Fo r E PIP EN® users a n d th eir fa milies

Carry it just to be safe
Be prepared for anaphylaxis

EPIPEN Guidebook®

[Editorial supervisor]

Dr. Motohiro Ebisawa

Director of Clinical Research Center for Allergy and Rheumatology,
National Hospital Organization Sagamihara National Hospital＊Please be sure to follow your doctor’s instructions on how to use EPIPEN®.

Mylan is a Viatris group company

What is anaphylaxis?
It is a severe, acute allergic reaction involving
the whole body in a short period of time.
An allergy is a condition causing various symptoms such as itch, sneezing, irritation, by overreacting“immunity”, a mechanism to protect human body from foreign substances. Anaphylaxis is a severe,
acute allergic reaction involving the whole body, usually occuring within minutes to several tensof minutes after exposure to the trigger (allergen).

● Typical causes of anaphylaxis (allergens)

Eating food
(Egg, milk, wheat,
buckwheat noodles(soba), peanuts, etc.)

Insect stings to bringtoxic substances
into body(Yellow hornets, paper wasps,
honeybees, etc.)

Medication(Antibiotics, antifebrile/analgesic drugs,
vaccines, anesthetic drugs, etc.)＊In addition, anaphylaxis may be caused by latex products(natural rubber gloves, etc.) or exercise.

1Anaphylaxis may lead to anaphylactic shock,which can be life-threatening.
Anaphylaxis causes various symptoms.
They change rapidly and may lead to a state called “anaphylactic shock”, in which blood pressure
drops and leads to shock symptoms such as impaired consciousness and life-threatening status,
Therefore, paying close attention is necessary.

● Main symptoms of anaphylaxis
Skin/mucosal
symptoms

Flushing, itching, urticaria, angioedema, morbilliform rash, piloerection, conjunctival hyperemia,
lacrimation, and intraoral swelling

Respiratory
symptoms

Nasal itching, nasal congestion, nasal discharge, sneezing, itchy throat, throat tightness, vocal
disorder, hoarseness, stridor, and intermittent dry cough.
Lower respiratory tract: increased respiratory rate, shortness of breath, chest tightness,
intense cough, wheezing/bronchospasm, cyanosis, and respiratory arrest

Digestive
symptoms

Abdominal pain, nausea, vomiting, diarrhea, and dysphagia

Cardiovascularsymptoms

Chest pain, tachycardia, bradycardia (rare), other arrhythmias,
palpitation, drop in blood pressure, syncope, incontinence, shock, and cardiac arrest

Central nervous
system symptoms

Feeling of impending doom, anxiety (sudden behavioral changes in infants or toddlers, such as
becoming irritable, stopping playing, and clinging to their parents), throbbing headache (before
adrenaline administration), restlessness, dizziness, and tunnel vision
Symptoms are taken from the "Anaphylaxis Guidelines 2022" published by the Japanese Society of Allergology( “Table 10. Clinical Findings” on p.17).

● Anaphylactic shock
Drop inblood
pressureDifficulty
breathing

Loss ofconsciousness

Anaphylactic shock is a life-threatening condition.
2

Unexpected risks of anaphylaxis
The majority of anaphylactic episodes in children are caused byfood. It is therefore most important to consult with a doctor first to
have the causative food (allergens) ascertained and then to avoid
such food in accordance with the instructions of the doctor.
However, it may be impossible to avoid food allergens at preschool,kindergarten and elementary school.

Actions taken by schools toprevent food allergy reactions
To build an environment that enables children with allergic diseases to besafe and comfortable at school (where they spend many hours), schools areadvised to take measures based on the school life management guidancetable (for allergic diseases)*. The tables should be completed by thephysicians caring for such children and submitted to schools by theirparents (the medical fee system was revised in 2022: The expense iscovered by insurance when the school life management guidance table issubmitted to a school doctor**). Schools then collect accurate informationon the children’s food allergies, determine the measures to be taken forschool meals by interviewing parents, remind all school personnel of therisk, and develop a system in case of emergency, etc.
Example: School life management guidance table (for allergic diseases)*School life management guidance table(https://www.gakkohoken.jp/book/ebook/ebook_R010100/ R010100.pdf)**School life management guidance table for allergic diseases issued by authorized
insurance medical institutions showing what is covered by insurance(https://www.gakkohoken.jp/book/ebook/ebook_R010100/20220401.pdf)※For the life management guidance table for allergic diseases at preschool(food allergies, anaphylaxis, and bronchial asthma), please visit the following website:
URL: https://www.mhlw.go.jp/content/000512752.pdf
From "Guidelines on Measures to be Taken for Allergies at Schools" (Revised in 2019):
https://www.gakkohoken.jp/book/ebook/ebook_R010060/R010060.pdf

3

eco
e.g.

● Potential situation causing anaphylaxis

beyond parental supervision
School meals
e.g. Tasting, refil, etc.

Field trip,
overnight school trips

Sports day

e.g. School trip, summer camp, etc.

Home
nomics class

On the way toand from school

Cooking egg, etc.

e.g. Trading snacks, etc.

Art and scienceclassese.g. Japanese buckwheat flower,
wheat clay, etc.

Birthday party,
rummage sales

4What is EPIPEN®?
EPIPEN® is a self-injection device thatadministers adrenalin to be used whenanaphylaxis occurs to temporarily delay
progression of symptoms andprevent anaphylactic shock
until treatment by a physician.

Any of the following symptoms Upon, inject EPIPEN®
and call an ambulance as soon as possible.
● Symptoms EPIPEN® should be used
Digestive
symptoms

Respiratory
symptoms

Systemic
symptoms●

Repeated
vomiting●

Persistent severe(unbearable)
abdominal pain●

Tightness in throat or chest●

Persistent intense coughing●

Hoarseness●

Wheezing●

Barking cough●

Difficulty breathing●

Pale lips and nails●

Clouding of consciousness●

Weak/irregular pulse●

Unconscious●

Loss of bladder or bowel control

Excerpt from Anaphylaxis Responses:
Indications for EPIPEN® for General Public by the Japanese Society of Pediatric Allergy and Clinical Immunology Working Grouphttps://www.jspaci.jp/gcontents/epipen/ browsed May 9, 2023

5

Anaphylaxis caused by food is reported to cause
cardiac arrest in only 30 minutes.
● Time from onset of anaphylaxis

caused by food to cardiac
arrest0Time (min)(median) [Overseas data][Study overview]
Subjects:
124 patients with anaphylaxis, including deaths,
registered at the Office for National Statistics (ONS,
UK) in 1992-1998.

45

Method:Based on findings from medical histories, shock
reactions, autopsy, etc. of patients with fatal
anaphylaxis, including death, time from onset ofanaphylaxis to cardiac arrest, timing of adrenalinuse, prognosis, etc. were surveyed.

15

Food
(n =37)30

Chart created based on: Pumphrey, R. S. H.: Clin Exp
Allergy 30(8): 1144, 2000

Keep in mind that symptoms like the following
may occur after EPIPEN® is injected.
● Major side effects of EPIPEN®
■ Palpitation■ Headache■ Dizziness■ Anxiety■ Tremor■ Symptom of sensitivity■ Nausea/Vomiting■ Sensation of heat

■ Sweating

etc.

The following symptoms may rarely be observed: difficulty breathing, increased pulse rate, andarrhythmia.
In such a case, stop using EPIPEN® and see a doctor promptly.
Consult a doctor or pharmacist when any concerning symptoms other than those mentioned above
are seen.
6

What kind of medicine is EPIPEN®?
EPIPEN® is a self-injection drug product withimproved safety, no needle exposed before
and after use.
● Features of EPIPEN®
Blue safety cap
Safety feature to improve visibility
and prevent unintentional injection

Ergonomically-designed,easy-to-grasp grip
Allows for a firm grip and easy handling

Built-in orange-colored
needle coverNo needle exposure before andafter use
(improved safety)

Before use

After use

Easy-to-understand,illustrated instructions
Large illustration allows for rapid
understanding of how to use

Easy-to-open, one-step,
push-up carrying case
Designed for one-hand
opening

Bright orange-colored tip
Allow to easily recognize
needle tip

Check

7

Never disassemble the main body of EPIPEN® as this may result in accidental
injection.

Properly store your EPIPEN® on a regular basis
so it is always ready for use.
● For proper storage of your EPIPEN®
● So you can use it anytime ...
Keep EPIPEN®
within reachat homeCarry EPIPEN®
with youwheneverleaving home

● How to store your EPIPEN®
Store and carry
EPIPEN® in the
carrying caseStore EPIPEN®
Preferably
at 15-30°C

Do not leave E PI P EN ® at hightemper at ures under direc t
sunlight or in a dashboard of avehicle in summer.

Do not keep it in a cold place(e.g. in a refrigerator).
Do not use E PI PEN® stored over
30°C.

Keep EPIPEN® out ofreach of small children● Precautions when carrying EPIPEN® with you
As EPIPEN® is made of plastic and if you drop it on a hard surface such as concrete, it may bedamaged.
If you would like to bring EPIPEN® in a plane, notify the airline upon reservation that you will becarrying EPIPEN® in the plane with you to avoid troubles at checking in.

● Tips for carrying EPIPEN® around in summer[Examples]

Put it in a cooler bag (Note: we do not provide any accompanying cooler bag)
Keep it in a bag with refrigerant stored in a refrigerator and wrapped in a towel (frozen
refrigerant can chill EPIP EN® too much).
● With no refrigerant, keep it in a bag with a plastic bottle of cold beverage.
●●

Note that we do not guarantee you can keep EPIPEN® below 30ºC with the above-mentioned
measures. Also, please be aware of the possibility of causing failure of EPIPEN® by cooling rapidly.

Check

Regularly check EPIPEN® if the drug
solution visible through the window of theinjector becomes discolored or has any
deposits. In such a case, immediately geta prescription for another EPIPEN®.

Solution istransparent.

Window of
the injector

Solution is brownish.
8What can I do for anaphylaxis symptoms
Diagnosis by a physician and periodical
consultations are important
The basis of dietary management is to avoid (remove) foods that trigger allergic reactions(allergen). However, for the healthy growth of children, unnecessary removal of foods should
be avoided. In fact, I have seen many parents who avoid foods more than necessary basedon self-judgment. To ensure minimal food avoidance and those children’s necessary nutrition
and improve quality of life of your child, parents should consult with a doctor to have theallergen(s) determined accurately and take the best course of action.
Parents may worry about their children because of therestrictions on what they can eat or because theirchildren cannot eat what other students eat. However,food allergies tend to fade with age, therefore parents
should have their children regularly checked forchanges in their allergies to confirm if they havebecome able to eat those foods.
There are still many foods people with food allergies caneat. With seasonal vegetables and fish, you can have an
enjoyable diet even without eggs, milk and wheat. Withbalanced meals, try to make children’s daily diet enjoyable.

“Preparing” anaphylactic symptoms
When children start to attend preschool,kindergarten and elementary school, they will
spend much of time beyond parents’supervision. It is necessary for parents andschools to share accurate information, based on
consultations with a doctor, on what foods
should be avoided, emergency responses etc.
However, no matter how careful, there is stillrisk for those children of accidentally being
exposed to causative foods with school meals
etc. Therefore it is important to carry an EPIPEN®
at all times to be prepared for especiallydeveloping anaphylactic symptoms.
9

by eating causative food?

Advice from

Dr. Ebisawa

Repeat practicing with EPIPEN® Trainer
on regular basis
Since EPIPEN® is an injection, some people may feel scared or hesitate to use it. However, theactive ingredient contained in EPIPEN® is a naturally occurring hormone secreted in our body(adrenalin＊). You may have experienced your heart beating faster when you get very angry,
excited or nervous. This is due to adrenalin. Your heart rate usually returns to normal after 15
minutes or so. This is also true for EPIPEN®. In about 15 minutes after injecting EPIPEN®, you
should feel normal again. This is such a medicine.
EPIPEN® is expected to help save those children’s lives in an emergency. Therefore, it is also
important to practice using EPIPEN® regularly with the “EPIPEN® Trainer”. Making sure thosechildren always carries their EPIPEN® will give you piece of mind to watch they grow.
＊：Adrenalin is a hormone secreted by an organ called adrenal gland when we’re angry, excited, or nervous and it
helps us in case of emergencies.
*School life management guidance table(https://www.gakkohoken.jp/themes/archives/40#q14) (refer to the version prepared on February 13, 2023)

10

Actions to be taken in cases ofanaphylaxis
Once you see any of symptoms for which EPIPEN®
should be used (see P.5), inject EPIPEN® into
the anterolateral (front-outer side) of your thighand call an ambulance immediately.
● Actions to be taken in cases of anaphylaxis

Call anambulance

To hospitalIn case of unconsciousness
or loss of consciousness.
Lay the child down on their back,keeping their feet raised.

In case ofnausea or vomiting.
Lay the child on their side.

Inject EPIPEN® into
the muscle of thefront-outer thigh.

In case of difficulty
breathing and unable tolay on the back.
Put the child in a seated position,
leaning back.
Illustration created based on: Simons, F. E. R. et al.: J Allergy Clin Immunol 127(3): 587, 2011
Illustration created based on: Food Allergy Emergency Response Manual (March 2018 Edition)by the Evaluation Committee on Measures for Allergic Disease, Tokyo Metropolitan Government
https://www.fukushihoken.metro.tokyo.lg.jp/allergy/pdf/pri06.pdf browsed May 9, 2023

If the child cannot inject EPIPEN® by him/herself, the parent
or teacher/childcare worker should do so instead.
(Unavoidable use of EPIPEN® by teachers and childcare workers for life-saving is allowed
under the Medical Practitioners’ Act, and they will be irresponsible.)11

How to use
EPIPEN® injection solution

Training

Keep practicing with the “EPIPEN® Trainer”
so you can inject EPIPEN® correctly when needed.
● How to use EPIPEN® –Practice with the “EPIPEN® Trainer”–
STEP

1

STEP

Preparation

2

Firmly hold the middle of the E PI P EN with yourd omina n t ha nd w i t h t he o r a nge t ip f acing
downward. With your other hand, remove the blue
safety cap straight upward.
®

Injection

Apply EPIPEN® vertically to your front-outer thigh, andpress the tip of the orange needle cover firmly until
you hear a “click”. Hold for several seconds withpressing it against your thigh.

Safety cap● Look at where you inject while practicing.
● Grip EPIPEN® so as not to place your thumb on the upper or lower tips.
● Only inject the solution into your front-outer thigh.
● Firmly hold E PIP EN ® not to move the administration site.
● Do not inject by swinging the E PIP EN ® onto your thigh.

Adapted with modification of image for “injection with E PIP EN® in sitting position” from page 21 of“Fully-understandable guidebook for food allergy to prevent asthma (zensoku yobo no tameno yokuwakaru shokumotu arerugi taio gaidobukku) 2023” ,https://www.erca.go.jp/yobou/pamphlet/form/00/pdf/archives_24514.pdf browsed May 9, 2023
STEP

STEP

After injection, check whether the orange needle
cover has been extended.

❶ Put the blue safety cap

3 Check

4

After treatment

back by pushing its tip
into its original position.

Orange needle cover❷ Place the tip of the orange

Before use
Extendedneedle cover
After useneedle cover on a hard surface(desk etc.). Put the main body ofthe trainer in by pressing it
downward while holding theupper part of the orange needle
cover on the both side with
fingers.

If a caregiver administers the injection●Please ask someone to firmly hold the upper

thigh and knee in place to keep the leg frommoving.

12

How to use EPIPEN®

Actual use

When you see signs or symptoms of anaphylaxis, inject EPIPEN®
● How to use EPIPEN® –When anaphylaxis occurs–
STEP

1

Preparation

Firmly hold the middle of the E PI P EN ® withyour dominant hand with the orange tip facing
downward. With your other hand, remove theblue safety cap straight upward.
Cover cap

Safety cap● While the blue safety cap is in place, the spring islocked so the needle will not come out accidentally.
Do not take the blue safety cap off until use.

● Handle the injector carefully after removing thesafety cap to prevent accidental injection.

● Never place your thumb, fingers or hands over the tipof the orange needle cover.

● Check before use if the blue safety cap is loosened, if the

drug solution visible through the window of the injector
is discolored, or if any deposits are in the solution.

● Do not apply transverse force when removing theblue safety cap.

STEP

2

Injection

Apply E PI P EN ® vertically to your front-outerthigh, and press the tip of the orange needle
cover firmly until you hear a “click”. Hold it on
your thigh for several seconds. Remove
EPIPEN® from your thigh.

● Grip E PI P EN ® so as not to place your thumb on theupper or lower tips.

● Only inject the solution into your front-outer thigh.
● Firmly hold E PIP EN ® so as not to move theadministration site.

● Do not inject by swinging the E PIP EN ® onto your thigh.
● In emergencies, you can inject the solution throughclothing.

Adapted with modification of image for “injection with E PIP EN® in sitting position”
from page 21 of“Fully-understandable guidebook for food allergy to prevent asthma (zensoku yobono tameno yokuwakaru shokumotu arerugi taio gaidobukku) 2021” ,https://www.erca.go.jp/yobou/pamphlet/form/00/pdf/archives_31321.pdf
browsed May 9, 2023

Checklist for EPIPEN® Use■□ Remove E PIP EN® from carrying case■
□ Check if the blue safety cap is loosened, if the drug solution
is discolored, or if any deposits are in the solution■□ Hold E PI P EN ® with your dominant hand with the orange tip
facing downward□ With the other hand, remove the blue safety cap straight■
upward□ If other person administers, fix the leg so as not to move■
□ When administering through clothing, empty pockets■□ Apply E PI P EN ® vertically to the front-outer thigh, and place■
the tip of the orange needle cover□ Press the tip firmly until you hear a “click” and hold it for■several seconds□ Remove E PI P EN ® from the thigh. Check whether the orange■
needle cover has been extended□ Put the used E PIP EN® back into carrying case■13

If a caregiver administers the injection●Please ask someone to firmly hold the upper thigh andknee in place to keep the leg from moving.

immediately into your front-outer thigh.
STEP

3

STEP

4

Check

After injection, check whether the orange
needle cover has been ex tended. If so,
injection is complete (The needle is within theorange needle cover).

For movie of how to use
visit EPIPEN®
site atwww.epipen.jp

After treatment

Put the used E PI P EN ®
back into the carrying
case with the orange
needle cover first.

Orange needle cover

Before use
Extendedneedle cover
After use
● If the orange needle cover is not extended, injection

is not complete. Repeat Steps 1 - 3 for injection.

● After injection, get a medical attention immediately.

● After injection, the cap of the carrying case cannot be

closed because the orange needle cover is extended.
Do not try to force it into the case.

● After injection, a large portion of the drug solution(about 1.7mL) remains in the injector, but the solution
cannot be injected again.

● Report to your doctor that you used EPIPEN ® injection

solution and give the used EPIPEN® injector and theblue safety cap to the medical institution, etc.

Check

EPIPEN® injection solution 0.3mg and EPIPEN® injection solution 0.15mg canbe used in the similar way.
Never inject the solution into your buttocks or arm. If you use EPIPEN® on thewrong site on your body, visit the nearest medical institution immediately.

★Correct way of holding to avoid

accidental injection● DANGER. Never place your fingers, thumb or handson the tip of the orange needle cover. The needle
comes out of the orange tip.About 1.5 cm (for 0.3 mg)
or about 1.3 cm (for 0.15 mg) of needle will come out
from the tip of the orange cover.
● DANGER. Never disassemble E PIP EN ®.

Correct
way ofholdingWrong
way ofholding
14

Attention: EPIPEN® has an expiration date!
Be sure to register with the “Expiration Reminder
Service” to prevent the use of an expired EPIPEN®.
● How to register with the “Expiration Reminder Service” for E PIPEN®
(Re-registration necessary for refill prescription)

Applicationforregistration

Notice of the
expiration
date

Visit medical
institution/
pharmacy

Get arefillprescription

Registration through App

Registration via the website

Registration with the postcard

After downloading “My EPI,” tap“Add new EPIPEN” button andimage the manufacturing
number and the expiration date.

Visit the “EPIPEN ” website(http://www.epipen.jp) and click on“Registration” button for “Expiration
Reminder Service.” Then, enter thenecessary information to the formand send it.

Fill out and the post theregistration postcard.

You will receive the notification about
one month before the expiration date.
＊If your address or e-mail address, etc. has
been changed, contact EPIPEN® Customer
Support Center below.

®

For Appe-mail and push notification

For Webe-mailFor postcard

postcard

Prior to the expiration date, bring the unused E PI P EN ® to your medical
institution/pharmacy.
＊Unused EPIPEN® is required to be disposed of as a medical waste.
For disposal, follow instructions from your doctor or pharmacist.

You should see your doctor again to receive a refill prescription of EPIPEN ®.
Register again as previously.

● The registration card is included in the box with the product.
● If you lose the registration postcard or you have moved and your address has been changed,

contact EPIPEN® Customer Support Center.

EPIPEN® Customer Support Center 0120-303-347 (toll-free in Japan)※We promise that your personal information provided will be used for the notice of the expiration date, etc., and will not be used for other purposes and theinformation will not be provided to third parties.

Prepared in May ����
EPI��N���A

Viatris Pharmaceuticals Japan Inc.
5-11-2 Toranomon Minato-ku, Tokyo
105-0001, Japan