Rx Only
Contents
Product Overview
Indications for Use
Contraindication

Patient Instructions for Use

Safety Information/Warnings/Precautions
Product Description
Supported Operating

Product Overview

Systems andRejoyn is a smartphone app to be used by adults 22 years and older with major
depressive disorder (MDD), commonly referred to as “depression.” It is intended
to reduce MDD symptoms.
Rejoyn requires a prescription from a healthcare provider.

Browsers
Security
Instructions for Use
Getting Started

Indications for Use

Contraindication

Rejoyn is a prescription digital
therapeutic for the treatment of Major
Depressive Disorder (MDD) symptoms
as an adjunct to clinician-managed
outpatient care for adult patients with
MDD age 22 years and older who are on
antidepressant medication. It is intended
to reduce MDD symptoms.

There are no contraindications tousing Rejoyn.

Terms of Use andPrivacy Notice
User Introduction
Set a ReminderHome Screen
Patient Profile
My Plan

Safety Information/Warnings/Precautions
Rejoyn is not intended to be used as a standalone treatment. Rejoyn does
not replace your current medication, including medication for treatment ofMDD. You should continue your current treatment as directed by yourhealthcare provider.

Tasks
Overall Clinical Trial(Mirai) Results
SupportRejoyn cannot send alerts or warnings to your healthcare provider. If you feelthat your depression symptoms are worsening or if you have feelings orthoughts of harming yourself or others, please contact your healthcare provider,dial 911, or go to the nearest emergency room immediately.
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Patient Instructions for Use

Product Description

Contents

Rejoyn is made up of three parts: Therapeutic Lessons, Brain Exercises, andPersonalized Reminders and Messaging (see Table 1).

Product Overview

Table 1: Rejoyn Features, Duration, and Frequency

Indications for Use
Contraindication

Core Feature

Typical Duration*

Frequency

Safety Information/Therapeutic Lessons**

3 to 4 minutes

3 times per week for 6 weeks

Warnings/Precautions

Brain Exercises

11 to 26 minutes*

3 times per week for 6 weeks

Less than 1 minute

Regularly throughout
treatment

Personalized Reminders
and Messages* In a clinical study of Rejoyn, a majority of Brain Exercises were completed in this time frame.
Duration will vary by individual user.
** Once the 6-week treatment period is over, Therapeutic Lessons are available to be revisited for anadditional 4 weeks.

Product Description
Supported OperatingSystems andBrowsers
Security
Instructions for Use

Supported Operating Systems and Browsers

Getting Started

Operating Information

Terms of Use andRefer to the app store to ensurecompatibility with your specificsmartphone and device Operating
System (OS) with an available internet
connection. Rejoyn operates with thefollowing operating systems:

We recommend that you keep 100 MBof available storage on your device touse Rejoyn.

• iOS®

Please log into Rejoyn on one
smartphone. This will make sure you
do not miss any important reminders
and will allow Rejoyn to remember
where you are in your treatment.

• Android™
Ensure your smartphone is runningan OS version matching those required.
If not, update your software version
before downloading and using Rejoyn.

Rejoyn is not currently compatible foruse with computers or tablets.

Security

Privacy Notice
User Introduction
Set a ReminderHome Screen
Patient Profile
My PlanTasks
Overall Clinical Trial(Mirai) Results
SupportYou are required to enter a username and password prior to use of Rejoyn. Please donot share your username or password with others.
Updates will be pushed to your smartphone automatically, if enabled, or application
updates can be downloaded from the app store and installed on your smartphone.
2Patient Instructions for Use

Instructions for Use

Contents
Product Overview

Overview
The purpose of this document is to provide instructions on how to use theRejoyn digital therapeutic app administered via your smartphone.

Indications for Use

Getting Started

Safety Information/

Rejoyn is intended for people with MDD who are proficient with written andspoken English, who have access to a smartphone, and who are familiar with theuse of mobile applications (apps).

Product Description

Your healthcare provider will prescribe Rejoyn and send yourprescription to a pharmacy that dispenses Rejoyn access codes.
An internet connection is required to download Rejoyn on yoursmartphone. Rejoyn is available for download from the Apple App Storeand Google Play Store. The app can be found by searching for Rejoyn.

Contraindication

Warnings/Precautions

Supported Operating
Systems andBrowsers
Security
Instructions for Use
Getting Started

When you open the Rejoyn app for the first time, you will need tocreate a user account by selecting “Yes” to the question “Do you havea prescription for Rejoyn” on the landing page and then clicking on“Sign Up.”

Terms of Use andPrivacy Notice
User Introduction
Set a ReminderHome Screen
Patient Profile
My PlanTasks
Overall Clinical Trial(Mirai) Results
Support3

Patient Instructions for Use
Contents

After your account is created and your email address and mobile
phone number are verified, an access code will be required to unlock
treatment. The code will be provided by the dispensing pharmacy.

Product Overview
Indications for Use
Contraindication
Safety Information/Warnings/Precautions
Product Description
Supported Operating
Systems andBrowsers
Security
Instructions for Use
Getting Started
Terms of Use andPrivacy Notice
User Introduction
Set a ReminderHome Screen
Patient Profile
My PlanTasks
Overall Clinical Trial(Mirai) Results
Support4

Patient Instructions for Use
Contents

Once the prescription access code is provided, you will then haveaccess to your treatment program and can begin. Follow prompts inthe app to complete your assigned activities.

Product Overview
Indications for Use
Contraindication
Safety Information/Warnings/Precautions
Product DescriptionSupported Operating
Systems andBrowsers
Security
Instructions for Use
Getting Started
Terms of Use andPrivacy Notice
User Introduction
Set a ReminderHome Screen
Patient Profile
My Plan
Tasks
Overall Clinical Trial(Mirai) Results
Support5Patient Instructions for Use
Contents
Product Overview
Indications for Use
Contraindication
Safety Information/Warnings/Precautions
Product Description
Supported Operating
Systems andBrowsers
Security
Instructions for Use
Getting Started
Terms of Use andPrivacy Notice
User Introduction
Set a ReminderHome Screen
Patient Profile
My Plan
Tasks
Overall Clinical Trial(Mirai) Results
Support6Patient Instructions for Use
Contents

Terms of Use and Privacy Notice

Product Overview

During account creation, you will be asked to agree to the “Terms of Use” and“Privacy Notice”. The “Terms of Use” and “Privacy Notice” are accessible byclicking on “Important Information” on the app landing page.

Indications for Use
Contraindication
Safety Information/

User Introduction

Warnings/Precautions

After you activate your prescription, you will be shown a set of screens that will
guide you through your assigned activities and how to use the app. Tap the“NEXT” button at the bottom of each screen to navigate to the next screen. Youcan also tap the back arrow at the top to navigate to the previous screen.

Product Description
Supported Operating
Systems andBrowsers

There are six tasks per week, and it is recommended you do one task per day,which will alternate between Therapeutic Lessons and Brain Exercises.

Security

For any reason if you miss a day, do not worry. You can catch up by doing
two tasks the next day to stay on your weekly schedule. You cannot do morethan two tasks per day. At the end of each week, any remaining Therapeutic
Lessons are unlocked so you can view them later, but the previous week’s Brain
Exercises will not be available.

Instructions for Use
Getting Started
Terms of Use andAn illustration of the recommended treatment schedule is shown in Table 2.

Privacy Notice

Table 2: Recommended Treatment Schedule

User Introduction

SundayMondayTuesday Wednesday Thursday

FridaySaturday

Week 1

Lesson 1

Exercise 1

Lesson 2

Exercise 2

Lesson 3

Exercise 3

Rest

Week 2

Lesson 4

Exercise 4

Lesson 5

Exercise 5

Lesson 6

Exercise 6

Rest

Week 3

Lesson 7

Exercise 7

Lesson 8

Exercise 8

Lesson 9

Exercise 9

Rest

Patient Profile

Week 4

Lesson 10 Exercise 10 Lesson 11 Exercise 11 Lesson 12 Exercise 12

RestMy Plan

Week 5

Lesson 13 Exercise 13 Lesson 14 Exercise 14 Lesson 15 Exercise 15

Rest

Week 6

Lesson 16 Exercise 16 Lesson 17 Exercise 17 Lesson 18 Exercise 18

Rest

Set a ReminderHome Screen

Tasks
Overall Clinical Trial

4 Weeks
ContinuedAccess

Option to revisit Lessons 1-18 at any time(Mirai) Results
Support*Lesson refers to Therapeutic Lessons**Exercise refers to Brain Exercises

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Patient Instructions for Use

Table 3 shows an example of an alternate treatment schedule where you start
treatment in the middle of the week and ‘double up’ on tasks some days.
Table 3: Alternate Treatment Schedule (Example)
Wednesday Thursday
Week 1

Lesson 1
Exercise 1Friday

SaturdaySunday

Week 2
Week 3

Lesson 7
Exercise 7

Tuesday

Lesson 16
Exercise 16

4 Weeks
Continued
AccessContraindication
Safety Information/Warnings/Precautions
Product Description

Lesson 8
Exercise 8

Lesson 9

Lesson 11

Lesson 12
Exercise 11
Exercise 12

Exercise 9

Lesson 13 Lesson 14
Lesson 15 Exercise 15
Exercise 13 Exercise 14

Week 5
Week 6

MondayLesson 2 Lesson 3
Exercise 2 Exercise 3

Lesson 10 Exercise 10

Product Overview
Indications for Use

Lesson 5 Lesson 6
Lesson 4 Exercise 4
Exercise 5 Exercise 6

Week 4Contents

Lesson 17 Lesson 18
Exercise 17 Exercise 18

Option to revisit Lessons 1-18 at any time

* Lesson refers to Therapeutic Lessons** Exercise refers to Brain Exercises

Supported Operating
Systems andBrowsers
Security
Instructions for Use
Getting Started
Terms of Use andPrivacy Notice
User Introduction
Set a Reminder

Set a ReminderHome Screen

You can choose to set a daily notification, which will remind you to do your daily task.
The first time you use Rejoyn, you will be prompted to set up this notification. You
can click on “Skip This” to continue without setting up these notifications.

Patient Profile

You can add your reminder to your smartphone’s calendar to help you stay on trackwith your program. A prompt will display during the initial app set-up. You can click
on “Add to Calendar” and follow the screen prompts. You can click “Skip This” tocontinue without setting up your calendar.

Tasks

My PlanOverall Clinical Trial(Mirai) Results
Support8Patient Instructions for UseHome Screen

Contents

Each time you re-open the app, you will be taken to the Home screen.

Product Overview

On the Home screen, you can:Indications for Use• Monitor your weekly progress goal at the top of the screen in terms of percent
completion.

Contraindication• Start a Therapeutic Lesson by tapping on “Start” under “Lesson.”

Warnings/Precautions

Safety Information/• Start a Brain Exercise by tapping on “Start” under “Brain Exercise.”

Product Description

Patient Profile

Supported Operating

You can access your profile by tapping on the “Profile” icon at the top of the Home screen.

SupportImportant Information

Tapping “Support” under “Profile” will
give you access to the number you cancall to report side effects or quality
complaints.

Tapping “Important information” under“Profile” will give you access to thefollowing information:

Edit Profile• Unique Device Identifier (UDI)• App Version• Caution statements

Systems andBrowsers
Security
Instructions for Use
Getting Started
Terms of Use andPrivacy Notice

Tapping “Edit Profile” under “Profile”
will allow you to change the following
information:• Indications for use

User Introduction• Compatible devices

Set a Reminder• Name• Terms of use• Password• Privacy notice

Patient ProfileLog OutMy Plan

You can log out of the app by tapping on“Log out” at the bottom of “Profile” page.

Tasks

Reset Password(Mirai) ResultsYour Password can be reset bytapping on “Forgot Password” on thelogin page or by editing “Profile” on your“Profile” page.

Support• Phone number

ReminderTapping “Reminder” under “Profile”
will allow you to manage your daily
notifications and make changes ifdesired.

• Cybersecurity information

Home Screen

Overall Clinical Trial

9Patient Instructions for Use

My PlanContents

Your plan progress or upcoming Therapeutic Lessons and Brain Exercises for theweek can be accessed by tapping on “My Plan.”

Product Overview

Tasks

Contraindication

Each week the Rejoyn treatment includes six tasks: three Therapeutic Lessons andthree Brain Exercises.

Safety Information/The Home screen will display your daily tasks. You will need to complete theTherapeutic Lesson before you can unlock the Brain Exercise.

Product Description

Therapeutic Lessons

Indications for Use

Warnings/Precautions

Supported OperatingSystems andBrowsers

To begin your assigned Therapeutic Lesson, go to the Home screen in the app and tap“Start” which can be found in the Therapeutic Lessons box. Follow the instructions inthe app to complete the Therapeutic Lesson.

Security

When you complete the Therapeutic Lesson, tap “Done” and you will return to theHome screen to start your next task.

Getting Started

You can go back to finish Therapeutic Lessons any time from the “Learn” tab on themenu bar at the bottom of your screen.

Instructions for Use

Terms of Use andPrivacy Notice
User Introduction

Learn Library
There are a total of 18 Therapeutic Lessons. The Therapeutic Lessons are stored in
the learn library and can be accessed by tapping “Learn.”

Set a ReminderHome Screen
Patient ProfileToolkitAfter the Therapeutic Lessons are completed, they will be added to the “Toolkit.” You
can revisit and practice completed Therapeutic Lessons by tapping on “Toolkit.”

My PlanTasks
Overall Clinical Trial

Brain Exercise(Mirai) Results

The Brain Exercises are designed to activate the parts of your brain that are
responsible for emotion recognition and emotion regulation. Activating these twoparts of the brain at the same time is believed to help strengthen the connection
between them. This may help the brain better process emotions and improve
symptoms of depression.

Support10Patient Instructions for Use

The app will give you directions on how to complete the Brain Exercises. This may
feel hard at times, but that is normal. You will have as much time as needed tocomplete the Brain Exercise once you begin; however, if you start a Brain Exercise
and are then interrupted for 15 minutes or more, the app will restart your Brain
Exercise session for the day. It’s not about speed or accuracy. The point is to keep
your brain challenged and engaged.
There are a total of 18 Brain Exercises. To begin your assigned Brain Exercise, goto the “Home” screen in the app and tap “Start” which can be found in the Brain
Exercise box.
When you complete the Brain Exercise, tap “Done” and you will return to the “Home”
screen.

Messages/Reminders
Rejoyn includes reminders to help keep you on schedule such as SMS text messages
that reinforce the skills taught in the lessons and are meant to encourage completionof the program. Personalized SMSs are sent based on your behavior and reinforce
concepts and skills acquired during the lessons.

Continued Access
The 6-week treatment course is followed by a 4-week lesson review period where
you will have continued access to the Therapeutic Lessons only. Brain Exercises will
no longer be available. After the 10-week time period (6-week treatment period plus
4-week lesson review period) has ended, you will no longer be able to access Rejoyn.

Contents
Product Overview
Indications for Use
Contraindication
Safety Information/Warnings/Precautions
Product Description
Supported Operating
Systems andBrowsers
Security
Instructions for Use
Getting Started
Terms of Use andPrivacy Notice
User Introduction
Set a ReminderHome Screen
Patient ProfileMy PlanTasks
Overall Clinical Trial(Mirai) Results
Support11Patient Instructions for Use

Overall Clinical Trial (Mirai) Results

Contents

SafetyProduct Overview

Adverse events were directly assessed via phone or video based on the trial being
conducted remotely. Adverse events were determined to be related or unrelated
to Rejoyn by the investigator. No Treatment Emergent Adverse Event (TEAE) wasassessed as related to Rejoyn during the trial. There were no discontinuations dueto TEAEs. There was 1 discontinuation due to lack of efficacy in the Sham group. Noserious TEAEs occurred during the treatment period. One serious TEAE of transientischemic attack (assessed as not related to Rejoyn) was reported during the extension
period.

Indications for Use

The most common TEAEs during the treatment period (all nonserious and not related
to Rejoyn) were upper respiratory tract infection (1.1% [n = 2] and 3.2% [n = 6] in Rejoyn
and Sham, respectively), nasopharyngitis (1.1% [n = 2] and 2.7% [n= 5] in Rejoyn andSham, respectively), and headache (2.1% [n = 4] and 1.6% [n = 3] in Rejoyn and Sham,respectively). Headache was the only TEAE that was experienced by at least 2% ofsubjects in the Rejoyn group at an incidence rate greater than Sham.

Systems andDuring the treatment period, one subject in the Rejoyn group experienced worsening
depressive symptoms (based on predefined protocol criteria). In the Rejoyn group,
3.21% (n = 6) of subjects reported clinically important suicidality (based on predefined
protocol criteria), compared to 4.84% (n = 9) of subjects in the Sham group. During
the extension period, 0.53% (n = 1) of subjects in the Rejoyn group and 1.08% (n = 2) ofsubjects in the Sham group had clinically important suicidality.

Contraindication
Safety Information/Warnings/Precautions
Product Description
Supported OperatingBrowsers
Security
Instructions for Use
Getting Started
Terms of Use andPrivacy Notice
User Introduction
Set a ReminderConclusions from the Mirai Trial
Effectiveness and safety data from the Mirai trial demonstrate that Rejoyn provides
a benefit to patients with MDD when added to antidepressant pharmacotherapy.
This data extends the findings from two earlier Emotional Faces Memory Task(EFMT) (Brain Exercises) studies where a reduction in depression symptoms wasdemonstrated in MDD patients. In the Mirai trial, the benefit of Rejoyn over Sham in
reducing depressive symptoms was consistently rated by independent assessors via
the MADRS, and by study investigators via the CGI-S.

Home Screen
Patient Profile
My PlanTasks
Overall Clinical Trial(Mirai) Results
Support12Patient Instructions for Use

The effects of Rejoyn observed in the Mirai trial were larger and more durable over time
for participants who had protocol-defined adherence (ie, completed 12 of 18 treatment
sessions) and for participants with full adherence (ie, completed 18 of 18 treatment
sessions) to the intervention. Rejoyn also showed benefit in depression symptoms inhighly anxious participants with MDD, a subgroup who have been shown to have poorer
outcomes.
These effectiveness data are particularly noteworthy in the context of Rejoyn’s safety
profile. Adverse events were directly assessed via phone or video based on the trial
being conducted remotely. Adverse events were determined to be related or unrelated
to Rejoyn by the investigator. Treatment-emergent adverse events were low infrequency, unrelated to Rejoyn, and not appreciably different across treatment groups.
Rate of discontinuation from the study was also low. Overall, Rejoyn offers a positive
therapeutic benefit-to-risk profile.
For additional details regarding the results of the clinical study, you can access theRejoyn Clinician Brief Summary or the Rejoyn 510(k) summary at the following links:• Rejoyn Clinician Brief Summary: https://rejoynhcp.com/Clinician-Brief-Summary.pdf,or• Rejoyn 510(k) summary: https://www.accessdata.fda.gov/cdrh_docs/pdf23/
K231209.pdf

Contents
Product Overview
Indications for Use
Contraindication
Safety Information/Warnings/Precautions
Product Description
Supported Operating
Systems andBrowsers
Security
Instructions for Use
Getting Started
Terms of Use andPrivacy Notice
User Introduction

SupportFor additional support with any aspect of the Rejoyn app, you can contact
Rejoyn Support via phone at 1-833-973-5696.

Set a ReminderHome Screen
Patient Profile

Manufactured For
Otsuka Pharmaceutical Development & Commercialization, Inc.
508 Carnegie Center Dr, Princeton, NJ 08540

My PlanTasks

Rx Only

Overall Clinical Trial(Mirai) Results
Support©2024 Otsuka Precision Health, Inc., All rights reserved.
Latest revision: 07/2024

20US24IBR0004

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