REPATHA 420 MG SOLUTION FOR INJECTION IN CARTRIDGE - patient leaflet, side effects, dosage

Package leaflet: Information for the user

Repatha 140 mg solution for injection in pre-filled pen evolocumab

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.

• – 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 is in this leaflet

Pregnancy and breast-feeding

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.

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’.

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 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.

• 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

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• 5. How to store Repatha

• 6. Contents of the pack and other information

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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.

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.

• 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.

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.

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 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

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.

Each pack contains one, two, three or six single use SureClick pre-filled pens.

Marketing Authorisation Holder

Amgen Limited

216 Cambridge Science Park

Milton Road

Cambridge

CB4 0WA

United Kingdom

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:

Amgen Limited

Tel: +44 (0)1223 420305

This leaflet was last revised in

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).

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.

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.

Children and adolescents

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.

Other medicines and Repatha

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

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. 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.

Yellow Card Scheme

Website: or search for MHRA Yellow Card in the

Google Play or Apple App Store

Inspect the Repatha pre-filled pen.

Important

Before you use the Repatha pre-filled pen, read this important information:

• Do not freeze or use the Repatha pre-filled pen if it has been frozen.
• Do not remove the orange cap from the Repatha pre-filled pen until you

are ready to inject.

• Do not use the Repatha pre-filled pen if it has been dropped on a hard surface. Part of the Repatha pre-filled pen may be broken even if you cannot see the break.

^^^^Tather all materials needed for your injection.

Wash your hands thoroughly with soap and water.

On a clean, well-lit work surface, place the:

• New pre-filled pen.
• Alcohol wipes.
• Cotton ball or gauze pad.
• Plaster.
• Sharps disposal container.

Prepare and clean your injection site.

• Only use these injection sites: Thigh.

• 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.

• Do not try to warm the pre-filled pen by using a heat source such as hot water or microwave.
• Do not leave the pre-filled pen in direct sunlight.
• Do not shake the pre-filled pen.
• Do not remove the orange cap from the pre-filled pen yet.
• Stomach area (abdomen), except for a 2 inch (5 centimetres) area around your belly button.
• Outer area of upper arm (only if someone else is giving you the injection).

Clean the injection site with an alcohol wipe. Let your skin dry.

• Do not touch this area again before injecting.
• 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.
• Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

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.

Orange cap

It is normal to see a drop of liquid at the end of the needle or yellow safety guard.

• Do not twist, bend or wiggle the orange cap.
• Do not put the orange cap back onto the pre-filled pen.
• Do not put fingers into the 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.

D 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 the skin firmly by moving your thumb and fingers in the opposite direction, creating an area about 2 inches (5 centimetres) wi­de.

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.

DKeep 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.

NOTE: After you remove the pre-filled pen from your skin, the needle will be automatically covered.

Step 4: Finish

Discard the used pre-filled pen and orange needle cap.

Step 3: Inject

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.

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.

• Do not reuse the pre-filled pen.
• Do not recap the pre-filled pen or put fingers into the

yellow safety guard.

• Do not recycle the pre-filled pen or sharps disposal container or throw them into household rubbish.

Examine the injection site.

Important: You must push all the way down but do not touch the grey start button until you are ready to inject.