Milsaperidone

Milsaperidone is an atypical antipsychotic medicine that is used in adults to treat schizophrenia and to manage manic or mixed episodes related to bipolar I disorder.

Milsaperidone may also be used for other reasons that are not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Milsaperidone is usually taken twice per day.

You may take milsaperidone with or without food.

If you have stopped taking milsaperidone for more than 3 days in a row, talk with your doctor before you start taking it again. You may need to restart the medicine at a lower dose.

Your blood sugar, cholesterol, triglycerides, weight, and blood cell counts may need to be checked. Your doctor will need to check your progress on a regular basis.

Milsaperidone can affect your pupils. Tell your eye doctor if you use or have used milsaperidone, especially before cataract surgery or other eye procedures.

Store at room temperature away from moisture, heat, and light.

Milsaperidone can cause serious heart rhythm issues (QT prolongation), which may result in fainting, an irregular heartbeat, or even sudden death. You may have a higher risk if you have certain heart conditions, low potassium or magnesium levels, or if you take other medications that affect heart rhythm.

Milsaperidone can reduce white blood cell counts, which may raise your risk of infection. Contact your doctor immediately if you experience fever, chills, a sore throat, mouth sores, or other signs of infection.

Milsaperidone may increase the risk of death in older adults who have dementia-related psychosis and is not approved for this use.

You should not use milsaperidone if you are allergic to it.

Tell your doctor if you have or have ever had:

• heart disease, heart rhythm disorder (arrhythmias or long QT syndrome), stroke;
• an electrolyte imbalance (such as low blood levels of potassium or magnesium);
• diabetes (your diabetes medicine may need to be adjusted);
• high or low blood pressure or fainting;
• high cholesterol or triglycerides;
• seizures or epilepsy;
• trouble swallowing;
• low white blood cell (WBC) counts; or
• severe liver disease.

Milsaperidone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Taking milsaperidone in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get 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 milsaperidone on the baby.

Do not breastfeed while using milsaperidone and for at least 6 days after your last dose. You may need to wait 8 days if your doctor tells you to.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Milsaperidone can cause a serious movement disorder that may not go away. Call your doctor if you have uncontrolled muscle movements in your face, lips, tongue, eyes, arms, or legs.

Milsaperidone can lower your white blood cells, which may increase your risk of infection. Call your doctor right away if you have signs of infection such as:

• fever, chills, sore throat;
• mouth sores, red or swollen gums; or
• pale skin, easy bruising, or unusual bleeding.

Milsaperidone may cause serious side effects. Call your doctor immediately if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, or sudden dizziness;
• high blood sugar—more thirst, more urination, dry mouth, fruity breath odor;
• severe nervous system reaction—very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling faint;
• breast swelling or discharge, missed menstrual periods, or sexual problems; or
• painful penis erection that lasts 4 hours or longer.

Serious side effects may be more likely in older adults.

Common side effects of milsaperidone may include:

• weight gain;
• low blood pressure, feeling faint;
• abnormal liver function tests;
• dizziness, drowsiness, tiredness;
• fast heartbeats; or
• dry mouth, stuffy nose.

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.

Usual Adult Dose for Schizophrenia:

Day 1: 1 mg orally twice a dayDay 2: 2 mg orally twice a dayDay 3: 4 mg orally twice a dayDay 4: 6 mg orally twice a dayDay 5: 8 mg orally twice a dayDay 6: 10 mg orally twice a dayDay 7: 12 mg orally twice a dayMaintenance dose: 6 to 12 mg orally twice a dayComments:-Titrate to reduce the risk of orthostatic hypotension.-Starting on Day 5, patients may continue with titration schedule OR continue 6 mg orally twice a day with any subsequent titration based on tolerability and response within the recommended dose range.-Consider CYP450 2D6 genetic testing prior to dosing; poor metabolizers require dose adjustment.Use: Treatment of schizophrenia

Usual Adult Dose for Bipolar Disorder:

Day 1: 1 mg orally twice a dayDay 2: 3 mg orally twice a dayDay 3: 6 mg orally twice a dayDay 4: 9 mg orally twice a dayDay 5: 12 mg orally twice a dayMaintenance dose: 12 mg orally twice a dayComments:-Titrate to reduce the risk of orthostatic hypotension.-Consider CYP450 2D6 genetic testing prior to dosing; poor metabolizers require dose adjustment.Use: Acute treatment of manic or mixed episodes associated with bipolar I disorder

If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose. If you miss more than 3 days in a row, contact your doctor before taking it again. You might need to start the dose schedule over from the beginning.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Avoid drinking alcohol.

• Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or doing hazardous activities until you know how milsaperidone will affect you. Your reactions could be impaired. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

• Avoid becoming overheated or dehydrated during exercise and in hot weather. Milsaperidone can decrease sweating and you may be more prone to heat stroke.

Sometimes, it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Milsaperidone can cause a serious heart problem or very low blood pressure. Your risk may be higher if you also take medicines that affect heart rhythm or lower blood pressure.

Many drugs can affect milsaperidone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Inform your doctor about all other medicines you are using.