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Repatha

Repatha 140 mg/ml 2 Pre-Filled Pen (Refrigerator)

1,758.45 SAR
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Package Leaflet: Information For The User

Evolocumab 140 mg solution for injection in pre-filled pen

What Evolocumab is and what it is used for

Evolocumab is a medicine that lowers levels of ’bad’ cholesterol, a type of fat, in the blood.
Evolocumab is a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body). It 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 Evolocumab is used for

Evolocumab 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
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).
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).

Evolocumab 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. Evolocumab 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 you need to know before you use Evolocumab

Do not use Evolocumab

Tell your doctor if you:

if you are allergic to Evolocumab or any other ingredient of this medicine

Warnings and precautions

You should let your doctor know:

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.
Other medicines and Evolocumab

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

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 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.

Evolocumab is given as an injection under the skin (subcutaneous).

Possible side effects

Stop using the product and seek immediate medical attention if
difficulty breathing or swallowing, swelling of face, lips, throat or tongue, skin rash

How to store Evolocumab

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, Evolocumab 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.

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