dm+d

406785006

Articles

Safety in Lactation: Antipsychotics

22 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Oral and non-depot antipsychotics with less…

Which medicines are considered safe for use in the acute porphyrias?

29 May 2020This updated Medicines Q&A presents a table of the medicines considered safe for use in the acute porphyrias. Inclusion of a drug does not guarantee…
Search Articles

Medicine Compliance Aid Stability

AbilifyOtsuka Pharmaceuticals UK Ltd

Otsuka Pharmaceuticals UK Ltd
Abilify
Tablets 5mg, 10mg, 15mg, 30mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Protect from moisture
Hygroscopic protect from moisture. Maximum of 7 days in MCA.
1 October 2015

Abilify OrodispersibleOtsuka Pharmaceuticals UK Ltd

Otsuka Pharmaceuticals UK Ltd
Abilify Orodispersible
Tablets orodispersible 10mg, 15mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Protect from moisture. Orodispersible in nature therefore likely to be hygroscopic.
1 October 2015

generic (Caduceus)Actavis UK Ltd

Actavis UK Ltd
generic (Caduceus)
Tablets orodispersible 10mg, 15mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Protect from moisture. Orodispersible in nature therefore likely to be hygroscopic.
1 October 2015

genericConsilient Health Ltd

Consilient Health Ltd
generic
Tablets 5mg, 10mg, 15mg, 30mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Protect from moisture
Hygroscopic protect from moisture. Maximum of 7 days in MCA.
1 October 2015

Lactation Safety Information

Oral / depot injection

Oral / depot injection
Quetiapine, Haloperidol
Very limited published evidence shows that maternal doses up to 15mg daily produce low levels in breast milk
Long half-life increases risk of accumulation in breastfed infants
Anecdotal unpublished reports of somnolence in breastfed infants
Monitor infant for sedation, poor feeding, behavioural effects, extrapyramidal symptoms, and developmental milestones
Possible effect on prolactin may decrease milk supply
22 January 2020

New Medicines

Abilify MyCiteSchizophrenia and bipolar I disorder - formulation embedded with Proteus® ingestible sensor

Information

Abilify MyCite
New formulation
Otsuka
Otsuka

Development and Regulatory status

Filing withdrawn
Filing withdrawn
Launched
Jul 20Filing withdrawn in EU. In its letter notifying the Agency of the withdrawal of the application, the company stated that it withdrew its application because the Agency concerns could not currently be resolved. The CHMP were concerned that there was not sufficient evidence that Abilify MyCite is able to reliably measure intake of the medicine in the target population. From a safety point of view, there is a risk the patient could take too many doses because the digital medicine system may not work reliably. In addition, the patch can cause skin and subcutaneous tissue reactions [8].
Jun 19Filed in EU in H1 19 [5].
Mar 19Otsuka advises on its ABILIFY MYCITE website that it anticipates that participating insurance plans will apprise patients of the availability of the product. Progress of this initial limited rollout will help them determine timing for a broader product launch [7].
Aug 18Otsuka announces a collaboration with Magellan Health in the US to make Abilify Mycite available to a limited number of patients at first in order to gather real world data. It is expected that it will cost $1,650 per month and likely be deployed to Medicaid members living in Florida and Virginia, among other regions. With initial rollout of the system within Magellan Health mental health provider network, each company will be focused on observing how it will be used by patients and practitioners alike. By reviewing these behaviors and the resulting real-world outcome data, Otsuka said that it will look into ways to continue improving the system for future use [6].
Nov 17Approved in the US as Abilify MyCite. Otsuka plans a small launch at first to see how the digital-smart pill system works in the real world [4].
May 17Re-filed in the US. A decision is expected in Q4 17 [3].
Apr 16FDA issues a complete response letter for the combination of Abilify and the Proteus ingestible sensor, requesting more evidence the target population can use the product safely and effectively. They also asked for more data on the performance of the product under real-world conditions [3].
Sep 15The FDA has determined that the NDA for the combination product of ABILIFY® embedded with a Proteus® ingestible sensor in a single tablet is sufficient to allow for a substantive review and is considered filed as of September 8, 2015. [1]

Category

Atypical antipsychotic - dopamine D2 receptor agonist, serotonin 5HT1A/2C receptor agonist & serotonin 5HT2A/7 receptor antagonist
In England: Schizophrenia, incidence of 15.2 per 100,000 person-years; 865 with bipolar disorder per 100,000 people; prevalence of major depression in primary care is between 5% and 10%. [2]
Schizophrenia and bipolar I disorder - formulation embedded with Proteus® ingestible sensor
Oral

Further information

Yes
To be confirmed

Trial or other data

May 17The FDA has previously approved the Proteus ingestible sensor. That decision allowed Proteus to embed its miniaturized sensor into inert pills in order to monitor compliance. Otsuka has formulated the sensor directly into its antipsychotic Abilify. This frees patients from taking another, sensor-only tablet and provides greater confidence in the data. A positive report from an inert pill implies the patient has taken their medicine. If the technology works as intended, a positive report from a sensor-enabled Abilify tablet guarantees the drug was taken. Otsuka saw these compliance monitoring capabilities as a way to differentiate Abilify in the face of generic competition. Outcomes for all patients are tied to the extent to which they take their drugs as prescribed. For mental health patients, the nature of their conditions makes compliance harder. This presented Otsuka with an opportunity to deliver better health outcomes using the same drug. For Proteus, Abilify could act as a proving ground for its technology [3].
Sep 15ABILIFY with the embedded ingestible sensor sends a signal to the wearable Proteus patch after it reaches the stomach. The patch records and time-stamps the information from the ingestible sensor, collects other patient metrics, including rest, body angle and activity patterns. This information is recorded and relayed to patients on a mobile phone or other Bluetooth-enabled device, and only with their consent, to their physician and/or their caregivers. Patients view the information using a secure and local software application on their mobile phone or device. Physicians and caregivers view the data using secure web portals. [1]

Evidence based evaluations