Learn about the ABILIFY MYCITE® System - 6

IMPORTANT SAFETY INFORMATION, for
ABILIFY MYCITE®
cont'd
Commonly Observed Adverse Reactions (incidence ≥5% and at least twice that for placebo) in
adult patients:
* Schizophrenia: akathisia
* Bipolar mania (monotherapy): akathisia, sedation, restlessness, tremor, and extrapyramidal disorder
* Bipolar mania (adjunctive therapy with lithium or valproate): akathisia, insomnia, and extrapyramidal
disorder
* Major depressive disorder (adjunctive treatment to antidepressant therapy): akathisia, restlessness,
insomnia, constipation, fatigue, and blurred vision
Dystonia: Symptoms of dystonia may occur in susceptible individuals during the first days of treatment
and at low doses.
Skin Irritation for MYCITE Patch: Symptoms of skin irritation localized at the site of the MYCITE Patch
may occur. In clinical studies, 12.4% of patients (n=61) experienced skin rashes at the site of patch
placement.
Pregnancy: Neonates exposed to antipsychotic drugs, including ABILIFY MYCITE, during the third
trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Consider the
benefits and risks of ABILIFY MYCITE and possible risks to the fetus when prescribing ABILIFY MYCITE
to a pregnant woman. Advise pregnant women of potential fetal risk. There is a pregnancy exposure
registry that monitors pregnancy outcomes in women exposed to ABILIFY MYCITE during pregnancy. For
more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388
or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
Lactation: Aripiprazole is present in human breast milk; however, there are insufficient data to
assess the amount in human milk, effects on the breastfed infant, or effects on milk production.
The development and health benefits of breastfeeding should be considered along with the mother's
clinical need for ABILIFY MYCITE and any potential adverse effects on the infant or from the underlying
maternal condition.
To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at
1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).
1. Depression. National Institute of Mental Health. Updated February 2018. Accessed May 13,
2021. https://www.nimh.nih.gov/health/topics/depression/index.shtml
2. Clayton AH, Goldstein I, Kim NN et al. The International Society for the Study of Women's Sexual
Health process of care for management of hypoactive sexual desire disorder in women. Mayo
Clin Proc. 2018;93(4):467-487.
3. Hatch A, Docherty JP, Carpenter D, Ross R, Weiden PJ. Expert consensus survey on medication
adherence in psychiatric patients and use of a digital medicine system. J Clin Psychiatry.
2017;78(7):e803-e812.
4. Otsuka and Proteus®
MYCITE®
announce the first U.S. FDA approval of a digital medicine system: ABILIFY
(aripiprazole tablets with sensor). News release. Otsuka America Pharmaceutical, Inc.
November 13, 2017. Accessed May 13, 2021. https://www.otsuka-us.com/discover/articles-1075
5. Sawesi S, Rashrash M, Phalakornkule K, Carpenter JS, Jones JF. The impact of information
technology on patient engagement and health behavior change: a systematic review of the
literature. JMIR Med Inform. 2016;4(1):e1.
6. Rossom RC, Shortreed S, Coleman KJ et al. Antidepressant adherence across diverse populations
and healthcare settings. Depress Anxiety. 2016;33(8):765-774.
7. Shafrin J, May SG, Shrestha A et al. Access to credible information on schizophrenia patients'
medication adherence by prescribers can change their treatment strategies: evidence from an
online survey of providers. Patient Prefer Adherence. 2017;11:1071-1081.
8. Elenko E, Underwood L, Zohar D. Defining digital medicine. Nat Biotechnol. 2015;33(5):456-461.
References:
(aripiprazole tablets with sensor),
610
Please click here to see the FULL PRESCRIBING INFORMATION, including BOXED WARNING.

https://www.nimh.nih.gov/health/topics/depression/index.shtml https://www.otsuka-us.com/discover/articles-1075 http://www.womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ http://www.fda.gov/medwatch https://www.otsuka-us.com/sites/g/files/qhldwo3916/files/media/static/ABILIFY-MYCITE-PI.pdf

Learn about the ABILIFY MYCITE® System

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