forxiga Tezspire 210 mg Solution for Injection in Pre-Filled Syringe Tezepelumab Instruction Manual

210 mg solution for injection in pre-filled syringe tezepelumab
Instructions for Use

Tezspire 210 mg Solution for Injection in Pre-Filled Syringe Tezepelumab

This ‘Instructions for Use’ contains information on how to inject Tezspire.
Before you use your Tezspire pre-filled syringe, your healthcare provider should show you or your caregiver how to use it the right way.
Read this ‘Instructions for Use’ before you start using your Tezspire pre- filled syringe and each time you get another injection. There may be new information. This information should not replace talking to your healthcare provider about your medical condition and your treatment.
If you or your caregiver have any questions, talk to your healthcare provider.
Important information you need to know before injecting Tezspire
Store Tezspire in a refrigerator between 2°C to 8°C in its outer carton until you are ready to use it. Tezspire may be kept at room temperature between 20°C to 25°C in the outer carton for a maximum of 30 days.
Once Tezspire has reached room temperature, do not put it back in the refrigerator.
Throw away (dispose of) Tezspire that has been stored at room temperature for more than 30 days (see Step 10).

Do not use your Tezspire pre-filled syringe if:| Do not shake your pre-filled syringe.
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it has been frozen| Do not share your pre-filled
it has been dropped or damaged| syringe or use it more than 1 time.
the security seal on the carton has been broken| Do not expose your Tezspire
the expiry date (EXP) has passed| pre-filled syringe to heat.

If any of the above happens, throw away the syringe in a puncture-resistant (sharps) container and use a new Tezspire pre-filled syringe.
Each Tezspire pre-filled syringe contains 1 dose of Tezspire that can only be used 1 time.
Keep Tezspire pre-filled syringe and all medicines out of the sight and reach of children.
Tezspire is given only as an injection under the skin (subcutaneous).

Your Tezspire pre-filled syringe

Do not remove the needle cover until Step 7 of these instructions when you are ready to inject Tezspire.
Do not touch the needle guard activation clips. This will keep you from activating the safety device (needle guard) too soon.

**Preparing to inject Tezspire

**

Step 1 – Gather supplies

• 1 Tezspire pre-filled syringe from the refrigerator
• 1 alcohol wipe
• 1 cotton ball or gauze
• 1 small bandage (optional)
• 1 puncture-resistant (sharps) disposal container. See Step 10 for instructions on how to throw away (dispose of) the used Tezspire pre-filled syringe safely.

| Pre-filled syringe
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| Alcohol wipe
| Cotton ball or gauze
| Bandage
| Sharps disposal container

Step 2 – Prepare to use your Tezspire pre-filled syringe
Let Tezspire come to room temperature between 20°C to 25°C for about 60 minutes or longer (up to a maximum of 30 days) before giving the injection.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Do not warm the pre-filled syringe in any other way. For example, do not warm it in a microwave or hot water, in direct sunlight, or near other heat sources.

Do not put Tezspire back in the refrigerator after it has reached room temperature. Throw away (dispose of) Tezspire that has been stored at room temperature for more than 30 days.
Do not remove the needle cover until Step 7.
Step 3 – Remove pre-filled syringe
Grab the syringe body to remove the pre-filled syringe from its tray. Do not grab the pre-filled syringe by the plunger.

Step 4 – Check the pre-filled syringe
Check the pre-filled syringe for damage. Do not use the prefilled syringe if the pre-filled syringe is damaged.
Check the expiry date on the pre-filled syringe. Do not use the pre-filled syringe if the expiry date has passed.
Look at the liquid through the viewing window. The liquid should be clear and colourless to light yellow.
Do not inject Tezspire if the liquid is cloudy, discoloured, or contains large particles.
You may see small air bubbles in the liquid. This is normal. You do not need to do anything about it.

Injecting Tezspire
Step 5 – Choose an injection site
If you are giving yourself the injection, the recommended injection site is the front of your thigh or the lower part of your stomach (abdomen). Do not inject yourself in the arm.
A caregiver may inject you in the upper arm, thigh, or abdomen.
For each injection, choose a different site that is at least 3 cm away from where you last injected.
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

Step 6 – Wash your hands and 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 7 – Pull off the needle cover
Do not remove the cap until you are ready to inject.
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 to the side and throw it away later.
You may see a drop of liquid at the end of the needle. This is normal.
Do not touch the needle or let it touch any surface.
Do not put the needle cover back on the syringe.

Step 8 – Inject Tezspire
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 will make the skin firmer.
Do not press down on the plunger head until the needle is inserted into the skin.
Do not pull back on the plunger head at any time.
Inject Tezspire by following the steps in figures a, b and c.

| Using a 45 degree angle, fully insert the needle into the pinched skin.
Do not try to change the position of the pre-filled syringe after you insert it into the skin.
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| Use your thumb to push down on the plunger head.
Keep pushing until it is down as far as it will go to make sure you inject all of the medicine.
| Keep your thumb pressed down on the plunger head as you take the needle out of the skin.
Slowly let go of the plunger until the needle guard covers the needle.

Step 9 – 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.

Disposing of Tezspire

Step 10 – Dispose of the used pre-filled syringe safely
Each pre-filled syringe contains a single dose of Tezspire and cannot be used again. Do not put the needle cover back on the pre-filled syringe.
Put your used syringe and needle cover in a sharps disposal container right away after use. Put other used supplies in your household trash.
Do not throw away the pre-filled syringe in your household trash.

Disposal guidelines
Dispose of the full container as instructed by your healthcare provider or pharmacist.
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
Do not recycle your used sharps disposal container.
RSP 22 0016

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