(RxWiki News) Abilify MyCite is the first digital medication system approved by the US Food and Drug Administration (FDA).
This digital medication system consists of a drug-device combination product that includes aripiprazole (Abilify) tablets and an ingestible event marker (IEM) sensor that communicates when the tablet has been ingested.
Abilify MyCite can be used similarly to regular Abilify. Abilify MyCite is approved to treat schizophrenia and bipolar I disorder. It can be also be used as an add-on treatment for adults with depression.
In addition to the drug-device combination product, the Abilify MyCite system includes a sensor patch and the MyCite phone application. The sensor patch is placed on the left side of the body and above the lower edge of the rib cage. The patch can be worn in water during showers, swimming or exercise. The MyCite app reminds patients to change the sensor patch weekly.
The tablet sensor is activated when the medication comes in contact with the acid in the stomach. Once activated, the tablet sensor sends a signal to the sensor patch. The patch communicates with the MyCite app through Bluetooth and reports the date and time the medication was taken. In addition, caregivers and health care providers can be given access to the information through an online portal.
Although this technology allows patients and health care providers to track medication habits, it has not been shown to improve patients’ consistency in taking their medication.
The most common side effects of Abilify MyCite include nausea and vomiting, uncontrolled body movements and skin irritation at the site where the sensor patch is placed.
Abilify MyCite carries a boxed warning that notes an increased risk of death for older patients with dementia-related psychosis. Abilify MyCite is not approved to treat those with dementia-related psychosis. An additional boxed warning identifies an increased risk of suicidal thoughts and behavior in children and adolescents, which is why young people taking the medication should be monitored.
The FDA granted approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd. Proteus Digital Health manufactures the sensor technology and patch.