Bysanti

Bysanti is used to treat schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. It is an oral tablet taken twice daily.

Your healthcare provider may recommend a genetic test before starting Bysanti to see how your body processes the medication, as this can affect the right dose for you. People who process it slowly (poor metabolizers) may need a different dosing schedule.

Bysanti (milsaperidone) gained FDA approval on February 20, 2026. There is no generic.

• Take Bysanti twice daily with or without food.
• Your healthcare provider may increase your dose of Bysanti slowly to reduce the risk of orthostatic hypotension.

When taking Bysanti, you should avoid drinking alcohol, and you should not breastfeed.

Be cautious about performing activities that require mental alertness, such as driving a motor vehicle or operating hazardous machinery, until you are sure that Bysanti won’t affect you adversely.

Avoid becoming overheated or dehydrated while taking Bysanti. Ensure you drink plenty of fluids during hot weather.

Avoid getting up suddenly from a seated or lying position. Bysanti can cause your blood pressure to drop suddenly, particularly when you are starting treatment, re-initiating treatment, or increasing the dosage.

Bysanti carries a Boxed Warning for the risk of dementia-related psychosis.

Elderly patients with psychosis related to dementia (having lost touch with reality due to memory loss and experiencing a decline in day-to-day functioning) who are treated with antipsychotic medications are at an increased risk of death compared to patients treated with a placebo. Bysanti is not approved for use in people with dementia-related psychosis.

Do not take Bysanti if you have a known allergy to Bysanti or its ingredients.

Before taking Bysanti, tell your healthcare provider about all your medical conditions, including if you:

• Have problems with your liver. Bysanti is not recommended with severe liver problems
• Have a pre-existing low white blood cell count (WBC) or a history of drug-induced leukopenia/neutropenia. You should have your CBC monitored while taking Bysanti
• Are taking or planning to take any other medications. There is a potential for clinically significant interactions between Bysanti and other medications
• Are pregnant or planning a pregnancy
• Are breastfeeding or planning to breastfeed.

Pregnancy

Unborn babies exposed to antipsychotic drugs during the third trimester of pregnancy are at risk of extrapyramidal and/or withdrawal symptoms following delivery. Notify your healthcare provider immediately if you become pregnant while taking Bysanti.

Pregnancy registry: Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Bysanti during pregnancy

Breastfeeding

Do not breastfeed during treatment with Bysanti treatment and for 6 days after the last dose in CYP2D6 normal metabolizers and 8 days after the last dose in CYP2D6 poor metabolizers.

Common Side Effects

The most common side effects for Bysanti in patients with schizophrenia are:

• Dizziness
• Dry mouth
• Feeling unusually tired or sleepy
• Stuffy nose
• Feeling faint/light-headed when standing quickly
• Racing heartbeat
• Weight gain.

The most common side effects for Bysanti in patients with bipolar I disorder are:

• Racing heartbeat
• Dizziness
• Dry mouth
• Increase in liver enzymes
• Stuffy nose
• Weight gain
• Low blood pressure
• Feeling unusually tired or sleepy.

Note about weight gain

Compared to placebo, the average weight gain in clinical studies in schizophrenia lasting 4 to 6 weeks was 6 pounds, and in a clinical study of patients with bipolar I disorder over 4 weeks was 7 pounds.

• If you experience any of these symptoms, talk with your healthcare provider.

Serious Side Effects

Bysanti may cause the following serious side effects:

• Allergic reactions, including anaphylaxis, rapid swelling of the skin (angioedema), and other symptoms of allergy (e.g., throat tightness; swelling of the throat, face, lips, mouth, and tongue; hives; rash and itching) have been reported with Bysanti
• An increased risk of stroke has been reported in clinical studies of elderly people with dementia-related psychosis. Bysanti is not approved for use in people with dementia-related psychosis
• Changes in heart rhythm (QTc Interval prolongation). Heart rhythm changes have occurred in patients taking Bysanti and are a risk factor for serious, even life-threatening medical issues. You should tell your healthcare provider if you have or have had heart problems. Contact your healthcare provider right away if you feel faint or have unpleasant feelings of irregular or forceful heartbeats as any of these feelings could be a sign of a rare, but serious side effect that could be fatal. You should not use Bysanti with other drugs that are known to cause these same heart rhythm issues
• Neuroleptic malignant syndrome. This is a rare and life-threatening reaction to the use of almost any kind of neuroleptic (antipsychotic) medication. Tell your healthcare provider if you have some or all of the following symptoms: very high fever, rigid muscles, shaking, confusion, sweating or increased heart rate and blood pressure. These may be signs of a condition called neuroleptic malignant syndrome (NMS), a rare but serious side effect that could be fatal. This may happen with Bysanti or drugs like it
• Tardive dyskinesia. Abnormal or uncontrollable movements of the face, tongue or other parts of the body, such as lip smacking or puckering, rapid blinking, or tongue thrusting, may be signs of a serious condition called tardive dyskinesia (TD), which could become permanent. The chance of this condition going away decreases, depending on how long and how much medication has been taken. Tell your healthcare provider if you have body movements you can't control
• Metabolic changes. Bysanti and medicines like it have been associated with metabolic changes (high blood sugar, high cholesterol and triglycerides, and weight gain) that can increase cardiovascular/cerebrovascular risks. Increases in blood sugar levels (hyperglycemia), which in some cases can be serious and associated with coma or death, have been reported in patients taking Bysanti and medicines like it. Changes in cholesterol and triglycerides have been seen in patients taking Bysanti and medicines like it. Some patients may gain weight while taking Bysanti. Your healthcare provider should check your blood sugar, fat levels, and weight before you start and regularly while you take Bysanti.
• Orthostatic hypotension. Light-headedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting or lying position (orthostatic hypotension) has been reported with Bysanti. This condition is most common when you start therapy, when restarting treatment, or when the dose of Bysanti is increased. You should consult your healthcare provider if you have or have had heart problems or conditions that lead to these sudden changes, since Bysanti should be used with caution in these patients
• Increased risk of falling. Bysanti may increase the risk of falls, which could cause fractures or other injuries.
• Seizures. Tell your healthcare provider if you have a history of or have a condition that may increase your risk for seizures before you begin taking Bysanti
• Decreases in infection-fighting white blood cells (WBCs) have been reported in some patients taking antipsychotic agents. Patients with a preexisting history of low WBC count or who have experienced a low WBC count due to drug therapy should have their blood tested and monitored during the first few months of therapy. Some (including fatal) cases of agranulocytosis, a serious decrease in specific types of WBCs called neutrophils or granulocytes, have been reported in drugs like Bysanti
• Increase in Prolactin. Bysanti can increase the level of the hormone prolactin. Tell your healthcare provider if you experience breast enlargement, breast pain, or breast discharge, abnormal menstrual cycles in females, or impotence in males. If elevated levels of prolactin persist, this may lead to bone loss
• Problems with Temperature Regulation. Medicines like Bysanti can impact your body's ability to reduce its body temperature. You should avoid overheating and dehydration
• Swallowing problems. Bysanti and medicines like it have been associated with swallowing problems (dysphagia). If you have or have had swallowing problems, you should tell your healthcare provider.
• Prolonged Erections. For males, in the rare event you have a painful or prolonged erection (priapism) lasting 4 or more hours, stop using Bysanti and seek immediate medical attention
• Cognitive impairment. Bysanti and medicines like it can affect your judgment, thinking or motor skills. You should not drive or operate hazardous machinery, including automobiles, until you know how Bysanti affects you
• Upcoming eye surgery. A condition called intraoperative floppy iris syndrome has been observed in some patients taking drugs like Bysanti. Please tell your healthcare provider if you take or have taken Bysanti before you undergo cataract or other eye surgeries, even if you no longer take Bysanti.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Experts aren't exactly sure how Bysant works to treat schizophrenia and Bipolar I disorder, but it may work by blocking dopamine D2 and serotonin 5-HT2 receptors. Milsaperidone, the active ingredient of Bysanti is rapidly converted to iloperidone in the body and shares a similar receptor-binding profile.

Bysanti belongs to the drug class called atypical antipsychotics.

Tell your healthcare provider about all prescription and non-prescription medicines and supplements you are taking. Some medications may interact with Bysanti.

If you take certain other medications that can affect how Bysanti works in your body (such as strong inhibitors of CYP2D6 or CYP3A4), your healthcare provider may need to lower your dose. Always tell your healthcare provider about all medicines you're taking to avoid interactions.

This is not a complete list of interactions. See the Bysanti Prescribing Information for a complete list.

Store the tablets at room temperature, 20°C to 25°C (68°F to 77°F).

Protect the tablets from exposure to light and moisture.

Keep out of reach of children.

Active ingredients: milsaperidone

Inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropylmethylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and water (removed during processing).

Bysanti (milsaperidone) tablets are supplied in the following strengths:

• 1 mg
• 2 mg
• 4 mg
• 6 mg
• 8 mg
• 10 mg
• 12 mg

Package Configurations for the Titration Packs

• Titration Pack A: For the treatment of schizophrenia
• Titration Pack B: For the acute treatment of manic or mixed episodes associated with bipolar I disorder
• Titration Pack C: For the acute treatment of manic or mixed episodes associated with bipolar I disorder in: CYP2D6 poor metabolizers Concomitant administration with strong CYP2D6 inhibitors and strong CYP3A4 inhibitors

Bysanti is distributed by Vanda Pharmaceuticals Inc., Washington, D.C. 20037 USA.