CAPLYTA is a prescription medicine used in adults:

• to treat schizophrenia
• alone to treat depressive episodes that happen with bipolar I or bipolar II disorder (bipolar depression)
• with the medicine lithium or valproate to treat depressive episodes that happen with bipolar I or bipolar II disorder (bipolar depression)

It is not known if CAPLYTA is safe and effective in children.

• have or have had heart problems or a stroke
• have or have had low or high blood pressure
• have or have had diabetes or high blood sugar, or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start and during treatment with CAPLYTA.
• have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides or low levels of HDL cholesterol
• have or have had seizures (convulsions)
• have or have had kidney or liver problems
• have or have had a low white blood cell count
• are pregnant or plan to become pregnant. CAPLYTA may harm your unborn baby. Taking CAPLYTA during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take CAPLYTA during pregnancy.
  • Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with CAPLYTA.
  • If you become pregnant during treatment with CAPLYTA, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
• are breastfeeding or plan to breastfeed. CAPLYTA passes into your breast milk. Talk to your healthcare provider about the risks and benefits of breastfeeding and the best way to feed your baby during treatment with CAPLYTA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

CAPLYTA and other medicines may affect each other causing possible serious side effects. CAPLYTA may affect the way other medicines work, and other medicines may affect how CAPLYTA works.

Your healthcare provider can tell you if it is safe to take CAPLYTA with your other medicines. Do not start or stop any medicines during treatment with CAPLYTA without first talking to your healthcare provider.

Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

• Take CAPLYTA exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking CAPLYTA without first talking to your healthcare provider.
• Take CAPLYTA 1 time each day with or without food.
• If you take too much CAPLYTA, call your healthcare provider or Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

• Do not drive, operate machinery, or do other dangerous activities until you know how CAPLYTA affects you. CAPLYTA may make you drowsy.
• Do not become too hot or dehydrated during treatment with CAPLYTA.
  • Do not exercise too much.
  • In hot weather, stay inside in a cool place if possible.
  • Stay out of the sun.
  • Do not wear too much clothing or heavy clothing.
  • Drink plenty of water.

• Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with CAPLYTA.
• Decreased blood pressure (orthostatic hypotension).You may feel lightheaded 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 fractures or other injuries.
• Seizures (convulsions).
• Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. See "What should I avoid while taking CAPLYTA?"
• Problems controlling your body temperature so that you feel too warm.See “What should I avoid while taking CAPLYTA?”
• Difficulty swallowingthat can cause food or liquid to get into your lungs.

The most common side effects of CAPLYTA include sleepiness, dizziness, nausea, and dry mouth.

CAPLYTA may cause fertility problems in females and males. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of CAPLYTA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store CAPLYTA at room temperature between 68°F to 77°F (20°C to 25°C).

General information about the safe and effective use of CAPLYTA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CAPLYTA for a condition for which it was not prescribed. Do not give CAPLYTA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about CAPLYTA that is written for healthcare professionals.