CAPLYTA is a brand name for lumateperone, an atypical antipsychotic medication in the form of lumateperone tosylate salt. It is formulated as capsules intended for oral administration, available in strengths of 42 mg, 21 mg, and 10.5 mg. Key inactive ingredients include croscarmellose sodium, gelatin, magnesium stearate, mannitol, and talc, with colorants like FD&C blue #1, red #3, and titanium dioxide used in different strengths.

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. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking this medication unless your care team tells you to stop. Stopping it too quickly can cause serious side effects. It can also make your condition worse. 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). 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, take 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 -Infection—fever, chills, cough, or sore throat -Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision -Pain or trouble swallowing -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 -Thoughts of suicide or self-harm, worsening mood, feelings of depression -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): -Dizziness -Drowsiness -Dry mouth -Headache -Nausea -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: -Dementia -Diabetes -Difficulty swallowing -Have trouble controlling your muscles -Heart disease -High cholesterol -History of stroke -Kidney disease -Liver disease -Low blood counts, like low white cell, platelet, or red cell counts -Low blood pressure -Parkinson's disease -Seizures -Suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member -An unusual or allergic reaction to lumateperone, 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: -Metoclopramide This medication may also interact with the following: -Antihistamines for allergy, cough, and cold -Aprepitant -Armodafinil -Bosentan -Carbamazepine -Certain antibiotics like ciprofloxacin, clarithromycin, erythromycin, nafcillin -Certain antifungals like fluconazole, itraconazole, voriconazole -Certain antivirals for HIV or hepatitis -Certain medications for anxiety or sleep -Certain medications for depression like amitriptyline, fluoxetine, nefazodone, sertraline -Cyclosporine -Fluvoxamine -General anesthetics like halothane, isoflurane, methoxyflurane, propofol -Grapefruit juice -Levodopa or other medications for Parkinson's disease -Medications for blood pressure -Medications for seizures like phenytoin -Medications that relax muscles for surgery -Modafinil -Narcotic medications for pain -Phenothiazines like chlorpromazine, prochlorperazine, thioridazine -Pioglitazone -Prednisone -Probenecid -Rifampin -St. John's Wort -Valproic acid

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 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. Watch for new or worsening thoughts of suicide or depression. This includes sudden changes in mood, behavior, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression. This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects. 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. Talk to your care team before breastfeeding. Changes to your treatment plan may be needed. This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

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. This medication may increase thoughts of suicide. This may be more common in children, teenagers, and young adults. The risk may increase after first starting the medication and after dose changes. Talk to your care team right away if you have changes in mood and behavior or thoughts of self-harm or suicide.