Rexulti

The active ingredient in Rexulti is brexpiprazole. This medication falls within the same class as aripiprazole. The exact mechanism of action of brexpiprazole is unknown. However, it is thought that the effects of Rexulti may be due to activity at serotonin and dopamine receptors, making it effective in schizophrenia and as an adjunctive therapy for the treatment of major depressive disorder.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Rexulti. However, the following is a synopsis of the general guidelines for the use of Rexulti:

• Typically, Rexulti is taken by mouth once a day with or without food.
• Use exactly as prescribed. Do not exceed the recommended dose or duration of use.
• Your starting dose of Rexulti may not be the one you continue for the rest of the treatment. Your healthcare provider may make dosage adjustments based on your clinical response and tolerability.
• Rexulti can cause drowsiness. Do not drive or operate heavy machinery until you are familiar with how Rexulti affects you.
• Rexulti can affect your body’s ability to regulate body temperature. Avoid becoming dehydrated or increasing your body temperature too much by staying cool during hot weather and maintaining adequate fluid intake.
• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

The most common side effects of Rexulti seen in clinical trials include:

• Weight gain
• Sleepiness
• Dizziness
• Symptoms of common cold like runny nose, cough, sore throat, fatigue, or fever
• Feelings of inner restlessness (akathisia)
• Headache
• Tremor
• Larger appetite
• Anxiety
• Heartburn
• Diarrhea

Some individuals may experience serious side effects while using Rexulti. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of suicidal thoughts or behaviors. Caregivers and the user should watch for thoughts about suicide or dying, new or worsening anxiety, panic attacks, new or worsening depression, trouble sleeping, mania, aggression, or any other unusual changes in mood, thoughts, and behaviors.
• Signs of stroke, especially in elderly people with dementia-related psychosis, such as slurred speech, facial drooping, or weakness in one arm.
• Signs of neuroleptic malignant syndrome (NMS) such as changes in pulse, blood pressure, heart rate, or breathing, increased sweating, fever, stiffness, or confusion. This is a life-threatening condition that must be addressed right away.
• Uncontrolled movements (tardive dyskinesia) especially in the face, tongue, or limbs.
• Signs of high blood sugar (hyperglycemia) such as excess thirst and hunger, nausea, increased urination, excessive fatigue, confusion, or fruity smell to the breath.
• Unusual and uncontrollable urges that may manifest as addictions or compulsions (gambling, shopping, binge eating, sexual urges).
• Signs of orthostatic hypotension such as dizziness when going from sitting to standing.
• Seizures.
• Feeling too warm. This could be a sign that you are having issues controlling your body temperature.
• Difficulty swallowing.
• Low white blood cell count that may be indicative of leukopenia or agranulocytosis. It is often symptomless so your healthcare provider may obtain baseline tests and send you for blood work during the course of treatment to ensure your count is within range.
• Excess sleepiness and drowsiness resulting in falls or impairment of daily activities.

These are not all of the possible side effects of Rexulti. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Rexulti, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Heart problems
• History of stroke
• Low or high blood pressure
• Personal or family history of diabetes
• High cholesterol or triglycerides
• Seizures
• Kidney problems
• Liver problems
• Low white blood cell count
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Boxed Warning

• The use of antipsychotic drugs in elderly patients with dementia-related psychosis can result in an increased risk of death. Rexulti is not approved for treating psychosis from dementia due to Alzheimer’s disease if there is no agitation.
• When used as an antidepressant, Rexulti can increase the risk of suicidal thoughts and behaviors in children and young adults.

Do not use Rexulti if you have:

• An allergy to brexpiprazole or any of the other ingredients found in Rexulti

Rexulti does take some time to work. Some benefits may be seen after a couple of weeks of regular use but is likely that you will need to take this medication daily for 6 to 8 before you see a noticeable difference.

When Rexulti is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Strong CYP3A4 inhibitors or inducers
• Strong CYP2D6 inhibitors (Note: dosage adjustments may not be required with fluoxetine and paroxetine but still notify your healthcare provider if you are using these medications)

Rexulti tablets are available in the following strengths:

• 0.25 mg
• 0.5 mg
• 1 mg
• 2 mg
• 3 mg
• 4 mg

Rexulti should be stored at room temperature away from light and out of reach of children.

Rexulti is manufactured by the pharmaceutical company Otsuka Pharmaceuticals.

No, there is not a generic version of Rexulti available.

Rexulti will need to be gradually tapered in order to prevent the negative effects of sudden discontinuation. Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Rexulti.

The use of antipsychotic medications in pregnancy can carry some risks. In regards to Rexulti, it can cause harm to the unborn child, especially if used in the third trimester. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown if Rexulti passes into the breastmilk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.