Olanzapine and samidorphan (Oral route)

Pronunciation:

oh-LAN-za-peen, sam-i-DOR-fan

Brand Names:

Lybalvi

Dosage Forms:

Tablet

Warnings:

Oral route(Tablet)

Warning: Increased Mortality in Elderly Patients with Dementia-Related PsychosisElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine/samidorphan is not approved for the treatment of patients with dementia-related psychosis .

Classifications:

Therapeutic—

Antipsychotic

Pharmacologic—

Opioid Antagonist

Chemical—

Thienobenzodiazepine

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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
LetibotulinumtoxinA-wlbg
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
Oliceridine
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
Viloxazine
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 of This Medicine:

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 While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine 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).

Tell healthcare providers that you are taking this medicine before you have any medical tests. The results of some tests (eg, urine drug screening test) may be affected by this medicine.

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 of This Medicine:

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: Black, tarry stools; burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings; chills; cough; difficulty in speaking; dizziness; fever; headache; inability to sit still; lack or loss of strength; loss of memory; lower back or side pain; need to keep moving; nosebleeds; numbness or tingling in the face, arms, or legs; pale skin; problems with memory; relaxed and calm; restlessness; shakiness in the legs, arms, hands, or feet; sleepiness; sore throat; sores, ulcers, or white spots in the mouth; trembling or shaking of the hands or feet; trouble breathing; unusual bleeding or bruising; unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness; weight gain

Incidence not known: Absent, missed, or irregular menstrual periods; aching or discomfort in lower legs or sensation of crawling in legs; anxiety; bloating; blurred vision; chest pain or tightness; clay-colored stools; cold sweats; confusion; constipation; dark urine; decreased interest in sexual intercourse; diarrhea; difficulty in breathing; dizziness, faintness, or lightheadedness when getting up from lying or sitting position; double vision; dry mouth; fainting; fast heartbeat; flushed, dry skin; fruit-like breath odor; inability to have or keep an erection; inability to move the arms, legs, or facial muscles; inability to move the eyes; inability to speak; increased blinking or spasms of the eyelid; increased hunger; increased sweating; increased thirst; increased urination; itching, rash; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; loss in sexual ability, desire, drive, or performance; loss of appetite; loss of bladder control; loss of consciousness; muscle cramps, aches, pain, or stiffness; nausea; pain, redness, or swelling in the arm or leg; pains in the stomach, side, or abdomen, possibly radiating to the back; painful or difficult urination; seizures; sever muscle stiffness; slow speech; sticking out of the tongue; stomachache; stopping of menstrual bleeding; stuttering; sweating; swelling of the breasts or breast soreness in both females and males; swelling of breasts or unusual milk production; swollen glands; trouble in swallowing; uncontrolled twisting movements of the neck, trunk, arms, or legs; unexpected or excess milk flow from the breasts; unexplained weight loss; unpleasant breath odor; unusual face expressions; vomiting; vomiting of blood; 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: Acid or sour stomach; back pain; belching; heartburn; indigestion; stomach discomfort, upset, or pain

Incidence not known: 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.

Last Updated: 4/24/2024

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