Is Lumateperone approved by the FDA?

Yes, lumateperone, marketed under the brand name Caplyta, is FDA approved. The U.S. Food and Drug Administration (FDA) approved Caplyta on December 20, 2019, for the treatment of schizophrenia in adults. Additionally, on December 17, 2021, the FDA approved lumateperone for the treatment of bipolar depression, both as monotherapy and as adjunctive therapy with lithium or valproate .

What is Lumateperone?

Lumateperone is an atypical antipsychotic used to treat schizophrenia in adults. It is also used to treat depressive episodes associated with bipolar I or II disorder, either alone or in combination with lithium or valproate. Lumateperone functions by modulating the activity of neurotransmitters in the brain, which helps in managing symptoms of these mental health conditions.

Dosage and Administration

Lumateperone is available in oral capsule form with dosages of 10.5 mg, 21 mg, and 42 mg. The typical dosage for both schizophrenia and bipolar depression is 42 mg taken once daily, with or without food.

Side Effects

Common side effects of lumateperone include:

• Nausea
• Dizziness
• Drowsiness
• Dry mouth

Serious side effects may include:

• Uncontrolled muscle movements
• High blood sugar levels
• Low white blood cell counts
• Severe nervous system reactions

It's important to monitor for signs of allergic reactions and sudden changes in mood or behavior, especially in young adults or individuals with a history of depression or mental illness.

Warnings and Precautions

• Lumateperone is not approved for use in older adults with dementia-related psychosis due to an increased risk of death.
• People with a history of heart problems, seizures, diabetes, or liver and kidney disease should inform their doctor before starting lumateperone.
• Pregnant women or those planning to become pregnant should discuss potential risks with their doctor.
• Avoid breastfeeding while using lumateperone.

Usage Considerations

• Follow the prescribed dosage and schedule carefully.
• Avoid driving or engaging in hazardous activities until you know how lumateperone affects you, as it can cause dizziness and drowsiness.
• Stay hydrated, especially in hot weather or during exercise, but avoid excessive fluid intake unless directed by your doctor.

Drug Interactions

Lumateperone can interact with various medications, including antibiotics, antifungals, antivirals, blood pressure medications, asthma medications, and others. It's crucial to inform your doctor about all the medications and supplements you are currently taking to avoid potential interactions.

Conclusion

Lumateperone, under the brand name Caplyta, is FDA approved for the treatment of schizophrenia and bipolar depression in adults. Its approval on December 20, 2019, and subsequent expansion for bipolar depression treatment on December 17, 2021, mark significant advancements in the management of these conditions.

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