Milsaperidone

Studies have shown that older adults with dementia (loss of memory and brain function) may have an increased risk of death if treated with antipsychotic medications such as milsaperidone. Older adults with dementia may also have a greater chance of having a stroke or mini-stroke during treatment with antipsychotics.

Milsaperidone is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking milsaperidone.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Milsaperidone is used to treat the symptoms of schizophrenia (a mental illness that affects how a person thinks, feels and behaves) and bipolar I disorder (a disease that causes depression, mania, and other abnormal moods). Milsaperidone is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Milsaperidone comes as a tablet to take by mouth. Take twice daily with or without food. Take milsaperidone at around the same times every day.

Take milsaperidone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of milsaperidone and gradually increase your dose every day in the first 5-7 days. Your doctor will also need to start you on a low dose of milsaperidone and gradually increase your dose if you do not take milsaperidone for 3 days or longer at any time during your treatment.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking milsaperidone,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• some medications should not be taken with milsaperidone. Other medications may cause dosing changes or extra monitoring when taken with milsaperidone. Make sure you have discussed any medications you are currently taking or plan to take before starting milsaperidone with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking milsaperidone, please get the advice of your doctor or pharmacist.
• tell your doctor if you or anyone in your family has or has ever had diabetes or prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), or if you have or have ever had a slow or irregular heartbeat, a recent heart attack, heart failure, high cholesterol levels, seizures, breast cancer, any condition that makes it difficult for you to swallow, or heart or liver disease. Also tell your doctor if you have severe vomiting or diarrhea or become dehydrated at any time during your treatment.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Do not breastfeed while taking milsaperidone or for 6 or 8 days after the final dose. If you become pregnant while taking milsaperidone, call your doctor. Milsaperidone may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
• if you are having surgery, including eye or dental surgery, tell the doctor or dentist that you are taking milsaperidone.
• you should know that milsaperidone may make you drowsy and also affect thinking, judgment, and ability to move. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking milsaperidone or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking milsaperidone: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include: dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.
• ask your doctor about the safe use of alcoholic beverages while you are taking milsaperidone. Alcohol can make the side effects from milsaperidone worse.
• you should know that milsaperidone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking milsaperidone. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Milsaperidone may cause side effects. Tell your doctor if any of these symptoms or those in SPECIAL PRECAUTIONS are severe or do not go away:

• weight gain
• dry mouth
• tiredness
• breast enlargement or discharge
• missed menstrual periods
• decreased sexual ability in men

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• rash, hives, itching, difficulty breathing or swallowing, or swelling of the face, lips, throat, tongue, hands, or feet
• dizziness; fast, pounding, or irregular heartbeat; or fainting
• fever, stiff muscles, sweating, confusion, or a fast, pounding, or irregular heartbeat
• unusual movements of the face or body that you cannot control
• seizures
• sore throat, fever, chills, and other signs of infection
• falling down
• painful erection that lasts for hours

Milsaperidone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• seizures
• extreme drowsiness
• fast heartbeat

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to milsaperidone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Bysanti^®