Bipolar DisorderLong-Acting Injection

Guidancefor patients using ABILIFY and their families

Supervisor: Hirohisa Hida
Director of Medical Corporation Soramugikai Hida Clinic

INDEX
Ｑ１ Are you taking medicine regularly?

3

Ｑ２ What is ABILIFY "LAI"?

4

Ｑ３ What are the advantages of ABILIFY LAI?

6

Ｑ４ How will your life change with ABILIFY LAI?

11

Ｑ５ Is the oral medicine no longer necessary
after switching to ABILIFY LAI?

12

Ｑ６ Where is ABILIFY LAI injected?

14

Ｑ７ Is ABILIFY LAI safe? Are there any adverseeffects?

15

Ｑ８ Can anyone use ABILIFY LAI?

16

Ｑ９ What should you do if you would like to use
ABILIFY LAI?

18

Follow your doctor's instructions even after
the symptoms have improved.

19

Illustrated by Muu Matsutori ⓒ

Ｑ1

Are you taking
medicine regularly?

Your medicine of your choice
In the treatment of schizophrenia, drug therapy is essential tostabilize the symptoms and prevent relapse.

However, it is not easy tocontinue taking your medicine regularly. You may feel bothered to take themedicine every day or may unintentionally miss a dose. To continue propertreatment, check if you have any trouble taking the medicine.
CHECK□

Do you have any trouble?
Sometimes miss a dose
Feel bothered to take the medicine every day
Feel uncomfortable to take the medicine in public
Sometimes adjust the amount of the medicine
by yourself
Sometimes get annoyed by your family or caregiver checking if you havetaken the medicine
Sometimes refrain from activities because of worrying about the time totake the medicine
Very concerned about relapse

If you have any trouble taking the medicine every day, you may
consider using a non-oral dosage form, the long-acting injection (LAI). Let
us learn about ABILIFY LAI with this booklet. You are the central player inthe treatment. Select the dosage form with which you can easily continue
treatment while living your own life.

3

Ｑ2 What is ABILIFY "LAI"?
ABILIFY long-acting injection (LAI) is an atypicalantipsychotic injection that remains effective for 4 weeks.
ABILIFY is one of the atypical antipsychotics used for the treatmentof bipolar disorder, similar to mood stabilizers. ABILIFY LAI is indicated forthe suppression of relapse of mood episodes in bipolar I disorder. It isinjected once every 4 weeks.
ABILIFY is also available in various oral forms, which are indicatedfor improving the manic symptoms of bipolar disorder.

Injection

Get injected at a medical institution
once every 4 weeks.
Long-acting injection

LAI is an
injection type ofmedicine.

ABILIFY LAI 300mg（syringe）

ABILIFY LAI
300mg（vial）

4

ABILIFY LAI
400mg（vial）

ABILIFY LAI 400mg（syringe）

LAI kunOralmedicine

Take once a day with a glass of water or lukewarm
water.
Tablets

ABILIFY tablets 1mgPowder

ABILIFY tablets 3mg

ABILIFY powder 1％

There are various
dosage forms !
ABILIFY tablets 6mg

ABILIFY tablets 12mg

Take every day without water.
Oral solution

Atipical Antipsychotic kun

Orally DisintegratingTablets(OD Tablets)

ABILIFY oral solution 0.1％ 1mL
ABILIFY OD Tablets 3mg

ABILIFY OD Tablets 6mg

ABILIFY OD Tablets 12mg

ABILIFY OD Tablets 24mg

ABILIFY oral solution 0.1％ 3mL

ABILIFY oral solution 0.1％ 6mL

ABILIFY oral solution 0.1％ 12mL5Ｑ3

What are the advantagesof ABILIFY LAI?

ABILIFY LAI is injected once every 4 weeks.
Oral medicines should be taken every day in the amount prescribedby the doctor at the prescribed time. As ABILIFY LAI remains at theinjection site (in the muscle) until gradually taken into the blood, it has
long-lasting effects once injected. If you visit the medical institution once
every 4 weeks for an injection, you can expect the same therapeutic effectas with taking the oral medicine every day without fail.

My next injection isin 4 weeks.

6ABILIFY LAI stabilizes the blood drug concentration.
ABILIFY has the same effect regardless of the dosage form, suchas oral medicine or LAI. ABILIFY LAI, however, has a characteristic thatthe active ingredient (aripiprazole) is slowly absorbed into the body after
injection to maintain concentration in the blood. Therefore, it is expected
to stabilize the symptoms.

After reaching a stableconcentration in the blood,
the medicine can help
stabilize the symptoms.

Change in blood concentration of aripiprazole (assumption)

Blood drug concentration
1st injection（Baseline）

Concentration at which the medicine exerts its effect

2nd injection（1 month later）

3rd injection（2 months later）

7

ABILIFY LAI can be effective in preventing relapse.
Bipolar disorder is considered to be a disease that mostly recurs if nottreated properly1) . With repeated relapse, some patients lose their social credit,properties, and jobs and may also have troubled relationship with their families.
However, starting an appropriate treatment from an early stage can prevent
such social damage. Repeated relapse of the disease shortens the time to thenext onset and induces rapid cycling, which may result in almost no period of
good health (remission period).
If you continue treatment with ABILIFY LAI, you can maintain the
medicine regularly in your body, and thus you can expect to stabilize thesymptoms and prevent relapse.

nt,treatme
correctl life.
deunantiWith con lead a norm
you camedicine

manic and depressive symptoms

Don't stop treatment
on your own.
If not treated, there isa risk of relapse.

1)

Goodwin, F.K. et al.: Manic-depressive illness. Bipolar disorders and recurrent depression. 2ndedition. Oxford University Press; 2007.

8relapseABILIFY LAI reduces your concern about missing a dose.
To prevent relapse, it is necessary to take the medicine every day
without fail. However, have you ever unintentionally missed a dose or
adjusted the dose at your own discretion?
ABILIFY LAI is injected at a medical institution once every 4 weeks.
It frees you from the daily concern about missing a dose. If you do not visit
your doctor as scheduled, the medical staff can notice and encourage you
to visit, which helps you continue treatment.

＊Percentage of patients with bipolar disorder who do not take medicines regularly＊Less than 80% of the total number of actual
medication days in the study period

（％）
100

Seems like it's noteasy to keep takingmedicines.

8060

59％

64％

40
20
0

１year

２years
Li, C. et al. : Psychiatry Res. 2014; 218(1-2), 75-78.

9

ABILIFY LAI supports continued treatment.
The treatment goal of bipolar disorder is to resolve manic anddepressive symptoms and prevent relapse. Once injected, ABILIFY LAI
remains effective for 4 weeks, and the therapeutic effect is expected to be
the same as that with daily medicine use. Therefore, it relieves you fromthe burden of taking the medicine

relapserelapseand the concern about missing adose. By continuing proper treatment,
you may be able to live your daily life
while controlling the symptoms.

relapserelapserelapse＝continue
treatment
prevent
relapseNORMAL
LIFE

10

Ｑ4

How will your life changewith ABILIFY LAI?

Advantages and disadvantages of ABILIFY LAIAdvantages (good points / what can be expected)
It ensures intake of the medicine.

― Eases your concern about relapse andhospitalization― Stabilizes the symptoms― Eliminates your concern about missing a dose

It is an easy-to-takedosage form, but
you must visit yourhospital once every
4 weeks！

It decreases (eliminates) the burden of taking the medicine.

― Allows you to remain active without worrying about the time
to take the medicine― Enables you to not care about what others think about you

Disadvantages (weak points)
Injection involves pain.

It may also cause "injection-related adverse
effects" (see P15).

Consult your doctor
if you have anyquestions！

Any adverse effect may result in prolonged symptoms.
If you feel that something is different, tell your doctor or
pharmacist immediately.

It takes time to have an effect.

Oral medicine will be used in combination for 2 weeks until
the efficacy is confirmed.

*ABILIFY LAI may cause sleepiness, decreased attention/concentration, and delayed
reactions, which are also caused by the oral medicine. Avoid operating dangerous machinery,
including driving a car during use.
*If you consume alcohol while using ABILIFY LAI, adverse effects such as dizziness andlightheadedness are more likely to occur. Avoid alcohol consumption during use.

11Ｑ5

Is the oral medicine no longer
necessary after switching to ABILIFYLAI?

It depends on the symptoms and the patient.
If you start treatment with ABILIFY LAI, the antipsychotic oral
medicine also needs to be taken until the blood drug concentration becomesstable. If the symptoms stabilize or adverse effects decrease, the amount andtype of medicine that is being taken may be decreased, and some patients
may no longer need the oral medicine. However, there are individualdifferences.

Periodical hospital visit is necessary.
Even after starting treatment with LAI and the symptoms stabilize,
if you discontinue treatment at your own discretion, it may lead toexacerbation and relapse of the disease. Periodically visit your hospitalonce every 4 weeks to continue treatment. Tell your doctor if you haveany adverse effects and other worrisome symptoms.

With both LAI and the oral medicine…

ercis

therapy. Taking care of your usual lifestyle, suchdail

12sythmy rhpas maintaining a healthy daily rhythm and trying

drug
therapysleesynergistic effect when combined with drugexeschizophrenia, which are expected to have

day

care

ition
nutr

various psychosocial methods to treat

pseduycho
cat ion

l
ona
ati
up py
occthera

In addition to the drug therapy, there are

Soc
ial Skills
Training

to sleep and exercise well, is also important to stabilize the symptoms. The
same is true with both the oral medicine and LAI.

Main medicines used for the treatment of bipolar disorder
The following medicines are used for the treatment of bipolar disorder:

Mood stabilizers

Basic treatment for bipolar disorder that is
effective in the treatment and preventionof manic and depressive symptoms.

Atypicalantipsychotics

Atypical antipsychotics, including ABILIFY,
block neurotransmitters, such as dopamine,
and are effectively used for the treatment
of schizophrenia as well as bipolar disorder.

Sleeping pills

Temporarily used to relieve symptoms ofinsomnia, such as having difficulty falling
asleep and waking up early in the morning.

13Ｑ6

Where is ABILIFY LAI
injected?

ABILIFY LAI is injected into your buttock or shoulder muscle.
ABILIFY LAI is injected into the muscle on theouter side of the buttocks called "gluteus medius" orthe muscle on the outer side of the shoulders called"eltoid". While both sites are suitable for the safe useof LAI, your doctor will select the injection site thatsuits you to avoid damaging important nerves andeltoid

gluteus medius

blood vessels, as there are individual differences inphysique and muscle mass. If you want to request
either one, tell your doctor.
LAI will be injected avoiding the previous site of injection. Afterinjection, be careful not to rub the injection site. If you feel strong pain or
discomfort during or after the injection, tell your doctor or the medical staff
immediately. It is reported that the injection site pain is milder at the gluteus
medius than at the eltoid.
Tell what you think！
Some people may be concerned about the injection
pain and injection into the buttocks. ABILIFY LAI is watersoluble and designed to reduce pain during injection. It is
injected at the relatively upper side of the buttocks,
and your doctor will respect your privacy during theinjection by covering with blankets and towels.
If you have any concerns about the injection, tell
your medical staff what you think.

14

Talk to your medical
staff if you have anyconcerns！

Ｑ7

Is ABILIFY LAI safe? Are
there any adverse effects?

ABILIFY LAI is used after confirming that it is suitable for you.
ABILIFY LAI is indicated for thesuppression of relapse of mood episodes. It
cannot be used for patients with severe
symptoms in the acute stage and for those withunstable symptoms. Before using ABILIFY LAI,
your doctor will give you the ABILIFY oralmedicine to see if it is appropriate for yourcondition (to confirm efficacy and safety). Whilethe long-acting effect of LAI is an advantage, it is also a disadvantage as
there is no way to remove the medicine from your body immediately in theevent of adverse effects. Discuss this thoroughly with your doctor beforeuse.

LAI-specific adverse effects
The adverse effects seen withABILIFY oral medicine are also seen withABILIFY LAI. In addition, LAI may cause
the symptoms described on the right asinjection-related adverse effects.

Injection-relatedadverse effects

Injection site has…
painredness

stiffnessswelling

If you feel that something is different or suspect adverse effects,
consult your doctor or pharmacist as soon as possible.

15

Ｑ8

Can anyone use
ABILIFY LAI?

Let's check !
Check if you can use ABILIFY LAI. Check whether the following
conditions apply:

START

You have a
specific "reason
to use" LAI.

You are currently
using ABILIFY for
the treatment of
Bipolar Disorder.

YESYou have noparticularly
troublesome
symptoms (adverseeffects).

YES

The symptoms
remain stable.

16YES

Consult yourdoctor if you haveany questions orconcerns about
LAI.

You can visit ahospital once
every 4 weeks.
YES

YES

You have
understood theadvantages anddisadvantages ofusing LAI with thisbooklet.
YES

You havediscussed withyour doctor about
the use of LAI.

YES

To Q917

Ｑ9

What should you do if you
would like to use ABILIFY LAI?

Tell your doctor about your intention.
If you fulfill the requirement for the use of ABILIFY LAI in Q8, tell
your doctor that you want to use ABILIFY LAI. However, consult yourdoctor if any of the following applies to you:・Under treatment (or have previously been treated) for other diseases
・Using other medicines
・Not under treatment but have some health concerns
・Have tried to commit suicide, sometimes feel like hurting yourself
・Being pregnant (potentially pregnant), breastfeeding
・Have had allergic symptoms after taking medicines
・Being elderly (65 years or older)18

Follow your doctor's instructions evenafter the symptoms have improved.
Do not discontinue treatment at your own discretion.
ABILIFY LAI is a medicine that is injected at a medical institution
once every 4 weeks. Even after the symptoms have improved, do notdiscontinue treatment at your own discretion and follow your doctor's
instructions.

Efforts to more easily continue treatment with ABILIFY LAI
Bring the "Dosage Schedule Card" for ABILIFY when visiting a
medical institution and enter the date of the hospital visit on your calendar
at home so that you can continue the treatment more easily.

"Dosage Schedule Card" for ABILIFY LAI*The form can be downloaded from the QR code below.

19Emergency contact
Name of the medical institution
Contact details
Your doctor
Your medical staff

2023 年 7 月作成
AB2306103
AT