LYBALVI is a combination medication containing olanzapine, an atypical antipsychotic, and samidorphan (as samidorphan L-malate), an opioid antagonist. It is available as film-coated, bilayer tablets for oral administration in various strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg of olanzapine and samidorphan, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. LYBALVI is intended for oral use.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medication. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision -High fever, stiff muscles, increased sweating, fast or irregular heartbeat, and confusion, which may be signs of neuroleptic malignant syndrome -High prolactin level—unexpected breast tissue growth, discharge from the nipple, change in sex drive or performance, irregular menstrual cycle -Infection—fever, chills, cough, or sore throat -Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision -Pain or trouble swallowing -Rash, fever, and swollen lymph nodes -Seizures -Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision -Trouble passing urine -Uncontrolled and repetitive body movements, muscle stiffness or spasms, tremors or shaking, loss of balance or coordination, restlessness, shuffling walk, which may be signs of extrapyramidal symptoms (EPS) Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Constipation -Dizziness -Drowsiness -Dry mouth -Headache -Upset stomach -Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Blockage in your bowels -Constipation -Dementia -Diabetes -Difficulty swallowing -Glaucoma -Have trouble controlling your muscles -Heart disease -High cholesterol -High levels of prolactin -History of breast cancer -History of substance use disorder -History of stroke -Irregular heartbeat or rhythm -Liver disease -Low blood pressure -Low white blood cell levels -Prostate disease -Seizures -Suicidal thoughts, plans, or attempt by you or a family member -Trouble passing urine -An unusual or allergic reaction to olanzapine, samidorphan, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Cisapride -Dronedarone -Opioids -Pimozide -Thioridazine This medication may also interact with the following: -Alcohol -Antihistamines -Atropine -Benzodiazepines, such as alprazolam, diazepam, lorazepam -Certain medications for depression, such as amitriptyline, fluvoxamine, trazodone -Certain medications for seizures, such as carbamazepine, phenobarbital, primidone -Certain medications for bladder problems, such as oxybutynin or tolterodine -Certain medications for fungal infections, such as ketoconazole, itraconazole, posaconazole -Certain medications for Parkinson disease, such as benztropine or trihexyphenidyl -Certain medications for stomach problems, such as dicyclomine or hyoscyamine -Certain medications for travel sickness, such as scopolamine -Ipratropium -Medications for blood pressure -Medications that cause drowsiness before a procedure, such as propofol -Medications that help you fall asleep -Medications that relax muscles -Other medications that cause heart rhythm changes -Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine -Rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. Do not suddenly stop taking this medication. You may develop a severe reaction. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose may be slowly lowered over time to avoid any side effects. Do not take this medication with narcotics. This can cause severe problems including death. Also, you may be more sensitive to lower doses of narcotics after you stop taking this medication. This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms. You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks. Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe. This medication can cause problems with controlling your body temperature. It can lower the response of your body to cold temperatures. If possible, stay indoors during cold weather. If you must go outdoors, wear warm clothes. It can also lower the response of your body to heat. Do not overheat. Do not over-exercise. Stay out of the sun when possible. If you must be in the sun, wear cool clothing. Drink plenty of water. If you have trouble controlling your body temperature, call your care team right away. This medication may increase blood sugar. Ask your care team if changes in diet or medications are needed if you have diabetes. If you smoke, tell your care team if you notice this medication is not working well for you. Talk to your care team if you are a smoker or if you decide to stop smoking.

What are the most serious risks of this medication?

This medication should not be used to treat mood and behavior changes caused by dementia. It may increase the risk of death in older adults with dementia.