What is a User Manual and why is it useful?

The user manual gives instructions on how to safely and effectively administer your medicine. It should be read in conjunction with the patient leaflet.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Below is a text only representation of the User Manual. The original leaflet can be viewed using the link above.


Fasenra 30 mg solution for injection in pre-filled syringe, instructions for use

Instructions for use

Fasenra 30mg

Solution for Injection in Pre-filled Syringe

Benralizumab

For Subcutaneous Injection

Single-use Pre-filled Syringe

Before using your Fasenra pre-filled syringe, your healthcare provider should show you or your caregiver how to use it correctly.

Read this 'Instructions for Use' before you start using your Fasenra pre-filled syringe and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

If you or your caregiver have any questions, talk to your healthcare provider.

Important information

Store Fasenra in a refrigerator between 2°C to 8°C in its carton until you are ready to use it. Fasenra may be kept at room temperature up to 25°C for a maximum of 14 days. After removal from the refrigerator, Fasenra must be used within 14 days or discarded.

Do not use your Fasenra pre-filled syringe if:

  • it has been frozen
  • it has been dropped or damaged
  • the security seal on the carton has been broken
  • the expiry date (EXP) has passed

Do not:

  • shake your pre-filled syringe
  • share or re-use your pre-filled syringe

If any of the above happens, throw away the syringe in a puncture-resistant sharps container and use a new pre-filled syringe.

Each Fasenra pre-filled syringe contains 1 dose of Fasenra that is for one-time use only.

Keep Fasenra and all medicines out of the sight and reach of children.

Your Fasenra pre-filled syringe

Do not remove the needle cover until you have reached Step 6 of these instructions and are ready to inject Fasenra.

Do not touch the needle guard activation clips to keep from activating the safety device (needle guard) too soon.

Step 1 - Gather Supplies

  • 1 Fasenra pre-filled syringe from the refrigerator
  • 1 alcohol wipe
  • 1 cotton ball or gauze
  • 1 puncture-resistant sharps container.
    (See Step 9 - Dispose the used pre-filled syringe)

Step 2 - Prepare to use your pre-filled syringe

Check the expiry (EXP) date. Do not use if the expiry date has passed.

Let Fasenra warm up at room temperature 20°C to 25°C for about 30 minutes before giving the injection.

Do not warm the pre-filled syringe in any other way. For example, do not warm it in a microwave or hot water, or put it near other heat sources.

Use Fasenra within 14 days of removing from the refrigerator.

Step 3 - Check the liquid

Grasp the syringe body (not the plunger) to remove the pre-filled syringe.

Look at the liquid through the viewing window. The liquid should be clear and colourless to yellow. It may contain small white particles.

Do not inject Fasenra if the liquid is cloudy, discoloured, or contains large particles.

You may see a small air bubble in the liquid. This is normal. You do not need to do anything about it.

Step 4 - Choose the injection site

The recommended injection site is the front of your thigh.

You may also use the lower part of your abdomen.

Do not inject:

  • into the 5 cm area around your belly-button
  • where the skin is tender, bruised, scaly or hard
  • into scars or damaged skin
  • through clothing

A caregiver may inject you in the upper-arm, thigh, or abdomen. Do not try to inject yourself in the arm.

For each injection, choose a different site that is at least 3 cm away from where you last injected.

Step 5 - Clean the injection site

Wash your hands well with soap and water.

Clean the injection site with an alcohol wipe in a circular motion. Let it air dry.

Do not touch the cleaned area before injecting.

Do not fan or blow on the cleaned area.

Step 6 - Pull off the needle cover

Hold the syringe body with 1 hand, and carefully pull the needle cover straight off with your other hand.

Do not hold the plunger or plunger head while removing the needle cover.

Put the needle cover aside to throw away later.

You may see a drop of liquid at the end of the needle. This is normal.

Do not use the syringe if it is dropped without the needle cover in place or if the needle is damaged or dirty.

Do not touch the needle, or let it touch any surface.

Go straight on to the next steps, without delay.

Step 7 - Inject Fasenra

Hold the pre-filled syringe in 1 hand as shown.

Use your other hand to gently pinch and hold the area of skin where you want to inject. This creates a firmer surface.

Do not press down on the plunger until the needle is completely inserted into the skin.

Do not pull back on the plunger at any time.

Inject Fasenra by following the steps in figures a, b and c.

Use a quick, dart-like motion to insert the needle into the pinched skin.

Insert the needle at an angle of 45 degrees.

Use your thumb to push down on the plunger head.

Keep pushing until it is down as far as it will go. This is to make sure you inject all of the medication.

Keep your thumb pressed down on the plunger head as you take the needle out of the skin.

Slowly ease up on the plunger until the needle guard covers the needle.

Step 8 - Check the injection site

There may be a small amount of blood or liquid where you injected. This is normal.

Gently hold pressure over your skin with a cotton ball or gauze until the bleeding stops.

Do not rub the injection site.

If needed, cover the injection site with a small bandage.

Step 9 - Dispose the used pre-filled syringe

  • Each pre-filled syringe contains a single dose of Fasenra and cannot be re-used.
  • Put your used pre-filled syringe in a puncture-resistant sharps container right away after use.

Do not throw away the pre-filled syringe in your household waste.

Do not re-cap the pre-filled syringe.

Throw away the cap and other used supplies in your household waste.

Disposal guidelines

Dispose of the full container as instructed by your healthcare provider or pharmacist.

Do not recycle your used sharps container.

Instructions for use was last approved in 07/2020

RSP 20 0030