Lumateperone Two New Dosages Approved: 21 mg & 10.5 mg
Lumateperone received its first FDA approval for the management of adult schizophrenia in 2019, and recently FDA has just approved this medication for depressive episodes associated with bipolar I or II disorder (bipolar depression).
Read our detailed post on this topic from Dec 20, 2021: Lumateperone: Newest FDA Approved Medication for Bipolar Depression.
This week FDA approved two additional dosages of Lumteperone for both of these indications: 21 mg and 10.5 mg.
We have summarized these two new dosages indications in this diagram:
Lumateperone was initially approved with one dose only: 42 mg once daily.
Here are the indications of when to use 21 mg and 10.5 mg dose:
21 mg once daily:
- Moderate or Severe Hepatic Impairment: Patients with moderate (Child-Pugh class B) and severe (Child-Pugh class C) hepatic impairment generally had higher exposure to lumateperone than patients with normal hepatic function; therefore, a dosage reduction is recommended.
- Moderate 3A4 Inhibitors: Amprenavir, ciprofloxacin, cyclosporine, diltiazem, erythromycin, fluconazole, fluvoxamine, verapamil.
10.5 mg daily:
- Strong 3 A4 Inhibitors: Clarithromycin, grapefruit juice, itraconazole, voriconazole, nefazodone, ritonavir, nelfinavir.
Reference:
- Lumateperone package insert (PDF)
FOR PEFA MEMBERS:
Watch our journal club for a detailed discussion on this topic:
This journal club will be summarized in the following topics/questions:
- Lumateperone: Mechanism of action.
- Recommended dosage and titration.
- Lumateperone 28 mg vs 42 mg vs 84 mg: which one is preferred?
- When is the onset of response with Lumateperone?
- Lumateperone: Common adverse events.
- Association of Lumateperone with EPS, metabolic side effects, QTc prolongation and increase in suicidal ideations?
- How Lumateperone compares with other antipsychotics in terms of effect size for reduction in PANSS total symptoms?
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