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Overview: Bysanti is an oral tablet that is used to treat certain mental health conditions. Common side effects include dizziness, dry mouth, tiredness, and nasal congestion. Contact your health care provider if you have movement problems, faint, or have a fast or skipping heartbeat. Bysanti can make you more likely to get overheated. Try to drink plenty of fluids and wear light, breathable clothing while taking Bysanti. Bysanti may interact with other medicines, so tell your health care providers about all medicines and supplements that you take or plan to take.

Uses

What is Bysanti used for?

Bysanti (milsaperidone) is commonly used for the following conditions.

Learn more about Bysanti for schizophrenia.

Learn more about Bysanti for bipolar disorder.

Bysanti may also be used for other conditions as determined by your health care provider.

How does Bysanti work (mechanism of action)?

Bysanti is thought to work by balancing brain chemicals called serotonin and dopamine. These chemicals are known to affect thoughts and mood.

How is Bysanti supplied (dosage forms)?

Brands and other names

  • Bysanti

Dosage forms and strengths

  • 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg oral tablets

How should I store Bysanti?

Store Bysanti at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Protect from moisture and light.

Side Effects

What are the most common side effects of Bysanti?

The most common side effects of Bysanti are listed below. These side effects may vary based on the condition being treated. Tell your health care provider if you have any of these side effects that bother you.

  • Dizziness
  • Dry mouth
  • Tiredness or drowsiness
  • Nasal congestion
  • Low blood pressure upon standing (see below)
  • Fast heartbeat
  • Weight gain
  • Increased liver enzymes

There may be other side effects of Bysanti that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Bysanti?

While less common, the most serious side effects of Bysanti are described below, along with what to do if they happen.

Severe Allergic Reactions. Bysanti may cause allergic reactions, which can be serious. Stop taking Bysanti and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Heart Rhythm Changes. Bysanti may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Tell your health care provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Neuroleptic Malignant Syndrome (NMS). Antipsychotic medicines, like Bysanti, can cause a rare but serious condition called neuroleptic malignant syndrome. NMS can lead to death. Stop taking Bysanti and call your health care provider right away if you have any of the following symptoms.

  • High fever
  • Muscle stiffness or rigidity, where it is hard to move
  • Changes in your breathing or heart rate
  • Increased sweating
  • Confusion

Uncontrolled Movements. Bysanti can cause some people to have movements that they cannot control. This condition, called tardive dyskinesia (TD), can cause jerky movements of the face, tongue, or body. TD can be permanent. Call your health care provider right away if you have any of the following symptoms of TD.

  • Tongue sticking out
  • Lip smacking or puckering
  • Grimacing
  • Rapid eye blinking
  • Jerking or twisting motion of the arms, legs, or trunk

Metabolism Problems. Bysanti can cause or worsen high blood sugar levels or diabetes, high cholesterol levels, and weight gain. Keep all appointments with your health care provider to check your blood work and weight. Tell your health care provider if you gain weight or have the following symptoms of high blood sugar.

  • Thirsty more than usual
  • Peeing more than usual
  • Increase in hunger
  • Tiredness
  • Feeling sick to your stomach
  • Confusion
  • Your breath smelling fruity

Low Blood Pressure Upon Standing (Orthostatic Hypotension) and Falls. Bysanti may cause a sudden drop in blood pressure when standing up from a seated or lying position. Some people faint or even fall when this happens. To help prevent this, be careful not to get up too quickly. If you feel dizzy, sit or lie down right away until the dizziness stops, then take your time getting up again. Tell your health care provider right away if you have any of the following symptoms of orthostatic hypotension.

  • Dizziness, feeling lightheaded, or fainting upon standing
  • Blurred vision
  • Confusion
  • Feeling weak

Seizures. Some people who have taken Bysanti have reported having seizures. There are many different types of seizures and some of them are not easy to recognize. Stop taking Bysanti and call your health care provider if you have any of the following signs that a seizure is happening or could happen.

  • Muscle twitching, jerking, spasms, tremors, or other uncontrolled movements
  • Stiffening of your arms and legs
  • Feeling anxious, nervous, confused, or a sense of dread
  • Feeling dizzy or lightheaded
  • Falling or losing consciousness

Blood Disorders. Bysanti can cause blood disorders, such as low white blood cell levels (leukopenia, neutropenia, or agranulocytosis). Keep all appointments with your health care provider to check your blood work. Stop taking Bysanti and get help right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

High Prolactin Levels. Bysanti may cause an increased level of the hormone prolactin in your blood (hyperprolactinemia). High levels of prolactin could lead to fertility or bone problems. Contact your health care provider if you have any of the following symptoms.

  • Vaginal dryness
  • Irregular or no periods 
  • Making breast milk when not pregnant or nursing
  • Trouble getting or keeping an erection
  • Enlarged breast size (gynecomastia)
  • Decreased muscle mass and body hair

Body Temperature Regulation. Bysanti can affect how well your body controls its temperature. This could make you become overheated or dehydrated, especially in hot weather or after exercising a lot. Drink plenty of water, wear light and breathable clothing, and try to avoid overheating. Call your health care provider right away if you are severely ill and have the following symptoms.

  • Excessive or no sweating
  • Dry mouth
  • Feeling very hot
  • Feeling thirsty 
  • Not able to pee

Trouble Swallowing. Bysanti can cause trouble swallowing (dysphagia), which can increase your risk of choking while eating or drinking. Eat small amounts of food, and chew your food well. Get emergency help if you are choking or have food stuck in your esophagus.

Painful, Prolonged Erection (Priapism). Bysanti may cause an unwanted erection that is persistent, painful, and that may occur without sexual arousal. Permanent damage to the penis may occur if priapism is not treated quickly. Stop taking Bysanti and get emergency help if you have any of the following symptoms of priapism. 

  • Erection lasting for more than 4 hours 
  • Erection that is unrelated to sexual stimulation
  • Painful or tender penis

Warnings & Precautions

Who should not use Bysanti?

Allergies to Ingredients. People who are allergic to any of the following should not take Bysanti.

  • Bysanti
  • Milsaperidone
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Bysanti.

What should I know about Bysanti before taking it?

Do not take Bysanti unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Bysanti with other people, even if they have the same condition as you. It may harm them.

Keep Bysanti out of the reach of children.

Bysanti can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Bysanti affects you.

People who are 65 or older can be at greater risk for some side effects from Bysanti. Talk to your health care provider about your risks if you are in this age group.

What should I tell my health care provider before taking Bysanti?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Bysanti is right for you.

In particular, make sure that you discuss any of the following.

Other Medicines and Supplements. Bysanti may interact with other medicines and supplements. Before taking Bysanti, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Genetic Differences. Some people’s bodies may break down Bysanti more slowly because of differences in their genes. This is called being a “poor metabolizer” and can lead to higher levels of the medicine in the body and a greater risk of side effects. Before taking Bysanti, tell your health care provider if you have any problems breaking down medicines or have been told you are a poor metabolizer. Your health care provider can let you know if Bysanti is safe for you. 

Planned Eye Surgery. Taking Bysanti may raise the risk of eye problems during or after cataract or glaucoma surgery or other eye procedures. Tell your health care provider if you are planning to have eye surgery. They may recommend that you wait until after the surgery is over to start Bysanti.

Psychosis Related to Dementia. There is a higher risk of death, stroke, or ministroke in older adults who take an antipsychotic medicine, such as Bysanti, and have memory loss or psychosis related to dementia. Bysanti is not approved to treat dementia-related psychosis.

Other Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.

Pregnancy. Taking Bysanti later in pregnancy may increase the risk of certain problems in your newborn. Tell your health care provider if you are pregnant or plan to become pregnant while taking Bysanti. Your health care provider will let you know if you should take Bysanti while you are pregnant or trying to get pregnant. If you become pregnant while taking Bysanti, you can register with the National Pregnancy Registry for Atypical Antipsychotics online or by calling 866-961-2388. This registry collects safety information about the use of psychiatric medicines during pregnancy.

Breastfeeding. You should not breastfeed while taking Bysanti and for 6 to 8 days after your last dose. It is not known if Bysanti passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider can let you know how long to wait after stopping Bysanti before breastfeeding.

How can I get more information about Bysanti?

For more information about Bysanti, you can visit the drugmaker’s website at www.bysanti.com or call them at 844-468-2632.

Interactions

Does Bysanti interact with foods or drinks?

There are no known interactions between Bysanti and foods.

You should avoid drinking alcohol while taking Bysanti. Drinking alcohol could increase your risk of dizziness, drowsiness, and other side effects of Bysanti.

Does Bysanti interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Bysanti.

  • An alpha-blocker, such as alfuzosin, doxazosin, prazosin, or terazosin, which is a medicine that may be used for high blood pressure and/or trouble peeing due to an enlarged prostate
  • Any medicine for high blood pressure
  • Any medicine that can cause QT prolongation, which is a potentially dangerous heart rhythm problem, such as amiodarone, chlorpromazine, methadone, moxifloxacin, quinidine, or sotalol
  • Paroxetine or fluoxetine, which is a medicine commonly used for anxiety and depression
  • Bupropion (Wellbutrin SR, Wellbutrin XL, Aplenzin, and others), which is a medicine used to treat depression or to help quit smoking
  • Ritonavir (Norvir), lopinavir/ritonavir (Kaletra), or nelfinavir (Viracept), which is a medicine commonly used to treat HIV
  • Itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
  • Clarithromycin, which is a medicine used for bacterial infections
  • An anticholinergic medicine, which includes antihistamines and certain medicines for overactive bladder, Parkinson’s disease, stomach problems, motion sickness, and others

Many other medicines may alter the blood levels of Bysanti. Tell your health care provider about all medicines that you use or have recently used.

This may not be a complete list of medicines that can interact with Bysanti. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally take too much Bysanti?

If you or someone else has used too much Bysanti, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Bysanti?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

If you miss more than 3 days of Bysanti, call your health care provider for instructions. You may need to restart treatment at a lower dose and slowly increase it. Do not restart your usual dose on your own.