lumateperone

What is the most important information I should know about lumateperone?

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. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

What is lumateperone?

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.

What should I discuss with my healthcare provider before taking lumateperone?

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.

This medicine may affect fertility (your ability to have children), whether you are a man or a woman.

How should I take lumateperone?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You will need frequent medical tests.

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?

What should I avoid while taking lumateperone?

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.

Grapefruit may interact with lumateperone and lead to unwanted side effects. Avoid the use of grapefruit products.

What are the possible side effects of lumateperone?

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.

• 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.

What other drugs will affect lumateperone?

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 lumateperone, especially:

• an antibiotic, antifungal, or antiviral medicine;
• blood pressure medication;
• bronchodilator asthma medication;
• cold or allergy medicine (Benadryl and others);
• medicine to treat depression, anxiety, mood disorders, or mental illness;
• medicine to treat overactive bladder;
• medicine to treat Parkinson's disease;
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
• seizure medicine; or
• St. John's wort.

This list is not complete and many other drugs may affect lumateperone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about lumateperone.