Indications

BYSANTI™ (milsaperidone) is a prescription medication used for the treatment of schizophrenia and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

Important Safety Information

Patients should not use BYSANTI™ if they have a known allergy to BYSANTI™ or its ingredients. 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.

Warnings and Precautions

• 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.
• BYSANTI™ may change your heart rhythm (meaning there is more time between heartbeats). 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.
• 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.
• Abnormal or uncontrollable movements of the face, tongue or other parts of the body 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.
• 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™.
• 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.
• BYSANTI™ may increase the risk of falls, which could cause fractures or other injuries.
• 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™.
• 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.
• Medicines like BYSANTI™ can impact your body's ability to reduce your body temperature. You should avoid overheating and dehydration.
• 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.
• 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.
• 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.
• 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 cataract or other eye surgeries.

The most common side effects for BYSANTI™ versus placebo in patients with schizophrenia were dizziness, dry mouth, feeling unusually tired or sleepy, stuffy nose, feeling faint/light-headed when standing quickly, racing heartbeat and weight gain. The most common side effects for BYSANTI™ versus placebo in a clinical study of patients with bipolar I disorder were racing heartbeat, dizziness, dry mouth, increase in liver enzymes, stuffy nose, weight gain, low blood pressure and feeling unusually tired or sleepy. 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.

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

You should notify your healthcare provider if you become pregnant or intend to become pregnant while taking BYSANTI™.

Tell your healthcare provider about any medical conditions that you have, including problems with your liver. BYSANTI™ is not recommended for patients with severe liver problems.

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

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.

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.

To access the full Prescribing Information, including BOXED WARNING, visit www.bysanti.com.

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.

DOWNLOAD FULL PRESCRIBING INFORMATION (PDF)