Schizophrenia

Long-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 proper
treatment, 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"?
LAI is one of the various dosage forms.
The dosage forms of the atypical antipsychotic ABILIFY include
various oral medicines as well as the long-acting injection (LAI). The
dosage form can be selected based on the ease, comfort, and purpose ofuse.

Oralmedicine

Take every day at prescribed times with a glass ofwater or lukewarm water.
Tablets

ABILIFY tablets 1mg

PowderABILIFY tablets 3mg

ABILIFY powder 1％

There are various
dosage forms !
ABILIFY tablets 6mg

ABILIFY tablets 12mg

Atipical Antipsychotic kun4Oralmedicine

Take every day at prescribed times
without water.
Oral solution

Orally Disintegrating
Tablets(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％ 6mLABILIFY oral solution 0.1％ 12mL

Injection

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

LAI is aninjection type ofmedicine.

ABILIFY LAI 300mg（syringe）

ABILIFY LAI
300mg（vial）

ABILIFY LAI
400mg（vial）

ABILIFY LAI 400mg（syringe）

LAI kun5

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 afterinjection 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.
Schizophrenia is a highly

If the disease recurs repeatedly...

recurrent psychiatric disorder, andrepeated relapses are associatedwith the risks described on theright. The most important goal ofschizophrenia treatment is toprevent relapse.
If you continue treatment

・Mental and social functions decline, andyou may no longer be able to do what
you have been able to do.
・The medicine becomes less effective,and you may need a longer time torecover.
・Many patients are readmitted to thehospital.

with ABILIFY LAI, the medicine will constantly be maintained in your body,and thus you can expect to stabilize the symptoms and prevent relapse.

Course and treatment goal of schizophrenia
If you continue
treatment toprevent relapse, you
can expect tomaintain yourfunction.

GoodOnset

Overall function

RelapseFunctional declinewith each relapse！

Bad

Early stage

Prodromalstage

It's important tocontinue treatment.
No treatment

Acute stage

Time

8

Continue treatment

Maintenance stage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 oradjusted the dose at your own discretion?
Data shows that people who discontinue the medicine even for 1
to 10 days have approximately twice the rate of readmission comparedwith those who do not miss a dose.
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.
Period of drug discontinuation and risk of hospitalization
Even 1 to 10 days ofdrug discontinuation
leads to approximately
twice the rate ofhospitalization！

（％）
25
Percentage of patients readmitted

2015
10
500

1～10days

11～30days>30日days

Longest period of drug discontinuation in a year
Weiden, P. J. et al. : Psychiatr. Serv. 2004 ; 55(8) : 886-891.

9

ABILIFY LAI supports your recovery.
The treatment goal of schizophrenia is to stabilize the symptoms
and help you "regain your own life and take a step toward your goal in lifeand your future (dream)", which iscalled "recovery". Recovery varies

relapserelapsefrom person to person; some peopleresume their studies and jobs, which
they discontinued due to thedisease, and others try something

relapserelapserelapsenew.
The essential aspect in aiming for recovery is to continue treatment
properly to prevent relapse. ABILIFY LAI is a dosage form that enables you
to work towards recovery without worrying about the medicine. It relieves
you from the burden of taking the medicine and is highly effective inpreventing relapse.
Regain your confidence by starting with what you can do without
trying too hard, for example, increasing the number of days you visit a daycare center and building up your physical strength.

＝

continue
treatment
prevent
relapse

10RECOVERY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 untilthe 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
becomes stable. If the symptoms stabilize or adverse effects decrease, theamount and type of medicine that is being taken may be decreased, andsome patients may no longer need the oral medicine. However, there areindividual differences.

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 rhp

as maintaining a healthy daily rhythm and trying

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

ition
nutr

various psychosocial methods to treat

pseduycho
cat ionlonaati
up pyoccthera

In addition to the drug therapy, there areSocial 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 schizophrenia
The following medicines, primarily antipsychotics, are used for thetreatment of schizophrenia:
Medicines playing a central role
Antipsychotics: Used to improve symptoms such as hallucination/delusion, agitation, having trouble putting thoughts together, having
difficulty in expressing your feelings and feeling unmotivated, and toprevent relapse.
Medicines that control the symptoms
Anxiolytics: Used to relieve strong anxiety and tension.
Antidepressants: Used to relieve depressed mood and increase
motivation.
Sleeping pills: A medicine with the right duration of action for thesymptom is used to control sleeping patterns, such as inability to sleep
well, having difficulty falling asleep, waking up early in the morning, andsleeping during the day and being awake at night.
Medicines to suppress the adverse effects of antipsychotics
Antiparkinsonian agents: Used to suppress extrapyramidal symptoms,
such as hand tremor, body stiffness, and numb legs.
Laxatives: Used to improve bowel movements.

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" or
the muscle on the outer side of the shoulders called"eltoid". While both sites are suitable for the safe use

eltoidof LAI, your doctor will select the injection site thatsuits you to avoid damaging important nerves andgluteus 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 intended for use toprevent exacerbation or relapse of psychiatric
symptoms. It cannot be used for patients withsevere symptoms in the acute stage and forpatients with unstable symptoms.
Before using ABILIFY LAI, your doctor
will give you the ABILIFY oral medicine to see if
it is appropriate for your condition (to confirm
efficacy and safety). While the long-acting effect of LAI is an advantage, itis also a disadvantage as there is no way to remove the medicine from yourbody immediately in the event of adverse effects. Discuss this thoroughlywith your doctor before use.

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

Injection-related
adverse effects

Injection site has…
pain

redness

stiffnessswelling

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

15Ｑ8Can anyone use
ABILIFY LAI?

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

START

You have aspecific "reason
to use" LAI.

You are currently
using ABILIFY for
the treatment ofschizophrenia.

YES

You have noparticularly
troublesome
symptoms(adverse effects).

YES

The symptoms
remain stable.

16

YES

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.
YESYou havediscussed withyour doctor about
the use of LAI.

YESTo Q917

Ｑ9

What should you do if youwould 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'sinstructions.

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
AB2306102
AT