Instructions for use of the Erelzi pre-filled pen

Read ALL the way through these instructions before injecting.

These instructions are to help you to inject correctly using the Erelzi pre-filled pen.

It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist.

Your Erelzi prefilled pen:

Erelzi pre-filled pen shown with the cap removed. Do not remove the cap until you are ready to inject.

Store your boxed pen in a refrigerator, between 2 °C to 8 °C and out of the sight and reach of children.

  • Do not freeze the pen.
  • Do not shake the pen.
  • Do not use the pen if it has been dropped with the cap removed.

For a more comfortable injection, take the pen out of the refrigerator 15‑30 minutes before injecting to allow it to reach room temperature.

What you need for your injection:

Included in the carton:

A new and unused Erelzi pre-filled pen.

Not included in the carton:

  • Alcohol wipe
  • Cotton ball or gauze
  • Sharps disposal container

Before your injection:

1. Important safety checks before you inject:

The solution should be clear or slightly opalescent, colourless to slightly yellowish, and may contain small white or almost translucent particles of protein. This appearance is normal for Erelzi.

Do not use if the liquid is cloudy, discoloured, or has large lumps, flakes, or coloured particles.

Do not use the pen if the expiry date has passed.

Do not use if the safety seal has been broken.

Contact your pharmacist if the pen fails any of these checks.

2a. Choose your injection site:

  • The recommended site is the front of the thighs. You may also use the lower abdomen, but not the area 5 centimetres around the navel (belly button).
  • Choose a different site each time you give yourself an injection.
  • Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks. If you have psoriasis, you should NOT inject directly into any raised, thick, red, or scaly skin patches or lesions (“psoriasis skin lesions”).

2b. Caregivers and healthcare professionals only:

  • If a caregiver or healthcare professional is giving you your injection, they may also inject into your outer upper arm.

3. Cleaning your injection site:

  • Wash your hands with soap and hot water.
  • Using a circular motion, clean the injection site with the alcohol swab. Leave it to dry before injecting.
  • Do not touch the cleaned area again before injecting.

Your injection:

4. Removing the cap:

  • Only remove the cap when you are ready to use the pen.
  • Twist off the cap in the direction of the arrows.
  • Throw away the cap. Do not try to re‑attach the cap.
  • Use the pen within 5 minutes of removing the cap.

 5. Holding your pen:

  • Hold the pen at 90 degrees to the cleaned injection site.

YOU MUST READ THIS BEFORE INJECTING.

During the injection you will hear 2 loud clicks.

The 1st click indicates that the injection has started. Several seconds later a 2nd click will indicate that the injection is almost finished.

You must keep holding the pen firmly against your skin until you see a green indicator fill the window and stop moving.

6. Starting your injection:

  • Press the pen firmly against the skin to start the injection.
  • The 1st click indicates the injection has started.
  • Keep holding the pen firmly against your skin.
  • The green indicator shows the progress of the injection.

7. Completing your injection:

  • Listen for the 2nd click. This indicates the injection is almost complete.
  • Check the green indicator fills the window and has stopped moving.
  • The pen can now be removed.

After your injection:

8. Check the green indicator fills the window:

  • This means the medicine has been delivered. Contact your doctor if the green indicator is not visible.
  • There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.

9. Disposing of your Erelzi pre-filled pen:

  • Dispose of the used pen in a sharps disposal container (i.e. a puncture‑resistant closable container, or similar).
  • Never try to re‑use your pen.

If you have any questions

Please talk to a doctor, nurse or pharmacist who is familiar with Erelzi.

Reference: Erelzi Summary of Product Characteristics  https://www.ema.europa.eu/en/documents/product-information/erelzi-epar-product-information_en.pdf