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Aristada

aripiprazole lauroxil
Used for Schizophrenia
Used for Schizophrenia

Aristada (aripiprazole lauroxil) is used to improve mood, thoughts, and behaviors in adults who have schizophrenia. It's a long-acting medication that's injected into your muscle every 1 to 2 months by your healthcare provider. It's only used in people who can tolerate Abilify (aripiprazole) oral tablets.

Last reviewed on December 6, 2021
basics-icon

What is Aristada (aripiprazole lauroxil)?

What is Aristada (aripiprazole lauroxil) used for?

  • Schizophrenia

How Aristada (aripiprazole lauroxil) works

Aristada (aripiprazole lauroxil) is a long-acting atypical antipsychotic. It works by balancing chemicals called dopamine and serotonin in your brain. This helps people with schizophrenia to improve their thoughts, mood, and behavior.

Are you looking for information on Abilify (aripiprazole) tablets or Abilify Maintena (aripiprazole) monthly injection instead?

Drug Facts

Common BrandsAristada, Aristada Initio
Drug ClassAtypical antipsychotic
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
basics-icon

What are the side effects of Aristada (aripiprazole lauroxil)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Restlessness (11%)
  • Unusual and uncontrollable muscle movements or muscle spasms (5-7%)

Other Side Effects

  • Injection site pain
  • Headache
  • Trouble sleeping
  • Weight gain

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Neuroleptic malignant syndrome (NMS): high fever, sweating, confusion, stiffness, blood pressure changes
  • Impulse-control problems: intense urges for and behaviors including gambling, shopping, binge eating, engaging in sexual activity
  • Extremely high blood sugar levels: feeling very hungry or thirsty, urinating more often, stomach pain, weakness, fruity-smelling breath
  • Uncontrolled muscle movements (tardive dyskinesia): involuntarily sticking out your tongue, puffing out your cheeks, puckering your mouth, lip smacking, chewing, and foot tapping
  • Seizures

Source: DailyMed

The following side effects have also been reported

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Difficulty with speaking

drooling

loss of balance control

muscle trembling, jerking, or stiffness

restlessness

shuffling walk

stiffness of the limbs

twisting movements of the body

uncontrolled movements, especially of the face, neck, and back

Less common

Blurred vision

dizziness

fast, pounding, or irregular heartbeat or pulse

headache

inability to move the eyes

increased blinking or spasms of the eyelid

nervousness

pounding in the ears

sticking out the tongue

trouble breathing or swallowing

unusual facial expressions

Rare

Fast heartbeat

high fever

increased sweating

lip smacking or puckering

loss of bladder control

muscle spasm or jerking of all extremities

puffing of the cheeks

rapid or worm-like movements of the tongue

seizures

severe muscle stiffness

sudden loss of consciousness

tiredness

uncontrolled chewing movements

uncontrolled movements of the arms and legs

unusually pale skin

Incidence not known

Hives or welts, itching, or skin rash

itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

redness of the skin

tightness in the chest

unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Infection from breathing foreign substance into the lungs

seizure that will not stop

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Belching

difficulty having a bowel movement

dry mouth

fear

fever

heartburn

hyperventilation

inability to sit still

indigestion

irritability

lightheadedness

need to keep moving

runny nose

shaking

sore throat

stomach discomfort, upset, or pain

trouble sleeping

weight gain

Less common

Accidental injury

bloating or swelling of the face, arms, hands, lower legs, or feet

body aches or pain

congestion

coughing

difficulty with moving

hoarseness

increased appetite

joint pain

muscle aching or cramping

muscle pains or stiffness

sneezing

stuffy nose

swollen joints

tender, swollen glands in the neck

tingling of the hands or feet

tremor

unusual weight gain or loss

voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

pros-and-cons

Pros and cons of Aristada (aripiprazole lauroxil)

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Pros

Can be given up to once every 2 months

Good option for people who have a hard time taking medications by mouth

Has fewer side effects compared to some other antipsychotic medications

Patient assistance programs are available to help lower the cost

thumbs-down

Cons

Can cause high blood sugar and weight gain

Must be injected in the muscle at your healthcare provider's office

Can cause soreness or pain at the injection site

Not recommended for use during pregnancy or breastfeeding

Can be expensive because it's only available as a brand medication

pharmacist-tips

Pharmacist tips for Aristada (aripiprazole lauroxil)

pharmacist
  • You should receive Aristada (aripiprazole lauroxil) injection regularly. Mark your calendar or set reminders for your injection appointments. If possible, plan ahead for when you're out of town. If needed, you can get your next injection up to 2 weeks early.

    • If you don't notice a change in mood or behavior after you first start Aristada (aripiprazole lauroxil), it doesn't mean that the medication isn't working. It might take up to several days after your first injection before you see any benefits of this medication.

      • Aristada (aripiprazole lauroxil) can make you feel drowsy or sleepy. Be careful and avoid activities that require you to be alert, such as driving a car, until you know how this medication affects you.

        • Aristada (aripiprazole lauroxil) can cause unusual, uncontrolled, or repetitive movements of your eyes, tongue, face, arm, or legs. Contact your healthcare provider right away because these might be signs of tardive dyskinesia, which can become permanent.

          • Aristada (aripiprazole lauroxil) can raise your blood sugar to dangerous levels. Let your provider know if you feel very thirsty, feel very hungry, are needing to urinate more, or if your breath has a fruity smell. You might need to check your blood sugar regularly before and during treatment with Aristada (aripiprazole lauroxil), especially if you have diabetes.

            • Make sure to chew your food completely and swallow carefully while taking Aristada (aripiprazole lauroxil). Rarely, this medication can cause the muscles in your throat to not work well and make it hard for you to swallow food.

              • Aristada (aripiprazole lauroxil) might make it hard for your body to maintain a normal body temperature. Drink water to stay hydrated, especially if you're out in the sun or exercising. Be careful if you're traveling to a place that's very hot.

                faqs

                Frequently asked questions about Aristada (aripiprazole lauroxil)

                What's the difference between Aristada and Aristada Initio?
                Aristada and Aristada Initio are both aripiprazole lauroxil injections, the long-acting version of Abilify (aripiprazole) used to treat schizophrenia. Aristada Initio is used as a loading dose to jumpstart your treatment on Aristada. Typically, you only take Aristada Initio the first time you start Aristada or when you restart Aristada after a missed dose. Aristada is typically used as a maintenance dose to continue treatment.
                Why do I need to take Abilify (aripiprazole) oral tablets before I can use Aristada (aripiprazole lauroxil)?
                While aripiprazole works well to treat schizophrenia, some people might experience more bothersome side effects. If you've never taken aripiprazole before, taking Abilify (aripiprazole) tablets first can help you and your provider understand how well your body responds to this medication. If you tolerate the oral tablets, then it's likely that Aristada (aripiprazole lauroxil), the long-acting injection, is a good option for you.
                What's the difference between Aristada (aripiprazole lauroxil) and Abilify Maintena (aripiprazole)?
                Aristada (aripiprazole lauroxil) and Abilify Maintena (aripiprazole) are both long-acting injections of Abilify (aripiprazole). Currently, Aristada is only FDA-approved to treat schizophrenia, but Abilify Maintena is approved for both bipolar I disorder and schizophrenia. Abilify Maintena injection is typically given every month, while Aristada can be given up to every 2 months. If you have schizophrenia and have been stable on Abilify Maintena, you can discuss with your provider if Aristada (aripiprazole lauroxil) is a possible option for you.
                What if I miss my regular appointment for Aristada (aripiprazole lauroxil)?
                If you miss your appointment, call your healthcare provider right away. They can schedule another appointment for you and give you information about the next steps. Depending on how much time passed since your last injection, you might need an Aristada Initio injection or take Abilify (aripiprazole) oral tablets (or some combination of both) to get you back on track with your treatment.
                Can I get my dose of Aristada (aripiprazole lauroxil) early if I can't make it to my regular appointment?
                If you're not able to make your regularly scheduled appointment, let your provider know right away so they can reschedule you. You can get your dose of Aristada (aripiprazole lauroxil) up to 2 weeks early, before your regularly scheduled dose.
                Can I use Aristada (aripiprazole lauroxil) if I am pregnant?
                Aristada (aripiprazole lauroxil) isn't recommended during pregnancy because it hasn't been studied. Babies born to mothers who took similar medications during the 3rd trimester of pregnancy have developed uncontrolled muscle movement or withdrawal symptoms at birth, such as tremors, agitation, and problems feeding. There is a National Pregnancy Registry for Psychiatric Medications to monitor the safety of certain medications during pregnancy. If you're currently pregnant and taking Aristada (aripiprazole lauroxil), it's encouraged that you enroll in the registry. Talk with your provider if you have questions about treatment for schizophrenia during pregnancy.
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                What are the risks and warnings for Aristada (aripiprazole lauroxil)?

                Aristada (aripiprazole lauroxil) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

                risk-warning

                Higher risk of death in older adults with dementia-related psychosis

                • Risk factors: Older adults with dementia-related psychosis

                  Older adults who also have dementia sometimes have some symptoms of schizophrenia, like hallucinations and delusions. This is called dementia-related psychosis, and it should not be treated with Aristada (aripiprazole lauroxil). If Aristada (aripiprazole lauroxil) is used for dementia-related psychosis, it can cause death. The cause of death is typically from heart problems, stroke, or infections. Let your provider know if you or your loved one has dementia before starting Aristada (aripiprazole lauroxil).

                  risk-warning

                  Neuroleptic malignant syndrome (NMS)

                  • Risk factors: Taking antipsychotic medications

                    Aristada (aripiprazole lauroxil) can cause neuroleptic malignant syndrome (NMS), which is a rare but serious condition that can lead to death. Be careful using Aristada (aripiprazole lauroxil) if you're also on other medications that might cause NMS. Symptoms include a very high fever, stiff muscles, problems thinking clearly, very fast or uneven heartbeat, and sweating. Stop taking Aristada (aripiprazole lauroxil) and get medical attention right away if you experience these symptoms.

                    risk-warning

                    Difficulty controlling muscle movements (tardive dyskinesia)

                    • Risk factors: Older adults | Female and 65 years or older | Higher than recommended doses of Aristada (aripiprazole lauroxil) | Taking Aristada (aripiprazole lauroxil) for a long time

                      Aristada (aripiprazole lauroxil) can cause uncontrolled and possibly permanent muscle movements in the tongue, face, mouth, lips, neck, hands, arms, legs, and feet (tardive dyskinesia). To lower your risk of tardive dyskinesia, use the lowest dose for your symptoms. Get medical help right away if you notice any unusual movements you can't control.

                      risk-warning

                      High blood sugar, high cholesterol, and weight gain

                      • Risk factors: History of diabetes | History of high cholesterol | Obesity

                        Aristada (aripiprazole lauroxil) can raise your blood sugar, sometimes to dangerous levels resulting in coma or death. Let your provider know if you have symptoms of high blood sugar, such as feeling very hungry or thirsty, urinating more often, stomach pain, weakness, or fruity-smelling breath.

                        Aristada (aripiprazole lauroxil) can also cause high cholesterol and weight gain. Your provider might check your weight and order blood tests regularly to make sure your blood sugar, cholesterol, and weight aren't too high.

                        risk-warning

                        Impulsive behavior

                        Aristada (aripiprazole lauroxil) can make it difficult for you to think through your actions and control your behavior. It can lead to strong urges for certain behaviors, such as gambling, eating, shopping, or sex. Because these behaviors can cause harm to yourself or others, your provider might lower your dose or stop the medication. If you or your loved ones notice a change in behavior, let your provider know.

                        risk-warning

                        Higher risk of falls

                        • Risk factors: Starting Aristada (aripiprazole lauroxil) for the first time | Recent rise in Aristada (aripiprazole lauroxil) dose | Older adults | Not enough fluids in your body | History of heart problems | History of low blood pressure | Taking medications that lower blood pressure

                          Aristada (aripiprazole lauroxil) can cause sleepiness, dizziness, difficulty keeping your balance, and drops in blood pressure when you sit up or stand too quickly. This can result in fainting and falling, leading to fractures or other injuries. Sit up or stand up slowly, especially during the first few days after you start Aristada (aripiprazole lauroxil) or when your provider raises your dose. Your risk of falls is higher if you have heart problems or if you don't have enough fluids in your body. Talk to your healthcare provider if you continue to experience dizziness while taking Aristada (aripiprazole lauroxil).

                          risk-warning

                          Higher risk of infections

                          • Risk factors: History of low white blood cell counts | Taking other medications that lower white blood cell counts

                            Aristada (aripiprazole lauroxil) can lower the amount of white blood cells in your body and put you at higher risk for serious infection. You might need to get lab work done regularly to make sure your white blood cell count is healthy. If the levels are too low, your provider might stop your medication. Talk to your provider right away if you experience symptoms of an infection, such as fever, weakness, or sore throat, while taking this medication.

                            risk-warning

                            Seizures

                            • Risk factors: History of seizures | Health conditions that raise the risk of seizures | Age 65 years or older

                              Aristada (aripiprazole lauroxil) can make you more likely to have seizures. Before starting this medication, let your provider know if you have a history of seizures or have a medical condition that puts you at risk of getting seizures.

                              dosage

                              Aristada (aripiprazole lauroxil) dosage forms

                              Typical dosing for Aristada (aripiprazole lauroxil)

                              Aristada (aripiprazole lauroxil) is only available as an injection by your healthcare provider. Please be aware that Aristada and Aristada Initio are not used in the same way and are not interchangeable.

                              There are two ways to start treatment on Aristada (aripiprazole lauroxil):

                              • Using Aristada Initio: Your provider will inject Aristada Initio 675 mg into the arm or buttock muscle once. You'll also take one dose of Abilify (aripiprazole) 30 mg by mouth once with this injection. Your provider will inject your dose of Aristada either on the same day or within 10 days of the Aristada Initio injection.

                              • Without using Aristada Initio: Your provider will inject your first dose of Aristada into the arm or buttock muscle once. Continue to take your usual dose of Abilify (aripiprazole) tablet by mouth daily for 21 days after this injection.

                              After your initial treatment, you typically continue Aristada (aripiprazole lauroxil) with one of the following dosing options:

                              • Monthly injections: 441 mg, 662 mg, or 882 mg

                              • Injection every 6 weeks: 882 mg

                              • Injection every 2 months: 1064 mg

                              Your dose might differ if you're also taking certain medications that interact with Aristada (aripiprazole lauroxil).

                              interactions

                              Interactions between Aristada (aripiprazole lauroxil) and other drugs

                              Aristada (aripiprazole lauroxil) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Aristada (aripiprazole lauroxil). Please note that only the generic name of each medication is listed below.

                              Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

                              Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

                              Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

                              alternatives

                              What are alternatives to Aristada (aripiprazole lauroxil)?

                              There are a number of medications that your doctor can prescribe in place of Aristada (aripiprazole lauroxil). Compare a few possible alternatives below.
                              Aristada (aripiprazole lauroxil)
                              Used for:
                              • Schizophrenia

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                              Aristada (aripiprazole lauroxil) images

                              white - Aristada 882mg / 3.2mL Extended-Release Suspension for Injection
                              This medicine is White Syringe.white - Aristada 882mg / 3.2mL Extended-Release Suspension for Injection

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