ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension is a long-acting atypical antipsychotic that is approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults. ARISTADA is available in four dose strengths with once-monthly dosing (441 mg, 662 mg, 882 mg), a six-week dosing option (882 mg) and a two-month dosing option (1064 mg).
ARISTADA INITIO® (aripiprazole lauroxil), in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults. ARISTADA INITIO is an extended-release injectable suspension available in a 675 mg single-dose pre-filled syringe. ARISTADA INITIO is only to be used as a single dose and is not for repeated dosing. ARISTADA and ARISTADA INITIO are not interchangeable due to differing pharmacokinetic profiles.
For more information, visit www.aristada.com.
INDICATION and IMPORTANT SAFETY INFORMATION for ARISTADA INITIO® (aripiprazole lauroxil) and ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular use
INDICATION
ARISTADA INITIO is a prescription medicine given as a one-time injection and is used in combination with oral aripiprazole to start ARISTADA treatment, or re-start ARISTADA treatment after a missed dose, when ARISTADA is used for the treatment of schizophrenia in adults.
ARISTADA is a prescription medicine given by injection by a healthcare professional and used to treat schizophrenia in adults.
It is not known if ARISTADA INITIO and/or ARISTADA are safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
Elderly people with dementia-related psychosis are at increased risk of death when treated with antipsychotic medicines including ARISTADA INITIO and ARISTADA. ARISTADA INITIO and ARISTADA are not for the treatment of people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Contraindication: Do not receive ARISTADA INITIO or ARISTADA if you are allergic to aripiprazole or any of the ingredients in ARISTADA. Allergic reactions to aripiprazole have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in the chest, and swelling of the mouth, face, lips, or tongue.
ARISTADA INITIO and/or ARISTADA may cause serious side effects including:
The most common side effects of ARISTADA INITIO and ARISTADA include restlessness or feeling like you need to move (akathisia). These are not all the possible side effects of ARISTADA INITIO and ARISTADA. You should tell your healthcare provider about any side effects you have.
Do not drive, operate hazardous machinery, or do other dangerous activities until you know how ARISTADA INITIO and ARISTADA affect you. ARISTADA INITIO and ARISTADA may affect your judgment, thinking or motor skills.
Before receiving ARISTADA INITIO and ARISTADA tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ARISTADA INITIO and ARISTADA and other medicines may affect each other causing possible serious side effects. Do not start or stop any medicines after you receive ARISTADA INITIO and ARISTADA without talking to your healthcare provider first.
If you have any questions about your health or medicines, talk to your healthcare provider. You are encouraged to report all side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information for ARISTADA INITIO and ARISTADA, including Boxed Warning, and Medication Guides for ARISTADA INITIO and ARISTADA.
ALKERMES® is a registered trademark of Alkermes, Inc. and ARISTADA® and logo, and ARISTADA INITIO® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes Inc., under license. ©2019 Alkermes, Inc. All rights reserved. ABILIFY® is a trademark of Otsuka Pharmaceutical Company. ABILIFY MAINTENA® is a trademark of Otsuka Pharmaceutical Co., Ltd.
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