Lumateperone is used to treat schizophrenia in adults.
Lumateperone is also used alone or with lithium or valproate to treat depression with bipolar disorder (manic depression).
Lumateperone may also be used for purposes not listed in this medication guide.
uses
What is Lumateperone (Caplyta) used for?
- Schizophrenia
- Bipolar Disorder
warnings
What is the most important information I should know about Lumateperone (Caplyta)?
You should not use lumateperone if you are allergic to it.
Lumateperone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.
Tell your doctor if you have ever had:
- trouble swallowing;
- high cholesterol or triglycerides;
- diabetes; or
- liver disease.
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 lumateperone 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 lumateperone.
This medicine may affect fertility (your ability to have children), whether you are a man or a woman.
Lumateperone is not approved for use by anyone younger than 18 years old.
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Side Effects
What are the side effects of Lumateperone (Caplyta)?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.
High doses or long-term use of lumateperone can cause a serious movement disorder that may not be reversible. The longer you use lumateperone, 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;
- a seizure;
- 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 side effects may include:
- weight gain;
- nausea;
- dizziness;
- drowsiness; or
- dry mouth.
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.
Pregnancy & Breastfeeding
Can I take Lumateperone (Caplyta) if I’m pregnant or breastfeeding?
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 lumateperone 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 lumateperone.
Interactions
What drugs and food should I avoid while taking Lumateperone (Caplyta)?
While you are taking lumateperone, 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 this medicine 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.
Dosage Guidelines & Tips
How to take Lumateperone (Caplyta)?
Use Lumateperone (Caplyta) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Take once a day with or with food.
You will need frequent medical tests.
Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, or heavy sweating. Call your doctor if you are sick with vomiting or diarrhea.
Store at room temperature away from moisture and heat.
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.
Overdose Signs
What happens if I overdose on Lumateperone (Caplyta)?
(800) 222-1222
911
Images
ITI 007 42 mg
Color: blue/white
Shape: capsule
Imprint: ITI 007 42 mg
ITI 007 10 5 mg
Color: pink
Shape: capsule
Imprint: ITI 007 10 5 mg
ITI 007 21 mg
Color: white
Shape: capsule
Imprint: ITI 007 21 mg