
  17. problems with memory
  18. relaxed and calm
  19. restlessness
  20. shakiness in the legs, arms, hands, or feet
  21. sleepiness
  22. sore throat
  23. sores, ulcers, or white spots in the mouth
  24. trembling or shaking of the hands or feet
  25. trouble breathing
  26. unusual bleeding or bruising
  27. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  28. weight gain

Incidence not known

  1. Absent, missed, or irregular menstrual periods
  2. aching or discomfort in lower legs or sensation of crawling in legs
  3. anxiety
  4. bloating
  5. blurred vision
  6. chest pain or tightness
  7. clay-colored stools
  8. cold sweats
  9. confusion
  10. constipation
  11. dark urine
  12. decreased interest in sexual intercourse
  13. diarrhea
  14. difficulty in breathing
  15. dizziness, faintness, or lightheadedness when getting up from lying or sitting position
  16. double vision
  17. dry mouth
  18. fainting
  19. fast heartbeat
  20. flushed, dry skin
  21. fruit-like breath odor
  22. inability to have or keep an erection
  23. inability to move the arms, legs, or facial muscles
  24. inability to move the eyes
  25. inability to speak
  26. increased blinking or spasms of the eyelid
  27. increased hunger
  28. increased sweating
  29. increased thirst
  30. increased urination
  31. itching, rash
  32. large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  33. loss in sexual ability, desire, drive, or performance
  34. loss of appetite
  35. loss of bladder control
  36. loss of consciousness
  37. muscle cramps, aches, pain, or stiffness
  38. nausea
  39. pain, redness, or swelling in the arm or leg
  40. pains in the stomach, side, or abdomen, possibly radiating to the back
  41. painful or difficult urination
  42. seizures
  43. sever muscle stiffness
  44. slow speech
  45. sticking out of the tongue
  46. stomachache
  47. stopping of menstrual bleeding
  48. stuttering
  49. sweating
  50. swelling of the breasts or breast soreness in both females and males
  51. swelling of breasts or unusual milk production
  52. swollen glands
  53. trouble in swallowing
  54. uncontrolled twisting movements of the neck, trunk, arms, or legs
  55. unexpected or excess milk flow from the breasts
  56. unexplained weight loss
  57. unpleasant breath odor
  58. unusual face expressions
  59. vomiting
  60. vomiting of blood
  61. yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  1. Acid or sour stomach
  2. back pain
  3. belching
  4. heartburn
  5. indigestion
  6. stomach discomfort, upset, or pain

Incidence not known

  1. Painful or prolonged erection of the penis

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.