InfoCons Consumer Protection informs you – Repatha – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• The warnings and instructions in this document are intended for the person taking the medicine.

If you are a parent or carer responsible for giving the medicine to someone else, such as a child, you will need to apply the information accordingly .

ℹ️ 1. What Repatha is and what it is used for

What Repatha is and how it works Repatha is a medicine that lowers levels of ‘bad’ cholesterol, a type of fat, in the blood.

Repatha contains the active substance evolocumab, a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body). Evolocumab is designed to attach to a substance called PCSK9 that affects the liver’s ability to take in cholesterol. By attaching to, and mopping up PCSK9, the medicine increases the amount of cholesterol entering the liver and so lowers the level of cholesterol in the blood.

What Repatha is used for

Repatha is used in addition to your cholesterol lowering diet if you are:

• an adult with a high cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non -familial] or mixed dyslipidaemia). It is given:
• together with a statin or other cholesterol lowering medication, if the maximum dose of a statin does not lower levels of cholesterol sufficiently.
• alone or together with other cholesterol lowering medications when statins do not work well or cannot be used.
• a child aged 10 years and older with a high cholesterol level in your blood because of a condition that runs in your family (heterozygous familial hypercholesterolaemia or HeFH). It is given alone or together with other cholesterol lowering treatments 78 • an adult or a child aged 10 years and older with a high cholesterol level in your blood because of a condition that runs in your family (homozygous familial hypercholesterolaemia or HoFH).

It is given together with other cholesterol lowering treatments.

• an adult with a high cholesterol level in your blood , who already has atherosclerotic cardiovascular disease or at high risk of developing a cardiovascular event . It is given:
• together with a statin or other cholesterol lowering medication, if the maximum dose of a statin does not lower levels of cholesterol sufficiently.
• alone or together with other cholesterol lowering medications when statins do not work well or cannot be used.

Repatha is used in patients who cannot control their cholesterol levels with a cholesterol lowering diet alone. You should stay on your cholesterol lowering diet while taking this medicine. In patients who are at high risk of developing a cardiovascular event, Repatha can help prevent heart attack, stroke, and certain heart procedures to restore blood flow to the heart due to a build -up of fatty deposits in your arteries (also known as atherosclerotic cardiovascular disease).

⚠️ 2. What you need to know before you use Repatha

Do not use Repatha if 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.

In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and the lot number of the product you have been given in your patient file. You may also wish to make a note of these details in case you are asked for this information in the future.

Children and adolescents

The use of Repatha has been studied in children 10 years of age and older 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 breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Repatha has not been tested in pregnant women. It is not known if Repatha will harm your unborn baby.

It is not known whether Repatha is found in breast milk.

It is important to tell your doctor if you are breast -feeding or plan to do so. Your doctor will then help you decide whether to stop breast -feeding, or whether to stop taking Repatha, considering the benefit of breast -feeding to the baby and the benefit of Repatha to the mother.

79 Driving and using machines Repatha has no or negligible influence on the ability to drive and use machines.

Repatha contains sodium

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

Repatha contains proline

This medicine contains 25 mg of proline in each 1.0 mL of 140 mg/mL evolocumab. Proline may be harmful for patients with hyperprolinaemia, a rare genetic disorder in which proline builds up in the body. If you (or your child) have hyperprolinaemia, do not use this medicine unless your doctor has recommended it.

💊 3. How to use Repatha

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

The recommended dose depends on the underlying condition:

• for adults with primary hypercholesterolaemia and mixed dyslipidaemia the dose is either 140 mg every two weeks or 420 mg once monthly.
• for children aged 10 years or older with heterozygous familial hypercholesterolaemia the dose is either 140 mg every two weeks or 420 mg once monthly.
• for adults or children aged 10 years or older with homozygous familial hypercholesterolaemia the recommended starting dose is 420 mg once monthly. After 12 weeks your doctor may decide to increase the dose to 420 mg every two weeks. If you also receive apheresis, a procedure similar to dialysis where cholesterol and other fats are removed from the blood, your doctor may decide to start you on a dose of 420 mg every two weeks to coincide with your apheresis treatment.
• for adults with established atherosclerotic cardiovascular disease or at high risk for developing a cardiovascular event, the dose is either 140 mg every two weeks or 420 mg once monthly.

Repatha is given as an injection under the skin (subcutaneous).

If your doctor decides that you or a caregiver can give the injections of Repatha using the automated mini-doser , you or your caregiver should receive training on how to prepare and inject Repatha correctly. Do not try to use the automated mini -doser until you have been shown how to do it by your doctor or nurse. It is recommended that 10 to 13 years old are supervised by an adult when they are using the automated mini -doser.

See the detailed “Instructions for Use” at the end of this leaflet for instructions about how to store, prepare, and use your Repatha automated mini -doser at home.

Before starting Repatha, you should be on a diet to lower your cholesterol. You should keep on this cholesterol lowering diet while taking Repatha.

If your doctor has prescribed Repatha along with another cholesterol lowering medicine, follow your doctor’s instructions on how to take these medicines together. In this case, please read the dosage instructions in the package leaflet of that particular medicine as well.

If you use more Repatha than you should

Contact your doctor or pharmacist immediately.

If you forget to take Repatha

Take Repatha as soon as you can after the missed dose. Then, contact your doctor who will tell you when you should schedule your next dose, and follow the new schedule exactly as your doctor has told you.

❗ 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)

• Flu (high temperature, sore throat, runny nose, cough and chills)
• Common cold, such as runny nose, sore throat or sinus infections (nasopharyngitis or upper respiratory tract infections)
• Feeling sick (nausea)
• Back pain
• Joint pain (arthralgia)
• Muscle pain
• Injection site reactions, such as bruising, redness, bleeding, pain or swelling
• Allergic reactions including rash
• Headache

Uncommon (may affect up to 1 in 100 people)

• Hives, red itchy bumps on your skin (urticaria)
• 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, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 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 carton 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 carton in order to protect from light and moisture .

Your medicine (cartridge and automated mini -doser) may be left outside the refrigerator to reach room temperature (up to 25 °C) before injection. This will make the injection more comfortable. After removal from the refrigerator, Repatha may be stored at room temperature (up to 25 °C) in the original carton and must be used within 1 month .

Do not use this medicine if you notice it is discoloured or contains large lumps, flakes or coloured particles .

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents 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.

What Repatha looks like and contents of the pack

Repatha is a solution which is clear to opalescent, colourless to yellowish, and practically free from particles.

Each pack contains one single use cartridge co -packed with a single use automated mini -doser .

Marketing Author isation Holder and Manufacturer Amgen Europe B.V.

Minervum 7061 4817 ZK Breda The Netherlands

Marketing Authorisation Holder

Amgen Europe B.V.

Minervum 7061 4817 ZK Breda The Netherlands

Manufacturer

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

Manufacturer

Amgen NV Telecomlaan 5 -7 1831 Diegem Belgium For any information about this medicine, please 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 82 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 S.r.l.

Italy Tel: +39 02 6241121 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 Tlf: +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 0606 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 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 83 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 This leaflet was last revised in .

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

Instructions for use:

Repatha single use automated mini -doser and cartridge Guide to parts Cartridge White plunger Cartridge top (Do not rotate) Cartridge bottom Medicine Cartridge label Automated mini -doser Front view Skin adhesive Status light Start button (Do not press until ready to inject) Cartridge door (do not close without cartridge) Medicine window Pull tabs Back view Needle cover Adhesive paper Battery strip Left pull tab Needle inside (under cover) Right pull tab Important: Needle is inside.

85 Important Before you use the automated mini -doser and cartridge for use with Repatha , read this important information:

Storing your automated mini -doser and cartridge

• Keep the automated mini -doser and cartridge out of the sight and reach of children.
• Do not store the automated mini -doser and cartridge in extreme heat or cold. For example, avoid storing in your vehicle’s glove box or boot. Do not freeze.

Using your automated mini -doser and cartridge

• Do not shake the automated mini -doser or cartridge.
• Do not remove the automated mini -doser and cartridge from the box or clear tray until you are ready to inject.
• Do not touch the start button until you place the loaded automated mini -doser and cartridge onto your skin and are ready to inject.
• Adult supervision is recommended for children age 13 years and younger while using the automated mini -doser and cartridge.
• You can only press the start button once. If an error occurs, the automated mini -doser cannot be used.
• Do not use the automated mini -doser and cartridge if either have been dropped onto a hard surface. Part of the automated mini -doser and cartridge may be broken even if you cannot see the break. Use a new automated mini -doser and cartridge .
• Do not reuse the automated mini -doser and cartridge . The automated mini -doser and cartridge are for single use only.
• Do not let the automated mini -doser get wet from water or any other liquids. It contains electronics that should not get wet.
• The single use automated mini -doser for subcutaneous injection is intended only for use with the cartridge.

In any above cases, use a new automated mini -doser and cartridge . A healthcare provider familiar with Repatha should be able to answer your questions.

86 Step 1: Prepare A Remove the automated mini -doser and cartridge carton from the refrigerator. Wait 45 minutes.

Important: Wait at least 45 minutes for the automated mini -doser and cartridge to naturally reach room temperature in the carton , before you inject.

• Do not try to warm the cartridge by using a heat source such as hot water or a microwave.
• Do not shake the automated mini -doser and cartridge.
• Do not use if any part of the cartridge appears cracked or broken.
• Do not use if the expiration date printed on the carton label has passed.

In any above cases, use a new automated mini -doser and cartridge.

B Open the carton and peel away the white paper cover. Remove the a utomated mini -doser cover from the clear tray.

Clear tray Cartridge Automated mini-doser Plastic cover Leave the automated mini -doser and cartridge in the clear tray until you are ready to inject.

• Do not touch the start button until the automated mini -doser is on your skin and you are ready to inject.
• Do not use if the white paper cover is missing or damaged.

C Gather all materials needed for your injection and then wash your hands thoroughly with soap and water.

On a clean, well -lit work surface, place the:

• Clear tray containing the automated mini -doser and cartridge
• Alcohol wipes
• Cotton ball or gauze pad
• Plaster
• Sharps disposal container 87 D Choose your automated mini -doser placement. Only use the outer arm if someone else is giving the injection.

You can use:

• Your thigh
• Stomach area (abdomen) , except for a 2 inches (5 centimetre s) area around your belly button
• Outer area of upper arm (only if someone else is giving the injection) Upper arm Stomach area (abdomen) Thigh Clean your injection site with an alcohol wipe. Let your skin dry.
• Do not touch this area again before injecting.
• Do not inject into areas where the skin is tender, bruised, red or hard. Avoid injecting into areas with wrinkles, skin folds, scars, stretch marks, moles and excessive hair.

If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.

Important: To attach the automated mini -doser securely, it is important to use a firm and flat skin surface.

Step 2: Get ready E Open the automated mini -doser by swinging the cartridge door to the right. Then, leave the door open.

Do not press the start button until you are ready to inject.

88 F Inspect the cartridge.

Cartridge bottom Medicine Cartridge label Cartridge top (do not rotate) White plunger Expiration date Make sure the medicine in the cartridge is clear and colourless to slightly yellow.

• Do not use if the medicine is cloudy or discoloured or contains flakes or particles.
• Do not use if any part of the cartridge appears cracked or broken.
• Do not use if pieces of the cartridge are missing or not securely attached.
• Do not use if the expiration date on the cartridge has passed.

In any above cases, use a new automated mini -doser and cartridge.

G Clean the cartridge bottom.

Grab here With one hand, hold the cartridge barrel and clean the cartridge bottom with an alcohol wipe.

• Do not touch the bottom of the cartridge after cleaning with alcohol wipe.
• Do not remove or rotate the cartridge top or bottom.

89 H Load the cleaned cartridge into the automated mini -doser and firmly press on the top until it is secured in place.

Load the cartridge straight Press down firmly Insert the cartridge bottom first.

• Do not insert the cartridge more than 5 minutes before injection. This can dry out the medicine.
• Do not touch the start button until you have placed the loaded automated mini -doser on your skin.

I Swing the door to the left. Then, squeeze firmly until it snaps shut.

Squeeze tight snap Make sure the cartridge fits securely in the automated mini -doser before you close the door.

• Do not close the door if the cartridge is missing or not fully inserted.
• Do not touch the start button until you have placed the loaded automated mini -doser on your skin.

Important: After you load the automated mini -doser , proceed to the next step without delay.

90 Step 3: Inject J Peel away both green pull tabs to show the adhesive. The automated mini -doser is on when the blue status light flashes.

Right pull tab Flashing Light Left pull tab Skin adhesive Beep -beep -beep You must remove both green pull tabs to turn the loaded automated mini -doser on. You will hear beeping and see a flashing blue status light.

• Do not touch the skin adhesive.
• Do not touch the start button until you have placed the loaded automated mini -doser on your skin.
• Do not touch or contaminate the needle cover area.
• Do not place the loaded automated mini -doser on your body if the red status light flashes for more than 5 seconds.
• Do not pull the skin adhesive backing off of the automated mini -doser .
• Do not fold the skin adhesive over onto itself.

K To securely attach the automated mini -doser , prepare and clean an injection site that is less likely to have body hair, or you can trim the area. Use a firm and flat skin surface.

Stomach area placement Thigh placement OR Stretch method for stomach Do not stretch for thigh Important: Adjust your body posture to avoid skin folds and bulges.

91 L When the blue light flashes, the automated mini -doser is ready. Keep the stretch (stomach area method only). Hold the loaded automated mini -doser with the blue light visible, and place it on your skin. You may hear beeps.

OR Flashing Light beep -beep -beep The loaded automated mini -doser will lay flat on your body. Make sure the entire adhesive is attached to your skin. Run a finger around the adhesive edges to secure it.

Make sure clothing does not get in the way of the loaded automated mini -doser , and you can see the blue light at all times.

• Do not try to reposition the loaded automated mini -doser after it has been placed onto your skin.

M Firmly press and release the start button. A flashing green light and a click signals the injection has started.

Flashing Light beep -beep -beep

• You may hear a pumping sound.
• You may feel a needle pinch.
• Make sure you see a green, flashing status light.
• You may hear beeps indicating your injection has started.

Important: If medication leaks from the loaded automated mini -doser contact your doctor or pharmacist.

N Injection takes about 5 minutes. The status light turns solid green, and the device beeps, when done.

It is okay to hear a pumping sound start and stop during injection .

• Moderate physical activities can be performed during the injection process, such as walking, reaching and bending.

Flashing Light 5 min Solid Light Injection is complete when:

• The status light changes to solid green.
• You hear several beeps. beep -beep -beep Step 4: Finish O When the injection is done, grab the skin adhesive to carefully peel the automated mini – doser off your skin. After removal, check the medicine window. The green light should now be off.

Used plunger Light Off beep -beep -beep Check to see that the used plunger completely fills the medicine window, and the green solid light turns off, letting you know all medicine has been injected. If the plunger did not fill the window, contact your doctor.

• The used automated mini -doser will beep when removed from your skin.
• It is normal to see a few drops of fluid on your skin after you remove the used automated mini – doser .

93 P Discard the used automated mini -doser in a sharps container.

• The automated mini -doser contains batteries, electronics, and a needle.
• Put the used automated mini -doser in sharps disposal container right away after use. Do not throw away (dispose of) the automated mini – doser in your household waste.
• Talk with your healthcare provider about proper disposal. There may be local guidelines for disposal.
• Do not remove the used cartridge from the automated mini -doser.
• Do not reuse the automated mini -doser.
• Do not recycle the automated mini -doser or sharps disposal container or throw them into household waste .

Important: Always keep the sharps disposal container out of the sight and reach of children.

Q Examine the injection site.

If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site.

Apply a plaster if needed.

Troubleshooting What to do if the loaded automated mini -doser status light continuously flashes red and you hear beeps.

Flashing Warning Light beep -beep -beep -beep -beep Stop using the loaded automated mini -doser . If the automated mini -doser is attached to your body, carefully remove it.

Additional environmental conditions Relative humidity range is 15% to 85%.

Altitude range is -300 metres to 3 500 metres ( -984 feet to 11 483 feet).

During injection, keep the automated mini -doser a minimum of 30 cm (12 inches) away from other electronics such as mobile phones.

Warning: Do not modify the device.

Automated mini -doser operating temperature range is 15 °C to 40 °C. www.devicepatents.com 94 SYMBOL TABLE

Do not use if

packaging is damaged Keep dry Refer to Instructions for Use Type BF Applied Part Single use Sterili sed using ethylene oxide 0344 Amgen Inc., One Amgen Cent er Drive, Thousand Oaks, CA, U.S.A.

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

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Repatha (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/15/1016).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.