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Repatha

Cardiology

Repatha

Repatha 140 mg solution for injection in pre-filled pen

 

Repatha 140 mg solution for injection in pre-filled pen

evolocumab

 

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.

 

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.

 

 

What is in this leaflet

 

  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

 

 

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.

 

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).

 

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.
  • 12 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.

 

 

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,
  • severe kidney problems.

 

The needle cover of the glass pre-filled pen is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.

 

Children and adolescents

 

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.

 

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

 

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.

 

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’.

 

 

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.

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

 

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.

 

 

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)
  • Injection site reactions, such as bruising, redness, bleeding, pain or swelling
  • Allergic reactions including rash

 

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. 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.

 

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 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 SureClick pre-filled pen 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.

 

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. 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.

 

Site of Manufacture of the Drug Product:

Amgen Manufacturing Limited State Road 31

Kilometer 24.6

Juncos 00777-4060 Puerto Rico

USA

 

Marketing Authorisation Holder and Manufacturer:

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda The Netherlands

 

 

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

 

This leaflet was last revised in November 2019.