REPATHA 140 mg Инъекционный Раствор

Содержание инструкции

1. Repatha 140 mg injectable solution in pre-filled syringe
   1. What is Repatha and what it is used for
   2. What you need to know before you use Repatha
   3. How to use Repatha
   4. Possible side effects
   5. How to store Repatha
   6. Contents of the pack and other information
2. Repatha 140 mg injectable solution in pre-filled pen
   1. What is Repatha and what is it used for
   2. What you need to know before you use Repatha
   3. How to use Repatha
   4. Possible side effects
   5. How to store Repatha
   6. Contents of the pack and other information
3. Repatha 420 mg injectable solution in cartridge
   1. What is Repatha and what is it used for
   2. What you need to know before you use Repatha
   3. How to use Repatha
   4. Possible side effects
   5. How to store Repatha
   6. Content of the pack and other information

Repatha 140 mg injectable solution in pre-filled syringe

evolocumab

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• The warnings and instructions in this document are intended for the person taking the medicine. Parents or responsible caregivers administering the medicine to others, such as a child, must follow the information accordingly.

Contents of this leaflet

• 1. What Repatha is and what it is used for
• 2. What you need to know before you use Repatha
• 3. How to use Repatha
• 4. Possible side effects
• 5. How to store Repatha
• 6. Contents of the pack and other information

1. What is Repatha and what it is used for

What is Repatha and how does it work
Repatha is a medicine that lowers levels of "bad" cholesterol, a type of fat present in the
blood.
Repatha contains evolocumab as the active ingredient, a monoclonal antibody (a type of specialized protein
designed to bind to a target substance in the human body). Evolocumab is
designed to bind to a substance called PCSK9 which influences the liver's ability to
absorb cholesterol. The medicine, by binding to and removing PCSK9, increases the amount of
cholesterol that enters the liver, thus lowering cholesterol levels in the blood.

What Repatha is used for
Repatha is used in addition to diet to lower cholesterol:

• in adults with high levels of cholesterol in the blood (primary hypercholesterolemia [familial heterozygous and non-familial] or mixed dyslipidemia). It is administered:
• together with a statin or another cholesterol-lowering medicine, if the maximum dose of a statin does not lower cholesterol levels sufficiently.
• alone or together with other cholesterol-lowering medicines when statins do not work well or cannot be used.
• in children aged 10 years and older with high levels of cholesterol in the blood caused by an inherited condition (familial heterozygous hypercholesterolemia or HeFH). It is administered alone or together with other cholesterol-lowering treatments.
• in adults and children aged 10 years and older with high levels of cholesterol in the blood caused by an inherited condition (homozygous familial hypercholesterolemia or HoFH). It is administered together with other cholesterol-lowering treatments.
• in adults with high levels of cholesterol in the blood and established atherosclerotic cardiovascular disease (history of heart attack, stroke, or blood vessel problems). It is administered:
• together with a statin or another cholesterol-lowering medicine, if the maximum dose of a statin does not lower cholesterol levels sufficiently.
• alone or together with other cholesterol-lowering medicines when statins do not work well or cannot be used.

Repatha is used in patients who are unable to control their cholesterol levels through diet alone
aimed at lowering them. During treatment with this medicine you should
continue to follow your cholesterol-lowering diet. Repatha may help prevent a
heart attack, stroke, and some cardiac procedures to restore blood flow to the heart
due to the build-up of fat deposits in the arteries (also known as atherosclerotic cardiovascular
disease).

2. What you need to know before you use Repatha

Do not use Repathaif you are allergic to evolocumab or any of the other ingredients of this
medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Repatha if you have liver disease.
The needle cap of the pre-filled glass syringe contains dry natural rubber (a derivative of
latex), which may cause severe allergic reactions.
In order to improve the traceability of this medicine, your doctor or pharmacist must record the
name and batch number of the product that has been administered to you in your patient file. You
may also note these details, should this information be requested of you in the future.

Children and adolescents
The use of Repatha has been studied in children aged 10 years and over who are being treated for
heterozygous or homozygous familial hypercholesterolemia.
The use of Repatha has not been studied in children under 10 years of age.

Other medicines and Repatha
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Repatha has not been studied in pregnant women. It is not known whether Repatha is harmful to the
unborn child.
It is not known whether Repatha passes into breast milk.
It is important that you tell your doctor if you are breastfeeding or are planning to breastfeed. Your doctor
will then help you decide whether to stop breastfeeding or stop taking Repatha, considering the
benefit of breastfeeding for the child and the benefit of Repatha for the mother.

Driving and using machines
Repatha does not affect or has a negligible effect on the ability to drive and operate machines.

Repatha contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. How to use Repatha

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor.
The recommended dose depends on your underlying conditions:

• for adults with primary hypercholesterolemia and mixed dyslipidemia the dose is 140 mg every two weeks or 420 mg once a month.
• for children aged 10 years and over with heterozygous familial hypercholesterolemia the dose is 140 mg every two weeks or 420 mg once a month.
• for adults or children aged 10 years and over with homozygous familial hypercholesterolemia the recommended starting dose is 420 mg once a month. After 12 weeks, your doctor may decide to increase the dose to 420 mg every two weeks. If you are also undergoing apheresis, a procedure similar to dialysis in which cholesterol and other fats are removed from the blood, your doctor may decide to start treatment at a dose of 420 mg every two weeks, coinciding with the apheresis.
• for adults with established atherosclerotic cardiovascular disease (a history of heart attack, stroke, or blood vessel problems) the dose is 140 mg every two weeks or 420 mg once a month.

Repatha is administered by subcutaneous injection.
If your doctor prescribes a 420 mg dose, you must use three prefilled syringes because each
prefilled syringe contains only 140 mg of medicine. After reaching room temperature,
all injections must be given within 30 minutes.
If your doctor decides that Repatha injections can be performed by you or the person who
cares for you, you will need to be trained on how to prepare and inject the medicine correctly. Do not
attempt to administer the Repatha injection before receiving instructions on how to do so from your doctor
or nurse.
For instructions regarding storage, preparation and administration of injections of
Before starting treatment with Repatha, you will need to follow a diet to lower cholesterol.
You should continue to follow this diet during treatment with Repatha.
If Repatha has been prescribed together with another medicine to lower cholesterol,
follow your doctor's instructions regarding the combined use of these medicines. In this case, read
medicinal product.

If you use more Repatha than you should
Contact your doctor or pharmacist immediately.

If you forget to take Repatha
After a missed dose, take Repatha as soon as possible. Then contact your doctor, who will
tell you when to schedule the next dose and follow the new instructions exactly.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common(may affect up to 1 in 10 people)

• Influenza (high temperature, sore throat, runny nose, cough and chills)
• Common cold, characterized by runny nose and sore throat, or sinus infection (nasopharyngitis or upper respiratory tract infections)
• Feeling unwell (nausea)
• Back pain
• Joint pain (arthralgia)
• Muscle pain
• Reactions at the injection site such as bruising, redness, bleeding, pain or swelling
• Allergic reactions including skin rash
• Headache

Uncommon(may affect up to 1 in 100 people)

• Urticaria, characterized by the appearance of red and itchy bumps on the skin
• Flu-like symptoms

Rare(may affect up to 1 in 1,000 people)

• Swelling of the face, mouth, tongue or throat (angioedema)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help to provide more information on the safety of this medicine.

5. How to store Repatha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging after
Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C–8 °C). Do not freeze.
Store in the original packaging to protect the medicine from light.
Before the injection, the pre-filled syringe can be left out of the refrigerator to
reach room temperature (up to 25 °C). This will make the injection less uncomfortable. Once
removed from the refrigerator, Repatha can be stored at room temperature (up to 25 °C) in the
original packaging and must be used within 1 month.
Do not use this medicine if you notice a change in colour or the presence of large lumps,
fragments or coloured particles.
Do not dispose of any medicine in waste water or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect
the environment.

6. Contents of the pack and other information

What Repatha contains

• The active substance is evolocumab. Each pre-filled syringe contains 140 mg of evolocumab in 1 mL of solution.
• The other ingredients are proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.

Description of the appearance of Repatha and contents of the pack
Repatha is a clear to opalescent, colourless to slightly yellow solution, essentially free from particles.
Each pack contains one single-use pre-filled syringe.

Marketing Authorisation Holder and Manufacturer
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
Netherlands

Marketing Authorisation Holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
Netherlands

Manufacturer
Amgen Technology (Ireland) Unlimited Company
Pottery Road
Dun Laoghaire
Co Dublin
Ireland

Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
s.a. Amgen n.v.
Tel/Tél: +32 (0)2 7752711

Lietuva
Amgen Switzerland AG Vilniaus filialas
Tel: +370 5 219 7474

България
Амджен България ЕООД
Тел.: +359 (0)2 424 7440

Luxembourg/Luxemburg
s.a. Amgen
Belgique/Belgien
Tel/Tél: +32 (0)2 7752711

Česká republika
Amgen s.r.o.
Tel: +420 221 773 500

Magyarország
Amgen Kft.
Tel.: +36 1 35 44 700

Danmark
Amgen, filial af Amgen AB, Sverige
Tlf: +45 39617500

Malta
Amgen B.V.
The Netherlands
Tel: +31 (0)76 5732500

Deutschland
AMGEN GmbH
Tel.: +49 89 1490960

Nederland
Amgen B.V.
Tel: +31 (0)76 5732500

Eesti
Amgen Switzerland AG Vilniaus filialas
Tel: +372 586 09553

Norge
Amgen AB
Tel: +47 23308000

Ελλάδα
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Τηλ.: +30 210 3447000

Österreich
Amgen GmbH
Tel: +43 (0)1 50 217

España
Amgen S.A.
Tel: +34 93 600 18 60

Polska
Amgen Biotechnologia Sp. z o.o.
Tel.: +48 22 581 3000

France
Amgen S.A.S.
Tél: +33 (0)9 69 363 363

Portugal
Amgen Biofarmacêutica, Lda.
Tel: +351 21 422 06 06

Hrvatska
Amgen d.o.o.
Tel: +385 (0)1 562 57 20

România
Amgen România SRL
Tel: +4021 527 3000

Ireland
Amgen Ireland Limited
Tel: +353 1 8527400

Slovenija
AMGEN zdravila d.o.o.
Tel: +386 (0)1 585 1767

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Amgen Slovakia s.r.o.
Tel: +421 2 321 114 49

Italia
Amgen S.r.l.
Tel: +39 02 6241121

Suomi/Finland
Amgen AB, sivuliike Suomessa/Amgen AB, filial
i Finland
Puh/Tel: +358 (0)9 54900500

Κύπρος
C.A. Papaellinas Ltd
Τηλ.: +357 22741 741

Sverige
Amgen AB
Tel: +46 (0)8 6951100

Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888

United Kingdom (Northern Ireland)
Amgen Limited
Tel: +44 (0)1223 420305

Altre fonti d’informazioni
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu .
__________________________________________________________________________________
Instructions for use:
Repatha, single-use pre-filled syringe

o Guide to the parts
Before use		c After use
Plunger Medicinal product Syringe cylinder n a i Grey needle cap l inserted t I		a Used plunger m us Cylinder F used l e Needle d Used a Grey needle cap removed
	a i The needle is inside.

Important
Before using a single-use prefilled syringe of Repatha, read these important
information:

• Donot freeze the Repatha prefilled syringe or use one that has been frozen.
• Donot use the Repatha prefilled syringe if the package is open or damaged.
• Donot use a Repatha prefilled syringe that has fallen onto a hard surface. Some parts of the syringe may have broken even if the break is not visible. Use a new Repatha prefilled syringe.
• Donot remove the grey needle cap from the Repatha prefilled syringe unless you are ready to administer the injection.

C

Choose the injection site.

o c Upper arm a Abdomen m Thigh r a F You can use: The thigh. The abdomen, except for the area within 5 centimeters around the navel. l The outer upper arm (only if someone else is giving you the injection). e Do not choose areas where the skin is sensitive or there are bruises, redness or hardening. Avoid d injecting into areas where there are scars or stretch marks. For each injection, choose a different site. If it is necessary to use the same injection site, make sure not to inject into the same point as the previous time.

D	Clean the injection site.
n a i l a t I Before administering the injection, clean the site with an alcohol-soaked cotton ball and let it dry. a Do not touch the disinfected area again before administering the injection.

E

Remove the prefilled syringe from the packaging.

Turn the packaging over. Apply slight pressure or c a m To remove the syringe: Tear the paper off the packaging. r Place the packaging on your hand. a Turn the packaging over and apply slight pressure to the center to release the syringe onto the palm of your hand. F If you are unable to remove the prefilled syringe, apply slight pressure to the back of the packaging. l Do not grasp or pull the prefilled syringe by the plunger or the grey needle cap. You e could damage the syringe. Do not remove the grey needle cap from the prefilled syringe unless you are ready to administer the injection. d Always hold the prefilled syringe by the cylinder.

F

Inspect the medicine and the syringe.

Cap or Grey Label of syringe with expiration needle date inserted c Plunger Cylinder of the syringe a m r a Medicine F Always hold the prefilled syringe by the cylinder. Check that: The label on the prefilled syringe shows the name Repatha. l The medicine in the prefilled syringe is clear, from colorless to slightly yellow. e d Do not use the prefilled syringe if any part of the prefilled syringe appears cracked or broken. Do not use the prefilled syringe if the grey needle cap is missing or not securely attached. a Do not use the prefilled syringe if the color of the medicine is altered or there are large clumps, fragments or colored particles. n Do not use the prefilled syringe if the expiration date on the prefilled syringe has passed.

Step 2: Preparation for the injection
A	Carefully remove the grey needle cap by pulling it upwards and away from you. Do not o leave the prefilled syringe without the grey cap for more than 5 minutes. This may dry out the medicine.
1. It is normal to notice a drop of medicine on the end of the needle.		c 2. a m r a Immediately dispose of the cap in the sharps disposal container.
F Do not twist or bend the grey needle cap. The needle could be damaged. Do not put the grey needle cap back on the prefilled syringe.

B

Remove bubbles/air voids.

e d There may be bubbles/air voids in the Repatha prefilled syringe. If you notice bubbles/air voids: Hold the prefilled syringe with the needle pointing upwards. a Gently tap the cylinder of the syringe with your fingers until the bubble/air void reaches the top of the syringe. n Gently and slowly press the plunger to expel the air from the prefilled syringe. a Be careful not to expel the medicine. i l a t I Do not tap the needle of the syringe.

C	i PINCH the injection site to create a stable surface.
z n e g A Firmly grasp a portion of skin with your thumb and other fingers, forming a fold about 5 centimeters wide. It is important to keep the skin raised during the injection.

Step 3: Injection
A	Keep the skin pinched. Insert the needle into the skin at a 45-90° angle.
o c a m Do not hold your finger on the plunger while inserting the needle.

B	a PRESS the plunger, applying slow and steady pressure until the syringe is empty.
d e l F

C	a Once finished, RELEASE your thumb and gently pull the syringe out of the skin.
n a i l a t I Do not put the grey needle cap back on the used syringe.

Step 4: Final step
A	Immediately dispose of the used syringe in the sharps disposal container.
o c a m r a F Ask your healthcare provider for the proper method for proper disposal. There may be specific local guidelines. Do not reuse a used syringe. l Do not use any remaining medicine in a used syringe. e Do not recycle the syringe or the sharps disposal container or throw them in the household waste. d Keep the used syringe and the sharps disposal container out of sight and reach of children.

Repatha 140 mg injectable solution in pre-filled pen

evolocumab

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• The warnings and instructions in this document are intended for the person taking the medicine. Parents or responsible caregivers administering the medicine to others, such as a child, must follow the information accordingly.

Contents of this leaflet

• 1. What Repatha is and what it is used for
• 2. What you need to know before you use Repatha
• 3. How to use Repatha
• 4. Possible side effects
• 5. How to store Repatha
• 6. Contents of the pack and other information

1. What is Repatha and what is it used for

What is Repatha and how does it work
Repatha is a medicine that lowers levels of “bad” cholesterol, a type of fat present in the
blood.
Repatha contains evolocumab as the active substance, a monoclonal antibody (a type of specialized protein
designed to bind to a target substance in the human body). Evolocumab is
designed to bind to a substance called PCSK9 which influences the liver's ability to
remove cholesterol. The medicine, by binding to and removing PCSK9, increases the amount of
cholesterol that enters the liver, thus lowering cholesterol levels in the blood.

What is Repatha used for
Repatha is used in addition to diet to lower cholesterol:

• in adults with high cholesterol levels in the blood (primary hypercholesterolemia [heterozygous and non-familial] or mixed dyslipidemia). It is administered:
• together with a statin or another cholesterol-lowering medicine, if the maximum dose of a statin does not lower cholesterol levels sufficiently.
• alone or together with other cholesterol-lowering medicines when statins do not work well or cannot be used.
• in children aged 10 years and over with high cholesterol levels in the blood caused by a hereditary condition (heterozygous familial hypercholesterolemia or HeFH). It is administered alone or together with other cholesterol-lowering treatments.
• in adults and children aged 10 years and over with high cholesterol levels in the blood caused by a hereditary condition (homozygous familial hypercholesterolemia or HoFH). It is administered together with other cholesterol-lowering treatments.
• in adults with high cholesterol levels in the blood and established atherosclerotic cardiovascular disease (history of heart attack, stroke, or blood vessel problems). It is administered:
• together with a statin or another cholesterol-lowering medicine, if the maximum dose of a statin does not lower cholesterol levels sufficiently.
• alone or together with other cholesterol-lowering medicines when statins do not work well or cannot be used.

Repatha is used in patients who are unable to control their cholesterol levels through diet alone
aimed at lowering them. During treatment with this medicine you should
continue to follow your cholesterol-lowering diet. Repatha may help prevent a
heart attack, stroke, and some cardiac procedures to restore blood flow to the heart
due to the accumulation of fat deposits in the arteries (also known as atherosclerotic cardiovascular
disease).

2. What you need to know before you use Repatha

Do not use Repathaif you are allergic to evolocumab or any of the other ingredients of this
medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Repatha if you have a liver disease.
The needle cap of the pre-filled glass pen contains dry natural rubber (a derivative of
latex), which may cause severe allergic reactions.
In order to improve the traceability of this medicine, your doctor or pharmacist must record the
name and batch number of the product that has been administered to you in your patient file. You
may also take note of these details, should you be asked for this information in the future.

Children and adolescents
The use of Repatha has been studied in children aged 10 years and over who are being treated for
heterozygous or homozygous familial hypercholesterolemia.
The use of Repatha has not been studied in children under 10 years of age.

Other medicines and Repatha
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Repatha has not been studied in pregnant women. It is not known whether Repatha is harmful to the
unborn child.
It is not known whether Repatha passes into breast milk.
It is important that you tell your doctor if you are breastfeeding or planning to breastfeed. Your doctor
will then help you decide whether to stop breastfeeding or stop taking Repatha, considering the
benefit of breastfeeding for the baby and the benefit of Repatha for the mother.

Driving and using machines
Repatha does not or negligibly alters the ability to drive vehicles or use machines.

Repatha contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

3. How to use Repatha

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor.
The recommended dose depends on your underlying conditions:

• for adults with primary hypercholesterolemia and mixed dyslipidemia the dose is 140 mg every two weeks or 420 mg once a month.
• for children aged 10 years or older with heterozygous familial hypercholesterolemia the dose is 140 mg every two weeks or 420 mg once a month.
• for adults or children aged 10 years or older with homozygous familial hypercholesterolemia the recommended initial dose is 420 mg once a month. After 12 weeks, your doctor may decide to increase the dose to 420 mg every two weeks. If you are also undergoing apheresis, a procedure similar to dialysis in which cholesterol and other fats are removed from the blood, your doctor may decide to start treatment at a dose of 420 mg every two weeks, coinciding with the apheresis.
• for adults with established atherosclerotic cardiovascular disease (a history of heart attack, stroke, or blood vessel problems) the dose is 140 mg every two weeks or 420 mg once a month.

Repatha is administered by subcutaneous injection.
If your doctor prescribes a 420 mg dose, you must use three pre-filled pens because each pre-filled
pen contains only 140 mg of medicine. After reaching room temperature, all
injections must be given within 30 minutes.
If your doctor decides that Repatha injections can be performed by you or the person who
cares for you, you will need to be trained on how to prepare and inject the medicine correctly. Do not
attempt to perform the Repatha injection before receiving instructions on how to do so from your doctor
or nurse.
For instructions regarding the method of storage, preparation and performance of pre-filled
pen injections, before administering the injection, position the correct end (yellow) of the
pen on the skin.
Before starting treatment with Repatha, you should follow a diet to lower cholesterol.
You should continue to follow this diet during treatment with Repatha.
If Repatha has been prescribed together with another medicine for lowering cholesterol,
follow your doctor's instructions regarding the combined use of these medicines. In this case, read the
package leaflet.

If you use more Repatha than you should
Contact your doctor or pharmacist immediately.

If you forget to take Repatha
After a missed dose, take Repatha as soon as possible. Then contact your doctor, who will
tell you when to schedule the next dose and follow the new instructions exactly.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common(may affect up to 1 in 10 people)

• Influenza (high temperature, sore throat, runny nose, cough and chills)
• Common cold, characterized by runny nose and sore throat, or sinus infection (nasopharyngitis or upper respiratory tract infections)
• Feeling unwell (nausea)
• Back pain
• Joint pain (arthralgia)
• Muscle pain
• Reactions at the injection site such as bruising, redness, bleeding, pain or swelling
• Allergic reactions including rash
• Headache

Uncommon(may affect up to 1 in 100 people)

• Urticaria, characterized by the appearance of red and itchy bumps on the skin
• Flu-like symptoms

Rare(may affect up to 1 in 1,000 people)

• Swelling of the face, mouth, tongue or throat (angioedema)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help to provide more information on the safety of this medicine.

5. How to store Repatha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the package after
Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C–8 °C). Do not freeze.
Store in the original package to protect the medicine from light.
Before the injection, the pre-filled pen can be left out of the refrigerator to allow it to
reach room temperature (up to 25 °C). This will make the injection less uncomfortable. Once
removed from the refrigerator, Repatha can be stored at room temperature (up to 25 °C) in the
original package and must be used within 1 month.
Do not use this medicine if you notice a change in colour or the presence of large lumps,
fragments or coloured particles.
Do not dispose of any medicine in wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect
the environment.

6. Contents of the pack and other information

What Repatha contains

• The active substance is evolocumab. Each SureClick pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.
• The other ingredients are proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.

Description of the appearance of Repatha and contents of the pack
Repatha is a solution from clear to opalescent, from colourless to slightly yellow and practically free
from particles.
Each pack contains one, two, three or six single-use SureClick pre-filled pens.

Marketing Authorisation Holder and Manufacturer
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
Netherlands

Marketing Authorisation Holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
Netherlands

Manufacturer
Amgen Technology (Ireland) Unlimited Company
Pottery Road
Dun Laoghaire
Co Dublin
Ireland

Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
s.a. Amgen n.v.
Tel/Tél: +32 (0)2 7752711

Lietuva
Amgen Switzerland AG Vilniaus filialas
Tel: +370 5 219 7474

България
Амджен България ЕООД
Тел.: +359 (0)2 424 7440

Luxembourg/Luxemburg
s.a. Amgen
Belgique/Belgien
Tel/Tél: +32 (0)2 7752711

Česká republika
Amgen s.r.o.
Tel: +420 221 773 500

Magyarország
Amgen Kft.
Tel.: +36 1 35 44 700

Danmark
Amgen, filial af Amgen AB, Sverige
Tlf: +45 39617500

Malta
Amgen B.V.
The Netherlands
Tel: +31 (0)76 5732500

Deutschland
AMGEN GmbH
Tel.: +49 89 1490960

Nederland
Amgen B.V.
Tel: +31 (0)76 5732500

Eesti
Amgen Switzerland AG Vilniaus filialas
Tel: +372 586 09553

Norge
Amgen AB
Tel: +47 23308000

Ελλάδα
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Τηλ.: +30 210 3447000

Österreich
Amgen GmbH
Tel: +43 (0)1 50 217

España
Amgen S.A.
Tel: +34 93 600 18 60

Polska
Amgen Biotechnologia Sp. z o.o.
Tel.: +48 22 581 3000

France
Amgen S.A.S.
Tél: +33 (0)9 69 363 363

Portugal
Amgen Biofarmacêutica, Lda.
Tel: +351 21 422 06 06

Hrvatska
Amgen d.o.o.
Tel: +385 (0)1 562 57 20

România
Amgen România SRL
Tel: +4021 527 3000

Ireland
Amgen Ireland Limited
Tel: +353 1 8527400

Slovenija
AMGEN zdravila d.o.o.
Tel: +386 (0)1 585 1767

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Amgen Slovakia s.r.o.
Tel: +421 2 321 114 49

Italia
Amgen S.r.l.
Tel: +39 02 6241121

Suomi/Finland
Amgen AB, sivuliike Suomessa/Amgen AB, filial
i Finland
Puh/Tel: +358 (0)9 54900500

Κύπρος
C.A. Papaellinas Ltd
Τηλ.: +357 22741 741

Sverige
Amgen AB
Tel: +46 (0)8 6951100

Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888

United Kingdom (Northern Ireland)
Amgen Limited
Tel: +44 (0)1223 420305

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu .
__________________________________________________________________________________
Instructions for use:
Repatha, single-use SureClick pre-filled pen

c Guide to the parts
Before use Grey start button Expiry date a n Window a i l Medicinal a Device t Orange-yellow safety cap inserted (needle a inside) i z		a After use m r Expiry date a F l e d Yellow window (injection completed) Yellow safety device (needle inside) Orange cap removed
	n Important: The needle is inside the yellow safety device.

Important
Before using the Repatha pre-filled pen, read the following important information:

• Do notfreeze the Repatha pre-filled pen or use one that has been frozen.
• Do notremove the orange cap from the Repatha pre-filled pen unless you are ready to administer the injection.
• Do notuse a Repatha pre-filled pen that has fallen onto a hard surface. Some parts of the pen may have been broken even if the break is not visible.

Step 1: Preparation
ARemove a prefilled Repatha pen from the packaging.

• 1. Remove the prefilled pen from the packaging in an upright position and with caution.
• 2. If the packaging contains other prefilled pens that have not yet been used, store it in the refrigerator.
• 3. Before proceeding with the injection, wait at least 30 minutes to allow the prefilled pen to naturally reach room temperature.
• Do nottry to warm the prefilled pen using heat sources such as hot water or a microwave oven.
• Do notexpose the prefilled pen to direct sunlight.
• Do notshake the prefilled pen.
• Do notremove the orange cap from the prefilled pen.

B

Check the prefilled Repatha pen.

a n Yellow safety device (needle inside) a i l a t Orange cap inserted Medicinal Window I Make sure the medicine in the appropriate window is clear, from colorless to slightly yellow. Check the expiration date. a Do not use the prefilled pen if the medicine is cloudy, discolored, or contains large clumps, fragments, or particles. i Do not use the prefilled pen if any part appears cracked or broken. z Do not use the prefilled pen if it has been dropped. n Do not use the prefilled pen if the orange cap is missing or is not securely attached. e Do not use the prefilled pen if the expiration date has passed. In all these cases, use a new prefilled pen.

C	Prepare everything needed to perform the injection.
Wash your hands thoroughly with soap and water. o On a clean and well-lit surface, prepare: A new prefilled pen. c Alcohol swabs. a A cotton ball or gauze. A bandage. A sharps disposal container.
F a r m

D

Prepare and clean the injection site.

e d Upper arm Stomach area (abdomen) a n Thigh a Use only these injection sites: i The thigh. l The stomach area (abdomen), except for the area within 5 centimeters around the navel. a Outer upper part of the arm (only if someone else is giving you the injection). t Clean the site with an alcohol swab and let it dry. I Do not touch the disinfected area again before performing the injection. Choose a different site for each injection. If it is necessary to use the same injection site, make sure not to inject in the same spot as the previous time. a Do not inject into areas where the skin is sensitive or there are bruises, redness, or hardening. Avoid injecting into areas where there are scars or stretch marks.

Step 2: Preparation for the injection
A	Remove the orange cap by pulling it horizontally only when you are ready to perform the injection. Do not leave the prefilled pen without the orange cap for more than 5 minutes. This may dry out the medicine.
c a m r a Orange cap F It is normal to notice a drop of liquid on the end of the needle or on the yellow safety device. Do not rotate, bend, or move the orange cap back and forth. l Do not reposition the orange cap on the prefilled pen. e Do not touch the yellow safety device with your fingers. d Important: Do not remove the orange cap from the prefilled pen if you are not ready to perform the injection. If you are unable to perform the injection, contact your healthcare provider.

B	Create a stable surface at the chosen injection site (thigh, stomach, or outer upper arm) using the distension method or the pinch method.
o Distension method c a m r a Stretch the skin well by moving your thumb and other fingers in the opposite direction, so as to create an area about 5 centimeters wide. F OR Pinch method l e d a n a i l Firmly grasp a portion of skin with your thumb and other fingers forming a fold about 5 centimeters wide. Important: It is important to keep the skin stretched or raised during the injection.

Step 3: Injection
A	Continue to hold the skin stretched or pinched. After removing the orange cap, position the yellow safety device on the skin at a 90° angle. The needle is inside the yellow safety device. Do not touch the gray start button yet.
c a m Yellow safety device (needle inside) r a F

B	Press the prefilled pen firmly against the skin until it stops moving.
i a n a d
l a Important: Press down as much as possible but do not touch the gray button until you are ready to perform the injection.

C	As soon as you are ready to perform the injection, press the gray button. You will hear a click.
I a “click” i z n e g

D	Continue to press down on the skin. Then lift your thumb while keeping the prefilled pen on the skin. The injection may take about 15 seconds.
o “click” c 15 seconds a m r Once the injection is complete, the transparent window will turn yellow. You may hear a second click.
F l NOTE: After lifting the prefilled pen from the skin, the needle will be automatically covered.

Step 4: Final step
A	Dispose of the prefilled pen and the orange cap.
a n a i l a t I Dispose of the prefilled pen and the orange cap in a sharps disposal container. Ask your healthcare provider for the appropriate method for proper disposal. There may be specific local guidelines. Keep the prefilled pen and the sharps disposal container out of the sight and reach of children. Do not reuse the prefilled pen. n Do not reposition the cap on the prefilled pen or touch the yellow safety device with your fingers. e Do not recycle the prefilled pen or the sharps disposal container or throw them in household waste.

Repatha 420 mg injectable solution in cartridge

evolocumab

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• The warnings and instructions in this document are intended for the person taking the medicine. Parents or caregivers responsible for administering the medicine to others, such as a child, must follow the information accordingly.

Contents of this leaflet

• 1. What Repatha is and what it is used for
• 2. What you need to know before you use Repatha
• 3. How to use Repatha
• 4. Possible side effects
• 5. How to store Repatha
• 6. Contents of the pack and other information

1. What is Repatha and what is it used for

What is Repatha and how does it work
Repatha is a medicine that lowers levels of “bad” cholesterol, a type of fat present in the
blood.
Repatha contains evolocumab as the active ingredient, a monoclonal antibody (a type of specialized protein
designed to bind to a target substance in the human body). Evolocumab is
designed to bind to a substance called PCSK9 which influences the liver's ability to
remove cholesterol. The medicine, by binding to and removing PCSK9, increases the amount of
cholesterol that enters the liver, thus lowering cholesterol levels in the blood.

What is Repatha used for
Repatha is used in addition to diet to lower cholesterol:

• in adults with high levels of cholesterol in the blood (primary hypercholesterolemia [familial heterozygous and non-familial] or mixed dyslipidemia). It is administered:
• together with a statin or another cholesterol-lowering medicine, if the maximum dose of a statin does not lower cholesterol levels sufficiently.
• alone or together with other cholesterol-lowering medicines when statins do not work well or cannot be used.
• in children aged 10 years and over with high levels of cholesterol in the blood caused by a hereditary condition (familial heterozygous hypercholesterolemia or HeFH). It is administered alone or together with other cholesterol-lowering treatments.
• in adults and children aged 10 years and over with high levels of cholesterol in the blood caused by a hereditary condition (homozygous familial hypercholesterolemia or HoFH). It is administered together with other cholesterol-lowering treatments.
• in adults with high levels of cholesterol in the blood and established atherosclerotic cardiovascular disease (history of heart attack, stroke, or blood vessel problems). It is administered:
• together with a statin or another cholesterol-lowering medicine, if the maximum dose of a statin does not lower cholesterol levels sufficiently.
• alone or together with other cholesterol-lowering medicines when statins do not work well or cannot be used.

Repatha is used in patients who are unable to control their cholesterol levels through diet alone
aimed at lowering them. During treatment with this medicine you should
continue to follow your cholesterol-lowering diet. Repatha can help prevent a
heart attack, stroke, and some cardiac procedures to restore blood flow to the heart
due to the accumulation of fat deposits in the arteries (also known as atherosclerotic cardiovascular
disease).

2. What you need to know before you use Repatha

Do not use Repathaif you are allergic to evolocumab or any of the other ingredients of this
medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Repatha if you have a liver disease.
In order to improve the traceability of this medicine, your doctor or pharmacist must record the
name and batch number of the product that has been administered to you in your patient record. You
may also take note of these details, should this information be requested from you in the future.

Children and adolescents
The use of Repatha has been studied in children aged 10 years and over who are being treated for
heterozygous or homozygous familial hypercholesterolaemia.
The use of Repatha has not been studied in children under 10 years of age.

Other medicines and Repatha
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Repatha has not been studied in pregnant women. It is not known whether Repatha is harmful to the
unborn child.
It is not known whether Repatha passes into breast milk.
It is important that you tell your doctor if you are breastfeeding or are planning to breastfeed. Your doctor
will then help you decide whether to stop breastfeeding or stop taking Repatha, considering the
benefit of breastfeeding for the baby and the benefit of Repatha for the mother.

Driving and using machines
Repatha does not affect, or has a negligible effect on, the ability to drive and operate machines.

Repatha contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. How to use Repatha

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor.
The recommended dose depends on your underlying conditions:

• for adults with primary hypercholesterolemia and mixed dyslipidemia the dose is 140 mg every two weeks or 420 mg once a month.
• for children aged 10 years or older with heterozygous familial hypercholesterolemia the dose is 140 mg every two weeks or 420 mg once a month.
• for adults or children aged 10 years or older with homozygous familial hypercholesterolemia the recommended initial dose is 420 mg once a month. After 12 weeks, your doctor may decide to increase the dose to 420 mg every two weeks. If you are also undergoing apheresis, a procedure similar to dialysis in which cholesterol and other fats are removed from the blood, your doctor may decide to start treatment at a dose of 420 mg every two weeks, coinciding with the apheresis.
• for adults with established atherosclerotic cardiovascular disease (a history of heart attack, stroke, or blood vessel problems) the dose is 140 mg every two weeks or 420 mg once a month.

Repatha is administered by subcutaneous injection.
If your doctor decides that Repatha injections can be performed by you or the person who
cares for you using the automatic mini-doser, you will need to be trained on how to prepare and
inject the medicine correctly. Do not attempt to use the automatic mini-doser before
receiving instructions on how to use it from your doctor or nurse. In case of use of the
automatic mini-doser by children between 10 and 13 years of age, adult supervision is recommended.
For instructions regarding storage, preparation and use of the mini-doser
Before starting treatment with Repatha, you will need to follow a diet to lower cholesterol.
You should continue to follow this diet during treatment with Repatha.
If Repatha has been prescribed together with another medicine to lower cholesterol,
follow your doctor's instructions regarding the combined use of these medicines. In this case, read
medicinal product.

If you use more Repatha than you should
Contact your doctor or pharmacist immediately.

If you forget to take Repatha
After a missed dose, take Repatha as soon as possible. Then contact your doctor, who will
tell you when to schedule the next dose and follow the new instructions exactly.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common(may affect up to 1 in 10 people)

• Influenza (high temperature, sore throat, runny nose, cough and chills)
• Common cold, characterized by runny nose and sore throat, or sinus infection (nasopharyngitis or upper respiratory tract infections)
• Feeling unwell (nausea)
• Back pain
• Joint pain (arthralgia)
• Muscle pain
• Reactions at the injection site such as bruising, redness, bleeding, pain or swelling
• Allergic reactions including skin rash
• Headache

Uncommon(may affect up to 1 in 100 people)

• Urticaria, characterized by the appearance of red and itchy bumps on the skin
• Flu-like symptoms

Rare(may affect up to 1 in 1,000 people)

• Swelling of the face, mouth, tongue or throat (angioedema)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Repatha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging after
Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Store in the original packaging to protect the medicine from light and moisture.
The medicine (cartridge and auto-injector) may be left out of the refrigerator to
reach room temperature (up to 25 °C) before injection. This will make the injection
less uncomfortable. Once removed from the refrigerator, Repatha can be stored at room temperature
(up to 25 °C) in the original packaging and must be used within 1 month.
Do not use this medicine if you notice a change in colour or the presence of large lumps,
fragments or coloured particles.
Do not dispose of any medicine in waste water or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect
the environment.

6. Content of the pack and other information

What Repatha contains

• The active substance is evolocumab. Each cartridge contains 420 mg of evolocumab in 3.5 mL of solution (120 mg/mL).
• The other ingredients are proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.

Description of the appearance of Repatha and contents of the pack
Repatha is a solution from clear to opalescent, from colourless to slightly yellow and practically free
from particles.
Each pack contains one single-use cartridge and one single-use automatic mini-injector.

Marketing Authorisation Holder and Manufacturer
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
Netherlands

Marketing Authorisation Holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
Netherlands

Manufacturer
Amgen Technology (Ireland) Unlimited Company
Pottery Road
Dun Laoghaire
Co Dublin
Ireland

Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
s.a. Amgen n.v.
Tel/Tél: +32 (0)2 7752711

Lietuva
Amgen Switzerland AG Vilniaus filialas
Tel: +370 5 219 7474

България
Амджен България ЕООД
Тел.: +359 (0)2 424 7440

Luxembourg/Luxemburg
s.a. Amgen
Belgique/Belgien
Tel/Tél: +32 (0)2 7752711

Česká republika
Amgen s.r.o.
Tel: +420 221 773 500

Magyarország
Amgen Kft.
Tel.: +36 1 35 44 700

Danmark
Amgen, filial af Amgen AB, Sverige
Tlf: +45 39617500

Malta
Amgen B.V.
The Netherlands
Tel: +31 (0)76 5732500

Deutschland
AMGEN GmbH
Tel.: +49 89 1490960

Nederland
Amgen B.V.
Tel: +31 (0)76 5732500

Eesti
Amgen Switzerland AG Vilniaus filialas
Tel: +372 586 09553

Norge
Amgen AB
Tel: +47 23308000

Ελλάδα
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Τηλ.: +30 210 3447000

Österreich
Amgen GmbH
Tel: +43 (0)1 50 217

España
Amgen S.A.
Tel: +34 93 600 18 60

Polska
Amgen Biotechnologia Sp. z o.o.
Tel.: +48 22 581 3000

France
Amgen S.A.S.
Tél: +33 (0)9 69 363 363

Portugal
Amgen Biofarmacêutica, Lda.
Tel: +351 21 422 06 06

Hrvatska
Amgen d.o.o.
Tel: +385 (0)1 562 57 20

România
Amgen România SRL
Tel: +4021 527 3000

Ireland
Amgen Ireland Limited
Tel: +353 1 8527400

Slovenija
AMGEN zdravila d.o.o.
Tel: +386 (0)1 585 1767

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Amgen Slovakia s.r.o.
Tel: +421 2 321 114 49

Italia
Amgen S.r.l.
Tel: +39 02 6241121

Suomi/Finland
Amgen AB, sivuliike Suomessa/Amgen AB, filial
i Finland
Puh/Tel: +358 (0)9 54900500

Kύπρος
C.A. Papaellinas Ltd
Τηλ.: +357 22741 741

Sverige
Amgen AB
Tel: +46 (0)8 6951100

Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888

United Kingdom (Northern Ireland)
Amgen Limited
Tel: +44 (0)1223 420305

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .
Instructions for use:
Repatha single-use cartridge and automatic mini-injector

Guide to the parts
Cartridge
Top of the
cartridge
White plunger (Do not rotate)

Bottom of the cartridge
Cartridge
label
Medicinal product

Automatic mini-injector
Front viewStart button
(Do not press until
you are ready for
the injection)
Skin status
indicator sticker

Cartridge door
(Do not close without the
Medicinal product
window
Pull tabs
cartridge)

Rear viewBattery cover Adhesive label

Battery strap
Needle inside
(Under the
cover)
Left pull tab Right
pull tab

Important:the needle is inside.

Important
Before using the automatic mini-injector and Repatha cartridge, read this important
information:
Storage of the automatic mini-injector and cartridge

• Keep the automatic mini-injector and cartridge out of the sight and reach of children.
• Donot store the automatic mini-injector and cartridge in extremely hot or cold places. For example, do not store them in the glove compartment or boot of the car. Donot freeze. Using the automatic mini-injector and cartridge
• Donot shake the automatic mini-injector or cartridge.
• Donot remove the automatic mini-injector and cartridge from the packaging or transparent tray unless you are ready to administer the injection.
• Donot touch the start button until the loaded automatic mini-injector and cartridge are positioned on the skin and you are ready to administer the injection.
• If the automatic mini-injector and cartridge are used by children up to 13 years of age, adult supervision is recommended.
• The start button can only be pressed once. If an error occurs, the automatic mini-injector cannot be used.
• Donot use the automatic mini-injector and cartridge if they have fallen onto a hard surface. Some parts of the automatic mini-injector and cartridge may be broken even if there are no visible signs of breakage. Use a new automatic mini-injector and a new cartridge.
• Donot reuse the automatic mini-injector and cartridge. The automatic mini-injector and cartridge are for single use only.
• Donot wet the automatic mini-injector and cartridge with water or any other liquid. They contain electronic components that must not be wetted.
• The single-use automatic mini-injector for subcutaneous injection must be used exclusively with the cartridge. If any of the above occurs, use a new automatic mini-injector and a new cartridge. A healthcare professional familiar with Repatha will be able to answer your questions.

B	F Open the pack and remove the white paper sticker. Remove the cover of the automatic mini-injector from the transparent tray.
l Transparent tray and Automatic mini-injector d Plastic cover Cartridge a n a
i Leave the automatic mini-injector and cartridge in the transparent tray until you are ready to administer the injection. Do not touch the start button until the automatic mini-injector is positioned on the skin and you are ready to administer the injection. l Do not use if the white paper sticker is missing or damaged.

C	R Collect the necessary materials for the injection and then wash your hands thoroughly with soap and water.
o On a clean and well-lit surface, prepare: The transparent tray with the automatic mini-injector and cartridge c Alcohol swabs a A cotton ball or gauze A plaster m A sharps container r a F l

DChoose where to position the mini-doser. Use the outer part of your arm only if
the injection is performed by another person.
You can use:

• The thigh
• The abdomen, except for the area of 5centimeters around the navel
• The outer upper part of the arm (only if the injection is performed by another person)

Upper arm
Abdomen
Thigh
Clean the site with a cotton ball soaked in alcohol and let it dry.

• Do nottouch the disinfected area again before performing the injection.
• Do notperform the injection in areas where the skin is sensitive or there are bruises, redness or hardening. Avoid injecting in areas where there are wrinkles, skin folds, scars, stretch marks, moles and fluff. If it is necessary to use the same injection site, make sure not to inject in the same point as the previous time. Important: To firmly apply the automatic mini-doser, it is important to use atonic and smooth skin surface.

Step 2: Preparation for the injection
E	Open the automatic mini-doser by moving the cartridge door to the right. Then leave the door open.
o c a Do not press the start button m until you are ready to perform the injection. r

F

Check the cartridge.

F Cartridge label Top of cartridge (do not rotate) l Bottom and of the cartridge Medicine White plunger Expiration date d a n a i l Make sure the medicine in the cartridge is clear, from colorless to slightly yellow. a Do not use if the medicine is cloudy and discolored or contains fragments or particles. Do not use if any part of the cartridge shows cracks or signs of breakage. t Do not use if the parts of the cartridge are missing or not securely attached. I Do not use if the expiration date indicated on the cartridge has been exceeded. If any of the above cases occur, use a new automatic mini-doser and a new cartridge.

G	Clean the bottom of the cartridge.
o c a m r a F l e Hold the cartridge here With one hand, hold the cartridge cylinder and clean the bottom of the cartridge with a d cotton ball soaked in alcohol. Do not touch the bottom of the cartridge after cleaning it with the alcohol-soaked cotton ball. Do not remove or rotate the top or bottom of the cartridge.

H	n Load the clean cartridge into the automatic mini-doser and press firmly on the top until it is locked into place.
a i l a t Load the Press vertically cartridge with firmly a i z n First insert the bottom of the cartridge. Do not insert the cartridge more than 5 minutes before the injection. The medicine may dry out.
e Do not touch the start button until the loaded automatic mini-doser is positioned on the skin.

I

Move the door to the left. Then press firmly until it clicks into position.

o Press firmly c a m r click to F l e Before closing the door, make sure the cartridge is securely attached to the mini-doser automatic. d Do not close the door if the cartridge is not present or has not been inserted completely. Do not touch the start button until the loaded automatic mini-doser is positioned on the skin. Important: after loading the automatic mini-doser, proceed immediately to the next step.

Step 3: Injection
J	Remove both green tear-off tabs to expose the adhesive. The mini-doser automatic is on when the blue status light flashes.
o Right tear-off tab Flashing light c right a m Bip-bip-bip r a F Left tear-off tab Skin adhesive l You must remove both green tear-off tabs to turn on the automatic mini-doser and loaded. You will hear a beep (audible beep) and notice a flashing blue light. Do not touch the skin adhesive. Do not touch the start button until the loaded automatic mini-doser is positioned on the skin. Do not touch or contaminate the needle cover area. Do not place the loaded automatic mini-doser on the body if the red light flashes for more than 5 seconds. Do not remove the skin adhesive from the automatic mini-doser. Do not fold the skin adhesive over itself.

KTo be able to firmly apply the automatic mini-doser, prepare and clean the injection site with less fluff, or shave the area. Use atonic and smooth skin surface.
Application on the abdomen Application on the thigh

OR

Method to stretch the abdominal skin Do notstretch the skin of the thighs

Important: correct the posture of the body to avoid the formation of skin folds or
swellings.

L

When the blue light flashes, the automatic mini-doser is ready for use. Keep the skin stretched (only if using the abdomen for the injection). Hold the automatic mini-doser loaded so that the blue light is visible and position it on the skin. You will hear beeps.

o Flashing light c a m OR Bip-bip-bip r a F The loaded automatic mini-doser will remain resting on the body. Make sure the adhesive adheres to the skin. Run your finger along the adhesive edges to secure it. l Make sure clothing does not get caught in the loaded automatic mini-doser and that the blue light is always visible. e Do not try to reposition the loaded automatic mini-doser after applying it to the skin.

M	a Press and release the start button firmly. A flashing green light and a “click” indicate the start of the injection.
n Flashing light a i l a Bip-bip-bip t I a i You may hear a sound similar to that produced by a pump. You may feel the sting of the needle. Make sure you see the flashing green light. You may hear a beep indicating the start of the injection. z Important: If the medicine leaks from the loaded automatic mini-doser, contact your doctor or pharmacist.

N	The injection lasts about 5 minutes. When the injection is finished, the green status light remains solid and the device emits a beep.
o Flashing light c a m 5 min r a F Solid light l It is normal to hear a sound similar to that produced by a pump starting and stopping during the injection. e You can perform moderate physical activity during the injection, such as walking, stretching and bending. The injection is complete when: Bip-bip-bip The green status light becomes solid. You hear several beeps.

a Step 4: Final procedures
O	i Once the injection is finished, take the skin adhesive to gently remove the mini-doser automatic from the skin. After removal, check the medicine window. Now the green light should be off.
a Used plunger t Light off I a i Bip-bip-bip z n e Make sure the used plunger completely occupies the medicine window and the green light is off. This indicates that all the medicine has been injected. If the plunger does not occupy the window, A contact your doctor. The used automatic mini-doser will emit a beep when removed from the skin. Once the used automatic mini-doser is removed, it is normal to see a couple of drops of liquid on the skin.

Troubleshooting
What to do if the loaded automatic mini-doser light is red and continues to flash and if you hear a beep.

P

Dispose of the automatic mini-doser in a sharps disposal container.

o The automatic mini-doser contains batteries, electronic components and c a needle. Dispose of the used automatic mini-doser in a sharps disposal container immediately after use. Do not dispose of (discard) the automatic mini-doser in household waste. Discuss appropriate disposal methods with your doctor; there may indeed be specific local guidelines. Do not remove the used cartridge from the automatic mini-doser. Do not reuse the automatic mini-doser. Do not recycle the automatic mini-doser or the sharps disposal container and do not throw them in household waste. Important: always keep the sharps disposal container out of sight and reach of children.

Flashing light

beep-beep-beep-beep-beep

Stopusing the loaded automatic mini-doser. If the automatic mini-doser is applied on the skin, remove it gently.

Further environmental conditions
The relative humidity range is 15%-85%.
The altitude range is between -300 meters and 3,500 meters.
During the injection, keep the automatic mini-doser at a distance of at least 30 cm from other
electronic devices, such as mobile phones.
Warning: do not modify the device.
The temperature range for the automatic mini-doser operation is 15°C - 40°C.
www.devicepatents.com

TABLE OF SYMBOLS
Do not use if the packaging is damaged	Store in a dry place	Consult the Instructions for use	BF type applied part	m r a Single use	Sterilized with ethylene oxide

0344

Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, U.S.A.

Amgen Europe B.V., Minervum 7061, 4817 ZK, Breda, Netherlands