REPATHA 140 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
SpainIt is used to reduce 'bad' cholesterol levels in the blood as an adjunct to diet. It is indicated for adults and children aged 10 years and older with high cholesterol levels due to various conditions, such as primary hypercholesterolemia, mixed dyslipidemia, or familial disorders (heterozygous or homozygous), as well as for adults with established cardiovascular disease.
Frequently asked questions
How should I take Repatha?
It is administered via an injection under the skin (subcutaneous route) in the thigh, the abdomen area (avoiding the 5 cm area around the navel), or the upper outer part of the arm. The dose varies depending on the medical condition and may be 140 mg every two weeks or 420 mg once a month, among other regimens indicated by your doctor.
When should I not use this medication?
Do not use Repatha if you are allergic to evolocumab or any of its components. Additionally, you must consult your doctor before use if you have any liver disease or if you are pregnant, breastfeeding, or planning to become pregnant.
What side effects can Repatha cause?
Common side effects include flu-like symptoms (fever, sore throat, cough, chills), the common cold, nausea, back pain, joint or muscle pain, injection site reactions (bruising, redness, swelling), allergic reactions such as skin rashes, and headache. Other less common effects include hives and, in rare cases, swelling of the face, mouth, tongue, or throat.
What should I do if I forget a dose or if I take more than prescribed?
If you forget a dose, administer it as soon as possible, but contact your doctor to instruct you on when to take the next dose. If you take more than the recommended dose, you must contact your doctor or pharmacist immediately.
How should I store the medication?
It must be stored in the refrigerator between 2 °C and 8 °C, do not freeze, and keep in its original packaging to protect it from light. The pen may be left out of the refrigerator to reach room temperature (up to 25 °C) before injection, but once removed, it must be used within 1 month.
Instructions for use
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Repatha 140mg solution for injection in a pre-filled pen
evolocumab
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
- The warnings and instructions contained in this document are intended for the person using the medicine. If you are a parent or caregiver responsible for administering the medicine to another person, for example, a child, you should follow this information accordingly.
Contents of the leaflet
- What Repatha is and what it is used for
- What you need to know before using Repatha
- How to use Repatha
- Possible side effects
- How to store Repatha
- Contents of the pack and other information
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 found in the blood.
Repatha contains the active substance evolocumab, a monoclonal antibody (a type of specialized protein designed to bind to a specific substance in the body). Evolocumab is designed to bind to a substance called PCSK9, which affects the liver's ability to remove cholesterol from the blood. By binding to and removing PCSK9, the medicine increases the amount of cholesterol taken up by the liver and reduces the level of cholesterol in the blood.
What Repatha is used for
Repatha is used as an add-on to diet to reduce cholesterol in patients:
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Adults with high blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial] or mixed dyslipidemia). It is administered:
- together with a statin or another cholesterol-lowering medicine, when cholesterol levels are not sufficiently controlled with the maximum tolerated dose of a statin.
- alone or together with other cholesterol-lowering medicines when statins are ineffective or cannot be used.
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Pediatric patients aged 10 years and older with high blood cholesterol levels due to an inherited disorder (heterozygous familial hypercholesterolemia or HeFH). It is administered alone or together with other cholesterol-lowering treatments.
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Adults and pediatric patients aged 10 years and older with high blood cholesterol levels due to an inherited disorder (homozygous familial hypercholesterolemia or HoFH). It is administered together with other cholesterol-lowering medicines.
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Adults with high blood cholesterol levels 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, when cholesterol levels are not sufficiently controlled with the maximum tolerated dose of a statin.
- alone or together with other cholesterol-lowering medicines when statins are ineffective or cannot be used.
Repatha is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you must continue to follow the cholesterol-lowering diet prescribed for you. Repatha may help prevent heart attacks, strokes, and certain cardiac procedures performed to restore blood flow to the heart, which are caused by the buildup of fatty deposits in the arteries (also known as atherosclerotic cardiovascular disease).
2. What you need to know before using Repatha
Do not use Repatha if you are allergic to evolocumab or to 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.
For the purpose of improving traceability of this medicine, your doctor or pharmacist should record in your medical record the name and batch number of the medicine that has been administered to you. You are advised to also write down this information in case you are asked about it in the future.
Children and adolescents
The use of Repatha has been studied in children aged 10 years and older 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 need to take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Repatha has not been studied in pregnant women. It is unknown whether Repatha can harm the fetus.
It is unknown whether Repatha is present in human breast milk.
It is important that you inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will help you decide whether to discontinue breastfeeding or treatment with Repatha, taking into account the benefits of breastfeeding for the baby and the benefits of Repatha for the mother.
Driving and using machines
The effect of Repatha on the ability to drive and use machines is negligible or none.
Repatha contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose; that is, essentially "sodium-free".
3. How to use Repatha
Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor again.
The recommended dose depends on the underlying condition:
- for adults with primary hypercholesterolemia and mixed dyslipidemia, the dose is 140 mg every two weeks or 420 mg once a month.
- for children from 10 years of age with heterozygous familial hypercholesterolemia, the dose is 140 mg every two weeks or 420 mg once a month.
- for adults or children from 10 years of age 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 also receive apheresis, a procedure similar to dialysis in which cholesterol and other fats are removed from the blood, your doctor may decide to start with a dose of 420 mg every two weeks to coincide with the apheresis treatment.
- for adults with established atherosclerotic cardiovascular disease (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 injection under the skin (subcutaneous route).
If your doctor prescribes a dose of 420 mg, you must use three pre-filled pens, as each pre-filled pen contains only 140 mg of medication. After reaching room temperature, all injections should be administered within a 30-minute interval.
If your doctor considers that you or a caregiver can administer Repatha injections, you or your caregiver must receive training on how to properly prepare and inject Repatha. Do not attempt to inject Repatha until your doctor or nurse has shown you how to do it.
See the detailed instructions for use at the end of this leaflet for information on how to store, prepare, and administer Repatha injections at home. If you use the pre-filled pen, place the correct end (yellow end) of the pen against the skin before injection.
Before starting treatment with Repatha, you should already be following a cholesterol-lowering diet. While using Repatha, you must continue this diet.
If your doctor has prescribed Repatha together with another cholesterol-lowering medicine, follow their instructions on how to use these medicines together. In this case, also read the administration instructions in the leaflet of that specific medicine.
If you use more Repatha than you should
Contact your doctor or pharmacist immediately.
If you forget to take Repatha
Administer the missed dose as soon as possible. Then contact your doctor to determine when to administer the next dose, and follow the new schedule exactly as instructed by your doctor.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Frequent (may affect up to 1 in 10 people)
- Influenza (fever, sore throat, nasal discharge, cough, and chills)
- Common cold, such as nasal discharge, sore throat, or sinus infection (nasopharyngitis or upper respiratory tract infections)
- Malaise (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)
- Red, itchy skin welts (urticaria)
- Influenza-like symptoms
Rare (may affect up to 1 in 1,000 people)
- Swelling of the face, mouth, tongue, or throat (angioedema)
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of 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 packaging after EXP or CAD. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.
Keep in the original packaging to protect from light.
The pre-filled pen may be removed from the refrigerator and allowed to reach room temperature (up to 25 °C) before injection. This will make the injection less uncomfortable. Once removed from the refrigerator, Repatha may be stored at room temperature (up to 25 °C) in its original container and must be used within 1 month.
Do not use this medicine if you notice any change in colour or if it contains clumps, flakes, or large coloured particles.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Repatha
- The active substance is evolocumab. Each SureClick pre-filled pen contains 140 mg of evolocumab in 1 ml of solution.
- The other components are proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.
Appearance of the medicinal product and contents of the pack
Repatha is a solution that is transparent to opalescent, colourless to yellowish, 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
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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Belgium/Belgium/Belgium s.a. Amgen S.A. Tel/Tel: +32 (0)2 7752711 | Lithuania Amgen Switzerland AG Vilnius Branch Tel: +370 5 219 7474 |
| Luxembourg/Luxembourg s.a. Amgen Belgium/Belgium Tel/Tel: +32 (0)2 7752711 |
Czech Republic Amgen s.r.o. Tel: +420 221 773 500 | Hungary Amgen Kft. Tel.: +36 1 35 44 700 |
Denmark Amgen, branch of Amgen AB, Sweden Tlf: +45 39617500 | Malta Amgen B.V. The Netherlands Tel: +31 (0)76 5732500 |
Germany AMGEN GmbH Tel.: +49 89 1490960 | Netherlands Amgen B.V. Tel: +31 (0)76 5732500 |
Estonia Amgen Switzerland AG Vilnius Branch Tel: +372 586 09553 | Norway Amgen AB Tel: +47 23308000 |
Greece Amgen Hellas Pharmaceuticals E.P.E. Tel.: +30 210 3447000 | Austria Amgen GmbH Tel: +43 (0)1 50 217 |
Spain Amgen S.A. Tel: +34 93 600 18 60 | Poland Amgen Biotechnologia Sp. z o.o. Tel.: +48 22 581 3000 |
France Amgen S.A.S. Tel: +33 (0)9 69 363 363 | Portugal Amgen Biofarmacêutica, Lda. Tel: +351 21 422 06 06 |
Croatia Amgen d.o.o. Tel: +385 (0)1 562 57 20 | Romania Amgen România SRL Tel: +4021 527 3000 |
Ireland Amgen Ireland Limited Tel: +353 1 8527400 | Slovenia AMGEN zdravila d.o.o. Tel: +386 (0)1 585 1767 |
Iceland Vistor hf. Tel: +354 535 7000 | Slovakia Amgen Slovakia s.r.o. Tel: +421 2 321 114 49 |
Italy Amgen S.r.l. Tel: +39 02 6241121 | Finland Amgen AB, Finland Branch/Amgen AB, filial i Finland Tel/Puh: +358 (0)9 54900500 |
Cyprus C.A. Papaellinas Ltd Tel.: +357 22741 741 | Sweden Amgen AB Tel: +46 (0)8 6951100 |
Latvia Amgen Switzerland AG Riga Branch Tel: +371 257 25888 | United Kingdom (Northern Ireland) Amgen Limited Tel: +44 (0)1223 420305 |
Date of the most recent review of this leaflet.
Other sources of information
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.euopa.eu.
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Instructions for use: Repatha single-use prefilled pen SureClick |
Components guide | |
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Important: The needle is inside the yellow safety shield. |
Important Before using a Repatha prefilled pen, read this important information:
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Step 1: Preparation | |
A | Remove a prefilled pen of Repatha from the carton. |
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B | Inspect the Repatha prefilled pen. |
Make sure the medicine in the viewing window is clear and colorless to slightly yellow. Check the expiration date.
If any of these situations apply, use a new prefilled pen. |
C | Gather all the materials you will need for the injection. |
Wash your hands thoroughly with soap and water. On a clean, well-lit work surface, place the following:
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D | Prepare and clean the injection site. |
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Use only these injection sites:
Clean the injection site with an alcohol wipe. Allow the skin to dry.
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Step 2: Prepare | |
A | Remove the orange cap by pulling it straight off, only when you are ready for the injection. Do not leave the pre-filled pen without the orange cap for more than 5 minutes, as this could dry out the medication. |
It is normal to see a drop of medication at the tip of the needle or yellow safety shield.
Important: Do not remove the orange cap from the pre-filled pen until you are ready to inject. If you are unable to perform the injection, consult your healthcare professional. |
B | Create a firm surface at the selected injection site (thigh, abdomen, or outer areas of the upper arm) using either the stretch method or the pinch method. |
Stretch method | |
Firmly stretch the skin by moving the thumb and fingers in opposite directions to create an area about 5 centimeters wide. Or Pinch method
Firmly pinch the skin between the thumb and fingers, covering an area about 5 centimeters wide. Important: It is essential to keep the skin stretched or pinched during the injection. |
Step 3: Inject | |
A | Keep the skin stretched or pinched. Once the orange cap has been removed, place the yellow safety shield against your skin at a 90-degree angle. The needle is inside the yellow safety shield. Do not press the grey start button yet. |
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B | Push the pre-filled pen firmly against the skin until it stops moving. |
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Important: You must push the pen as far as it will go, but do not touch the gray start button until you are ready to inject. |
C | When ready for injection, press the grey start button. You will hear a click. |
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D | Continue pushing on the skin. Then, remove your thumb while keeping the pre-filled pen against your skin. The injection may take about 15 seconds to complete. |
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| NOTE: Once you remove the pre-filled pen from the skin, the needle will be covered automatically. |
Step 4: Finish | |
A | Remove the used pre-filled pen and the orange needle cap. |
Dispose of the used pre-filled pen and the orange needle cap in a sharps disposal container. Ask your healthcare professional how to properly dispose of the pens. There may be local regulations regarding this. Keep the pre-filled pen and the sharps disposal container out of sight and reach of children.
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B | Examine the injection site. |
If you see blood, press the injection site with a cotton ball or gauze. Do not rub the injection site. Apply a bandage if necessary. |
Similar drugs
| Brand name | Dosage form | Active substance / Dosage | Manufacturer |
|---|---|---|---|
| REPATHA 140 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN | solution for injection in pre-filled pen |
|
Amgen Europe B.V. |
The original data is available in the language of the country of manufacture.
Data source: Online Medicines Information Centre (CIMA) — AEMPS
Data last verified: September 21, 2026