Abilify MyCite with Adherence Sensor Approved
November 14, 2017 – The U.S. FDA has approved Abilify MyCite® (aripiprazole tablets with sensor), manufactured by Otsuka. This is the first drug product containing a tracker to be approved for use in the United States. Abilify MyCite contains an ingestible sensor, which is roughly the size of a grain of sand, in every tablet. The sensor is designed to track whether a patient is taking Abilify MyCite as prescribed.
The sensor contained in Abilify MyCite begins to transmit a signal once it comes in contact with stomach acid. That signal is detected by a patch, worn by the patient, which can then convey information to a smartphone app. From there, the information can be accessed through a web portal by designated individuals, who may include the patient’s physicians, caregivers, or family members. This can allow the patient and those with access to the tracking information to receive electronic confirmation that a dose has been taken as prescribed. Prescribers should work with patients to ensure that they understand and are able and willing to use all components of Abilify MyCite appropriately before prescribing the medication.
Abilify MyCite is indicated to treat schizophrenia and acute manic and mixed episodes associated with bipolar I disorder. It is also indicated as an adjunct treatment for depression in adults. However, Abilify MyCite’s effect on medication adherence has not been proven, and it cannot track drug ingestion in real time or during an emergency. Information transfer from the sensor to a detection device may be delayed or may not occur.
As with other forms of Abilify, Abilify MyCite carries a black box warning to indicate that it should not be used in elderly patients who have dementia, and that it may increase the risk of thoughts or actions of self-harm in children, adolescents, and young adults. Recommended dosing is 2mg to 15mg once per day. Dosing should not exceed 30mg per day.
Abilify was first approved by the FDA in 2002, and the tracker used in Abilify MyCite has been in use in the United States as a separate component since 2012. Initial launch for Abilify MyCite is expected to be limited.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.