Micro8 is a secure application that may help the Hemophilia A community manage infusion schedules and track bleeding episodes, and may help clinicians stay updated on their patients’ care. Micro8 provides mobile app, text- messaging and web-based tracking options for individuals and caregivers, who have historically logged infusions and bleeding episodes on paper or have not tracked this information on a regular basis.
Anyone in the U.S. can use Micro8, and the application includes tailored functionality and resources for individuals receiving ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] and their caregivers. ELOCTATE is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia A (congenital factor VIII deficiency). Biogen Idec, the maker of ELOCTATE, and MicroHealth, a digital health company focused on hemophilia, introduced this infusion log and treatment monitoring application in July 2014.
Click here to learn more about Micro8
Click here to read this Micro8 Fact Sheet in its entirety
Selected Important Safety Information
Do not use ELOCTATE if you have had an allergic reaction to it in the past. Allergic reactions may occur with ELOCTATE. Your body can also make antibodies called, “inhibitors,” against ELOCTATE, which may stop ELOCTATE from working properly. Common side effects of ELOCTATE are joint pain and general discomfort.
Please see below for additional Important Safety Information and full Prescribing Information.
What is the Need?
We believe there is a need for digital health applications that can help remind people of their prophylaxis infusion schedules and keep clinicians informed on their patients’ progress. Today, doctors and nurses may need to rely on their patients’ long-term recall of past bleeding episodes or treatment adherence.
In a clinical study, people with severe hemophilia A who were on a prophylaxis infusion schedule experienced fewer bleeding episodes compared to individuals receiving on-demand treatment Prophylaxis is the regular administration of clotting factor therapy designed to prevent or reduce bleeding episodes, and on-demand therapy is intended to control bleeding when it occurs.
Flexible, Community-Friendly Application
With Micro8, individuals with hemophilia A and caregivers may help manage their treatment via smartphone, text- messaging and web platforms. These flexible options can help community members incorporate the application’s use into their daily lives, whether at home or on the go.
Micro8 may help individuals and caregivers keep records of scheduled and logged infusions, as well as the severity and location of bleeds, and upload bleeding episode photos. Users have the option to share this information with their care team. Additionally, caregivers can log in on behalf of their children and manage their children’s infusion and bleeding information, as well as customized infusion schedule reminders, through one account.
The Micro8 application has additional functionality tailored to people receiving ELOCTATE. Individuals and caregivers can scan ELOCTATE vial information using the Micro8 application, avoiding manual entry. This may help them keep track of the expiration date and precise amounts of factor they have infused. The application also includes ELOCTATE resources.
Healthcare Team Connectivity
If an individual chooses to share infusion history and bleeding episode logs with their care team, then doctors or nurses can use this information to support their clinical decisions. Viewing the logs could potentially help clinicians identify who among their patients may need additional support.
Clinicians face many care responsibilities, so the ability to customize notifications related to their patients’ logs is important. With Micro8, clinicians can set up thresholds for receiving alerts. For example, doctors or nurses can be notified if any of their patients do not log more than a certain number of infusions, or report more than a certain number of bleeding episodes.
Because ELOCTATE has a prolonged half-life, the therapy’s prophylaxis dosing regimen may be different. Half-life
Protecting the Community’s Data and Privacy
The Micro8 team is committed to securing the personal health information of the application’s users. Individuals or caregivers have full control over who can access their Micro8 information; they can choose if they would like to share this data with their clinicians. The team uses multiple security measures, such as encryption, access control logs and intrusion detection systems, which are each designed to protect information from unauthorized access. The application supports compliance with the Health Insurance Portability and Accessibility Act (HIPAA), which is federal legislation designed to maintain patient privacy. Additionally, Micro 8 data is stored on secure MicroHealth servers, rather than on an individual’s or clinician’s mobile device. Biogen Idec does not have any access to Micro8 information. For more information, please go to Micro8’s privacy policy at Micro8.org.
How to Access Micro8
Individuals, caregivers and clinicians can sign up for the application at Micro8.org. They can download the free app onto their iPhone or iPad through the App store, or onto their Android phone or tablet through Google Play.2
Indications for ELOCTATE
ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: control and prevention of bleeding episodes, perioperative management (surgical prophylaxis), and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. ELOCTATE is not indicated for the treatment of von Willebrand disease.
Important Safety Information
Do not use ELOCTATE if you have had an allergic reaction to it in the past.
Tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have any allergies, are breastfeeding, are pregnant or planning to become pregnant, or have been told you have inhibitors (antibodies) to Factor VIII.
Allergic reactions may occur with ELOCTATE. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.
Your body can also make antibodies called, “inhibitors,” against ELOCTATE, which may stop ELOCTATE from working properly.
Common side effects of ELOCTATE are joint pain and general discomfort. These are not all the possible side effects of ELOCTATE. Talk to your healthcare provider right away about any side effect that bothers you or that does not go away, and if bleeding is not controlled after using ELOCTATE.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
