TM Owner Otsuka
Rexulti 0.5mg Tablet
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Indications & Clinical Uses
- Rexulti 0.5mg tablets contain brexpiprazole, an atypical (second-generation) antipsychotic.
- It is FDA-approved as add-on treatment with antidepressants for major depressive disorder in adults; for schizophrenia in adults and adolescents aged 13 and older; and for agitation associated with dementia due to Alzheimer's disease in adults.
- It is marketed by Otsuka, originally developed in Japan and co-marketed with Lundbeck (Denmark) in several markets.
- The 0.5mg strength is one of six available (0.25mg to 4mg) and is typically used during dose titration or for patients needing a lower maintenance dose, such as those with hepatic or renal impairment or taking interacting medicines.
- Rexulti is taken by mouth once daily, with or without food, and is usually self-administered at home under ongoing psychiatric follow-up.
Side Effects
- Rexulti's label carries a boxed warning: elderly patients with dementia- related psychosis treated with antipsychotics, including brexpiprazole, have an increased risk of death, mostly from heart-related events or infection - Rexulti is not approved for dementia-related psychosis.
- A second boxed warning applies when Rexulti is added to an antidepressant: antidepressants increase the risk of suicidal thoughts and behaviour in children, adolescents and young adults up to 24, so close monitoring is needed, especially early in treatment.
- Very common side effects include weight gain, restlessness (akathisia) and sleepiness; in dementia-related agitation, common effects include cold-like symptoms, dizziness and urinary tract infection.
- Headache, tremor, constipation and involuntary movements can also occur.
- Seek urgent help for high fever with muscle stiffness and confusion, or for new or worsening suicidal thoughts.
Precautions & Warnings
- Rexulti is not approved for treating psychosis related to dementia, because of the increased risk of death in this group.
- Watch for and report high fever, severe muscle stiffness, confusion or irregular heartbeat, which can signal neuroleptic malignant syndrome, and for uncontrollable, repetitive movements (tardive dyskinesia), which may be irreversible.
- Rexulti can raise blood sugar, cholesterol and weight, so these are checked periodically, and it can lower blood pressure on standing, increasing fall risk, particularly in older adults.
- It may cause difficulty swallowing, low white blood cell counts, seizures, and impaired judgement or motor skills that affect driving.
- Compulsive urges such as gambling, shopping, eating or sexual behaviour have been reported and usually stop when the dose is lowered or the medicine is stopped.
- Tell your prescriber if you are pregnant, since antipsychotics late in pregnancy can cause withdrawal or movement symptoms in the newborn.
Avoid Interactions
- Strong or moderate inhibitors of CYP3A4 or CYP2D6 (such as ketoconazole, fluoxetine, paroxetine or quinidine) raise brexpiprazole levels, so the Rexulti dose is usually reduced when these are combined - do not change the dose yourself.
- Strong CYP3A4 inducers, such as rifampin, carbamazepine or St John's wort, lower brexpiprazole levels and may need a higher dose.
- Combining Rexulti with other centrally-acting medicines or alcohol can increase drowsiness and impair coordination.
- Because it can lower blood pressure on standing, combining it with antihypertensives needs caution.
- Tell your prescriber about all antidepressants you take, since the boxed warning on suicidal thoughts applies specifically when Rexulti is added to antidepressant therapy.
- Always tell your healthcare provider and pharmacist about every prescription, over-the-counter medicine and supplement you use.
References
Frequently Asked Questions
Rexulti (brexpiprazole) is an antipsychotic tablet used with an antidepressant for major depressive disorder, alone for schizophrenia in people 13 and older, and for agitation linked to Alzheimer's dementia in adults. The 0.5mg strength is often used while your dose is being adjusted.
Rexulti tablets are taken by mouth once daily, with or without food, at roughly the same time each day. Your doctor sets the dose and may raise it gradually from a low starting dose such as 0.5mg. Don't stop suddenly without medical advice.
Common side effects of brexpiprazole include weight gain, restlessness (akathisia), sleepiness, tremor and headache. Rexulti carries a boxed warning: in elderly people with dementia-related psychosis, antipsychotics raise the risk of death, and Rexulti isn't approved for that use.
Avoid alcohol and other sedating medicines, which can add to drowsiness. Rexulti carries a boxed warning that antidepressants, including when combined with Rexulti, can increase suicidal thoughts in people under 24 - report any new or worsening mood changes right away.
Tell your doctor about all your medicines. Strong CYP3A4 or CYP2D6 inhibitors, like fluoxetine or ketoconazole, raise brexpiprazole levels and usually mean a lower Rexulti dose; enzyme inducers like rifampin can lower its effect. Never adjust your dose without medical advice.
Rexulti is not approved to treat psychosis in elderly patients with dementia, because antipsychotics in this group carry a boxed warning for increased risk of death, mainly from heart problems or infection. It is only approved for agitation linked to Alzheimer's dementia.
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