Lumateperone (Caplyta)
Lumateperone is used in adults to treat schizophrenia.
Lumateperone is also used alone or with lithium or valproate to treat depression with bipolar I or bipolar II disorder in adults.
Lumateperone is also used with antidepressants to treat major depressive disorder (MDD) in adults.
Lumateperone may also be used for purposes not listed in this medication guide.
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 or have ever had:
- heart problems or a stroke;
- high or low blood pressure;
- seizures;
- trouble swallowing;
- low white blood cell count;
- high cholesterol or triglycerides;
- diabetes or high blood sugar (in you or a family member); or
- liver or kidney disease.
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.
Taking this medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant or think you are pregnant. Do not stop the medicine 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.
Ask a doctor if it is safe to breastfeed while using this medicine.
Lumateperone may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.
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.
Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.
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 light-headed or like you might pass out when standing up;
- 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;
- abnormal blood tests (high cholesterol or triglycerides);
- low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough; 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:
- nausea, diarrhea;
- dizziness, feeling tired, 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 this medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant or think you are pregnant. Do not stop the medicine 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.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Lumateperone (Caplyta)?
Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Lumateperone can decrease sweating and you may be more prone to heat stroke.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
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.
Lumateperone is usually taken once per day. Follow your doctor's instructions.
You may take lumateperone with or without food.
Drink plenty of liquids while you are taking lumateperone.
You may need frequent medical tests before and during treatment with lumateperone including checking for blood sugar, cholesterol and triglycerides blood levels, and weight gain.
Your doctor will need to check your progress on a regular basis. Keep all of your follow-up appointments.
Do not stop this medicine or change your dose without your doctor's advice.
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)?
Images
ITI 007 10 5 mg
Color: pink
Shape: capsule
Imprint: ITI 007 10 5 mg
ITI 007 42 mg
Color: blue/white
Shape: capsule
Imprint: ITI 007 42 mg
ITI 007 21 mg
Color: white
Shape: capsule
Imprint: ITI 007 21 mg