For more information about Aristada forschizophrenia, see the “Aristada uses” section below.

Drug details

You’ll find key information about Aristada below.

• Drug form:intramuscular injection
• Generic available? no
• Prescription required? yes
• Controlled substance? no
• Year of FDA approval: 2015

Aristada and Aristada Initio

Aristada and a medication called Aristada Initio both contain the active ingredient aripiprazole lauroxil. But they contain different amounts of this ingredient. And even though they contain the same active ingredient, these medications are used slightly differently.

Aristada is meant to be used as a long-term treatment for schizophrenia. However, Aristada Initio is given only before starting Aristada treatment for schizophrenia. If your doctor recommends Aristada Initio at the start of treatment, you will take it withoral aripiprazole. After you receive Aristada or Aristada Initio, your body turns the prodrug* aripiprazole lauroxil into aripiprazole.

Aristada Initio and oral aripiprazole provide a loading dose of aripiprazole. A loading dose helps your aripiprazole levels reach your target range more quickly. This helps ensure there’s enough medication in your body for your first dose of Aristada to start working right away.

This article primarily focuses on Aristada, not on Aristada Initio. If you have questions about Aristada Initio, talk with your doctor or pharmacist.

* A prodrug is inactive when it first enters your body. The drug only begins to work after it undergoes chemical changes in your body.

Aristada generic

Aristada is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug ingredient in a brand-name medication.

Note: Aristada contains the active ingredient aripiprazole lauroxil, which isn’t available in generic form. However, there is a generic form ofaripiprazole, which is the active ingredient in a similar brand-name medication calledAbilify.

These active ingredients aren’t exactly the same. After you receive Aristada, your body turns the prodrug aripiprazole lauroxil into aripiprazole.

Aristada dosage

TheAristada dosage your doctor prescribes will depend on several factors. These include:

• the severity of yourschizophrenia symptoms
• other medications you may take

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Aristada comes as a liquid solution that a healthcare professional gives as anintramuscular injection.

The drug is available in the following strengths and sizes:

Aristada Initio

Aristada Initio is a drug similar to Aristada that you may receive as a one-time dose prior to Aristada treatment. Both drugs contain the active ingredient aripiprazole lauroxil. However, Aristada Initio is available in only one strength: 675 mg (2.4 mL).

Like Aristada, Aristada Initio comes as a liquid solution that a healthcare professional gives as an intramuscular injection. See the following “Dosage for schizophrenia” section for details about Aristada Initio.

Dosage for schizophrenia

The table below describes Aristada’s dosing schedule for treatingschizophrenia.

Note: Aristada (and Aristada Initio) may be injected into either the deltoid (shoulder) muscle or gluteal (buttock) muscle. However, certain strengths of Aristada may only be injected into the gluteal muscle, as listed in the table below.

Before beginning Aristada treatment or on the day of your first Aristada injection:

• you may be given a one-time injection of Aristada Initio along withoral aripiprazole, or
• starting on the day you receive your first Aristada injection, you may take oral aripiprazole for 21 days

This provides a loading dose of aripiprazole.* A loading dose helps ensure there’s enough medication in your body for your first dose of Aristada to start working right away.

If your doctor prescribes Aristada Initio, you may receive it on the same day as your first Aristada injection. Or a healthcare professional may administer it up to 10 days before your first Aristada injection.

* Aristada Initio is given withoral aripiprazole when used for this purpose. After you receive Aristada or Aristada Initio, your body turns the prodrug aripiprazole lauroxil into aripiprazole. A prodrug is inactive when it first enters your body. The drug only begins to work after it undergoes chemical changes in your body.

What if I miss a dose?

If you miss an injection of Aristada, contact your doctor’s office to reschedule your missed dose as soon as possible. Depending on how much time has passed since your missed dose and your last Aristada injection, your doctor may give you a dose of Aristada Initio, a dose of oral aripiprazole, or both.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. Writing down your appointment in your calendar or planner can also help.

Will I need to use this drug long term?

Aristada is meant to be used as a long-term treatment. If you and your doctor determine that Aristada is safe and effective for you, you’ll likely receive it long term.

Aristada side effects

Aristada can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while receiving Aristada. These lists do not include all possibleside effects of Aristada.

For more information about the possible side effects of Aristada, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Aristada, you can do so throughMedWatch.

Mild side effects

Mild side effects* of Aristada can include:

• akathisia (restlessness and agitation)†
• pain at the injection site
• headache

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Aristada. To learn about other mild side effects, talk with your doctor or pharmacist or visit Aristada’sprescribing information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Aristada aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Neuroleptic malignant syndrome (a rare and possibly fatal reaction toantipsychotic drugs such as Aristada). Symptoms can include:
  • fluctuations between high and low blood pressure
  • excessive sweating
  • fast heart rate
  • highfever
  • rigid muscles
• Low levels of white blood cells orneutrophils (a type of white blood cell). Symptoms can include:
  • fever
  • infections that don’t go away
• Problems with how your body regulates temperature. Symptoms can include:
  • deepening or lightening of skin color
  • sweating
• Dysphagia (difficulty swallowing). Symptoms can include:
  • feeling like food is stuck in your throat
  • heartburn
  • pain when swallowing
• Cognitive impairment (difficulty thinking) or motor impairment (difficulty moving). Symptoms can include:
  • decreased motor skills
  • difficulty thinking clearly
  • feeling tired
• Orthostatic hypotension (decreasedblood pressure caused by changing positions, such as standing up), which can lead to falls.* Symptoms can include:
  • dizziness
  • syncope (fainting)
  • lightheadedness
• Allergic reaction.*†
• Changes in yourmetabolism.*
• Compulsive behaviors (urges that are unusual or hard to control).*†
• Tardive dyskinesia (a movement disorder).*
• Falls.*
• Suicidal thoughts or behaviors.‡

* For more information about this side effect, see “Side effect details” below.
† This side effect was not reported inclinical trials of Aristada. However, it was reported after the drug became available to prescribe.
‡ For more information, see the “Common questions about Aristada” section later in this article.

Side effect details

You may wonder how often certain side effects occur with this drug.Here’s some detail on certain side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after receiving Aristada. It is unknown how many people may have had an allergic reaction to Aristada inclinical trials.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• difficulty breathing

Call your doctor right away if you have an allergic reaction to Aristada, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Changes in your metabolism

Aristada may cause changes inmetabolism. In general, metabolism refers to processes in your body that make and use energy.

Inclinical trials, Aristada caused the following changes in metabolism:

• changes in cholesterol levels
• increased blood sugar levels
• weight gain

Before beginning treatment with Aristada, your doctor will review your medical history. You and your doctor will discuss anything that may put you at risk of changes in your metabolism. During Aristada treatment, you’ll be monitored for changes in your metabolism. This may include having blood tests.

Tell your doctor if you notice any of the following symptoms while receiving Aristada:

• increased blood sugar levels, which can cause:
  • increased need to urinate
  • increased thirstiness
  • excessive hunger
  • weakness
• unintended weight gain

Changes in cholesterol levels don’t cause noticeable symptoms in most people. Instead, your doctor will monitor your cholesterol with blood tests while you’re receiving Aristada.

If you experience metabolism changes during Aristada treatment, your doctor may lower your Aristada dosage. They may also prescribe a medication to treat metabolism changes while you continue receiving Aristada. Or your doctor may decide to have you take a medication other than Aristada to treat your condition.

Compulsive behaviors

It’s possible for Aristada to cause compulsive (unusual or uncontrollable) urges to do certain things.

Although compulsive behaviors weren’t reported inclinical trials of Aristada, this side effect has occurred in people takingoral aripiprazole. (Aristada contains the active ingredient aripiprazole lauroxil. After you receive Aristada, your body turns the prodrug aripiprazole lauroxil into aripiprazole.)

Examples of compulsive behaviors that you may experience during Aristada treatment include:

• gambling (this is reported to be the most common compulsive behavior that occurs with aripiprazole)
• binge eating
• sexual behaviors or impulses
• shopping

However, it’s important to note that compulsive behaviors and difficulty controlling impulses can be symptoms ofschizophrenia, which Aristada is used to treat.

If you have any unusual urges or difficulty controlling impulses while receiving Aristada, be sure to tell your doctor. Your family and friends should also help watch for these behaviors because you may not notice these impulses developing.

Your doctor will likely lower your Aristada dosage if you have difficulty with impulse control. Or they may have you stop receiving Aristada and try a different medication.

Restlessness and agitation

Aristada can causeakathisia (restlessness and agitation). This can sometimes be a side effect of antipsychotic drugs such as Aristada. Inclinical trials, akathisia was a common side effect of Aristada.

Symptoms of akathisia may include:

• restlessness and a strong urge to move (which may lead to behaviors such as pacing or crossing and uncrossing legs while seated)
• irritability
• anxiety
• a sense of impatience

If you experience restlessness, agitation, or other symptoms of akathisia while receiving Aristada, contact your doctor. They’ll likely evaluate your symptoms to determine the best way to continue your treatment.

Tardive dyskinesia

Tardive dyskinesia (TD) is a movement disorder that can occur as a side effect of antipsychotic drugs, such as Aristada. However, it is unknown how many people may have experienced TD inclinical trials of Aristada.

Symptoms of TD can include:

• jerking of your face and jaw
• having movements that you can’t control

If you develop TD while taking Aristada, it may go away once you stop taking the drug. However, it’s also possible that TD may be irreversible once it develops.

TD most commonly develops in older adults, but it can affect people of any age. Your risk of TD may increase as you continue to take Aristada. For this reason, your doctor will prescribe Aristada at the lowest possible dosage for managing your symptoms. And they’ll monitor you over time to evaluate whether you need to continue treatment with Aristada.

If you develop symptoms of TD, tell your doctor right away. They can discuss the risks and benefits of continuing your treatment with Aristada.

Risk of falls

It’s possible for Aristada to increase the risk of falls. This is because Aristada can cause side effects that can increase this risk, such as:

• dizziness
• sleepiness
• changes inblood pressure
• problems with coordination

For example, Aristada can causeorthostatic hypotension, even in people with normal blood pressure.

With orthostatic hypotension, your blood pressure may become very low when you move from lying or sitting down to standing up. This could cause you to fall when standing up. And if your blood pressure drops low enough, this may causesyncope (fainting). Falling can lead to bonefractures and other injuries.

Aristada may increase your risk of falls if you have a condition that already increases your risk of falls or if you take another medication that puts you at risk for falls.

If you’re concerned about your risk of falls while taking Aristada, talk with your doctor. They can discuss potential ways to lower your risk. Or they may have you take a medication other than Aristada.

Alternatives to Aristada

Other drugs are available that can treatschizophrenia. Some may be a better fit for you than others. If you’re interested in finding an alternative to Aristada, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are usedoff-label to treat these specific conditions. Off-label drug use means using a drug for a purpose other than what the FDA has approved it for.

Examples of other drugs that may be used to treat schizophrenia include:

• aripiprazole (Abilify, Abilify Maintena)
• asenapine (Saphris)
• cariprazine (Vraylar)
• chlorpromazine
• clozapine (Clozaril)
• fluphenazine
• haloperidol (Haldol)
• lithium
• olanzapine (Zyprexa)
• paliperidone (Invega, Invega Sustenna)
• quetiapine (Seroquel)
• risperidone (Risperdal)

Aristada vs. Abilify Maintena

You may wonder how Aristada compares with other medications that are prescribed for similar uses. Here we look at how Aristada and Abilify Maintena are alike and different.

Ingredients

Aristada contains the active ingredient aripiprazole lauroxil. Abilify Maintena contains the active ingredientaripiprazole.

These two active ingredients aren’t exactly the same. After you receive Aristada, your body turns the prodrug aripiprazole lauroxil into aripiprazole.

Both Aristada and Abilify Maintena belong to a drug class calledatypical antipsychotic drugs. (A drug class is a group of medications that work in a similar way.)

Uses

The Food and Drug Administration (FDA) has approved both Aristada and Abilify Maintena to treatschizophrenia in adults.

Abilify Maintena is also approved to treatbipolar I disorder in adults.

Drug forms and administration

Aristada comes as a liquid solution that a healthcare professional gives as anintramuscular injection. Aristada also comes in a version called Aristada Initio, which is a one-time injection given at the beginning of treatment.

Abilify Maintena comes as a powder that’s mixed with liquid. Abilify Maintena is also given by a healthcare professional as an intramuscular injection. Abilify is available in other forms for treating schizophrenia, including a suspension for intramuscular injection called Abilify Asimtufii.

Side effects and risks

Aristada and Abilify Maintena both contain a form of aripiprazole. Therefore, these medications can cause very similar side effects, as well as some different ones. Below are examples of these side effects.

Mild side effects

These lists contain more common mild side effects that can occur with either Aristada or Abilify Maintena, as well as mild side effects that both drugs may share.

• Can occur with Aristada:
  • headache
• Can occur with Abilify Maintena:
  • sedation (feeling excessively tired or sluggish)
• Can occur with both Aristada and Abilify Maintena:
  • injection site pain
  • akathisia (restlessness and agitation)

Serious side effects

The following serious side effects can occur with both Aristada and Abilify Maintena:

• allergic reaction
• changes inmetabolism, such as weight gain
• compulsive behaviors (urges that are unusual and hard to control)
• orthostatic hypotension (decreasedblood pressure caused by changing positions, such as standing up)
• dysphagia (difficulty swallowing)
• increased risk of falls
• cognitive impairment (difficulty thinking) or motor impairment (difficulty moving)
• low levels of white blood cells orneutrophils (a type of white blood cell)
• neuroleptic malignant syndrome (a rare and possibly fatal reaction to antipsychotic drugs)
• problems with how your body regulates temperature
• suicidal thoughts and behaviors*
• tardive dyskinesia (a movement disorder)

* For more information, see the “Common questions about Aristada” section.

Effectiveness

Both Aristada and Abilify Maintena are used to treat schizophrenia in adults.

These drugs haven’t been directly compared in clinical trials. But clinical trials have found bothAristada andAbilify Maintena to treat schizophrenia in adults effectively.

Costs

The actual price you’ll pay for either Aristada or Abilify Maintena depends on your dosage, your insurance plan, your location, and the medical facility or pharmacy where you receive your injections.

Aristada and Abilify Maintena are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

You can visitOptum Perks to find coupons and savings for Aristada and Abilify Maintena.

How Aristada is administered

Only a healthcare professional can administer Aristada. You won’t need to learn how to give yourself Aristada injections.

You’ll receive Aristada as anintramuscular injection. The injection site is either the deltoid (shoulder) muscle or the gluteal (buttock) muscle. This depends on which strength of the drug you’re receiving. (See the “Aristada dosage” section earlier in the article for details.)

When it’s given

Before beginning treatment with Aristada:

• you may be given a one-time dose of Aristada Initio along withoral aripiprazole, or
• starting on the day you receive your first Aristada injection, you may take oral aripiprazole for 21 days

Aristada Initio is a medication that contains the same active ingredient as Aristada, aripiprazole lauroxil. After you receive Aristada, your body turns the prodrug aripiprazole lauroxil into aripiprazole.

Aristada Initio is given as a one-time intramuscular injection. Aristada Initio may be given with oral aripiprazole on the same day as your first Aristada injection. Or these drugs may be given up to 10 days before your first Aristada injection.

Beginning your treatment in one of these ways provides a loading dose of aripiprazole. A loading dose ensures there’s enough medication in your body for your first dose of Aristada to start working right away.

If you’ve never taken aripiprazole before, your doctor may make sure your body can tolerate the medication before starting Aristada. They’ll do this by having you take oral aripiprazole.

To help make sure that you don’t miss a dose, try using amedication reminder. This can include setting an alarm on your phone or downloading a reminder app. Writing down your appointment in your calendar or planner can also help.

Aristada uses

The Food and Drug Administration (FDA) approves prescription drugs such as Aristada to treat certain conditions. Aristada may also be usedoff-label for other conditions. Off-label drug use means using a drug for a purpose other than what the FDA has approved it for.

Aristada for schizophrenia

Aristada is approved by the FDA for treatingschizophrenia in adults.

Schizophrenia is a disorder that disrupts a person’s behaviors and thoughts. This disorder can greatly impact a person’s everyday activities, social interactions, and the lives of those around them.

Symptoms of schizophrenia typically affect people during their teenage or young adult years. Males are usually affected at younger ages than females.

Symptoms of schizophrenia vary from person to person but may include:

• Positive symptoms: These are thoughts or behaviors that occur in people with schizophrenia but not in people who don’t have this condition. Examples of positive symptoms include:
  • changes in body movements
  • hallucinations (seeing or hearing something that’s not really there)
  • unusual thoughts
• Negative symptoms: These symptoms may cause a person to have very little or no emotion. They also may not want to talk as often as usual.
• Symptoms that affect your memory and ability to think: Examples include difficulty paying attention, focusing, and remembering things.

It’s thought that genetics, environmental factors, and changes in certainneurotransmitters (brain chemicals) may contribute to the development of schizophrenia.

It is unknown how Aristada works to treat schizophrenia. The drug may help reduce symptoms by affecting levels of certain neurotransmitters. See the “How Aristada works” section below for more information.

To learn more about schizophrenia, see ourlist of articles on this condition.

Note:Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Effectiveness for schizophrenia

In a clinical trial, Aristada was found to be effective in treating schizophrenia in adults. For information about this clinical trial, see the Aristadaprescribing information.

Aristada for other conditions

In addition to the use listed above, Aristada may also be usedoff-label for other conditions. Off-label drug use means using a drug for a purpose other than what the FDA has approved it for.

Below is information about another possible use for Aristada.

Aristada for bipolar disorder

Aristada is not approved for treating bipolar disorder, and it is not currently used off-label to treat this condition.

However,Abilify (aripiprazole) is approved to treat manic and mixed episodes related tobipolar I disorder in adults. And Aristada contains the active ingredient aripiprazole lauroxil. After you receive Aristada, your body turns the prodrug aripiprazole lauroxil into aripiprazole.

If you have questions about treating bipolar disorder, talk with your doctor.

Aristada and children

Aristada is not approved for use in children because the drug hasn’t been studied in children. Aristada is only approved for treating schizophrenia in adults.

Aristada use with other drugs

For treatingschizophrenia, Aristada may be used on its own. Or it may be used with other drugs.

Before beginning Aristada treatment or starting on the day of your first Aristada injection, your doctor may give you a one-time dose of Aristada Initio along withoral aripiprazole.

Aristada Initio is a medication that contains the same active ingredient as Aristada, aripiprazole lauroxil. And after you receive Aristada or Aristada Initio, your body turns the prodrug* aripiprazole lauroxil into aripiprazole.

Aristada Initio is given as a one-timeintramuscular injection. You may receive Aristada Initio and oral aripiprazole on the same day as your first Aristada injection. Or you may receive these drugs up to 10 days before your first Aristada injection.

Alternatively, your doctor may begin your Aristada treatment by having you take aripiprazole tablets. In this case, you’ll take a tablet once per day for 21 days, starting on the day you receive your first Aristada injection.

Beginning your treatment in one of these ways provides a loading dose of aripiprazole. A loading dose ensures there’s enough medication in your body for your first dose of Aristada to start working right away.†

Your doctor may also prescribe Aristada Initio with oral aripiprazole if you miss a dose of Aristada.

* A prodrug is inactive when it first enters your body. The drug only begins to work after it undergoes chemical changes in your body.
† When Aristada is received by itself, it can take about 27 days for the drug to reach its peak (highest) level in your body. However, when a loading dose is given with Aristada, peak levels are reached in about 4 days instead.

Aristada cost and coupons

As with all medications, thecost of Aristada can vary. The actual price you’ll pay depends on your insurance plan, your location, and the medical facility or pharmacy where you receive your injections.

Before approving coverage for Aristada, your insurance company may require you to getprior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide whether the drug will be covered.

If you’re not sure whether you’ll need to get prior authorization for Aristada, contact your insurance company.

Drug coupons

You can visit Optum Perks for price estimates of Aristada. These estimates are based on the use of Optum Perks coupons.Note: Optum Perks coupons cannot be used with any insurancecopays or benefits.

Financial and insurance assistance

If you need financial support to pay for Aristada, or if you need help understanding your insurance coverage, help is available.

Alkermes, the manufacturer of Aristada, offers a copay savings card that may help lower the cost of Aristada. For more information and to find out if you’re eligible for support, call 866-274-7823 or visit thedrug’s website.

For tips on how to save on the cost of prescription drugs, seethis article.

Generic version

Aristada is not available in a generic form. A generic drug is an exact copy of the active drug ingredient in a brand-name medication. Generics tend to cost less than brand-name drugs.

How Aristada works

Aristada is approved by the FDA for treatingschizophrenia in adults. Aristada’s exact mechanism of action (the way the drug works) in the brain is unknown. It may treat schizophrenia by affecting receptors (attachment sites) for certain brain chemicals. These brain chemicals may include:

• dopamine, which helps regulate how you feel and think, and
• serotonin, which helps regulate your behaviors and mood

It’s thought that schizophrenia (as well as certain other mental health conditions) may cause you to have too much dopamine or serotonin in your brain. See “Aristada uses” above for more information about schizophrenia.

Aristada may work by balancing your dopamine and serotonin levels so you don’t have too much or too little inside your brain. This may make your thoughts and behaviors easier to control.

How long does it take to work?

How long it takes Aristada to work can vary from person to person. It can take around 27 days for the drug to reach its peak (highest) concentrations in the body.

However, you may be given a loading dose ofaripiprazole* before starting Aristada treatment or starting on the day of your first Aristada injection. This helps ensure there’s enough medication in your body for your first dose of Aristada to start working right away.

When Aristada is given with a loading dose, peak levels are reached in about 4 days instead.

* Aristada contains the active drug aripiprazole lauroxil. After you receive Aristada, your body turns the prodrug aripiprazole lauroxil into aripiprazole. A prodrug is inactive when it first enters your body. The drug only begins to work after it undergoes chemical changes in your body.

Common questions about Aristada

Here are answers to some frequently asked questions about Aristada.

Will I have to store Aristada?

No, you should not need to store Aristada or keep the drug at home. Only a healthcare professional can give Aristada injections. So the drug may be stored at the medical facility or pharmacy where you receive your injections.

Is it safe to drive while I’m using Aristada?

Maybe. It depends on how the drug affects you.

Antipsychotic drugs such as Aristada have been shown to affect thinking, judgment, and coordination. As a result, Aristada could impact your ability to drive or operate machinery.

For this reason, you should not drive a car or operate machinery until you know how Aristada will affect you. If you have questions about this, talk with your doctor.

Will Aristada give me unusual and uncontrollable urges to do certain things?

It’s possible for Aristada to cause compulsive behaviors (unusual or uncontrollable urges).

Examples of compulsive behaviors you may have while receiving Aristada include:

• gambling (this is reported to be the most common compulsive behavior that occurs with aripiprazole*)
• binge eating
• sexual behaviors or impulses
• shopping

However, it’s important to note that compulsive behaviors and difficulty controlling urges can be symptoms ofschizophrenia, which Aristada treats. For more information about compulsive behaviors while receiving Aristada, see the “Aristada side effects” section above.

* Aristada contains the active drug aripiprazole lauroxil. After you receive Aristada, your body turns the prodrug aripiprazole lauroxil into aripiprazole. A prodrug is inactive when it first enters your body. The drug only begins to work after it undergoes chemical changes in your body.

Am I at risk of falls while I’m receiving Aristada?

Possibly. Receiving Aristada could increase your risk of falls, depending on how the drug affects you.

Aristada can cause dizziness, sleepiness, changes inblood pressure, and problems with coordination. These side effects can increase your risk of falling. For more information, see the “Aristada side effects” section.

If I have diabetes, can I use Aristada?

Maybe. Whether someone withdiabetes can use Aristada depends on how well their condition is managed. It also depends on whether their doctor thinks the medication is safe for them.

There have beenreports of people developinghigh blood sugar when taking antipsychotic drugs, such as Aristada. And Aristada may cause changes in yourmetabolism. These changes could lead to high blood sugar levels or even diabetes.

If you already have diabetes or high blood sugar, tell your doctor before you start Aristada. The drug could make it harder to manage your blood sugar. So your doctor will likely work with you to make sure your blood sugar ismonitored more frequently during treatment. This is to ensure your blood sugar doesn’t become too high.

While receiving Aristada, be sure to watch for any side effects of high blood sugar, such as feeling more thirsty than usual, urinating more than usual, and feeling weak.

Contact your doctor if these symptoms occur. They can work with you to determine whether Aristada is the best treatment for you.

Does Aristada increase the risk of suicidal thoughts or behaviors?

Inclinical trials, Aristada wasn’t shown to increase the risk ofsuicidal thoughts or behaviors.

Abilify (aripiprazole), which is a drug that’s similar to Aristada, has aboxed warning for increased risk* of suicidal thoughts and behaviors. (A boxed warning is the most serious warning from the FDA.) This is because Abilify is used as anantidepressant, andclinical trials have shown that antidepressants can cause this effect to occur.

In separate clinical trials of adults receivingAbilify andAristada, suicide did occur. However, the studies did not report the exact number of suicides. And it is unknown how much each drug may have contributed to suicidal thoughts or behaviors, if at all.

Aristada is an antipsychotic, not an antidepressant. Since Aristada is not used to treat depression, the FDA hasn’t applied this boxed warning to Aristada. However, Aristada does have a boxed warning for increased risk of death in certain older adults receiving the drug. See “FDA Warning” at the beginning of this article for more information.

It’s important to note that your results from Aristada may vary from those seen in clinical trials. And if you have questions about whether Aristada is right for you, talk with your doctor.

If you’re receiving Aristada and you have new or worsened depression, or you’re feeling sad or anxious, contact your doctor right away. But if you’re having thoughts of harming yourself, call 911 or your local emergency service.

* Abilify’s boxed warning applies to children and adults ages 24 years and younger receiving the drug. See Abilify’sprescribing information for details.

Aristada and alcohol

There are no knowninteractions between alcohol and Aristada.

However, alcohol can cause difficulty focusing, dizziness, sleepiness, and decreasedblood pressure. Aristada can also cause these side effects. So drinking alcohol during Aristada treatment could increase your risk of these side effects.

Studies have found a link betweenschizophrenia (which Aristada is used to treat) andalcohol use disorder. These studies found that having alcohol use disorder may make schizophrenia treatment less effective than usual.

For these reasons, if you drink alcohol, be sure to talk with your doctor before you start Aristada. They may recommend that you avoid drinking alcohol while receiving Aristada.

Aristada interactions

Aristada caninteract with several other medications. It can also interact with certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Aristada and other medications

Below are lists of medications that can interact with Aristada. These lists do not contain all drugs that may interact with Aristada.

Before starting Aristada, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about anyvitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Aristada and drugs that affect its level in your body

Aristada is metabolized (broken down by)enzymes (certain proteins) made in your liver. Specifically, two enzymes called CYP2D6 and CYP3A4 metabolize Aristada.

Some drugs can affect the amount of these enzymes that your liver makes. So taking these drugs with Aristada can alter the level of Aristada in your body. Some drugs may cause Aristada levels to increase, while others may decrease Aristada levels. Read on for more information on these types of drugs.

If you’re taking any of the medications listed, your doctor may adjust the dosage of either Aristada or the other drug.

Aristada and strong CYP3A4 inhibitors

Some medications inhibit (block) CYP3A4 from breaking down Aristada. When this happens, levels of Aristada in your body could increase. This, in turn, could increase your risk of side effects from the medication.

Examples of strong CYP3A4 inhibitors include:

• ketoconazole, anantifungal medication
• clarithromycin, anantibiotic

Aristada and strong CYP2D6 inhibitors

Some medications inhibit (block) CYP2D6 from breaking down Aristada. When this happens, levels of Aristada in your body could increase. And this could increase your risk of side effects from the medication.

Examples of strong CYP2A6 inhibitors include:

• quinidine, a drug for irregular heart rhythm
• fluoxetine (Prozac), anantidepressant
• paroxetine (Paxil), an antidepressant

Aristada and strong CYP3A4 inducers

Some medications induce (activate) the CYP3A4 enzyme, causing the enzyme to break down Aristada. When this happens, levels of Aristada in your body could decrease. This may cause the medication not to work as well as usual or to stop working entirely.

Examples of strong CYP3A4 inducers include:

• carbamazepine (Tegretol), a medication for treatingseizures
• rifampin, an antibiotic

Aristada and certain blood pressure medications

Aristada can interact with certainblood pressure medications. Aristada can lower your blood pressure, so taking certain blood pressure drugs with Aristada could cause your blood pressure to become dangerously low.

Examples of blood pressure medications that can interact with Aristada include:

• carvedilol (Coreg)
• lisinopril (Zestril)
• prazosin

If you’re taking a blood pressure medication, be sure to tell your doctor before you start Aristada treatment. They may have you take a lower dosage of either medication. Or they may have you take different medications for your condition.

Aristada and benzodiazepines

Aristada can interact with a class of drugs calledbenzodiazepines. Benzodiazepines may be used to treat a variety of conditions, includinganxiety and seizures.

Examples of benzodiazepines include:

• alprazolam (Xanax)
• clonazepam (Klonopin)
• diazepam (Valium)
• lorazepam (Ativan)

Both Aristada andaripiprazole* can cause yourblood pressure to decrease, especially when changing body positions (such as sitting up or standing up). They may both also cause sedation (excessive tiredness and sluggishness). Receiving Aristada together with a benzodiazepine may worsen these effects.

Before starting Aristada, be sure to tell your doctor if you’re taking a benzodiazepine. If your doctor prescribes a benzodiazepine along with Aristada, they’ll monitor your blood pressure more often than usual. They’ll also make sure you don’t become excessively sleepy when you take your medications. In addition, your doctor may have you try a lower dosage of one or both medications, to help decrease your risk of these side effects.

* Aripiprazole can also cause these side effects. After you receive Aristada, your body turns the prodrug aripiprazole lauroxil into aripiprazole.

Aristada and herbs and supplements

There are no herbs or supplements that have been specifically reported to interact with Aristada. However, you should still check with your doctor or pharmacist before using any of these products while receiving Aristada.

Aristada and foods

Aristada is known to interact with grapefruit, which is described below. No other foods have been reported to interact with Aristada. If you have any questions about consuming grapefruit or other foods with Aristada, talk with your doctor.

Aristada and grapefruit

You should avoid eating grapefruit and drinking grapefruit juice while you’re receiving Aristada.

This is because grapefruit prevents your liver from breaking down Aristada. When this occurs, the level of Aristada in your body can increase. And this can increase your risk of side effects from the drug. Avoiding grapefruit will help ensure that Aristada levels in your body don’t become too high.

Aristada and pregnancy

It is unknown whether Aristada is safe to receive during pregnancy.

When taken during pregnancy,antipsychotic drugs such as Aristada have not been shown to increase the risk of fetal anomalies (commonly known asbirth defects) or loss of pregnancy.

However, taking antipsychotic medications during the third trimester of pregnancy may cause the following symptoms in newborn babies:

• withdrawal symptoms*, such as:
  • agitation
  • tremors (uncontrollable shaking in a part of the body)
  • difficulty breathing
• extrapyramidal symptoms (movement disorders that can be side effects of certain antipsychotic drugs and other drugs), such as tremors or shaking

Animal studies of aripiprazole lauroxil (the active ingredient in Aristada) given to pregnant animals didn’t show any negative effects from the drug. These animal studies used doses up to 15 times larger than those used in humans. However,clinical trials ofaripiprazole† use in pregnant animals showed that aripiprazole may cause:

• decreased birth weight
• fetal death
• problems with fetal development

It’s important to note that animal studies don’t always predict what will happen in humans.

If you’re pregnant or planning to become pregnant, talk with your doctor before starting Aristada. They can discuss the risks and benefits of using this drug during pregnancy.

* Withdrawal symptoms may occur when suddenly stopping a drug that the body has become dependent on. Drug dependence can result when your body needs a drug in order to function as usual.
† After you receive Aristada, your body turns the prodrug aripiprazole lauroxil into aripiprazole.

Pregnancy registry for Aristada

If you receive Aristada while pregnant, there’s a pregnancy registry you’re encouraged to join. A pregnancy registry collects information about any effects that a drug may have on a pregnancy. The information is then studied to determine whether the drug is a safe option for use during pregnancy.

For more information or to enroll in the National Pregnancy Registry for Atypical Antipsychotics, visit theregistry website or call 866-961-2388.

Aristada and birth control

It is unknown whether Aristada is safe to receive during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about yourbirth control needs while you’re using Aristada.

For more information about receiving Aristada during pregnancy, see the “Aristada and pregnancy” section above.

Aristada and breastfeeding

It is unknown whether Aristada is safe to receive while breastfeeding.Aripiprazole* does pass into human breast milk. But whether the drug causes any effects in people who are breastfeeding or children who are breastfed is unknown.

If you’re breastfeeding or planning to breastfeed, talk with your doctor before starting Aristada. They can discuss with you the risks and benefits of using this drug while you’re breastfeeding.

* Aristada contains the active drug aripiprazole lauroxil. After you receive Aristada, your body turns the prodrug aripiprazole lauroxil into aripiprazole.

Aristada precautions

This drug comes with several precautions.

FDA warning: Increased risk of death in certain older adults

This drug has aboxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

People ages 65 years and older who have certain conditions may have an increased risk of death while takingantipsychotic drugs, such as Aristada.

Specifically, older adults withpsychosis related to dementia (memory loss) are at increased risk. (With psychosis, you lose touch with reality, and you may hear or see things that aren’t really there.) Due to this risk, Aristada should not be used by older adults with dementia-related psychosis.

Other precautions

Before starting Aristada, talk with your doctor about your health history. Aristada may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

CYP2D6 poor metabolizers: Aristada is broken down by anenzyme (a type of protein) called CYP2D6. It’s possible for this enzyme not to work as well as it should in some people. In such people, Aristada could build up in the body, which may cause serious side effects. If you’ve been told you metabolize CYD2D6 poorly or have problems with your CYP enzyme, it’s very important to tell your doctor before you receive Aristada. Your doctor will start you on a lower-than-usual dosage of Aristada. They may also monitor you for side effects more frequently.

Diabetes: Aristada may cause changes in yourmetabolism, which could lead to havinghigh blood sugar levels ordiabetes. If you already have diabetes or high blood sugar, tell your doctor before you start Aristada. They’ll likely work with you to make sure your blood sugar is monitored more frequently during your treatment. This helps ensure your blood sugar levels don’t become too high while receiving Aristada.

Falls: In some people, Aristada can cause dizziness, sleepiness, changes inblood pressure, or problems with coordination. If you have a condition or you take a different medication that also puts you at risk of these side effects, Aristada may increase your risk of falls. And falls can lead to bonefractures and other injuries. If you have a condition or take a medication that increases your risk of falls, talk with your doctor before starting Aristada.

Heart problems or stroke: People with a history of heart problems (such asheart failure orheart attack) orstroke may have a higher risk of blood pressure problems during Aristada treatment (see “Low blood pressure” just below). Be sure to tell your doctor about any history of heart problems or stroke before you receive Aristada.

Low blood pressure: Aristada can cause yourblood pressure to become too low. Your blood pressure may become very low when you move from lying down or sitting to standing up. This is calledorthostatic hypotension. Also, in people who already have blood pressure problems, Aristada could make these problems worse. For this reason, your doctor may have you monitor your blood pressure more frequently while you receive Aristada.

Low white blood cell level: Like other antipsychotic drugs, Aristada may cause alow white blood cell level. This can increase your risk ofinfections. People who have a history of low white blood cell levels may have a higher risk of this side effect. If you have a history of low white blood cell levels, be sure to tell your doctor before you start treatment with Aristada. They’ll likely want to monitor your white blood cell levels more frequently, at least during your first few months of Aristada treatment.

Risk of high body temperature: Antipsychotic drugs such as Aristada may affect the body’s ability to control its temperature. Engaging in strenuous exercise, taking certain medications, or exposure to extreme heat can increase your risk of this side effect. Be sure to talk with your doctor about your physical activity or if you’ll be exposed to extreme weather before starting Aristada.

Difficulty swallowing: Antipsychotic drugs such as Aristada may cause problems with swallowing. It can even causeaspiration, which occurs when you breathe in foreign objects, such as food or saliva, when you swallow. Because of this risk, people who already havedysphagia (difficulty swallowing) should use Aristada with caution. Be sure to talk with your doctor about any swallowing problems you have before starting Aristada.

Seizures: If you’ve hadseizures in the past, taking an antipsychotic drug such as Aristada may increase your risk of seizures orconvulsions (sudden irregular movements). If you have any history of seizures or convulsions, talk with your doctor before you begin Aristada treatment.

Allergic reaction: If you’ve had anallergic reaction to Aristada or any of its ingredients, you should not receive Aristada. Ask your doctor what other medications are better options for you.

Pregnancy: It is unknown whether Aristada is safe to receive during pregnancy. For more information, see the “Aristada and pregnancy” earlier in the article.

Breastfeeding: It is unknown whether Aristada is safe to receive while breastfeeding. For more information, see the earlier section on “Aristada and breastfeeding.”

Note: For more information about the potential negative effects of Aristada, see the “Aristada side effects” section above.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.