Repatha - patient leaflet, side effects, dosage

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 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).

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 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.

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.

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’.

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 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.

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)
• 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 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.

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 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.

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 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.

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 single use pre-filled syringe.

Marketing Authorisation Holder and Manufacturer

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

Marketing Authorisation Holder

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

Manufacturer

Amgen Technology (Ireland) Unlimited Company

Pottery Road

Dun Laoghaire

Co Dublin

Ireland

Manufacturer

Amgen NV

Telecomlaan 5–7

1831 Diegem

Belgium

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

Belgie/Belgiqu­e/Belgien s.a. Amgen n.v. Tel/Tél: +32 (0)2 7752711	Lietuva Amgen Switzerland AG Vilniaus filialas Tel: +370 5 219 7474
BtnrapuH ÄMg’/KeH Enrapna EOOfl Ten.: +359 (0)2 424 7440	Luxembourg/Lu­xemburg s.a. Amgen Belgique/Belgien Tel/Tél: +32 (0)2 7752711
Česká republika Amgen s.r.o. Tel: +420 221 773 500	Magyarország Amgen Kft. Tel.: +36 1 35 44 700
Danmark Amgen, filial af Amgen AB, Sverige Tlf: +45 39617500	Malta Amgen B.V. The Netherlands Tel: +31 (0)76 5732500
Deutschland AMGEN GmbH Tel.: +49 89 1490960	Nederland Amgen B.V. Tel: +31 (0)76 5732500
Eesti Amgen Switzerland AG Vilniaus filialas Tel: +372 586 09553	Norge Amgen AB Tel: +47 23308000
EZZáóa Amgen EÁÁác OappaKsuTiKá E.n.E. Tn^.: +30 210 3447000	Österreich Amgen GmbH Tel: +43 (0)1 50 217
España Amgen S.A. Tel: +34 93 600 18 60	Polska Amgen Biotechnologia Sp. z o.o. Tel.: +48 22 581 3000
France Amgen S.A.S. Tél: +33 (0)9 69 363 363	Portugal Amgen Biofarmaccutica. Lda. Tel: +351 21 422 06 06
Hrvatska Amgen d.o.o. Tel: +385 (0)1 562 57 20	Romania Amgen Romania SRL Tel: +4021 527 3000
Ireland Amgen Ireland Limited Tel: +353 1 8527400	Slovenija AMGEN zdravila d.o.o. Tel: +386 (0)1 585 1767
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika Amgen Slovakia s.r.o. Tel: +421 2 321 114 49

Suomi/Finland

Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland

Puh/Tel: +358 (0)9 54900500

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

Instructions for use:

Repatha single use pre-filled syringe

Guide to parts
Before use		After use
Plunger rod '' J Medicine --- Syringe barrel Grey ____o needle cap on		Used tT— plunger l«3 a Used syringe barrel y Used Needle ----° 1 Grey M--- needle cap off
	Needle is inside.

Important

Before you use a single use Repatha pre-filled syringe, read this important information:

	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.

	Do not try to warm the Repatha pre-filled syringe by using a heat source such as hot water or microwave.
	Do not leave the Repatha pre-filled syringe exposed to direct sunlight.
	Do not shake the Repatha pre-filled syringe.

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:

	One Repatha pre-filled syringe in its tray.
	Alcohol wipes.
	Cotton ball or gauze pad.
	Plaster.
	Sharps disposal container.
	Do not use if expiry date on the Repatha pre-filled syringe carton has passed.

Choose your injection site.

You can use:

• Thigh.
• Belly, except for the 2 inches (5 centimetres) around the belly button.
• Outer area of upper arm (only if someone else is giving you the injections).
• Do not choose an area where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

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.

• Do not touch this area of skin again before injecting.

To remove:

• Peel the paper off of the tray.
• Place the tray on your hand.
• Turn the tray over and gently press the middle of the tray’s back to release the syringe into your

palm.

• If the pre-filled syringe does not release from the tray, gently press on the back of tray.
• Do not pick up or pull the pre-filled syringe by the plunger rod or grey needle cap. This could damage the syringe.
• Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject.

Always hold the pre-filled syringe by the syringe barrel.

F Inspect medicine and syringe.

Medicine

Always hold the pre-filled syringe by the syringe barrel.

Check that:

• The name Repatha appears on the pre-filled syringe label.
• The medicine in the pre-filled syringe is clear and colourless to slightly yellow.
• Do not use the pre-filled syringe if any part of the pre-filled syringe appears cracked or broken.
• Do not use the pre-filled syringe if the grey needle cap is missing or not securely attached.
• Do not use the pre-filled syringe if the medicine is discoloured or contains large lumps, flakes or

coloured particles.

• Do not use the pre-filled syringe if the expiration date on the pre-filled syringe has passed.

Step 2: Get ready

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.

• Do not twist or bend the grey needle cap. This can damage the needle.
• Do not put the grey needle cap back onto the pre-filled syringe.

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:

• Hold the pre-filled syringe with the needle facing up.
• Gently tap the syringe barrel with your fingers until the air bubble/gap rises to the top of the syringe.
• Slowly and gently push the plunger rod up to get the air out of the pre-filled syringe. Be very careful not to push out any medicine.
• Do not tap the syringe needle.

Using slow and constant pressure, PUSH the plunger rod all the way down until the syringe is empty.

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.

• Do not reuse the used syringe.
• Do not use any medicine that is left in the used syringe.
• Do not recycle the syringe or the sharps disposal container or throw it into household rubbish.

Keep the used syringe and sharps 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. Apply a plaster if needed. Do not rub the injection site.