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FDA approved Rexulti (brexpiprazole) for Agitation in Alzheimer's DementiaFDA approved Rexulti to treat agitation in Alzheimer's patients

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Key Takeaway
Note: Rexulti is approved for agitation in Alzheimer's dementia but not for prn use; follow specific titration schedule.

The FDA has approved Rexulti (brexpiprazole) for the treatment of agitation associated with dementia due to Alzheimer's disease, expanding the atypical antipsychotic's indications. This approval provides a new option for managing a challenging symptom in this population. The recommended starting dose is 0.5 mg once daily for the first week, titrated to 1 mg on days 8-14, then to 2 mg on day 15. The maximum dose is 3 mg daily. Clinicians should note that Rexulti is not approved for as-needed (prn) use. The approval is based on clinical studies demonstrating efficacy, though specific trial data are not detailed in the label. Safety considerations include boxed warnings for increased mortality in elderly patients with dementia-related psychosis, as with other antipsychotics.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Not reported in label.

Indication & Patient Population

Rexulti is indicated for treatment of agitation associated with dementia due to Alzheimer's disease in adults. Limitation of Use: Not indicated as an as-needed (prn) treatment.

Dosing & Administration

Administer orally once daily with or without food. Starting dosage: 0.5 mg once daily on Days 1 to 7. Increase to 1 mg once daily on Days 8 through 14, then to 2 mg once daily on Day 15. Recommended target dose: 2 mg once daily. Maximum dose: 3 mg once daily (increase after at least 14 days based on response/tolerability). For moderate to severe hepatic impairment (Child-Pugh ≥7) or CrCl <60 mL/min: maximum 2 mg once daily. See label for CYP2D6 poor metabolizer and drug interaction adjustments.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Rexulti offers a new treatment option for agitation in Alzheimer's dementia, with a specific dosing regimen. It is not for prn use. As an atypical antipsychotic, it carries risks including increased mortality in elderly dementia patients, though specific warnings are not detailed in this label excerpt.

The FDA has approved a new use for the drug Rexulti (brexpiprazole). It is now approved to treat agitation in people with dementia caused by Alzheimer's disease. Agitation can include restlessness, pacing, or verbal outbursts. This approval gives doctors another tool to help manage these symptoms.

Rexulti is a type of medicine called an atypical antipsychotic. It is taken as a pill once a day. The starting dose is low and is increased over two weeks. The maximum dose is 3 mg per day. This medicine is not meant for use as needed or for sudden symptoms.

This approval is based on studies that showed Rexulti can reduce agitation. However, like other antipsychotics, it carries a boxed warning about an increased risk of death in older adults with dementia-related psychosis. This is a serious warning that doctors and families should discuss carefully.

If you or a loved one has Alzheimer's disease and agitation, talk to your doctor about whether Rexulti might be an option. It is important to weigh the benefits and risks together. This medicine is not a cure for Alzheimer's and does not slow the disease.

What this means for you:
Rexulti is a new option for agitation in Alzheimer's, but talk to your doctor about risks and benefits.

Study Details

Study typeFda approval
PublishedJul 2015
View Original Abstract ↓
1 INDICATIONS AND USAGE REXULTI is indicated for: Adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults Treatment of schizophrenia in adults and pediatric patients ages 13 years and older Treatment of agitation associated with dementia due to Alzheimer's disease Limitations of Use: REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease [see Clinical Studies (14.3) ] . REXULTI is an atypical antipsychotic indicated for: Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults ( 1 , 14.1 ) Treatment of schizophrenia in adults and pediatric patients ages 13 years and older ( 1 , 14.2 ) Treatment of agitation associated with dementia due to Alzheimer's disease ( 1 , 14.3 ) Limitations of Use : REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease ( 1 )
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