• Caplyta is a brand (trade) name for lumateperone which may be used to treat schizophrenia or bipolar disorder.
• Experts aren't sure exactly how Caplyta works but suggest it may be through inhibition of central serotonin 5-HT_2A receptors and postsynaptic antagonist activity (inhibition) at central dopamine D₂ receptors.
• Caplyta belongs to the class of medicines known as atypical antipsychotics. Atypical means it is less likely than older antipsychotics to cause side effects, such as extrapyramidal symptoms (EPS). EPS are drug-induced movement disorders and include tremors, Parkinson's-like symptoms (walking with a shuffle, mask-like facial features), and tardive dyskinesia (this describes abnormal, repetitive facial movements such as lip-smacking or poking the tongue out).

• May be used to treat schizophrenia in adults.
• Also approved to treat depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, either by itself or in addition to lithium or valproate.
• Available as 10.5mg, 21mg, and 42mg capsules.
• The recommended dosage is 42 mg unless a person is also taking moderate-to-strong CYP3A4 inhibitors or has liver impairment (Child-Pugh class B or C).
• 42mg Caplyta capsules are equivalent to 60mg lumateperone tosylate.
• May be taken with or without food.
• Caplyta does not require dosage titration.
• May be less likely to cause weight gain than some other antipsychotics. In patients followed up to 1 year a weight loss of 2kg at day 175 and 3.2kg at day 350 was reported.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Drowsiness, nausea, dry mouth, dizziness, fatigue, and loss of appetite are commonly reported side effects.
• Interacts with several different medicines. A lower dosage is necessary when taken with moderate or strong CYP3A4 inhibitors or in people with moderate to severe liver disease.
• Avoid in people who have previously reacted to lumateperone (reactions have included rashes and itchy skin). May not be suitable for those with a history of swallowing problems.
• Should not be used for the treatment of dementia-related psychosis in elderly people as associated with a higher risk of death.
• Rarely, may cause Neuroleptic Malignant Syndrome; symptoms include high body temperature, muscle rigidity, and mental disturbances; discontinue immediately and seek urgent medical advice.
• Potentially irreversible tardive dyskinesia can develop, even with low dosages used short-term. Symptoms include facial grimacing, repetitive chewing, and tongue thrusting.
• May increase blood sugar levels. People with a history of diabetes or at risk of diabetes should be monitored closely. May also cause undesirable changes in blood cholesterol and lipid levels or weight loss or gain.
• Leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotic agents including Caplyta. The risk is higher in people with a pre-existing low white blood cell count or absolute neutrophil count or a history of drug-induced leukopenia or neutropenia. perform regular complete blood cell counts in those at high risk during the first few months of treatment and monitor for signs of fever or other symptoms of infection. Discontinue Caplyta and treat promptly in those with neutrophil counts < 1000/mm³.
• May cause a drop in blood pressure on standing, particularly during the initial dose-titration period; dosage may need reducing. May not be suitable for people with known cardiovascular disease (history of a heart attack, angina, heart failure, or arrhythmia), stroke, seizure disorders, and people at risk of dehydration. May also increase the risk of falls. The risk of seizures is greatest in those with a history of seizures or with other conditions that lower the seizure threshold.
• Not approved for use by anyone younger than 18 years old.
• There is not enough data to know the risks of Caplyta on an unborn baby; however, antipsychotic use in the last 3 months of pregnancy has been associated with breathing problems, feeding problems, or withdrawal symptoms in the newborn. Enroll women who become pregnant on the National pregnancy registry of atypical antipsychotics at 1-866-961-2388. Breastfeeding is not recommended while using Caplyta. Caplyta may affect fertility in men and women.
• No generic is available.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Take with or without food. Keep your appointments with your healthcare provider as you may need regular blood tests to monitor the effects of Caplyta, particularly during the first few months of treatment. While you are taking Caplyta, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.
• May cause sedation or impair judgment skills and affect your ability to drive or operate machinery. Avoid alcohol.
• Avoid overheating and dehydration.
• Seek urgent medical advice if you develop unusual body movements, confusion, high fever, lightheadedness, fainting, seizures, have problems controlling your body temperature, or difficulty swallowing. Call your doctor if you are sick with vomiting or diarrhea.
• Caplyta may make you feel dizzy when going from a sitting or lying down position to standing. This may increase your risk of falls. Stand up slowly and remove any fall hazards from your home (such as loose rugs).
• Talk with your doctor if you develop any worrying side effects such as uncontrollable facial grimacing, restlessness, severe dizziness, or severe abdominal discomfort. if you have diabetes, monitor your blood sugars more regularly and tell your doctor if you are having difficulty managing your blood sugar levels.
• Tell your doctor if you are intending to become pregnant and you are taking aripiprazole as your doctor may wish to change you to a different medication. Caplyta is incompatible with breastfeeding.
• Grapefruit may interact with Caplyta and lead to unwanted side effects. Avoid the use of grapefruit products.
• Taking antipsychotic medicine such as Caplyta in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away and your doctor should enroll you on the National pregnancy registry of atypical antipsychotics at 1-866-961-2388. Do not stop taking Caplyta without your doctor's advice. You should not breastfeed while using Caplyta. Caplyta may affect your ability to have children, whether you are a man or a woman. Talk to your doctor about this.

• Two studies investigated the use of Caplyta compared with placebo on adults under the age of 65 for 28 days with schizophrenia using the PANSS scale (Positive and Negative Syndrome Scale). In Study 1, patients assigned Caplyta 42mg showed a statistically significant mean change from baseline PANSS of -13.2 compared to -7.4 with placebo. In study 2 the mean change from baseline PANSS was -14.5 with Caplyta compared to -10.3 with placebo.

Medicines that interact with Caplyta may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Caplyta. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Over 540 medications interact with Caplyta; most of these interactions are considered major or moderate. Common medications that may interact with Caplyta include:

• anti-anxiety medications such as diazepam and oxazepam
• antibiotics, such as ciprofloxacin, clarithromycin, or erythromycin
• anticonvulsants, such as carbamazepine or phenytoin
• antidepressants, such as amitriptyline, imipramine, nortriptyline
• antifungals, such as fluconazole, itraconazole, or ketoconazole
• antihistamines that cause sedation, such as diphenhydramine or azelastine
• aprepitant
• biologics, such as imatinib or nilotinib
• bupropion
• cannabis
• corticosteroids, such as dexamethasone,
• CYP3A4 moderate or strong inhibitors (such as amprenavir, ciprofloxacin, cyclosporine, clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, or grapefruit). Avoid
• CYP3A4 inducers (such as carbamazepine, efavirenz, modafinil, prednisone, rifampin, St, John's Wort). Avoid
• cyclosporine
• diuretics, such as furosemide
• duloxetine
• herbals, such as echinacea
• HIV medications such as atazanavir, cobicistat, indinavir, or ritonavir
• grapefruit juice and products
• levodopa
• lithium
• medications for diabetes, such as insulin or metformin
• metoclopramide
• monoamine oxidase inhibitors, such as selegiline, isocarboxazid, or phenelzine
• opioid analgesics such as alfentanyl, codeine, oxycodone, or morphine
• muscle relaxants such as baclofen or cyclobenzaprine
• serotonin modulators, such as nefazodone and trazodone
• sleeping pills, such as zolpidem
• some heart medications, such as atenolol, doxazosin, or prazosin
• other medications used to treat mental illness, such as clozapine and thioridazine
• UGT inhibitors, such as valproic acid and probenecid. Avoid.

Alcohol may worsen the side effects of Caplyta such as drowsiness, dizziness, and liver toxicity.

Note that this list is not all-inclusive and includes only common medications that may interact with Caplyta. You should refer to the prescribing information for Caplyta for a complete list of interactions.