We understand that side effects might be a concern when thinking about starting a new medicine.
What to expect with CAPLYTA
The most common side effects with CAPLYTA are sleepiness and dry mouth. Your healthcare provider may tell you what time of day or night is best for you to take CAPLYTA. Sleepiness was mainly mild. Follow your healthcare provider's direction on when and how to take CAPLYTA.
Dry mouth (6%)
CAPLYTA can cause sleepiness and trouble concentrating. Until you know how CAPLYTA affects you, do not drive, operate heavy machinery, or do other dangerous activities.
Does blood glucose, cholesterol, or triglycerides go up on CAPLYTA?
In clinical trials, changes in blood glucose, cholesterol, and triglycerides in patients taking CAPLYTA were similar to those in patients taking a sugar pill
What about weight change?
In a long-term study, patients on CAPLYTA for one year had an average weight loss of 7 pounds
CAPLYTA, like other drugs used to treat schizophrenia, may cause problems with your metabolism, including high blood sugar, diabetes, increased fat (cholesterol and triglyceride) levels in your blood, and weight gain. Your doctor should check your blood sugar, fat levels, and weight before you start and during your treatment with CAPLYTA. Extremely high blood sugar levels can lead to coma or death. Tell your doctor if you have symptoms of high blood sugar, which include feeling very thirsty, hungry, sick to your stomach, weak/tired, or needing to urinate more than usual.
Each drug has its own specific risk profile.
Do patients on CAPLYTA experience movement disorders?
In clinical trials, movement disorders were uncommon and similar to sugar pill.
6.7% of patients taking CAPLYTA vs. 6.3% of patients taking a sugar pill
Like other schizophrenia medications, CAPLYTA may cause movements that you cannot control in your face, tongue, or other body parts. This can be a sign of tardive dyskinesia. Tardive dyskinesia is a movement disorder that may not go away, even if you stop taking CAPLYTA. Tardive dyskinesia may also start after you stop taking CAPLYTA.
Additional Important Safety Information
Medicines like CAPLYTA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). CAPLYTA is not approved for treating people with dementia-related psychosis.
Tell your doctor right away if you have any of the following serious side effects:
Stroke (cerebrovascular problems) in elderly people that can lead to death.
Neuroleptic malignant syndrome (NMS): high fever, confusion, changes in your breathing, heart rate, and blood pressure, stiff muscles, and increased sweating; these may be symptoms of a rare but potentially fatal condition. Contact your doctor or go to the emergency room if you experience signs and symptoms of NMS.
Uncontrolled body movements (tardive dyskinesia, TD) in your face, tongue, or other body parts. TD may not go away, even if you stop taking CAPLYTA. It may also occur after you stop taking your medication.
Problems with your metabolism including high blood sugar, diabetes, increased fat (cholesterol and triglyceride) levels in your blood and weight gain. Your doctor should check your blood sugar, fat levels and weight before you start and during your treatment with CAPLYTA. Extremely high blood sugar levels can lead to coma or death. Tell your doctor if you have symptoms of high blood sugar, which include feeling very thirsty, hungry, sick to your stomach, weak/tired or needing to urinate more than usual.
Low white blood cell count. Your doctor may do blood tests during the first few months of treatment with CAPLYTA.
Decreased blood pressure (orthostatic hypotension). You may feel lightheaded, dizzy, or faint when you rise too quickly from a sitting or lying position.
Falls. CAPLYTA may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause broken bones or other injuries.
Sleepiness and trouble concentrating: Until you know how CAPLYTA affects you, do not drive, operate heavy machinery, or do other dangerous activities.
Problems controlling your body temperature so that you feel too warm. Avoid getting overheated or dehydrated while taking CAPLYTA.
The most common side effects of CAPLYTA include sleepiness or drowsiness and dry mouth.
These are not all of the possible side effects of CAPLYTA. You should notify your doctor if you become pregnant or intend to become pregnant while taking CAPLYTA. CAPLYTA may cause extrapyramidal (abnormal involuntary movements) and/or withdrawal symptoms in newborn babies exposed to CAPLYTA during the third trimester. When taking CAPLYTA, you should not breastfeed. Tell your doctor if you have liver problems and about all the medicines you're taking, since there are some risks for drug interactions. Avoid eating grapefruit or drinking grapefruit juice during treatment with CAPLYTA. Grapefruit and grapefruit juice may affect the amount of CAPLYTA in your blood. You are encouraged to report negative side effects of prescription drugs. Contact Intra-Cellular Therapies, Inc. at 1-888-611-4824 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Prescribing Information, including Boxed Warning.