Aristada is the first atypical antipsychotic with once-monthly and six-weekly dosing options.
The U.S. Food and Drug Administration (FDA) has approved Aristada (aripiprazole lauroxil), an extended-release injectable atypical antipsychotic for the treatment of patients with schizophrenia.
Important information
Each injection of Aristada must be administered by a healthcare professional only.
Aristada may cause serious side effects, including:
Increased risk of death in elderly people with dementia-related psychosis. Aristada is not for the treatment of people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Neuroleptic malignant syndrome (NMS) a serious condition that can lead to death. Tell your healthcare provider right away if you have some or all of the following symptoms of NMS:
High fever
Stiff muscles
Confusion
Sweating
Changes in pulse, heart rate, and blood pressure
Call your healthcare provider right away if you have any of these symptoms.
Aristada is a prescription medicine given by injection by a healthcare professional and used to treat schizophrenia. It is not known if it is safe and effective in children under 18 years of age.
Before you receive Aristada, tell your healthcare provider if you:
have never taken Abilify, Abilify Maintena or any aripiprazole product previously
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 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. It is not known if Aristada will harm your unborn baby.
If you become pregnant while taking Aristada, talk to your
healthcare provider.
are breastfeeding or plan to breastfeed. Aristada can pass into your milk and it is not known if it may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment.
Aristada and other medicines may affect each other causing possible serious side effects. Aristada may affect the way other medicines work, and vice versa.
Aristada side effects
Aristada may cause serious side effects, including:
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): movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop treatment. Tardive dyskinesia may also start after you stop treatment.
Problems with your metabolism such as:
High blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take Aristada. 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, and during your treatment.
Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving Aristada:
Feel very thirsty
Feel very hungry
Feel sick to your stomach
Need to urinate more than usual
Feel weak or tired
Feel confused, or your breath smells fruity
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
The most common side effects include feeling like you need to move to stop unpleasant feelings in your legs (restless leg syndrome or akathisia).
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Source: drugs.com