Lumateperonedrug info
lumateperone 10.5 MG Oral Capsule [Caplyta]
What it is used for
CAPLYTA is indicated for: Treatment of schizophrenia in adults. Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate. Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. CAPLYTA is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate. Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective June 20, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Lumateperone is an atypical antipsychotic present as lumateperone tosylate salt with the chemical name 4-((6b R,10a S )-3-methyl-2,3,6b,9,10,10 a -hexahydro-1 H,7 H -pyrido[3',4':4,5]pyrrolo[1,2,3- de ]quinoxalin-8-yl)-1-(4-fluoro-phenyl)-butan-1-one 4-methylbenzenesulfonate. Its molecular formula is C 31 H 36 FN 3 O 4 S, and its molecular weight is 565.71 g/mol with the following structure: CAPLYTA (lumateperone) capsules are for oral administration.
Each capsule contains: 42 mg of lumateperone (equivalent to 60 mg of lumateperone tosylate), or 21 mg of lumateperone (equivalent to 30 mg of lumateperone tosylate), or 10.5 mg of lumateperone (equivalent to 15 mg of lumateperone tosylate). The capsules include the following inactive ingredients: croscarmellose sodium, gelatin, magnesium stearate, mannitol, and talc. Colorants include FD&C blue #1 and red #3 (42 mg), FDA/E172 black iron oxide, FDA/E172 red iron oxide and FD&C red #3 (10.5 mg), and titanium dioxide (42 mg, 21 mg and 10.5 mg). Chemical Structure
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective June 20, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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