Latest news with #lumateperone
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4 days ago
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Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo
Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo CAPLYTA® is FDA approved to treat schizophrenia and is the first and only approved treatment for bipolar I and II depression as an adjunctive and monotherapy With the addition of CAPLYTA® to Johnson & Johnson's robust portfolio of therapies, the Company now offers the broadest range of treatment options for adults with schizophrenia TITUSVILLE, N.J., July 8, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based upon long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for the prevention of relapse in schizophrenia. CAPLYTA® is the newest addition to Johnson & Johnson's portfolio of schizophrenia therapies, which now offers the broadest range of oral and long-acting injectable treatment options to support each patient's individual treatment journey. "For people living with schizophrenia, relapses can be devastating as they disrupt lives, undo hard-earned treatment progress toward patients' goals, and increase the risk of hospitalization with each episode," said Christoph U. Correll, M.D., Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, New York.a "CAPLYTA® substantially lowers the chance of relapse for patients compared to placebo, which is often a major source of anxiety and suffering for them and their families." The submission is supported by positive results from a Phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal trial, which on the primary endpoint found time to relapse during the 26-week double-blind treatment phase was significantly longer in patients receiving CAPLYTA® compared to those receiving placebo (p=0.0002). Treatment with CAPLYTA® was also associated with a 63 percent reduction in risk of relapse versus placebo (hazard ratio [95% CI] = 0.37, [0.22, 0.65]). The key secondary endpoint showed a significantly delayed time to all-cause discontinuation, including relapse, compared with placebo during the double-blind phase (p=0.0007). The safety profile of CAPLYTA® was consistent with the existing body of clinical data, and no new safety concerns were identified. The most commonly reported adverse event that was observed at a rate greater than or equal to 5% and twice the rate of placebo was headache.i Schizophrenia affects up to an estimated 2.8 million adults in the United States, yet it remains insufficiently treated, with approximately 40 percent of people not receiving When left untreated, this complex mental health disorder can lead to episodes of psychosis, hallucinations, or other disruptive behaviors, which can damage and interrupt the lives of those living with schizophrenia as well as their loved Relapses, or a recurrence of symptoms, are associated with significant functional decline, increased caregiver burden, and a greater likelihood of On average, an adult with schizophrenia experiences nine relapses in less than six "Relapse prevention is a critical goal for the long-term care and management of this debilitating disorder," said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. "These Phase 3 results provide compelling evidence of meaningful relapse prevention, which is critical in preserving long-term patient stability, breaking the cycle of hospitalization, and helping to control symptom progression. We're committed to building on the decade of research reinforcing the robust efficacy, proven safety, and favorable tolerability of CAPLYTA® and providing additional data to support the long-term use of this medicine in neuropsychiatric disorders." While its exact mechanism of action is unknown, CAPLYTA® is characterized by high serotonin 5-HT2A receptor occupancy and lower amounts of dopamine D2 receptor occupancy at therapeutic doses. In short-term clinical studies, CAPLYTA® was similar to placebo in weight change, metabolic effects, and extrapyramidal symptoms, which are often cited as reasons for treatment discontinuation. The most commonly reported adverse events were somnolence/sedation, dizziness, nausea, and dry mouth. CAPLYTA® can be taken at any time of day with or without food and does not require titration, allowing adult patients to start treatment at the effective dose. CAPLYTA® is FDA approved for the treatment of schizophrenia, as well as depressive episodes associated with bipolar I or II disorder in adults, as monotherapy, and as adjunctive therapy with lithium or valproate. An sNDA for CAPLYTA® as an adjunctive treatment for adults with major depressive disorder (MDD) is currently under FDA review. If approved, CAPLYTA® has the potential to become a new standard of care to treat some of today's most prevalent and debilitating mental health disorders. Editor's note: a. Christoph U. Correll, M.D., has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work. About Schizophrenia Schizophrenia is a complex, chronic brain disorder that affects how people think, feel, speak, and act. It affects up to an estimated 2.8 million adults in the United States yet remains widely misunderstood and insufficiently Symptoms vary by person, but confusion and distortions in perceptions, emotions, and behavior are common. Evidence shows that the first three to five years after diagnosis – "the critical period" – from symptom onset are key for a patient's treatment, as this is when the condition progresses most rapidly.v,vi A comprehensive treatment plan, which may include medication, therapy, and psychosocial services, can be critical in delaying the time to relapse for adults with About Study 304This study was a multicenter, multi-national, double-blind, placebo-controlled, randomized withdrawal study of lumateperone for the prevention of symptomatic relapse in adult patients with schizophrenia. The approximately 47-week study included an 18-week open-label phase where patients with schizophrenia were treated with lumateperone 42 mg per day. Patients who met the stabilization criteria during the open-label period progressed to the double-blind treatment phase. These patients were randomized to continue on lumateperone 42 mg (N=114) or switched to placebo (N=114) for up to 26 weeks or until the time to relapse occurred. The primary endpoint was time to first symptom relapse and the key secondary endpoint was time to all cause discontinuation during the double-blind phase. About CAPLYTA® (lumateperone) CAPLYTA® 42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy, and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA® is unknown, the efficacy of CAPLYTA® could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors. CAPLYTA® is under FDA review for potential approval as an adjunctive treatment for adults with major depressive disorder and is being studied for other neuropsychiatric and neurological disorders. CAPLYTA® is not FDA-approved for these disorders. CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. Important Safety Information Boxed Warnings: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients. Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria. Warnings & Precautions: Antipsychotic drugs have been reported to cause: Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above. Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room. Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued. Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment. Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors. Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension. Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA. Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold. Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them. Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics. Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration. Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors. Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Dose reduction is recommended for patients with moderate or severe hepatic impairment. Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth. CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules. Please click here to see full Prescribing Information including Boxed Warnings. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at Follow us at @JNJInnovMed. © Johnson & Johnson and its affiliates 2025. All rights reserved. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of CAPLYTA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Footnotes i Intra-Cellular Therapies Announces Positive Topline Results in Phase 3 Trial Evaluating CAPLYTA for the Prevention of Relapse in Patients with Schizophrenia. GlobeNewswire, 05 Nov. 2024, ii "Schizophrenia Fact Sheet." Treatment Advocacy Center, 10 Mar. 2025, iii Alphs L, et al. Factors associated with relapse in schizophrenia despite adherence to long-acting injectable therapy. Int Clin Psychopharmacol. 2016;31(4)202-209. doi:10.1097/YIC.0000000000000125 iv Lafeuille MH, Gravel J, Lefebvre P, et al. Patterns of relapse and associated cost burden in schizophrenia patients receiving atypical antipsychotics. J Med Econ. 2013;16(11):1290-1299. doi: 10.3111/13696998.2013.841705 v Birchwood, M. "Early intervention and sustaining the management of vulnerability." The Australian and New Zealand journal of psychiatry vol. 34 Suppl (2000): S181-4. doi:10.1080/000486700241 vi Tandon, Rajiv et al. "The schizophrenia syndrome, circa 2024: What we know and how that informs its nature." Schizophrenia research vol. 264 (2024): 1-28. doi:10.1016/ View original content to download multimedia: SOURCE Johnson & Johnson
Health Line
23-05-2025
- Health
- Health Line
Caplyta (Lumateperone) Overview
Key takeaways Caplyta (lumateperone) is a prescription oral capsule used to treat certain mental health conditions, including schizophrenia. Experts aren't sure exactly how it works, but they believe it affects two specific brain chemicals to treat certain mental health conditions. You'll usually take Caplyta by mouth once per day. While it should start working soon after you take your first dose, it may take time to notice a difference in your symptoms. Caplyta may cause some side effects. Mild side effects include nausea, weight gain, and headache, and these may go away after a few weeks. Serious side effects include seizures, low blood pressure, and high cholesterol. Caplyta basics Caplyta is used in adults to treat: schizophrenia depression related to bipolar I disorder or bipolar II disorder Caplyta contains the active ingredient lumateperone. (An active ingredient is what makes a drug work.) It belongs to a group of drugs called atypical antipsychotics. Caplyta is a brand-name prescription medication. A generic version of the drug isn't currently available. Caplyta uses Caplyta is used in adults to treat: schizophrenia depression related to bipolar I disorder or bipolar II disorder Caplyta is not used to treat these conditions in children. Schizophrenia causes problems with perception. It's possible for people with schizophrenia to have delusions (believing in something that's false) or hallucinations (seeing, sensing, or hearing things that aren't there). Bipolar disorder causes extreme changes in mood, such as feeling euphoric or manic, energetic, or depressed. Two common kinds of bipolar disorder are bipolar I disorder and bipolar II disorder. With the first kind, you have a manic episode with or without a depressive episode. With the second, you experience depressive episodes and hypomanic episodes (which are less severe than manic episodes). Caplyta is used to treat depression associated with bipolar I disorder or bipolar II disorder. (This drug isn't used to treat mania or hypomania.) For this purpose, it can be used alone or with lithium (Lithobid) or valproate. Although the causes of schizophrenia and bipolar disorder aren't known, these conditions may occur due to an imbalance of chemicals in the brain. It's thought that Caplyta affects two different hormones in the brain, serotonin and dopamine, which may help to decrease the symptoms of these conditions. What are Caplyta's side effects? Like most drugs, Caplyta may cause mild or serious side effects. The lists that follow describe some of the more common side effects that Caplyta may cause. These lists don't include all possible side effects. Keep in mind that side effects of a drug can depend on: your age other health conditions you have other medications you take Your doctor or pharmacist can tell you more about the potential side effects of Caplyta. They can also suggest ways to help reduce side effects. Mild side effects Here's a short list of some of the mild side effects that Caplyta can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Caplyta's prescribing information. Mild side effects of Caplyta that have been reported include: nausea dry mouth dizziness sleepiness or sedation (feeling drowsy or less alert) weight gain headache For more information about some of these side effects, see the 'Side effect focus' section. Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist. Serious side effects Serious side effects from Caplyta can occur, but they aren't common. If you have serious side effects from Caplyta, call your doctor right away. But if you think you're having a medical emergency, immediately call 911 or your local emergency number. Serious side effects of Caplyta or antipsychotic drugs such as Caplyta that have been reported include: neuroleptic malignant syndrome, a rare but serious condition that can occur in people taking antipsychotic medications high blood sugar, which can lead to diabetes high cholesterol or high triglycerides difficulty swallowing seizures problems maintaining body temperature low levels of white blood cells low blood pressure when standing up that can lead to passing out tardive dyskinesia, which causes unusual and unintended muscle movements boxed warnings: risk of suicidal thoughts or behaviors risk of death in older adults with psychosis related to dementia (problems with thinking, memory, and communication) allergic reaction For more information about Caplyta's boxed warnings and allergic reaction, see the next section. Side effect focus Learn more about some of the side effects Caplyta may cause. Boxed warning: Risk of suicidal thoughts and behaviors in certain people Caplyta has a boxed warning for the risk of suicidal thoughts and behaviors in certain people. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). Antidepressant medications may increase the risk of suicidal thoughts or behaviors in children and young adults. This includes Caplyta, which is prescribed to treat depression related to bipolar disorder. Since Caplyta is only approved for use in adults, this risk may affect adults ages 18 to 24 years who take this drug. What might help Before you start taking Caplyta, talk with your doctor about your mental health history. And tell your family and friends about this warning for Caplyta. Your risk of suicidal thoughts or behaviors can be worse at the start of treatment and when your doctor changes your drug dosage. If you notice any symptoms of worsening depression, changes in mood, or suicidal thoughts or behaviors, contact a doctor right away for treatment. Examples of symptoms to watch for include: feeling alone not enjoying activities that used to make you happy thoughts of harming yourself anxiety changes in your sleep patterns If you notice worsening of your mood or that you're having suicidal thoughts or behaviors, your doctor may recommend that you stop taking Caplyta. Help is out there If you or someone you know is in crisis and considering suicide or self-harm, please seek support: Call or text the 988 Suicide and Crisis Lifeline at 988 or chat at Caring counselors are available to listen and provide free and confidential support 24/7. Text HOME to the Crisis Text Line at 741741 to connect with a volunteer crisis counselor for free and confidential support 24/7. Not in the United States? Find a helpline in your country with Befrienders Worldwide. Call 911 or your local emergency services number if you feel safe to do so. If you're calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely. If you're not in the same household, stay on the phone with them until help arrives. Boxed warning: Risk of death in older adults with psychosis related to dementia Caplyta has a boxed warning for the risk of death in older adults with psychosis related to dementia. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). Antipsychotic drugs such as Caplyta may increase the risk of death in adults ages 65 years or older with dementia -related psychosis. Dementia is a condition that affects memory. Psychosis involves losing touch with reality. Older adults with dementia-related psychosis who take Caplyta may also have an increased risk of stroke. What might help Due to the risk of death, it's not likely that a doctor would prescribe Caplyta to an older adult with dementia-related psychosis. Before starting Caplyta treatment, tell your doctor about any history of dementia-related psychosis that you have. In this case, your doctor may recommend a different treatment option for you. Weight gain Antipsychotic medications such as Caplyta may cause weight gain. This is because the drug can cause changes in a person's metabolism. Although weight gain wasn't one of the most common side effects of Caplyta, it may still occur in people taking it. What might help Before you start taking Caplyta, your doctor will check your weight and continue to monitor it throughout treatment. If you experience weight gain while you're taking Caplyta, talk with your doctor. They may be able to recommend changes in your diet or exercise routine that can help you with weight management. Headache You may have headaches from taking Caplyta, although this isn't one of the most common side effects of the drug. In studies, only people taking this medication to treat depression related to bipolar disorder reported headaches. This side effect wasn't reported in people taking it for schizophrenia. What might help If you have headaches during Caplyta treatment, talk with your doctor. They may recommend ways to help treat this side effect. For example, your doctor may suggest taking an over-the-counter pain medication, such as acetaminophen (Tylenol), to ease headache pain. Allergic reaction Some people may have an allergic reaction to Caplyta. Symptoms of a mild allergic reaction can include: skin rash itchiness flushing (temporary warmth, redness, or deepening of skin color) A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under your skin, usually in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause difficulty breathing. Call your doctor right away if you have an allergic reaction to Caplyta. But if you think you're having a medical emergency, call 911 or your local emergency number. What are some frequently asked questions about Caplyta? Find answers to some commonly asked questions about Caplyta. How does Caplyta work (what is its mechanism of action)? Caplyta contains the active ingredient lumateperone, which belongs to the atypical antipsychotic group of drugs. Caplyta is used to treat schizophrenia and depression related to bipolar disorder. It's not entirely clear how Caplyta works to treat these conditions. Researchers believe the drug affects certain brain chemicals, which decreases symptoms of schizophrenia and depression related to bipolar disorder. » For more about Caplyta's mechanism of action, see this overview on how Caplyta works. What should I know about alternatives to Caplyta, such as Vraylar, clozapine, Abilify, Latuda, and Seroquel? Many different treatment options are available for schizophrenia and depression related to bipolar disorder. Before starting any treatment options, you should discuss with your doctor what may be the best medication for you. The following list includes a few examples of drugs used to treat schizophrenia and depression related to certain kinds of bipolar disorder: cariprazine (Vraylar) aripiprazole (Abilify) lurasidone (Latuda) quetiapine (Seroquel) Clozapine (Clozaril) can be used to treat schizophrenia. Some of these medications can also be prescribed to treat other conditions. These medications may have different side effects and different dosing schedules. Some will likely require different lab tests for monitoring certain side effects. Before you start treatment for schizophrenia or depression related to bipolar disorder, talk with your doctor. They can work with you to determine which medication may be best for your condition. What's the half-life of Caplyta? The half-life of Caplyta is about 18 hours. A half-life is the amount of time it takes for the body to rid itself of half of a dose of medication. So taking your dose of Caplyta every day helps to keep a consistent amount of the drug in your body. Caplyta's price and coupons As with other prescription drugs, the cost of Caplyta can vary depending on many factors. These factors include what your insurance plan covers and which pharmacy you use. If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. You can also visit the Caplyta manufacturer's website to see whether it has support options that you qualify for. And check out these tips for saving money on prescriptions. Savings for Caplyta You can visit Optum Perks for price estimates of Caplyta. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with insurance copays or benefits. What is Caplyta's dosage? Your doctor will recommend the dosage of Caplyta that's right for you. Here you'll find commonly used dosages, but always take the dosage your doctor prescribes. Form and strengths Caplyta comes as a capsule that you swallow. It's available in three strengths: 42 milligrams (mg) 21 mg 10.5 mg Recommended dosage The recommended dosage of Caplyta is 42 mg once per day, which you'll take by mouth. The dosage is the same for schizophrenia and depression related to bipolar I disorder or bipolar II disorder, the conditions Caplyta is used to treat. Your doctor may lower your dosage if you take certain medications or have liver problems. Before you start taking Caplyta, be sure to tell your doctor about any medications you may take and health conditions you may have. Questions about Caplyta's dosage Here are some answers to questions you may have about Caplyta's dosage. What if I miss a dose of Caplyta? If you miss your dose of Caplyta, talk with your doctor or pharmacist about the best time to take your next dose. In some cases, they may recommend that you take your dose as soon as you remember. Or they may recommend that you skip the dose you missed and continue with your regular dosing schedule. Will I need to use Caplyta long term? If Caplyta works for you, your doctor will likely recommend that you take it long term. How long does Caplyta take to work? Caplyta begins working as soon as you take your first dose. But since the drug affects chemical levels in your brain, it may take time to notice a difference in your mood. It takes about 5 days for Caplyta to reach a consistent level in your body. How is Caplyta taken? Your doctor will explain how you should take Caplyta. They'll also explain how much to take and how often. Be sure to follow your doctor's instructions. Taking Caplyta You'll take Caplyta capsules by mouth once daily. Try to take your dose of Caplyta at about the same time each day. This helps to keep a consistent level of the medication in your body. Accessible medication containers and labels If it's hard for you to read the label on your prescription, tell your doctor or pharmacist. Certain pharmacies may provide medication labels that: have large print use braille contain a code you can scan with a smartphone to change the text into audio Your doctor or pharmacist may be able to recommend a pharmacy that offers these options if your current pharmacy doesn't. Also, if you're having difficulty opening your medication bottles, let your pharmacist know. They may be able to put Caplyta in an easy-open container. Your pharmacist may also recommend tools to help make it easier to open the drug's container. Taking Caplyta with other drugs In some cases, your doctor may recommend that you take your dose of Caplyta together with other medications for your condition. For example, to treat depression related to bipolar disorder, your doctor may recommend that you also take either lithium (Lithobid) or valproate with Caplyta. Before you start taking Caplyta, your doctor will recommend the best treatment plan for your condition. Questions about taking Caplyta Here are some answers to questions you may have about taking Caplyta. Can Caplyta be chewed, crushed, or split? No, you should not chew, crush, or split Caplyta tablets. The manufacturer of Caplyta doesn't specify whether the capsules can be opened. So it's recommended that you take your Caplyta dose as a whole capsule. If you have difficulty swallowing your capsules, see these tips for swallowing pills. Or talk with your doctor about using a different treatment for your condition. Should I take Caplyta with food? You can take your dose of Caplyta with or without food. Questions for your doctor You may have questions about Caplyta and your treatment plan. It's important to discuss all your concerns with your doctor. Here are a few tips that might help guide your discussion: Before your appointment, write down questions such as: How will Caplyta affect my body, mood, or lifestyle? Bring someone with you to your appointment if doing so will help you feel more comfortable. If you don't understand something related to your condition or treatment, ask your doctor to explain it to you. Remember, your doctor and other healthcare professionals are available to help you. And they want you to get the best care possible. So don't be afraid to ask questions or offer feedback on your treatment. What should be considered before taking Caplyta? Before you start taking Caplyta, it's important to talk with your doctor about other medications that you take. You should also tell your doctor about any medical conditions that you have. Letting your doctor know about these factors will help them determine whether Caplyta may be a safe and effective treatment option for you. Interactions Taking a medication with certain vaccines, foods, and other items can affect how the medication works. These effects are called interactions. Before taking Caplyta, be sure to tell your doctor about all medications you take, including prescription and over-the-counter kinds. Also describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any interactions Caplyta may cause with these items. Interactions with drugs or supplements Caplyta can interact with several kinds of drugs. These drugs include: certain seizure medications, such as phenytoin (Dilantin) and carbamazepine (Tegretol) certain antibiotics, such as ciprofloxacin (Cipro), erythromycin (Eryc), and clarithromycin certain antifungal medications, such as fluconazole (Diflucan), itraconazole (Sporanox), and voriconazole (Vfend) certain heart medications, such as diltiazem (Cardizem) and verapamil (Verelan) certain HIV medications, such as ritonavir (Norvir), nelfinavir (Viracept), efavirenz, and etravirine (Intelence) the antidepressant medication nefazodone the tuberculosis medication rifampin (Rimactane) the lung medication bosentan (Tracleer) the narcolepsy drugs modafinil (Provigil) and armodafinil (Nuvigil) the nausea and vomiting medication aprepitant (Emend) This list does not contain all kinds of drugs that may interact with Caplyta. Your doctor or pharmacist can tell you more about these interactions and any others that may occur with Caplyta. Other interactions You should avoid consuming grapefruit or grapefruit juice while taking Caplyta. Grapefruit can reduce how your liver breaks down Caplyta, which can cause you to have more side effects. In addition, Caplyta can also interact with the herbal supplement St. John's wort. If you're taking this supplement, talk with your doctor before starting Caplyta. Boxed warnings Caplyta has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA) about drug effects that may be dangerous. Caplyta's boxed warnings include: Risk of suicidal thoughts or actions in certain people: Antidepressant medications may increase the risk of suicidal thoughts or behaviors in children and young adults. This includes Caplyta, which is used to treat depression related to bipolar disorder. Since Caplyta is only approved for use in adults, this risk may affect adults ages 18 to 24 years who take this drug. For more information about these boxed warnings, see the ' What are Caplyta's side effects? ' section. Other warnings Before taking Caplyta, discuss your health history with your doctor. Caplyta may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you: diabetes an allergic reaction to Caplyta or any of its ingredients high triglycerides or high cholesterol levels low white blood cell levels seizures low or high blood pressure liver problems heart problems a history or risk of stroke difficulty regulating body temperature Caplyta and alcohol There are no known interactions between Caplyta and alcohol. But drinking alcohol while taking this medication may increase your risk of certain side effects. Examples include nausea, vomiting, and sleepiness. In addition, consuming alcohol while taking Caplyta can affect your ability to drive a car. Keep in mind that you should not drive or operate machinery until you know how Caplyta affects you. This is because the drug may cause problems with motor skills, thinking, or judgment, which can impact your ability to do certain activities, including driving a car. If you drink alcohol, talk with your doctor about how much alcohol (if any) is safe for you to drink while you're taking Caplyta. Pregnancy and breastfeeding It's unknown whether Caplyta is safe to take during pregnancy or while breastfeeding. If you can become pregnant, are breastfeeding, or are using birth control, it's important to consider whether Caplyta is a safe choice for you. You can refer to this Caplyta reproductive health article for more information. If you have additional questions, talk with your doctor. What should be done in case of overdose? Do not take more Caplyta than your doctor prescribes. Taking more than this can lead to serious side effects. What to do in case you take too much Caplyta Call your doctor if you think you've taken too much Caplyta. You can also call 800-222-1222 to reach America's Poison Centers or use its online resource. But if you have severe symptoms, immediately call 911 or your local emergency number. Or go to the nearest emergency room. Ask a pharmacist A: It's unlikely that your doctor would change your dose of Caplyta if it isn't working. The manufacturer of Caplyta doesn't recommend any changes to the drug's dosage after a person starts taking it. One study of Caplyta for treating schizophrenia found that a dose of 42 mg resulted in significantly decreased symptoms compared with a lower dose. Another found that a higher dose of the drug didn't result in increased benefits for users. Similarly, in studies of Caplyta for treating bipolar disorder -related depression, Caplyta 42 mg once per day showed a significant decrease in symptoms. If you feel like Caplyta isn't working for you, contact your doctor. They may be able to recommend adding another drug to your treatment or changing to another treatment for your condition. The Healthline Pharmacist Team Answers represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice. Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
