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The product code(s) for this leaflet are: PLGB 13832/0043, PLGB 13832/0044, PLGB 13832/0078.
Repatha SureClick
Repatha 140 mg solution for injection in pre-filled pen
evolocumab
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
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:
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).
Do not use Repatha if you are allergic to evolocumab or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor, pharmacist or nurse before using Repatha if you have liver disease.
The needle cover of the glass pre-filled pen 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:
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 pens because each pre-filled pen 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. If using the pre-filled pen, place the correct (yellow) end of the pen on the skin before injecting.
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.
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store
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 pen 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.
Repatha is a solution which is clear to opalescent, colourless to yellowish, and practically free from particles.
Each pack contains one, two, three or six single use SureClick pre-filled pens.
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in March 2022.
Repatha single use SureClick pre-filled pen
Guide to parts
Important: Needle is inside the yellow safety guard.
Before you use the Repatha pre-filled pen, read this important information:
A Remove one Repatha pre-filled pen from the package.
1. Carefully lift the pre-filled pen straight up out of the box.
2. Put the original package with any unused pre-filled pens back in the refrigerator.
3. Wait at least 30 minutes for the pre-filled pen to naturally reach room temperature before injecting.
B Inspect the Repatha pre-filled pen.
Make sure the medicine in the window is clear and colourless to slightly yellow.
Check the expiration date.
In all cases, use a new pre-filled pen.
C Gather all materials needed for your injection.
Wash your hands thoroughly with soap and water.
On a clean, well-lit work surface, place the:
D Prepare and clean your injection site.
Only use these injection sites:
Clean the injection site with an alcohol wipe. Let your skin dry.
A Pull the orange cap straight off, only when you are ready to inject. Do not leave the orange cap off for more than 5 minutes. This can dry out the medicine.
It is normal to see a drop of liquid at the end of the needle or yellow safety guard.
Important: Do not remove the orange cap from the pre-filled pen until you are ready to inject.
If you are unable to inject, please contact your healthcare provider.
B Create a firm surface at the selected injection site (thigh, stomach, or outer areas of the upper arm), by using either the stretch method or the pinch method.
Stretch method
Stretch the skin firmly by moving your thumb and fingers in the opposite direction, creating an area about 2 inches (5 centimetres) wide.
OR
Pinch method
Pinch the skin firmly between your thumb and fingers, creating an area about 2 inches (5 centimetres) wide.
Important: It is important to keep skin stretched or pinched while injecting.
A Keep holding the stretched or pinched skin. With the orange cap off, put the yellow safety guard on your skin at 90 degrees. The needle is inside the yellow safety guard.
Do not touch the grey start button yet.
B Firmly push down the pre-filled pen onto the skin until it stops moving.
Important: You must push all the way down but do not touch the grey start button until you are ready to inject.
C When you are ready to inject, press the grey start button. You will hear a click.
D Keep pushing down on the skin. Then lift your thumb while still holding the pre-filled pen on your skin. Your injection could take about 15 seconds.
Window turns from clear to yellow when the injection is done. You may hear a second click.
NOTE: After you remove the pre-filled pen from your skin, the needle will be automatically covered.
A Discard the used pre-filled pen and orange needle cap.
Discard the used pre-filled pen and the orange cap in a sharps disposal container.
Talk with your healthcare provider about proper disposal. There may be local guidelines for disposal.
Keep the pre-filled pen and the sharps disposal container out of the sight and reach of children.
B 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.