What is Caplyta?
Caplyta capsules contain lumateperone, an antipsychotic medicine.
Caplyta is a once-daily capsule used to control the symptoms of schizophrenia in adults.
Although the physical cause of schizophrenia is unknown, it is believed that imbalances between chemicals, such as dopamine, serotonin, and glutamate, in the brain is the probable cause. The exact way Caplyta works is unknown but it is thought to affect the balance of these brain-signaling chemicals to help control schizophrenia symptoms.
Caplyta is not approved for use in older adults with dementia-related psychosis. Caplyta can increase the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Before taking this medicine
You should not use Caplyta if you are allergic to lumateperone.
Caplyta may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.
To make sure Caplyta is safe for you, tell your doctor if you have ever had:
Taking antipsychotic medicine 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. Do not stop taking Caplyta without your doctor's advice.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of lumateperone on the baby.
You should not breastfeed while using Caplyta.
Caplyta may affect fertility (your ability to have children), whether you are a man or a woman.
Caplyta is not approved for use by anyone younger than 18 years old.
How should I take Caplyta?
Take Caplyta exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Take with food.
You will need frequent medical tests.
Store at room temperature away from moisture and heat.
Usual Adult Dose for Schizophrenia:
42 mg orally once a day
-Dose titration is not necessary.
-This drug should be taken with food.
Use: Treatment of schizophrenia
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Caplyta?
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.
Avoid driving or hazardous activity until you know how lumateperone will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
Grapefruit may interact with lumateperone and lead to unwanted side effects. Avoid the use of grapefruit products.
Caplyta side effects
Get emergency medical help if you have signs of an allergic reaction to Caplyta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
High doses or long-term use of lumateperone can cause a serious movement disorder that may not be reversible. The longer you use Caplyta, the more likely you are to develop this disorder, especially if you are a woman or an older adult.
Call your doctor at once if you have:
feeling unsteady, feeling like you might pass out;
uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
tightness in your neck or throat, trouble swallowing;
trouble breathing or speaking;
high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;
low white blood cell counts - fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing; or
severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.
Common Caplyta side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Caplyta?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Tell your doctor about all your current medicines. Many drugs can affect Caplyta, especially:
an antibiotic, antifungal, or antiviral medicine;
blood pressure medication;
bronchodilator asthma medication;
cold or allergy medicine (Benadryl and others);
medicine to treat overactive bladder;
medicine to treat Parkinson's disease;
seizure medicine; or
This list is not complete and many Other drugs may interact with lumateperone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Caplyta treatment does not appear to be associated with the weight gain that some other antipsychotic drugs cause.
Results from a number of trials combined together showed that the weight gain observed in patients treated with Caplyta was similar to the weight gain observed in patients who received placebo.
Positive results were also reported by a study that followed patients for one year after they switched from standard of care to Caplyta. Significant improvements in mean body weight were observed during the year of treatment with Caplyta (-2.1 kg, P <0.001) and significant reductions in body mass index (BMI) and waist circumference were also observed.
Caplyta should be taken once a day with food. The recommended dosage of Caplyta is one 42mg capsule a day. Caplyta can cause somnolence and sedation, but these side effects are reported less frequently when Caplyta is taken in the evening.
After one week of treatment with Caplyta, patients enrolled in a phase III trial started to show improved Positive and Negative Syndrome Scale (PANSS) total scores. PANSS is a scale used to measure the severity of schizophrenia symptoms. Symptoms continue to improve the longer you take the drug.
While there may be some signs of improvement during the initial weeks of treatment, it can take up to 2-3 months for the full effects of Caplyta to be felt.
In the first 1-2 weeks, hallucinations, disorganized thinking and delusions may improve, although sometimes they won’t go away altogether. It can also take at least 1-2 weeks for motivation and the desire to be around other people to improve.
More about Caplyta (lumateperone)
- Side Effects
- During Pregnancy
- Dosage Information
- Patient Tips
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- 27 Reviews
- Drug class: atypical antipsychotics
- FDA Approval History
Related treatment guides
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Caplyta only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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