Repatha ® 140 mg Solution

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.

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 REPATHA ® (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 medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 breastfeeding or plan to do so. Your doctor will then help you decide whether to stop breastfeeding, or whether to stop taking REPATHA ®, considering the benefit of breastfeeding 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’.

Always use REPATHA ® 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.

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 side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 . By reporting side effects, you can help provide more information on the safety of REPATHA ®. Alternatively, suspected adverse events can be reported to: Amgen South Africa (Pty) Ltd. Tel: +27 (0)11 100 5300, Email: [email protected] , Adverse Event Reporting Fax: 0800 166 513

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 injecting. 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.