Evolocumab

What is Evolocumab for?

Evolocumab is a type of monoclonal antibody (a man-made protein that attaches to a target in the body) that increases the liver’s ability to remove bad cholesterol. This lowers the amount of ‘bad cholesterol’ in the blood.

High ‘bad cholesterol’ levels can cause blood vessels to clog up and lead to chest pain (angina), heart attack or stroke. By reducing the amount of bad cholesterol in the body, this medication reduces the risk of future heart attack and stroke.

This medication may also be used for patients with high ‘bad cholesterol’ levels in their blood because of a hereditary condition (a medical condition that runs in the family).

How should I take or use Evolocumab?

• Do not stop your medication without checking with your healthcare professional.
• You may use this medication with or without food.
• Use the injection pen as advised by your healthcare professional and as described in the manual.

Before using the pre-filled injection pen,

• Do not use the pre-filled pen if it has been frozen or is frozen.
• Do not use the pre-filled pen if it has been dropped on a hard surface. Part of the pre-filled pen may be broken even if you cannot see the breakage.
• Ensure that the contents of your pre-filled pen appear clear and colourless to slightly yellow before use. Do not use it if it appears cloudy, discoloured, grainy or if particles are seen.
• Do not shake the pre-filled pen.
• Wait at least 30 minutes for the pre-filled pen to naturally reach room temperature before injecting. Do not warm the pre-filled pen by using a heat source such as hot water or microwave.
• Do not remove the orange cap from the pre-filled pen until you are ready to inject.

Using the pre-filled injector pen,

• Select and clean your injection site. Always rotate the injection site. Injection sites that can be used include:
  • Thigh
  • Stomach area (abdomen), except for a 5 centimetre area around your belly button
  • Outer area of upper arm (only if someone else is giving you the injection)
• 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 medication.
• Pinch your skin firmly to form a fold that is around 5 centimetres wide.
• With the orange cap off, put the yellow safety guard on your pinched skin at 90 degrees, right-angled to the skin. Firmly push the pre-filled pen all the way down onto the skin until the yellow safety cover is no longer visible. The pen will not work if the yellow safety cover is not depressed fully.
• Do not press the start button until the pen is fully pushed down onto the skin. This button can only be pushed once.
• When you are ready to inject, press the start button. You will hear the first click sound.
• Keep pushing down the pre-filled pen onto the pinched skin during the injection process. The injection may take about 15 to 20 seconds.
• When the injection is completed, the window will turn from clear to yellow. You may hear a soft second click sound. Do not rub or massage the injection site.
• Throw the pen and orange cap away properly in a container that cannot be punctured. Do not replace the orange cap back on the pen.

What should I do if I forget to take or use Evolocumab?

• If it has been less than 7 days, take it as soon as you remember. Then take your next dose at the usual time.
• If it has been 7 days or more since the missed dose:
  • if on every 2 weeks dosing, skip dose and administer next dose on the original schedule.
  • If on every 4 week dosing, administer the dose then start a new schedule based on this date.
• Do not take two doses to make up for the missed dose.

What precautions should I take when taking or using Evolocumab?

Inform your healthcare professional if:

• You are allergic to this medication or any of the other ingredients of this medication (e.g. latex allergy).
• You are pregnant, planning to become pregnant, or breastfeeding.
• You have liver problems.
• You are taking any other medications, including supplements, traditional medications and herbal remedies.

What are some common side effects of Evolocumab?

• Nose or throat irritation, flu-like symptoms (runny nose, sore throat)
• Back pain, headache
• Injection-site reactions – redness, irritation or swelling where the injection was used

What are some rare but serious side effects that I need to seek medical advice immediately?

The symptoms of a drug allergy include one or more of the following:

• Swollen face/eyes/lips/tongue
• Difficulty in breathing
• Itchy skin rashes over your whole body

If you experience any of these symptoms, you should stop your medication and see your healthcare professional immediately.

How should I store Evolocumab?

Store in the refrigerator between 2-8°C. Do not freeze or shake.

If needed, you may store this medication at room temperature (in a cool dry place away from sunlight) for up to 30 days. If stored at room temperature and not used within 30 days, throw this medication away.

How do I throw away Evolocumab safely?

If used at home, you may throw this injection away along with the used needles, into a metal tin, glass jar or thick plastic container (e.g. detergent bottles) to prevent any needlestick injury.