Repatha
evolocumab
evolocumab
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
What Repatha is and what it is used for
What you need to know before you use Repatha
How to use Repatha
Possible side effects
How to store Repatha
Contents of the pack and other information
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.
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
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 and established atherosclerotic cardiovascular disease (a history of heart attack, stroke or blood vessel problems). 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. 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).
Talk to your doctor, pharmacist or nurse before using Repatha if you have liver disease.
The needle cover of the glass pre-filled syringe is made from 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 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.
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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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.
Repatha has no or negligible influence on the ability to drive and use machines.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.
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 (a history of heart attack, stroke or blood vessel problems) 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 prescribes a dose of 420 mg you must use three pre-filled syringes because each
pre-filled syringe only contains 140 mg of medicine. After reaching room temperature, all injections should be given within a 30 minute period.
If your doctor decides that you or a caregiver can give the injections of Repatha, you or your caregiver should receive training on how to prepare and inject Repatha correctly. Do not try to inject Repatha until you have been shown how to do it by your doctor or nurse.
See the detailed “Instructions for Use” at the end of this leaflet for instructions about how to store, prepare, and give your Repatha injections 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.
Contact your doctor or pharmacist immediately.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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
Hives, red itchy bumps on your skin (urticaria)
Flu-like symptoms
Swelling of the face, mouth, tongue, or throat (angioedema)
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.
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.
Your pre-filled syringe 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.
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.
Repatha is a solution which is clear to opalescent, colourless to yellowish, and practically free from particles.
Each pack contains one single use pre-filled syringe.
Amgen Europe B.V. Minervum 7061
4817 ZK Breda The Netherlands
Amgen Europe B.V. Minervum 7061
4817 ZK Breda The Netherlands
Amgen Technology (Ireland) Unlimited Company Pottery Road
Dun Laoghaire Co Dublin Ireland
1831 Diegem Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
s.a. Amgen n.v.
Tel/Tél: +32 (0)2 7752711
Amgen Switzerland AG Vilniaus filialas Tel: +370 5 219 7474
Амджен България ЕООД Тел.: +359 (0)2 424 7440
s.a. Amgen Belgique/Belgien
Tel/Tél: +32 (0)2 7752711
Amgen s.r.o.
Tel: +420 221 773 500
Amgen Kft.
Tel.: +36 1 35 44 700
Amgen, filial af Amgen AB, Sverige Tlf: +45 39617500
Amgen B.V. The Netherlands
Tel: +31 (0)76 5732500
Amgen B.V.
Tel: +31 (0)76 5732500
Amgen Switzerland AG Vilniaus filialas Tel: +372 586 09553
Amgen AB
Tel: +47 23308000
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε. Τηλ.: +30 210 3447000
Amgen GmbH
Tel: +43 (0)1 50 217
Amgen S.A.
Tel: +34 93 600 18 60
Amgen Biotechnologia Sp. z o.o. Tel.: +48 22 581 3000
Amgen S.A.S.
Tél: +33 (0)9 69 363 363
Amgen Biofarmacêutica, Lda. Tel: +351 21 422 06 06
Amgen d.o.o.
Tel: +385 (0)1 562 57 20
Amgen România SRL Tel: +4021 527 3000
Amgen Ireland Limited Tel: +353 1 8527400
AMGEN zdravila d.o.o. Tel: +386 (0)1 585 1767
Vistor hf.
Sími: +354 535 7000
Amgen S.r.l.
Tel: +39 02 6241121
Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland
Puh/Tel: +358 (0)9 54900500
C.A. Papaellinas Ltd Τηλ.: +357 22741 741
Amgen AB
Tel: +46 (0)8 6951100
Amgen Switzerland AG Rīgas filiāle Tel: +371 257 25888
Amgen Limited
Tel: +44 (0)1223 420305
Instructions for use:
Repatha single use pre-filled syringe
Guide to parts | |
Before use | After use |
Plunger rod Medicine Syringe barrel Grey needle cap on | Used plunger Used syringe barrel Used Needle Grey needle cap off |
Needle is inside. | |
Do not freeze or use the Repatha pre-filled syringe if it has been frozen.
Do not use the Repatha pre-filled syringe if the packaging is open or damaged.
Do not use the Repatha pre-filled syringe if it has been dropped onto a hard surface. Part of the syringe may be broken even if you cannot see the break. Use a new Repatha pre-filled syringe.
Do not remove the grey needle cap from the Repatha pre-filled syringe until you are ready to inject.
Step 1: Prepare | |
A | Remove the Repatha pre-filled syringe carton from the refrigerator and wait 30 minutes. |
Wait at least 30 minutes for the pre-filled syringe in the carton to naturally reach room temperature before injecting. Check that the name Repatha appears on the carton label.
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B | Gather all materials needed for your injection. |
Wash your hands thoroughly with soap and water. On a clean, well-lit, flat work surface, place:
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C | Choose your injection site. |
Upper arm Belly Thigh You can use:
Choose a different site each time you give yourself an injection. If you need to use the same injection site, just make sure it is not the same spot on that site you used last time. | |
D | Clean your injection site. |
Clean your injection site with an alcohol wipe. Let your skin dry before injecting.
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E | Remove the pre-filled syringe from the tray. |
Turn tray over Gently Press
To remove:
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F | Inspect medicine and syringe. |
Syringe label with Grey needle Plunger rod Syringe barrel expiration date cap on
Medicine Always hold the pre-filled syringe by the syringe barrel. Check that:
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Step 2: Get ready | ||
A | Carefully pull the grey needle cap straight out and away from your body. Do not leave the grey needle cap off for more than 5 minutes. This can dry out the medicine. | |
1. It is normal to see a drop of medicine at the end of the needle. | 2. Immediately place the cap in the sharps disposal container. | |
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B | Remove the air bubble / gap. |
You may notice an air bubble/gap in the Repatha pre-filled syringe. If you notice an air bubble/gap:
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C | PINCH your injection site to create a firm surface. |
Pinch skin firmly between your thumb and fingers, creating an area about 2 inches (5 centimetres) wide.
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Step 3: Inject | |
A | Hold the PINCH. Insert the needle into the skin using a 45 to 90 degree angle. |
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B | Using slow and constant pressure, PUSH the plunger rod all the way down until the syringe is empty. |
C | When done, RELEASE your thumb, and gently lift the syringe off skin. |
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Step 4: Finish | |
A | Immediately place the used syringe in a sharps disposal container. |
Talk with your healthcare provider about proper disposal. There may be local guidelines for disposal.
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B | Examine the injection site. |
If there is blood, press a cotton ball or gauze pad on your injection site. Apply a plaster if needed.
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