Dec 20, 2021.
We know that Lumateperone received its first FDA approval for the management of adult schizophrenia in 2019, but FDA has just approved this medication for a new indication:
- Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and
- as adjunctive therapy with lithium or valproate.
Before this approval, we had four medications with FDA approval for bipolar depression:
- Fluoxetine + Olanzapine
Lumateperone will be the fifth medication FDA approved for bipolar depression, but this is the only medication that has received FDA approval for bipolar I or II as monotherapy and as an adjunct.
Note that Lamotrigine is not included in this list, because lamotrigine is not FDA approved for acute but for maintenance treatment of bipolar depression.
We have summarized this topic in the following sections:
- How is Lumateperone FDA indication different compared to the other four FDA-approved medications for bipolar depression?
- Lumateperone: Likely mechanism of action.
- Recommended dose and titration.
- When to avoid Lumateperone?
- Common side effects reported during bipolar depression trials.
(1) COMPARING FDA APPROVED MEDICATIONS FOR BIPOLAR DEPRESSION
(2) LUMATEPERONE: MECHANISM OF ACTION
You can watch one of our old video on Lumateperone’s likely mechanism of action below:
(3) RECOMMENDED DOSE & TITRATION
- 42 mg administered orally once daily with or without food.
- Dose titration is not required.
(4) WHEN TO AVOID LUMATEPERONE?
- Hepatic impairment: moderate or severe (Child-Pugh B or C)
- Moderate CYP3A4 Inhibitors: Amprenavir, ciprofloxacin, cyclosporine, diltiazem, erythromycin, fluconazole, fluvoxamine, verapamil.
- Strong CYP3A4 Inhibitors: Clarithromycin, grapefruit juice, itraconazole, voriconazole, nefazodone, ritonavir, nelfinavir.
- Breastfeeding: recommended to avoid breastfeeding with Lumateperone.
(5) MOST COMMON SIDE EFFECTS REPORTED DURING BIPOLAR DEPRESSION TRIALS?
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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