Aripiprazole lauroxil

Aripiprazole lauroxil is a prescription medication used to treat adults with schizophrenia.

Aripiprazole lauroxil is a prescription medication used to treat adults with schizophrenia.

It is not known if aripiprazole lauroxil is safe and effective in children under 18 years of age. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Aripiprazole lauroxil may be found in some form under the following brand names:

• Aristada

Serious side effects have been reported with aripiprazole lauroxil. See the “Aripiprazole lauroxil Precautions” section.

The most common side effect of aripiprazole lauroxil is the feeling like you need to move to stop unpleasant feelings in your legs (restless leg syndrome or akathisia).

This is not a complete list of aripiprazole lauroxil side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)
• medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), fluoxetine (Prozac, Sarafem), amitriptyline (Elavil), and paroxetine (Paxil)
• medications to treat high blood pressure
• benzodiazepines such as lorazepam (Ativan)

This is not a complete list of drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with aripiprazole lauroxil including the following:

• Stroke in elderly people (cardiovascular problems) that can lead to death.
• Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms.
• Uncontrolled body movements (tardive dyskinesia): Aripiprazole lauroxil may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving aripiprazole lauroxil. Tardive dyskinesia may also start after you stop receiving aripiprazole lauroxil.
• Problems with your metabolism such as:
  • High blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take aripiprazole lauroxil. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start receiving aripiprazole lauroxil and during your treatment. Call your healthcare provider if you have symptoms of high blood sugar while receiving aripiprazole lauroxil such as feeling very thirsty, the need to urinate more than usual, feeling very hungry, feeling weak or tired, feeling sick to your stomach, confusion, and/or fruity breath
  • Increased fat levels (cholesterol and triglycerides) in your blood.
  • Weight gain. You and your healthcare provider should check your weight regularly.
• Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
• Low white blood cell count
• Seizures (convulsions)
• Problems controlling your body temperature so that you feel too warm.
• Difficulty swallowing 
• Gambling urges and other uncontrollable (compulsive) behaviors such as an increased sex drive, spending money (compulsive shopping), binge eating or eating that you cannot control. If you or your family members notice any of these behaviors, speak with your health care provider. 

This medication may make you feel tired or have trouble with balance. This may lead to the risk of falls. 

Aripiprazole lauroxil may make you feel drowsy. Do not drive a car, operate machinery, or do other dangerous activities until you know how aripiprazole lauroxil affects you.

Do not drink alcohol while you receive aripiprazole lauroxil.

Do not become too hot or dehydrated while you receive aripiprazole lauroxil.

• Do not exercise too much.
• In hot weather, stay inside in a cool place if possible.
• Stay out of the sun.
• Do not wear too much clothing or heavy clothing.
• Drink plenty of water

Do not take this medication if you are allergic to aripiprazole lauroxil or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of aripiprazole lauroxil, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking aripiprazole lauroxil, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to aripiprazole lauroxil or to any of its ingredients
• have never taken ABILIFY, ABILIFY MAINTENA or any aripiprazole product before
• have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start receiving aripiprazole lauroxil and during your treatment.
• have or had seizures (convulsions)
• have or had low or high blood pressure
• have or had heart problems or a stroke
• have or had a low white blood cell count
• have any other medical problems including problems that may affect you receiving an injection in your buttocks or your arm 
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Aripiprazole lauroxil use during pregnancy can cause extrapyramidal and/or withdrawal symptoms in neonates in women exposed during the third trimester of pregnancy.

If you become pregnant while taking aripiprazole lauroxil, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. This registry monitors pregnancy outcomes in women exposed to aripiprazole lauroxil during pregnancy. For more information, contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Aripiprazole lauroxil has been detected in human breast milk. There is not enough data to determine the effects of aripiprazole lauroxil on the breastfed infant or the effects on milk production. Because of the possibility for adverse reactions in nursing infants from aripiprazole lauroxil, talk to your healthcare provider about the best way to feed your baby if you receive aripiprazole lauroxil. The importance of the drug to the mother should will be considered.

Take aripiprazole lauroxil exactly as prescribed. Follow your aripiprazole lauroxil treatment schedule exactly as your healthcare provider tells you to.

This medication is available in an extended release injectable form to be given directly into the muscle (IM) in your arm or buttock by a healthcare professional.

The 441 mg is the only dose that will be injected in to the arm. 

If you have never taken aripiprazole, your health care provider will more than likely start you on aripiprazole formulations that are taken by mouth, before starting this medication. 

Aristada is given 1 time a month, 1 time every 6 weeks, 1 time every 2 months, depending on the dose. 

You may feel a little pain in your arm or buttock during the injection.

After your first injection of aripiprazole lauroxil you should continue your current antipsychotic medicine for 21 days.

Do not miss a dose of aripiprazole lauroxil. If you miss a dose for some reason, call your healthcare provider right away to discuss what you should do next.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The doses available of Aristada (aripiprazole lauroxil) are 441 mg, 662 mg, 882 mg or 1064 mg.  

This medication can be started at a dose of 441 mg, 662 mg or 882 mg administered monthly, 882 mg dose every 6 weeks, or 1064 mg dose every 2 months.

If aripiprazole lauroxil is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Do not miss a dose of aripiprazole lauroxil. If you miss a dose for some reason, call your healthcare provider right away to discuss what you should do next.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
• ARISTADA is not approved for the treatment of patients with dementia-related psychosis.