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Repatha 140 mg solution for injection in pre-filled pen
Repatha 140 mg solution for injection in pre-filled pen
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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 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).
Repatha is used in addition to your cholesterol lowering diet if you are:
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:
The needle cover of the glass pre-filled pen is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.
The use of Repatha has not been studied in children under 18 years of age being treated for primary hypercholesterolaemia and mixed dyslipidaemia.
The use of Repatha has not been studied in children under 12 years of age being treated for homozygous familial hypercholesterolaemia.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Repatha has not been tested in pregnant women. It is not known if Repatha will harm your unborn baby.
Inform your doctor if you are trying to get pregnant, think you may be pregnant or become pregnant taking Repatha.
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.
Repatha is given as an injection under the skin (subcutaneous). The recommended dose depends on the underlying condition:
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.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. 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 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
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. Do not use this medicine if you notice it is discoloured or contains large lumps, flakes or coloured particles.
Each pack contains one, two, three or six single use SureClick pre-filled pens. Not all pack sizes may be marketed.
Amgen Manufacturing Limited State Road 31
Juncos 00777-4060 Puerto Rico
Amgen Europe B.V.
4817 ZK Breda The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.